Telmichek-H

What are the side effects you encounter while taking this medicine?
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Telmichek-H uses

Telmichek-H consists of Hydrochlorothiazide, Telmisartan.

Hydrochlorothiazide:


Telmichek-H information

Telmichek-H (Hydrochlorothiazide) is an antihypertensive, diuretic drug that acts on the electrolyte reabsorption in the renal tubular mechanism increasing the excretion of chloride and sodium in equivalent amounts. The exact mechanism of its antihypertensive action is not known at this time.

Telmichek-H indications

Telmichek-H (Hydrochlorothiazide) is typically employed for the treatment of patients suffering from hypertension, either as monotherapy or in combination with other antihypertensive medication. It is also employed in some cases as a diuretic agent. Telmichek-H (Hydrochlorothiazide) therapy may also be prescribed for the treatment of hepatic cirrhosis, edema (in patients suffering from congestive heart failure), nephrotic syndrome, drug induced edema, chronic renal failure or acute glomerulonephritis. Health care professionals may prescribe this drug in order to treat other medical conditions as well; if you would like to know more about the reasons you have been prescribed this drug, it is advised to ask your personal physician.

Telmichek-H warnings

Telmichek-H (Hydrochlorothiazide) may not be used in the treatment of patients who are allergic to this drug, any of its components or other sulfonamide-derived medication. Also, this drug may not be suitable for use in patients that are suffering from anuria, azotemia or impaired renal functions. Caution should be employed if the patient is suffering from hepatic disease. Other medical conditions may also influence the examining health care provider's decision of prescribing Telmichek-H (Hydrochlorothiazide); it is strongly recommended to make sure that the health care professional is fully aware of your health condition and medical history before starting a treatment with this drug.

Use of Telmichek-H (Hydrochlorothiazide) during pregnancy or breast-feeding is also not recommended. This medicine may affect an unborn baby and it also passes into breast milk. As such, use of this drug in pregnant women or breast-feeding mothers should not be employed.

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Telmichek-H intake guidelines

You should always take Telmichek-H (Hydrochlorothiazide) as you have been directed by the prescribing health care specialist. While in some cases daily administration of the drug is recommended, other patients may be prescribed an intermittent therapy. Also, the number of daily doses may vary. As such, it is best that you do not follow another patient's intake schedule. If you have difficulties understanding the intake guidelines that your prescribing health care professional has provided, you should ask for further explanations from an authorized health care specialist - such as a pharmacist, a doctor or a nurse.

Telmichek-H dosage

The exact Telmichek-H (Hydrochlorothiazide) dosage may vary greatly from one case to another, depending on the condition being treated, on the patient's medical history and general health condition, on his or her age as well as on a number of other factors. As such you are advised to use the exact Telmichek-H (Hydrochlorothiazide) dosage that has been prescribed to you and never use the dosage prescribed to another patient or a dosage that you have been prescribed in the past. Taking a different Telmichek-H (Hydrochlorothiazide) dose may cause the treatment to not have the desired effect, and if you take this drug in larger doses you may have a higher risk of developing side effects, or you may suffer from an overdose.

Telmichek-H overdose

You should never exceed the Telmichek-H (Hydrochlorothiazide) prescribed dosage, in order to avoid an overdose with this medication. However, if you consider that you are affected by an overdose with this drug it is advised to immediately consult your personal health care provider, the local poisons center or to go to the nearest medical facility to seek emergency medical attention. The common symptoms of an overdose with Telmichek-H (Hydrochlorothiazide) are dehydration and cardiac arrhythmia. The patient may also suffer from electrolyte depletion and thus may present the relevant signs and symptoms.

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Telmichek-H missed dose

In case you have missed a dose of Telmichek-H (Hydrochlorothiazide), it is advised that you take the dose as soon as you remember. If the moment when you remember is too close to another intake of the medication, you should completely skip the missed Telmichek-H (Hydrochlorothiazide) dose and take the next scheduled dose on time. You should never take a larger dose of the drug in order to make up for a missed dose, unless your prescribing health care provider directs you to do so.

Telmichek-H side effects

In some patients Telmichek-H (Hydrochlorothiazide) may cause side effects. While they are not very common, it is recommended to let your personal health care provider know if you begin experiencing any side effects. Several types of symptoms are possible: dizziness, headache, paresthesias, gastric irritation, anorexia, nausea and vomiting, diarrhea or constipation, pancreatitis, jaundice, hypotension. Metabolic side effects may include glycosuria, hyperglycemia, hyperuricemia, hypokalemia or hyponatremia. Renal failure or dysfunction may develop, as well as interstitial nephritis. Some patients reported experiencing muscle spasms, restlessness, unusual weakness and blurred vision. In some cases photosensitivity, anaphylactic reactions, respiratory distress, fever, rashes, vasculitis or toxic epidermal necrolysis have occurred.

