Telminorm^® (Tablets) Instructions for Use

Marketing Authorization Holder

Micro Labs Limited (India)

ATC Code

C09CA07 (Telmisartan)

Active Substance

Telmisartan (Rec.INN WHO registered)

Dosage Forms

	Telminorm®	Tablets 40 mg: 7, 10, 14, 28, 30, 50, 90 or 100 pcs.
		Tablets 80 mg: 7, 8, 10, 14, 28, 30, 50 or 90 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, oval, biconvex, with an engraving “T” on one side and smooth on the other.

Excipients : mannitol – 155.89 mg, meglumine – 12 mg, sodium hydroxide – 3.36 mg, povidone K30 – 6 mg, crospovidone (type A) – 11.75 mg, magnesium stearate – 6 mg.

7 pcs. – Al/Al blisters (1) – cardboard packs.
7 pcs. – Al/Al blisters (2) – cardboard packs.
7 pcs. – Al/Al blisters (4) – cardboard packs.
10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (5) – cardboard packs.
10 pcs. – Al/Al blisters (9) – cardboard packs.
10 pcs. – Al/Al blisters (10) – cardboard packs.

Tablets white or almost white, capsule-shaped, biconvex, with an engraving “T80” on one side and smooth on the other.

Excipients : mannitol – 311.78 mg, meglumine – 24 mg, sodium hydroxide – 6.72 mg, povidone K30 – 12 mg, crospovidone (type A) – 23.5 mg, magnesium stearate – 12 mg.

7 pcs. – Al/Al blisters (1) – cardboard packs.
7 pcs. – Al/Al blisters (2) – cardboard packs.
7 pcs. – Al/Al blisters (4) – cardboard packs.
8 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (1) – cardboard packs.
10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (5) – cardboard packs.
10 pcs. – Al/Al blisters (9) – cardboard packs.

Clinical-Pharmacological Group

Angiotensin II receptor antagonist

Pharmacotherapeutic Group

Angiotensin II receptor antagonist

Pharmacological Action

Antihypertensive agent, angiotensin II receptor antagonist (type AT1). It has a very high affinity for this receptor subtype. By selectively and durably binding to the receptors, Telmisartan displaces angiotensin II from binding to AT1 receptors.

It does not show affinity for other AT receptor subtypes. The functional significance of other receptor subtypes and the effect of increased (as a result of telmisartan administration) levels of angiotensin II on them is not known.

Telmisartan reduces plasma aldosterone levels, does not inhibit plasma renin, does not block ion channels, and does not inhibit ACE (kinase II), which also breaks down bradykinin. Therefore, side effects associated with bradykinin are not observed.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. When taken simultaneously with food, the reduction in AUC ranges from 6% (at a dose of 40 mg) to 19% (at a dose of 160 mg).

After 3 hours, the plasma concentration levels out, regardless of whether it is taken with food or on an empty stomach. Plasma protein binding is 99.5%. The mean apparent V_d at steady state is 500 L.

It is metabolized by conjugation with glucuronic acid. The metabolites are pharmacologically inactive.

T_1/2 is more than 20 hours. It is excreted through the intestine unchanged. Cumulative renal excretion is less than 1%. Total plasma clearance is 1000 ml/min (renal blood flow is 1500 ml/min).

Indications

Arterial hypertension.

ICD codes

Dosage Regimen

Initiate treatment for arterial hypertension with a 40 mg dose taken once daily.

Consider a starting dose of 20 mg for patients with a potential for excessive blood pressure response.

If blood pressure control is inadequate after 4-8 weeks, increase the dose to 80 mg once daily.

The maximum recommended daily dose is 80 mg.

Administer Telmisartan with or without food; take consistently with regard to meals.

No initial dosage adjustment is necessary for elderly patients.

No initial dosage adjustment is required for patients with mild to moderate renal impairment.

Use Telmisartan with caution in patients with severe renal impairment or kidney artery stenosis; it is contraindicated in severe cases.

For patients with mild to moderate hepatic impairment, the maximum recommended daily dose is 40 mg.

Do not use in patients with severe hepatic impairment or biliary obstruction.

Monitor blood pressure following the initial dose to assess for symptomatic hypotension.

Correct volume and/or salt depletion prior to administration to minimize hypotensive risk.

Use in combination with a thiazide diuretic for an additive antihypertensive effect.

The full therapeutic effect is typically attained within 4 to 8 weeks of therapy initiation.

Adverse Reactions

From the central nervous system headache, dizziness, fatigue, insomnia, anxiety, depression, seizures.

From the digestive system abdominal pain, dyspepsia, nausea, diarrhea, increased activity of liver transaminases.

From the respiratory system cough, pharyngitis, upper respiratory tract infections.

From the hematopoietic system decreased hemoglobin level.

Allergic reactions rash; in isolated cases – angioedema.

From the urinary system peripheral edema, urinary tract infections, increased uric acid level, hypercreatininemia.

From the cardiovascular system pronounced decrease in blood pressure, palpitations, chest pain.

From the musculoskeletal system low back pain, myalgia, arthralgia.

From laboratory parameters hyperkalemia, anemia, hyperuricemia.

Other flu-like syndrome.

Contraindications

Biliary obstruction, severe impairment of liver and kidney function, pregnancy, lactation (breastfeeding), hypersensitivity to telmisartan.

Use in Pregnancy and Lactation

Telmisartan is contraindicated for use during pregnancy and during lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

There are no data on the safety and efficacy of telmisartan use in children and adolescents.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

Telmisartan should be used with caution in case of liver dysfunction, gastric and duodenal ulcer in the acute stage, other gastrointestinal diseases, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, coronary artery disease, heart failure.

In patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney, the use of telmisartan increases the risk of severe arterial hypotension and renal failure. Therefore, Telmisartan should be used with caution in this category of patients.

During the use of telmisartan in patients with impaired renal function, it is necessary to monitor the plasma levels of potassium and creatinine.

Currently, there are no data on the use of telmisartan in patients with a recent kidney transplant.

Symptomatic arterial hypotension may occur in patients with reduced blood volume and/or hyponatremia, especially after the first dose of telmisartan. Therefore, such conditions should be corrected before starting therapy.

It is not recommended to use Telmisartan in patients with primary aldosteronism, as such patients are insensitive to drugs that affect the renin-angiotensin system.

The use of telmisartan is possible in combination with thiazide diuretics, as such a combination provides an additional reduction in blood pressure.

When considering the possibility of increasing the dose of telmisartan, it should be remembered that the maximum antihypertensive effect is usually achieved after 4-8 weeks from the start of treatment.

Use in pediatrics

There are no data on the safety and efficacy of telmisartan use in children and adolescents.

Effect on ability to drive vehicles and operate machinery

The issue of the possibility of engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions should be decided only after assessing the individual reaction to Telmisartan.

Drug Interactions

With simultaneous use with antihypertensive drugs, an increase in the antihypertensive effect is possible.

With simultaneous use with potassium-sparing diuretics, heparin, dietary supplements, salt substitutes containing potassium, the development of hyperkalemia is possible.

With simultaneous use with lithium preparations, an increase in the plasma concentration of lithium is possible.

With simultaneous use, an increase in the plasma concentration of digoxin is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.