Micardis 40mg. 80mg Tablets

Treatment of mild to moderate hypertension, either alone or in combination with hydrochlorothiazide. Reduction of cardiovascular morbidity and mortality in patients 55 years or older at high risk of cardiovascular disease; the benefit of treatment is evident after at least 6 months of continued treatment.

Adults: Treatment of essential hypertension: The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, the MICARDIS dose can be increased to a maximum of 80 mg once daily. Alternatively, MICARDIS may be used in combination with a low dose thiazide diuretic such as hydrochlorothiazide 12,5 mg, which has been shown to have an additive blood pressure lowering effect with MICARDIS. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. Reduction of cardiovascular morbidity and mortality: The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of MICARDIS are effective in preventing cardiovascular morbidity and mortality. When initiating MICARDIS therapy for the prevention of cardiovascular morbidity and mortality, monitoring of blood pressure is recommended and, if appropriate, adjustment of medications that lower blood pressure may be necessary. The benefit of treatment is evident only after 6 months of continued treatment. Renal impairment: No dosage adjustment is required for patients with renal impairment, including those on haemodialysis. MICARDIS is not removed from blood by hemofiltration. Hepatic impairment: In patients with mild to moderate hepatic impairment the dosage should not exceed 40 mg once daily. Elderly: No dosing adjustment is necessary. Children and adolescents up to 18 years: The safety and efficacy of MICARDIS for use in children below 18 years have not been established.

• Hypersensitivity to any of the ingredients of MICARDIS
• A history of angioedema related to previous therapy with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs): These patients must never again be given these medicines.
• Hereditary or idiopathic angioedema
• Hypertrophic obstructive cardiomyopathy (HOCM)
• Bilateral renal artery stenosis
• Renal artery stenosis in patients with a single kidney
• Severe renal function impairment (creatinine clearance less than 30 mL/min)
• Aortic stenosis
• Concomitant therapy with potassium sparing diuretics such as spironolactone, triamterene, amiloride (see WARNINGS AND SPECIAL PRECAUTIONS)
• Porphyria
• Lithium therapy: Concomitant administration with MICARDIS may lead to toxic blood concentrations of lithium (see INTERACTIONS)
• Pregnancy and lactation (see WARNINGS AND SPECIAL PRECAUTIONS and PREGNANCY AND LACTATION)
• Severe hepatic impairment
• Obstructive biliary disorders
• In case of rare hereditary conditions that may be incompatible with sorbitol, an excipient of the product, the use of MICARDIS is contraindicated (please refer to WARNINGS AND SPECIAL PRECAUTIONS)
• The concomitant use of MICARDIS with aliskiren-containing products is contraindicated (see WARNINGS AND SPECIAL PRECAUTIONS and INTERACTIONS)
• Concomitant use of fluoroquinolones with Angiotensin-converting enzyme (ACE) inhibitors/Angiotensin receptor blockers (ARBs) is contraindicated in patients with moderate to severe renal impairment (Creatinine Clearance u2264 30 mL/min) and in elderly patients.

Pregnancy: MICARDIS should not be initiated during pregnancy. Should a woman become pregnant while receiving MICARDIS, the treatment should be stopped promptly and switched to a different class of antihypertensive medicine (see CONTRAINDICATIONS and PREGNANCY AND LACTATION). 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 MICARDIS (see CONTRAINDICATIONS). Renal impairment and kidney transplant: When MICARDIS is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of MICARDIS in patients with a recent kidney transplant (see CONTRAINDICATIONS).