Telmichek-H drug reactions

Telmichek-H (Hydrochlorothiazide) may interact with barbiturates and narcotics, as well as with alcohol. If you are also following a treatment course with antidiabetic drugs, their dosage may need to be adjusted before starting to take Telmichek-H (Hydrochlorothiazide). This drug may have an additive effect with other antihypertensive medication. ACE inhibitors, ACTH, corticosteroids and skeletal muscle relaxants may also interact with this drug causing unwanted effects. This drug may not be properly absorbed if the patient is also taking Colestipol resins or Cholestyramine. NSAIDs, lithium and Pressor amines may affect or be affected by Telmichek-H (Hydrochlorothiazide), and as such it is strongly recommended to let the prescribing health care provider know if you are taking these or any other drugs before starting a therapy course with this medicine. Other drug interactions that are not listed here are also possible.

Telmisartan:


WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue Telmichek-H (Telmisartan) as soon as possible .
  • Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus .

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning.

  • When pregnancy is detected, discontinue Telmichek-H (Telmisartan) as soon as possible (5.1)
  • Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus (5.1) .

1  INDICATIONS AND USAGE

Telmichek-H is an angiotensin II receptor blocker (ARB) indicated for:

  • Treatment of hypertension (1.1)
  • Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors (1.2)

1.1  Hypertension

Telmichek-H (Telmisartan) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents [seeClinical Studies (14.1)].

1.2  Cardiovascular Risk Reduction

Telmichek-H (Telmisartan) is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.

High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage . MICARDIS can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy) .

Studies of Telmichek-H (Telmisartan) in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.

Use of Telmichek-H (Telmisartan) with an ACE inhibitor is not recommended .

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2  DOSAGE AND ADMINISTRATION

  • May be administered with or without food
  • When used for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary (2.2)
Indication Starting Dose Dose Range
Hypertension (2.1) 40 mg once

daily

40 to 80 mg once

daily

Cardiovascular

Risk Reduction (2.2)

80 mg once

daily

80 mg once

daily

2.1  Hypertension

Dosage must be individualized. The usual starting dose of Telmichek-H (Telmisartan) tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg .

Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmichek-H (Telmisartan) is required, a diuretic may be added.

No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.

Telmichek-H (Telmisartan) tablets may be administered with other antihypertensive agents.

Telmichek-H (Telmisartan) tablets may be administered with or without food.

2.2  Cardiovascular Risk Reduction

The recommended dose of Telmichek-H (Telmisartan) tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of Telmichek-H (Telmisartan) are effective in reducing the risk of cardiovascular morbidity and mortality.

When initiating Telmichek-H (Telmisartan) therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.

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3  DOSAGE FORMS AND STRENGTHS

  • 20 mg, white or off-white, round, uncoated tablets imprinted with BI logo on one side and 50 H on the other side
  • 40 mg, white or off-white, oblong, uncoated tablets imprinted with BI logo on one side and 51 H on the other side
  • 80 mg, white or off-white, oblong, uncoated tablets imprinted with BI logo on one side and 52 H on the other side
  • Tablets: 20 mg, 40 mg, 80 mg (3)

4  CONTRAINDICATIONS

Telmichek-H (Telmisartan) is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis or angioedema) to Telmichek-H (Telmisartan) or any other component of this product .

  • Known hypersensitivity (e.g., anaphylaxis or angioedema) to Telmichek-H (Telmisartan) or any other component of this product (4)

5  WARNINGS AND PRECAUTIONS

  • Avoid fetal or neonatal exposure
  • Hypotension: Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension (5.2)
  • Monitor carefully in patients with impaired hepatic (5.4) or renal function (5.5)
  • Avoid concomitant use of an ACE inhibitor and angiotensin receptor blocker (5.6)

5.1  Fetal Toxicity

Pregnancy Category D

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmichek-H (Telmisartan) as soon as possible .

5.2  Hypotension

In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients, symptomatic hypotension may occur after initiation of therapy with Telmichek-H (Telmisartan). Either correct this condition prior to administration of Telmichek-H (Telmisartan), or start treatment under close medical supervision with a reduced dose.

If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

5.3  Hyperkalemia

Hyperkalemia may occur in patients on ARBs, particularly in patients with advanced renal impairment, heart failure, on renal replacement therapy, or on potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.

5.4  Impaired Hepatic Function

As the majority of Telmichek-H is eliminated by biliary excretion, patients with biliary obstructive disorders or hepatic insufficiency can be expected to have reduced clearance. Initiate Telmichek-H (Telmisartan) at low doses and titrate slowly in these patients .

5.5  Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system, anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure or renal dysfunction), treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar results have been reported with Telmichek-H (Telmisartan) .

