Telpres (Tablets) Instructions for Use

Marketing Authorization Holder

Xantis Pharma, Limited (Cyprus)

Manufactured By

Laboratorios Liconsa, S.A. (Spain)

ATC Code

C09CA07 (Telmisartan)

Active Substance

Telmisartan (Rec.INN registered by WHO)

Dosage Forms

	Telpres	Tablets 20 mg: 28, 56, or 98 pcs.
		Tablets 40 mg: 28, 56, or 98 pcs.
		Tablets 80 mg: 28, 56, or 98 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, with a bevel, engraved with “LC” on one side.

Excipients: sodium hydroxide – 1.7 mg, povidone K25 – 5.4 mg, meglumine – 6 mg, mannitol – 81.9 mg, magnesium stearate – 2 mg, crospovidone – 3 mg.

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.
14 pcs. – blisters (7) – cardboard packs.

Tablets white, oblong, biconvex, engraved with “LC” on one side.

Excipients: sodium hydroxide – 3.4 mg, povidone K25 – 10.8 mg, meglumine – 12 mg, mannitol – 163.8 mg, magnesium stearate – 4 mg, crospovidone – 6 mg.

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.
14 pcs. – blisters (7) – cardboard packs.

Tablets white, oblong, biconvex, engraved with “LC” on one side.

Excipients: sodium hydroxide – 6.7 mg, povidone K25 – 21.6 mg, meglumine – 24 mg, mannitol – 327.7 mg, magnesium stearate – 8 mg, crospovidone – 12 mg.

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.
14 pcs. – blisters (7) – cardboard packs.

Clinical-Pharmacological Group

Angiotensin II receptor antagonist

Pharmacotherapeutic Group

Agents acting on the renin-angiotensin system, angiotensin II receptor antagonists

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 exhibit 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 with a 40 mg dose taken once daily.

Alternatively, a 20 mg dose may be used for patients with a potential for excessive hypotensive response.

The antihypertensive effect is typically attained within 4-8 weeks of continuous therapy.

If blood pressure control is inadequate after this period, increase the dose to 80 mg once daily.

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

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

Administer the tablet with or without food, at approximately the same time each day.

Monitor blood pressure regularly to assess therapeutic response.

Monitor serum potassium and creatinine levels periodically, particularly in patients with renal impairment.

Correct any volume depletion or hyponatremia prior to initiation of therapy to mitigate the risk of symptomatic hypotension.

Adverse Reactions

From the 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 hepatic and renal impairment, pregnancy, lactation (breastfeeding), hypersensitivity to telmisartan.

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

Data on the safety and efficacy of telmisartan use in children and adolescents are not available.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

Telmisartan should be used with caution in cases of impaired liver function, gastric and duodenal ulcers 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 solitary 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 plasma potassium and creatinine levels.

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 initiating therapy.

The use of Telmisartan is not recommended in patients with primary aldosteronism, as such patients are not sensitive to drugs affecting 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 of treatment.

Use in pediatrics

Data on the safety and efficacy of telmisartan use in children and adolescents are not available.

Effect on ability to drive vehicles and operate machinery

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

Drug Interactions

With simultaneous use with antihypertensive drugs, an enhancement of 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.