Telmicard 5/805 mg+80 mg

Amlodipine besilate and telmisartan combination tablets are used for the treatment of hypertension (high blood pressure), either as initial therapy in patients likely to need multiple medicines to control their blood pressure, or as replacement therapy in patients already controlled on the individual components given together.

Contains amlodipine (as amlodipine besilate) and telmisartan as active ingredients, formulated as oral tablets. This combination is commonly marketed in four fixed strengths: amlodipine 5 mg with telmisartan 40 mg, amlodipine 10 mg with telmisartan 40 mg, amlodipine 5 mg with telmisartan 80 mg, and amlodipine 10 mg with telmisartan 80 mg. Confirm the exact strength on the specific product dispensed, since the four combinations are not interchangeable without medical guidance.

Amlodipine besilate and telmisartan is a combination antihypertensive medicine that pairs a calcium channel blocker (amlodipine) with an angiotensin II receptor blocker (telmisartan). Amlodipine relaxes and widens blood vessels, while telmisartan blocks a hormone that narrows blood vessels; together, they provide more effective blood pressure control than either medicine alone. It is available in four fixed-dose strengths, allowing the treating doctor to tailor the combination to the patient's blood pressure response.

Therapeutic Class: Antihypertensive Combination (Calcium Channel Blocker + Angiotensin II Receptor Blocker)

Amlodipine is well absorbed orally, with peak plasma levels reached in 6-12 hours and a long elimination half-life supporting once-daily dosing. Telmisartan is also taken once daily; its absolute bioavailability is dose-dependent, and food modestly reduces its absorption. Both components are highly protein-bound and undergo hepatic metabolism, with amlodipine and telmisartan pharmacokinetics not meaningfully altered when combined in this fixed-dose product compared to the individual components.

• Taken orally, once daily, at approximately the same time each day
• May be taken with or without food
• Swallow the tablet whole with water

The following should be assessed by a healthcare professional before combining with this medicine:

• Aliskiren, which must not be co-administered with this combination in patients with diabetes, due to increased risk of kidney impairment, low blood pressure, and high potassium
• Other antihypertensive medicines, which may increase blood-pressure-lowering effect
• Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium, which may increase the risk of high blood potassium when combined with telmisartan
• NSAIDs, which may reduce the blood-pressure-lowering effect of telmisartan and increase the risk of kidney impairment, particularly in patients with pre-existing kidney disease or on diuretics
• Digoxin, whose blood levels may be increased when combined with telmisartan; monitoring may be needed
• Strong CYP3A4 inhibitors, which may increase amlodipine blood levels

Common side effects

• Swelling of the ankles or feet (peripheral edema)
• Dizziness
• Fatigue
• Flushing
• Headache
• Upper respiratory tract infection symptoms

Serious side effects (seek urgent medical attention)

• Signs of a severe allergic reaction: swelling of the face, lips, tongue, or throat, difficulty breathing
• Signs of very low blood pressure: severe dizziness, fainting
• Signs of kidney problems: reduced urination, swelling
• Signs of high potassium: muscle weakness, irregular heartbeat
• Chest pain or worsening of angina, particularly when starting or increasing amlodipine in patients with severe coronary artery disease

Pregnancy

This combination is contraindicated in pregnancy. Drugs that act on the renin-angiotensin system, such as telmisartan, can cause injury and death to the developing fetus when used in the second and third trimesters. Discontinue as soon as pregnancy is detected, and switch to an alternative antihypertensive treatment as advised by the treating doctor.

Breastfeeding

Because of the potential risk to a nursing infant, breastfeeding is not recommended during treatment with this combination; a decision should be made with the treating doctor whether to discontinue breastfeeding or discontinue the medicine, taking into account the mother's need for treatment.

• Fetal toxicity: This combination is contraindicated in pregnancy due to the risk of fetal injury and death; discontinue immediately if pregnancy is detected.
• Hypotension: Correct any volume or salt depletion before starting therapy; observe for signs and symptoms of low blood pressure, particularly in volume-depleted patients.
• Worsening angina or myocardial infarction: Rarely, initiation of a calcium channel blocker such as amlodipine may be associated with increased frequency, duration, or severity of angina, particularly in patients with severe obstructive coronary artery disease.
• Renal impairment: Monitor renal function, as changes may occur, particularly in patients whose kidney function depends on the renin-angiotensin system (such as severe heart failure or renal artery stenosis).
• Hyperkalemia: Monitor serum potassium, especially in patients with renal impairment, diabetes, or those taking potassium supplements or potassium-sparing diuretics.
• Do not stop this medicine suddenly without medical advice.

Overdose may cause excessive lowering of blood pressure, with symptoms such as marked dizziness, fainting, and, from the amlodipine component, potentially a reflex fast heart rate or, in severe cases, shock. Overdose is a medical emergency requiring urgent evaluation and supportive treatment in a healthcare facility; symptomatic patients should seek immediate medical care.

Store at controlled room temperature, protected from moisture and light, as this combination is hygroscopic and light-sensitive. Keep in the original container and out of reach of children. Follow the specific product's label for exact storage instructions.

• Elderly (65 years and older): Start with a low initial amlodipine dose; initial therapy with this fixed-dose combination is generally not recommended in patients 75 years and older, given limited data at treatment initiation in this age group.
• Renal impairment: No initial dose adjustment is generally required in mild to moderate impairment, but monitor renal function and potassium, particularly in more significant impairment.
• Hepatic impairment: Use with caution, particularly with telmisartan, which is primarily eliminated via biliary excretion; dose adjustment may be needed in significant hepatic impairment, per the treating physician's assessment.

This combination is generally used long-term as maintenance therapy for chronic hypertension, with the duration determined by ongoing blood pressure control and the physician's assessment. It should not be stopped abruptly without medical advice.

Drug Class: Dihydropyridine calcium channel blocker (amlodipine) combined with an angiotensin II receptor blocker (telmisartan)

Amlodipine blocks calcium channels in vascular smooth muscle, reducing calcium entry into these cells and causing blood vessels to relax and widen, which lowers blood pressure. Telmisartan blocks angiotensin II from binding to its receptor on blood vessels, preventing the vessel-narrowing and sodium/fluid-retaining effects of this hormone. Together, these complementary mechanisms provide more substantial blood pressure lowering than either agent alone.

Safety and effectiveness of this combination have not been established in patients younger than 18 years, and it is not recommended for use in children.