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen were observed. There has been no long term use of Telmichek-H (Telmisartan) in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen with ACE inhibitors.

5.6  Dual Blockade of the Renin-Angiotensin-Aldosterone System

As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function (including acute renal failure) have been reported. Dual blockade of the renin-angiotensin-aldosterone system (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should include close monitoring of renal function.

The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to Telmichek-H (Telmisartan) only, ramipril only, or the combination, and followed them for a median of 56 months. Patients receiving the combination of Telmichek-H (Telmisartan) and ramipril did not obtain any additional benefit compared to monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acuterenal failure) compared with groups receiving Telmichek-H (Telmisartan) alone or ramipril alone. Concomitant use of Telmichek-H (Telmisartan) and ramipril is not recommended.

6  ADVERSE REACTIONS

The following adverse reaction is described elsewhere in labeling:

Renal dysfunction upon use with ramipril

  • Hypertension: The most common adverse events (≥1%) reported in hypertension trials are back pain, sinusitis, and diarrhea (6.1)
  • Cardiovascular risk reduction: The serious adverse events (≥1%) reported in cardiovascular risk reduction trials were intermittent claudication and skin ulcer (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1  Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

MICARDIS has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of Telmichek-H (Telmisartan) (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with Telmichek-H (Telmisartan) and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with Telmichek-H (Telmisartan) and at a Greater Rate Than Patients Treated with Placebo

Telmichek-H (Telmisartan)

n=1455

%

Placebo

n=380

%

Upper respiratory tract infection 7 6
Back pain 3 1
Sinusitis 3 2
Diarrhea 3 2
Pharyngitis 1 0

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treatedwith Telmichek-H (Telmisartan) tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.

The incidence of cough occurring with Telmichek-H (Telmisartan) in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with Telmichek-H (Telmisartan) monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Telmichek-H (Telmisartan) tablets:

Autonomic Nervous System : impotence, increased sweating, flushing; Body as a Whole : allergy, fever, leg pain, malaise; Cardiovascular : palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG; CNS : insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia; Gastrointestinal : flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders; Metabolic : gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal : arthritis, arthralgia, leg cramps; Psychiatric : anxiety, depression, nervousness; Resistance Mechanism : infection,fungal infection, abscess, otitis media; Respiratory : asthma, bronchitis, rhinitis, dyspnea, epistaxis; Skin : dermatitis, rash, eczema, pruritus; Urinary : micturition frequency, cystitis; Vascular : cerebrovascular disorder; and Special Senses : abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Telmichek-H (Telmisartan) tablets.

Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Telmichek-H (Telmisartan) patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% Telmichek-H (Telmisartan) patients compared with 0.3% placebo patients. One telmisartan-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with Telmichek-H (Telmisartan); all marked elevations occurred at a higher frequency with placebo. No telmisartan-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of Telmichek-H (Telmisartan) in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Telmichek-H (Telmisartan) for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on Telmichek-H (Telmisartan) and 7.6% on placebo. The only serious adverse events at least 1% more common on Telmichek-H (Telmisartan) than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

6.2  Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Telmichek-H (Telmisartan). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Telmichek-H (Telmisartan).

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patientsreceiving angiotensin II receptor blockers, including Telmichek-H (Telmisartan).

7  DRUG INTERACTIONS

Digoxin : When Telmichek-H (Telmisartan) was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing Telmichek-H (Telmisartan) for the purpose of keeping the digoxin level within the therapeutic range.

Lithium : Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Telmichek-H (Telmisartan). Therefore, monitor serum lithium levels during concomitant use.

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Telmichek-H (Telmisartan), may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Telmichek-H (Telmisartan) and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Telmichek-H (Telmisartan) may be attenuated by NSAIDs including selective COX-2 inhibitors.

Ramipril and Ramiprilat : Co-administration of Telmichek-H (Telmisartan) 80 mg once daily and ramipril 10 mg once daily to healthysubjects increases steady-state Cmax and AUC of ramipril 2.3- and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4- and 1.5-fold, respectively. In contrast, Cmax and AUC of Telmichek-H (Telmisartan) decrease by 31% and 16%, respectively. When co-administering Telmichek-H (Telmisartan) and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of Telmichek-H (Telmisartan). Concomitant use of Telmichek-H (Telmisartan) and ramipril is not recommended.

Other Drugs : Co-administration of Telmichek-H (Telmisartan) did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmichek-H (Telmisartan) is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmichek-H (Telmisartan) is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.

  • NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect (7)

8  USE IN SPECIFIC POPULATIONS

  • Nursing Mothers: Choose to discontinue nursing or drug
  • Geriatric Patients: No overall difference in efficacy or safety vs younger patients, but greater sensitivity of some older individuals cannot be ruled out (8.5)

8.1  Pregnancy

Pregnancy Category D. .

