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COMPOSITION of  Telmisartan 40mg STADA 

Each tablet contains: Telmisartan 40mg

Excipients q.s   1 tablet

(Lactose monohydrate, magnesium carbonate, croscarmellose sodium, povidone K30. magnesium stearate)

Telmisatan 40mg Stada

DESCRIPTION

Off – white colour, caplet tablet with a breakable line on one side and plain on the other side.

PHARMACODYNAMICS

Telmisartan 40mg is an orally active and specific angiotensin II receptor (type AT) antagonist Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT. receptor subtype, which is responsible for the known actions of angiotensin II. Telmisartan does not exhibit any partial agonist activity at the AT. receptor. Telmisartan selectively binds the AT, receptor. The binding is long-lasting Telmisartan does not show affinity for other receptors, including AT, and other less characterised AT receptors. The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan. Plasma aldosterone levels are decreased by telmisartan Telmisartan does not inhibit human plasma renin or block ion channels. Telmisartan does not inhibit angiotensin converifeg enzyme (kininase II), the enzyme which also degrades bradykinin. Therefore it is not expected to potentiate bradykinin-mediated adverse effects.

In human, an 80 mg dose of telmisartan almost completely inhibits the angiotensin II evoked blood pressure increase. The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.

After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours. The maximum reduction in blood pressure is generally attained 4 – 8 weeks after the start of treatment and is sustained during long-term therapy.

PHARMACOKINETICS

Telmisartan 40mg is rapidly absorbed from the gastrointestinal tract. The absolute oral bioavailability is dose dependent and is about 42% after a 40 mg dose and 58% after a 160 mg dose. Peak plasma concentrations of telmisartan are reached about 0.5 to 1 hour after an oral dose. Telmisartan is over 99% bound to plasma proteins. It is excreted almost entirely in the faeces via bile, mainly as unchanged drug. The terminal elimination half-life of telmisartan is about 24 hours.

INDICATIONS

Telmisartan 40mg is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents

DOSAGE AND ADMINISTRATION

Telmisartan 40mg STADA is administered orally, taken without regard to meals.

–        Adults: In hypertension, telmisartan is given in an initial dose of 40 mg once daily. This may be adjusted, if necessary, within the range of 20 to 80 mg once daily.

–        Renal impairment An initial dose of 20 mg once daily.

–        Hepatic impairment: In patients with mild to moderate hepatic Impairment, the posoiogy should not exceed 40 mg once daily.

–        Elderly patients: No dose adjustment is necessary.

–        Adolescents aged below 18 years: The safety and efficacy of telmisartan have not been established.

CONTRAINDICATIONS

–        Hypersensitivity to the active substance or to any of the excipients.

–        Second and third trimesters of pregnancy and lactation.

–        Biliary obstructive disorders.

–        Severe hepatic impairment.

PRECAUTIONS

Hepatic impairment: Telmisartan 40mg is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment since telmisartan is mostly eliminated with the bile These patients can be expected to have reduced hepatic clearance for telmisartan. Telmisartan should be used only with caution in patients with mild to moderate hepatic impairment.

Renovascular hypertension: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin – angiotensin – aldosterone system.

Renal impairment and kidney transplant: When Telmisartan 40mg is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of telmisartan in patients with recent kidney transplantation. Intravascular hypovolaemia: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of Telmisartan 40mg.

Other conditions with stimulation of the renin – angiotensin – aldosterone system: In patients whose vascular tone and renal function depend predominantly on the activity of the renin – angiotensin – aldosterone system (e g patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia. ohguna, or rarely acute renal failure Primary aldosteronism: Patients with primary aldosteronism generally wii not respond to antihypertensive medicinal products acting through inNbition of the renin – angiotensin system Therefore, the use of telmisartan is not recommended Aortic end mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution is indicated in patients suffering from

aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy Hyperkalaemia

* The use of medicinal products that affect the renin – angiotensin – aldosterone system may cause hyperkalaemia

– In the elderly, in patients with renal insufficiency, in diabetic patients, in patients concomitantly treated with other medicinal products that may potassium levels, and/or in patients with intercucrent events. may be fatal

Other

– As observed foranaotanain converting enzyme inhibitors, telmisartan and the other angiotensin II receptor antagonists are apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of higher prevalence of low-renin states in the states in the black hypertensive population

– As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiovascular disease could result in a myocardial infarction or stroke

DRUG INTERACTIONS

–        Digoxin When telmisartan was coadministered with digoxin, median increases in digoxin peak plasma concentration (49%) and trough concentration (20%) were observed It is. therefore, recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing telmisartan to avoid posstfft over – or under – digitalization

–        Warfann Telmisartan administered for 10 days stighfly decreased the mien warfarin trough plasma concentration, the decrease did not result in a change In International Normalized Ratio (INR).

–        Other drugs Coadmimstration of telmisartan did not result a dmcaiy signtitoant interaction with acetaminophen, amlodipme, ghbendamtde, simvesletin hydrochlorothiazide or ibuprofen. Telmisartan is not melatiotized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes except for some inhibition of CYP2C19

PREGNANCY AND LACTATION

Pregnancy

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin – angiotensin system can cause injury and even death to the developing fetus When pregnancy is detected, Telmisartan 40mg should be discontinued as soon as possible

Lactation

It is not known whether Telmisartan 40mg is excreted in human milk, but Telmisartan 40mg was shown to be present in the mifk of lactating rats Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Telmisartan 40mg.

ADVERSE REACTIONS

These adverse reactions’occur generally mikj and transient, rarely be discontinued.

Uncommon

–        Body Fatigue, headache, dizziness, limb edema, sweating

–        Central nervous system (CHS) Agitation condition

–        Gastrointestinal: Dry mouth, nausea, abdominal pain, acid reflux, indigestion, flatulence, loss of appetite, diarrhea.

–        Urology Reduced renal function, creatinine and blood urea nitrogen (BUN), urinary tract infection

–        Respiratory: Pharyngitis, sinusitis, upper respiratory tract infection

–        Bones-joinfs. Back pam, pain and spasms muscle

–        Metabolism: Hyperkalemia

Rarefy

–        Body Angioedema.

–        Eye Visual disturbances

–        Cardiovascular: Tachycardia, hypotension or syncope

–        Gastrointestinal: Gastrointestinal – bowel bleeding.

–        Skin Rash, urticaria, pruritus.

–        Liver: Liver enzymes increased.

–        Stood. Hemoglobin reduced, neutrophil decreased.

–        Metabolism: Blood uric acid increased, blood cholesterol Increased

OVERDOSAGE AND TREATMENT

Symptoms

Limited data are available with regard to overdosage in humans. The meet NuNy manifestations of overdosage would be hypotension, dizziness end tachycardia, bradycardia could occur from parasympathetic (vagal) stimuietton

Treatment

If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan 40mg is not removed by hemodialysis STORAGE: Store in a well-dosed container, in a dry place Do not store above 30°C

SHELF-LIFE : 24 months from the date of manufacturing.

PACKAGING : Blister of 7 tablets Box of 4 blisters SPECIFICATION : Manufacturer’s specification

Some drugs have composition Telmisartan 40mg : Telmicos 40mg , Cardisan 40mg , Miratel 40mg …

Telmicos 40mg 80mg

Cardisan 40mg

Miratel 40mg

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