MICARDIS may increase the hypotensive effect of other antihypertensive agents. Co-administration of MICARDIS did not result in a clinically significant interaction with digoxin, warfarin, hydrochlorothiazide, glibenclamide, paracetamol, ibuprofen, simvastatin and amlodipine. For digoxin a 20 % increase in median plasma digoxin trough concentration has been observed (in a single case a 39 %). Monitoring of plasma digoxin levels should be considered. In one study the co-administration of MICARDIS and ramipril led to an increase of up to 2,5 fold in the AUC 0-24 and C max of ramipril and ramiprilat. The clinical relevance of this observation is not known. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Increased serum levels have also been reported with MICARDIS. Careful monitoring of serum lithium levels is recommended during concomitant use. Concomitant treatment with NSAIDs (including aspirin at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) is associated with the potential for acute renal insufficiency in patients who are dehydrated. Compounds acting on the Renin-Angiotensin-System like MICARDIS may have synergistic effects. Patients receiving NSAIDs and MICARDIS should be adequately hydrated and be monitored for renal function at the beginning of combined treatment. A reduced effect of antihypertensive medicines like MICARDIS by inhibition of vasodilating prostaglandins has been reported during combined treatment with NSAIDs. Dual blockade of the RAAS with ARBs, ACE inhibitors or aliskiren Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (see CONTRAINDICATIONS and WARNINGS AND SPECIAL PRECAUTIONS). Concomitant use of fluoroquinolones and Angiotensin-converting enzyme (ACE) inhibitors/Angiotensin receptor blockers (ARBs) may precipitate acute kidney injury. The mechanism of the possible interaction between the different classes of medicines, over and above different mechanisms of kidney damage, is unknown (see CONTRAINDICATIONS).

Safety in pregnancy and lactation has not been established (see CONTRAINDICATIONS). When pregnancy is planned or confirmed MICARDIS should be discontinued. Medicines affecting the renin-angiotensin system, such as MICARDIS, can cause embryonal toxicity, foetal and neonatal morbidity and mortality when administered to pregnant women. Women of childbearing age should ensure effective contraception.

No studies on the effect on the ability to drive and use machines have been performed. However, when driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy including MICARDIS.

The incidence of adverse events in controlled clinical trials was not dose related and showed no correlation with gender, age or race of the patients. The following frequency classification is used: very common u2265 1/10; common u2265 1/100 and < 1/10; uncommon u2265 1/1 000 and < 1/100; rare u2265 1/10 000 and < 1/1 000; very rare < 1/10 000. Infections and infestations: Uncommon: urinary tract infections (including cystitis), upper respiratory tract infections. Blood and the lymphatic systemic disorders: Uncommon: anaemia. Rare: thrombocytopenia. Immune system disorders: Rare: hypersensitivity, angio-oedema (with fatal outcome). Metabolism and nutrition disorders: Uncommon: hyperkalaemia. Psychiatric disorders: Uncommon: depression, insomnia. Rare: anxiety. Nervous system disorders: Uncommon: syncope/fainting. Eye disorders: Rare: visual disturbance. Ear and labyrinth disorders: Uncommon: vertigo. Cardiac disorders: Uncommon: bradycardia. Rare: tachycardia. Vascular disorders: Uncommon: hypotension, orthostatic hypotension. Respiratory, thoracic and mediastinal disorders: Common: cough. Uncommon: dyspnoea. Gastro-intestinal disorders: Uncommon: abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting. Rare: dry mouth, stomach discomfort. Skin and subcutaneous tissue disorders: Uncommon: increased sweating (hyperhidrosis), pruritus, rash. Rare: eczema, erythema, drug eruption, toxic skin eruption. Musculoskeletal, connective tissue and bone disorders: Uncommon: back pain, muscle spasms (cramps in legs), myalgia. Rare: arthralgia, pain in extremity (leg pain). Renal and urinary disorders: Uncommon: renal impairment including acute renal failure. General disorders and administration site conditions: Uncommon: chest pain, asthenia (weakness). Rare: influenza-like symptoms. Investigations: Uncommon: blood creatinine increased. Rare: haemoglobin decreased, blood uric acid increased, hepatic enzymes increased, blood creatine phosphokinase increased. Post-marketing: Side effects which have been spontaneously reported since the introduction of MICARDIS into the market. Infections and infestations: Sepsis including fatal outcome. Blood and the lymphatic systemic disorders: Eosinophilia. Immune system disorders: Anaphylactic reaction. Skin and subcutaneous tissue disorders: Urticaria. Musculoskeletal, connective tissue and bone disorders: Tendon pain (tendinitis like symptoms). Metabolism and nutrition disorders: Hypoglycaemia (in diabetic patients). Hepato-biliary disorders: Hepatic function abnormal/liver disorder.

Limited information is available with regard to overdose in humans. The most prominent manifestations of MICARDIS overdose were hypotension and tachycardia; bradycardia also occurred. If symptomatic hypotension should occur, supportive treatment should be instituted. MICARDIS is not removed by haemodialysis.