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Telmichek-H (Telmisartan) as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.

In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Telmichek-H (Telmisartan), unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Telmichek-H (Telmisartan) for hypotension, oliguria, and hyperkalemia .

8.3  Nursing Mothers

It is not known whether Telmichek-H is excreted in human milk, but Telmichek-H (Telmisartan) was shown to be present in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4  Pediatric Use

Neonates with a history of in utero exposure to Telmichek-H (Telmisartan):

If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.

Safety and effectiveness in pediatric patients have not been established .

8.5  Geriatric Use

Of the total number of patients receiving Telmichek-H in hypertension clinical studies, 551 (19%) were 65 to 74 years of age and 130 (4%) were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Of the total number of patients receiving Telmichek-H (Telmisartan) in the cardiovascular risk reduction study (ONTARGET), the percentage of patients ≥65 to <75 years of age was 42%; 15% of patients were ≥75 years old. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

8.6  Hepatic Insufficiency

Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or hepatic insufficiency .

10  OVERDOSAGE

Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage with Telmichek-H (Telmisartan) tablets would be hypotension, dizziness and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmichek-H (Telmisartan) is not removed by hemodialysis.

11  DESCRIPTION

Telmichek-H (Telmisartan) is a non-peptide angiotensin II receptor (type AT1) antagonist.

Telmichek-H (Telmisartan) is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and its structural formula is:

Telmichek-H (Telmisartan) is a white to slightly yellowish solid. It is practically insoluble in water and in the pH range of 3 to 9, sparingly soluble in strong acid (except insoluble in hydrochloric acid), and soluble in strong base.

Telmichek-H (Telmisartan) is available as tablets for oral administration, containing 20 mg, 40 mg or 80 mg of Telmichek-H (Telmisartan). The tablets contain the following inactive ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate. Telmichek-H (Telmisartan) tablets are hygroscopic and require protection from moisture.

Telmichek-H (Telmisartan) structure

12  CLINICAL PHARMACOLOGY

12.1  Mechanism of Action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme. Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effectsthat include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmichek-H (Telmisartan) blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmichek-H (Telmisartan) has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because Telmichek-H (Telmisartan) does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Telmichek-H (Telmisartan) does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of Telmichek-H (Telmisartan) on blood pressure.

12.2  Pharmacodynamics

In normal volunteers, a dose of Telmichek-H (Telmisartan) 80 mg inhibited the pressor response to an intravenous infusion of angiotensin II by about 90% at peak plasma concentrations with approximately 40% inhibition persisting for 24 hours.

Plasma concentration of angiotensin II and plasma renin activity (PRA) increased in a dose-dependent manner after single administration of Telmichek-H (Telmisartan) to healthy subjects and repeated administration to hypertensive patients. The once-daily administration of up to 80 mg Telmichek-H (Telmisartan) to healthy subjects did not influence plasma aldosterone concentrations. In multiple dose studies with hypertensive patients, there were no clinically significantchanges in electrolytes (serum potassium or sodium), or in metabolic function (including serum levels of cholesterol, triglycerides, HDL, LDL, glucose, or uric acid).

In 30 hypertensive patients with normal renal function treated for 8 weeks with Telmichek-H (Telmisartan) 80 mg or Telmichek-H (Telmisartan) 80 mg in combination with hydrochlorothiazide 12.5 mg, there were no clinically significant changes from baseline in renal blood flow, glomerular filtration rate, filtration fraction, renovascular resistance, or creatinine clearance.

12.3  Pharmacokinetics

Following oral administration, peak concentrations (Cmax) of Telmichek-H (Telmisartan) are reached in 0.5 to 1 hour after dosing. Food slightly reduces the bioavailability of Telmichek-H (Telmisartan), with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of Telmichek-H (Telmisartan) is dose dependent. At 40 and 160 mg the bioavailability was 42% and 58%, respectively. The pharmacokinetics of orally administered Telmichek-H (Telmisartan) are nonlinear over the dose range 20 to 160 mg, with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses. Telmichek-H (Telmisartan) shows bi-exponential decay kinetics with a terminal elimination half life of approximately 24 hours. Trough plasma concentrations of Telmichek-H (Telmisartan) with once daily dosing are about 10% to 25% of peak plasma concentrations. Telmichek-H (Telmisartan) has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing.

Distribution

Telmisartan is highly bound to plasma proteins (>99.5%), mainly albumin and α1 - acid glycoprotein. Plasma protein binding is constant over the concentration range achieved with recommended doses. The volume of distribution for Telmichek-H (Telmisartan) is approximately 500 liters indicating additional tissue binding.

Metabolism and Elimination

Following either intravenous or oral administration of 14C-labeled Telmichek-H (Telmisartan), most of the administered dose (>97%) was eliminated unchanged in feces via biliary excretion; only minute amounts were found in the urine (0.91% and 0.49% of total radioactivity, respectively).

Telmichek-H (Telmisartan) is metabolized by conjugation to form a pharmacologically inactive acyl glucuronide; the glucuronide of the parent compound is the only metabolite that has been identified in human plasma andurine. After a single dose, the glucuronide represents approximately 11% of the measured radioactivity in plasma. The cytochrome P450 isoenzymes are not involved in the metabolism of Telmichek-H (Telmisartan).

Total plasma clearance of Telmichek-H (Telmisartan) is >800 mL/min. Terminal half-life and total clearance appear to be independent of dose.

Specific Populations

Renal Insufficiency

No dosage adjustment is necessary in patients with decreased renal function. Telmichek-H (Telmisartan) is not removed from blood by hemofiltration .

Hepatic Insufficiency

In patients with hepatic insufficiency, plasma concentrations of Telmichek-H (Telmisartan) are increased, and absolute bioavailability approaches 100% .

Gender

Plasma concentrations of Telmichek-H (Telmisartan) are generally 2 to 3 times higher in females than in males. In clinical trials, however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women. No dosage adjustment is necessary.

Geriatric Patients

The pharmacokinetics of Telmichek-H (Telmisartan) do not differ between the elderly and those younger than 65 years .

Pediatric Patients

Telmisartan pharmacokinetics have not been investigated in patients <18 years of age.

13  NONCLINICAL TOXICOLOGY

13.1  Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of carcinogenicity when Telmichek-H was administered in the diet to mice and rats for up to 2 years. The highest doses administered to mice (1000 mg/kg/day) and rats (100 mg/kg/day) are, on a mg/m2 basis, about 59 and 13 times, respectively, the maximum recommended human dose (MRHD) of Telmichek-H (Telmisartan). These same doses have been shown to provide average systemic exposures to Telmichek-H (Telmisartan) >100 times and >25 times, respectively, the systemic exposure in humans receiving the MRHD (80 mg/day).

Genotoxicity assays did not reveal any telmisartan-related effects at either the gene or chromosome level. These assays included bacterial mutagenicity tests with Salmonella and E. coli (Ames), a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with human lymphocytes, and a mouse micronucleus test.

No drug-related effects on the reproductive performance of male and female rats were noted at 100 mg/kg/day (the highest dose administered), about 13 times, on a mg/m2 basis, the MRHD oftelmisartan. This dose in the rat resulted in an average systemic exposure (telmisartan AUC as determined on day 6 of pregnancy) at least 50 times the average systemic exposure in humans at the MRHD (80 mg/day).

13.3  Developmental Toxicity

There is no clinical experience with the use of Telmichek-H (Telmisartan) tablets in pregnant women. No teratogenic effects were observed when Telmichek-H (Telmisartan) was administered to pregnant rats at oral doses of up to 50mg/kg/day and to pregnant rabbits at oral doses up to 45 mg/kg/day. In rabbits, embryolethality associated with maternal toxicity (reduced body weight gain and food consumption) was observed at 45 mg/kg/day [about 12 times the maximum recommended human dose (MRHD) of 80 mg on a mg/m2 basis]. In rats, maternally toxic (reduction in body weight gain and food consumption) Telmichek-H (Telmisartan) doses of 15 mg/kg/day (about 1.9 times the MRHD on a mg/m2 basis), administered during late gestation and lactation, were observed to produce adverse effects in neonates, including reduced viability, low birth weight, delayed maturation, and decreased weight gain. Telmichek-H (Telmisartan) has been shown tobe present in rat fetuses during late gestation and in rat milk. The no observed effect doses for developmental toxicity in rats and rabbits, 5 and 15 mg/kg/day, respectively, are about 0.64 and 3.7 times, on a mg/m2 basis,the maximum recommended human dose of Telmichek-H (Telmisartan) (80 mg/day).

14  CLINICAL STUDIES

14.1  Hypertension

The antihypertensive effects of Telmichek-H have been demonstrated in six principal placebo-controlled clinical trials, studying a range of 20 to 160 mg; one of these examined the antihypertensive effects of Telmichek-H (Telmisartan) and hydrochlorothiazide in combination. The studies involved a total of 1773 patients with mild to moderate hypertension (diastolic blood pressure of 95 to 114 mmHg), 1031 of whom were treated with Telmichek-H (Telmisartan). Following once dailyadministration of Telmichek-H (Telmisartan), the magnitude of blood pressure reduction from baseline after placebo subtraction was approximately (SBP/DBP) 6-8/6 mmHg for 20 mg, 9-13/6-8 mmHg for 40 mg, and 12-13/7-8 mmHg for 80 mg. Larger doses (up to 160 mg) did not appear to cause a further decrease in blood pressure.

Upon initiation of antihypertensive treatment with Telmichek-H (Telmisartan), blood pressure was reduced after the first dose, with a maximal reduction by about 4 weeks. With cessation of treatment with Telmichek-H (Telmisartan) tablets,blood pressure gradually returned to baseline values over a period of several days to one week. During long term studies (without placebo control) the effect of Telmichek-H (Telmisartan) appeared to be maintained for up to at least one year. The antihypertensive effect of Telmichek-H (Telmisartan) is not influenced by patient age, gender, weight, or body mass index. Blood pressure response in black patients (usually a low-renin population) is noticeably less than that in Caucasian patients. This has been true for most, but not all, angiotensin II antagonists and ACE inhibitors.

In a controlled study, the addition of Telmichek-H (Telmisartan) to hydrochlorothiazide produced an additional dose-related reduction in blood pressure that was similar in magnitude to the reduction achieved with Telmichek-H (Telmisartan) monotherapy. Hydrochlorothiazide also had an added blood pressure effect when added to Telmichek-H (Telmisartan).

The onset of antihypertensive activity occurs within 3 hours after administration of a single oral dose. At doses of 20, 40, and 80 mg, the antihypertensive effect of once daily administration of Telmichek-H (Telmisartan) ismaintained for the full 24-hour dose interval. With automated ambulatory blood pressure monitoring and conventional blood pressure measurements, the 24-hour trough-to-peak ratio for 40 to 80 mg doses of Telmichek-H (Telmisartan) was 70 to 100% for bothsystolic and diastolic blood pressure. The incidence of symptomatic orthostasis after the first dose in all controlled trials was low (0.04%).

There were no changes in the heart rate of patients treated with Telmichek-H (Telmisartan) in controlled trials.

14.2  Cardiovascular Risk Reduction

Support for use to reduce therisk of cardiovascular events was obtained in a pair of studies. Both enrolledsubjects age ≥55 years, at high cardiovascular risk as evidenced by coronary artery disease (75%), diabetesmellitus (27%) accompanied with end-organ damage (e.g., retinopathy, leftventricular hypertrophy, and, in ONTARGET only, macro- or microalbuminuria),stroke (16%), peripheral vascular disease (13%), or transient ischemic attack(4%). Patients without a history of intolerance to ACE inhibitors enteredONTARGET, and those with such a history, usually cough (90%), entered TRANSCEND,but patients with >1+ proteinuria on dipstick were excluded from TRANSCEND. For both ONTARGET and TRANSCEND trials, the primary4-component composite endpoint was death from cardiovascular causes, myocardialinfarction, stroke, and hospitalization for heart failure. The secondary3-component composite endpoint was death from cardiovascular causes, myocardialinfarction, and stroke.

ONTARGET was a randomized, active-controlled, multinational,double-blind study in 25,620 patients who were randomized to Telmichek-H (Telmisartan) 80 mg,ramipril 10 mg, or their combination. The population studied was 73%male, 74% Caucasian, 14% Asian, and 57% were 65 years of age or older. Baseline therapy included acetylsalicylic acid (76%), lipid lowering agents(64%), beta-blockers (57%), calcium channel blockers (34%), nitrates (29%), anddiuretics (28%). The mean duration of follow up was about 4 years and 6months. During the study, 22.0% (n=1878) of Telmichek-H (Telmisartan) patientsdiscontinued the active treatment, compared to 24.4% (n=2095) of ramiprilpatients and 25.3% (n=2152) of telmisartan/ramipril patients.

TRANSCEND randomized patientsto Telmichek-H (Telmisartan) 80 mg (n=2954) or placebo (n=2972). The mean duration of followup was 4 years and 8 months. Thepopulation studied was 57% male, 62% Caucasian, 21% Asian, and 60% were 65years of age or older. Baseline therapy included acetylsalicylic acid(75%), lipid lowering agents (58%), beta-blockers (58%), calcium channelblockers (41%), nitrates (34%) and diuretics (33%). During the study, 17.7%(n=523) of Telmichek-H (Telmisartan) patients discontinued the active treatment, compared to19.4% (n=576) of placebo patients.

The results for the TRANSCENDtrial are summarized in Table 2, and the results for ONTARGET are summarized inTable 3, below:

*The primary endpoint was defined as the time to first event. In case of multiple simultaneous events, all individual events were considered; the sum of patients with individual outcomes may exceed the number of patients with composite (primary or secondary) outcomes.

**For individual components of the primary composite endpoints, all events, regardless whether or not they were the first event, were considered. Therefore, they are more than the first events considered for the primary or secondary composite endpoint.

Telmichek-H (Telmisartan) vs. Placebo

(n=2954) (n=2972)

No. of Events

Telmichek-H (Telmisartan) / Placebo

Hazard Ratio

95% CI

p-value
*Composite of CV death, myocardial infarction, stroke, or hospitalization for heart failure 465 (15.7%) / 504 (17.0%) 0.92 (0.81 – 1.05) 0.2129
*Composite of CV death, myocardial infarction, or stroke 384 (13.0%) / 440 (14.8%) 0.87 (0.76 – 1.00) 0.0483
Individual components of the primary composite endpoint No. of Events

Telmichek-H (Telmisartan) / Placebo

Hazard Ratio

95% CI

p-value
**All non-fatal MI 114 (3.9%) / 145 (4.9%) 0.79 (0.62 – 1.01) 0.0574
**All non-fatal strokes 112 (3.8%) / 136 (4.6%) 0.83 (0.64 – 1.06) 0.1365
Telmichek-H (Telmisartan) vs. Ramipril

(n=8542) (n=8576)

No. of Events

Telmisartan / Ramipril

Hazard Ratio

97.5% CI

Composite of CV death, myocardial infarction, stroke, or hospitalization for heart failure 1423 (16.7%) / 1412 (16.5%) 1.01 (0.93 – 1.10)
Composite of CV death, myocardial infarction, or stroke 1190 (13.9%) / 1210 (14.1%) 0.99 (0.90 – 1.08)

Althoughthe event rates in ONTARGET were similar on Telmichek-H (Telmisartan) and ramipril, theresults did not unequivocally rule out that Telmichek-H (Telmisartan) may not preserve ameaningful fraction of the effect of ramipril in reducing cardiovascular events. However, theresults of both ONTARGET and TRANSCEND do adequately support Telmichek-H (Telmisartan) beingmore effective than placebo would be in this setting, particularly for the end pointof time to cardiovascular death, myocardial infarction, or stroke.

In ONTARGET, there was noevidence that combining ramipril and Telmichek-H (Telmisartan) reduced the risk of death fromcardiovascular causes, myocardial infarction, stroke, or hospitalization for heartfailure greater than ramipril alone; instead, patients who received thecombination of ramipril and Telmichek-H (Telmisartan) in ONTARGET experienced an increasedincidence of clinically important renal dysfunction (e.g., acute renal failure)compared to patients receiving Telmichek-H (Telmisartan) or ramipril alone.

Multiple sub-group analysesdid not demonstrate any differences in the 4-component composite primaryendpoint based on age, gender, or ethnicity for either ONTARGET or TRANSCENDtrial.

16  HOW SUPPLIED/STORAGE AND HANDLING

Telmichek-H (Telmisartan) is available as white or off-white, uncoated tablets containing Telmichek-H (Telmisartan) 20 mg, 40 mg, or 80 mg. Tablets are marked with the BOEHRINGER INGELHEIM logo on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows:

Telmichek-H (Telmisartan) tablets 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0039-37).

Telmichek-H (Telmisartan) tablets 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0040-37).

Telmichek-H (Telmisartan) tablets 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0041-37).

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Tablets should not be removed from blisters until immediately before administration.

17  PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling

17.1  Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to Telmichek-H (Telmisartan) during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible .

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

Copyright 2012 Boehringer Ingelheim International GmbH

ALL RIGHTS RESERVED

OT1200SA252012

090340194/12

IT12004O

10005385/9

Patient Information

Telmichek-H (Telmisartan)® (my-CAR-dis)

(telmisartan)

Tablets

Read this Patient Information before you start taking Telmichek-H (Telmisartan) tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Telmichek-H (Telmisartan) tablets?

Telmichek-H (Telmisartan) can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Telmichek-H (Telmisartan), tell your doctor right away.

What is Telmichek-H (Telmisartan)?

Telmichek-H (Telmisartan) is a prescription medicine used:

  • to treat high blood pressure (hypertension)
  • in certain high risk people aged 55 years and older to help lower their risk of having certain cardiovascular problems such as stroke, heart attack, or death

It is not known if Telmichek-H (Telmisartan) is safe and effective in children.

Who should not take Telmichek-H (Telmisartan)?

You should not take Telmichek-H (Telmisartan) tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet.

What should I tell my doctor before taking Telmichek-H (Telmisartan) tablets?

Before you take Telmichek-H (Telmisartan) tablets, tell your doctor if you:

  • have liver problems
  • have kidney problems
  • have heart problems
  • have any other medical conditions
  • are pregnant or are planning to become pregnant. See "What is the most important information I shouldknow about Telmichek-H (Telmisartan) tablets?"
  • are breast-feeding or plan to breast-feed. It is not known if Telmichek-H (Telmisartan) passes into your breast milk. You and your doctor should decide if you will take Telmichek-H (Telmisartan) tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Telmichek-H (Telmisartan) tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Telmichek-H (Telmisartan) may affect the way other medicines work, and other medicines may affect how Telmichek-H (Telmisartan) works. Especially tell your doctor if you take:

  • digoxin (Lanoxin®, Lanoxicaps®)
  • lithium (Eskalith®, Lithobid®)
  • medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
  • ramipril (Altace®) or other medicines used to treat your high blood pressure or heart problem
  • water pills (diuretic)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take Telmichek-H (Telmisartan) tablets?

  • Take Telmichek-H (Telmisartan) tablets exactly as your doctor tells you to take it.
  • Your doctor will tell you how much Telmichek-H (Telmisartan) to take and when to take it.
  • Do not change your dose unless your doctor tells you to.
  • Take Telmichek-H (Telmisartan) one time each day at the same time.
  • Take Telmichek-H (Telmisartan) tablets with or without food.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
  • If you take too much Telmichek-H (Telmisartan), call your doctor, or go to the nearest hospital emergency room right away.
  • Read the "How to Open the Blister" at the end of this leaflet before you use Telmichek-H (Telmisartan). Talk with your doctor if you do not understand the instructions.

What are the possible side effects of Telmichek-H (Telmisartan) tablets?

Telmichek-H (Telmisartan) tablets may cause serious side effects, including:

  • Injury or death to your unborn baby. See "What is the most important information I should know about Telmichek-H (Telmisartan) tablets?"
  • Low blood pressure (hypotension) is most likely to happen if you also:
    • take water pills (diuretics)
    • are on a low-salt diet
    • get dialysis treatments
    • have heart problems
    • get sick with vomiting or diarrhea
  • If you feel faint or dizzy, lie down and call your doctor right away.
  • Kidney problems, which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of Telmichek-H (Telmisartan) tablets. Call your doctor if you get:
    • swelling in your feet, ankles, or hands
    • unexplained weight gain
  • Call your doctor right away if you get any of the symptoms listed above.
  • High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as needed.

Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms:

  • swelling of the face, tongue, throat
  • difficulty breathing
  • skin rash

The most common side effects of Telmichek-H (Telmisartan) tablets include:

  • sinus pain and congestion (sinusitis)
  • back pain
  • diarrhea

These are not all the possible side effects with Telmichek-H (Telmisartan) tablets. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Telmichek-H (Telmisartan) tablets?

  • Store Telmichek-H (Telmisartan) tablets between 59°F to 86°F (15°C to 30°C).
  • Do not remove Telmichek-H (Telmisartan) tablets from blisters until right before you take them.

Keep Telmichek-H (Telmisartan) tablets and all medicines out of the reach of children.

General information about Telmichek-H (Telmisartan) tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Telmichek-H (Telmisartan) tablets for a condition for which it was not prescribed. Do not give MICARDIStablets to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Telmichek-H (Telmisartan) tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor forinformation about Telmichek-H (Telmisartan) tablets that is written for health professionals.

For more information, call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, or (TTY) 1-800-459-9906.

What are the ingredients in Telmichek-H (Telmisartan) tablets?

Active Ingredient: Telmichek-H (Telmisartan)

Inactive Ingredients: sodium hydroxide, meglumine, povidone, sorbitol, and magnesium stearate

What is High Blood Pressure (Hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Telmichek-H (Telmisartan) tablets can help your blood vessels relax so your blood pressure is lower. High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

What is Cardiovascular Risk?

Patients older than 55 years of age who have been diagnosed with blood vessel disease in the heart, legs, or brain (coronary, peripheral, or cerebral vascular disease) or diabetes with end organ damage (for example: kidney, heart, and brain) are at higher risk of cardiovascular events (for example: death from cardiovascular causes, stroke, and/or heart attack).

How to open the blister:

1. Tear (You may also use scissors to tear the blister apart)

2. Peel (Peel off the paper layer from the aluminum foil)

3. Push (Push the tablet through the foil)

Distributed by:

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

Copyright 2012 Boehringer Ingelheim International GmbH

ALL RIGHTS RESERVED

Revised: January 2012

OT1200SA252012

090340194/12

IT12004O

10005385/9

Tear the blister apart Peel off the paper layer from the aluminum foil Push (Push the tablet through the foil)

Telmichek-H pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Telmichek-H available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Telmichek-H destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Telmichek-H Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Telmichek-H pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MICARDIS (TELMISARTAN) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."HYDROCHLOROTHIAZIDE TABLET [QUALITEST PHARMACEUTICALS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."AMLODIPINE BESYLATE; TELMISARTAN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Telmichek-H?

Depending on the reaction of the Telmichek-H after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Telmichek-H not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Telmichek-H addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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sdrugs.com conducted a study on Telmichek-H, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Telmichek-H consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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