controlled with amlodipine 10 mg or valsartan mg alone or with Exforge 5 mg / mg. Exforge . No drug-drug interaction studies have been performed with Exforge and other medicinal products. Read the package leaflet before use. Exforge 5 mg/ mg: 41 Exforge 10 mg/ mg: 42 SH EXF APL JUN15 CL V8 COR FEB17 CL. PATIENT PACKAGE INSERT. EXFORGE is a high blood pressure medication. Learn more about how to * EXFORGE is a CCB/ARB single-pill combination product. It contains 2 prescription.

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Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.

Thrombocytopenia, sometimes with purpura. This system is lnsert ‘scheduling’. In double-blind, controlled clinical trials, the incidence of peripheral oedema by dose was as follows:.

Arrhythmias including bradycardia, ventricular tachycardia, and atrial fibrillation. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. Exforge should be discontinued immediately in patients who develop angioedema and should not be re-administered.

In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan. Some of these patients previously experienced angioedema with other medicinal products, including ACE inhibitors. To view the changes to a medicine you must sign up and log in.

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Exforge 5mg/80mg film coated tablets – Summary of Product Characteristics (SmPC) – (eMC)

Hepatic impairment Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment. Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.


In vitro studies with amlodipine have shown that approximately Each film-coated tablet contains 5 mg of amlodipine as amlodipine besylate and mg of valsartan. At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.

When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. Correction of this condition prior to administration of Exforge or close medical supervision at the start of treatment is recommended.

Individual dose titration with the components i. Histopathological inseft of inflammation of the glandular stomach was seen in male rats at an exposure of about 1. No information is available regarding the use of Exforge during breast-feeding, therefore Exforg is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.

Treatment can be continued once blood inert has been stabilised. There were only modest signs of maternal toxicity moderate reduction of body weight in this study.

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If patients taking amlodipine suffer from dizziness, headache, fatigue or nausea the ability to react may be impaired. Carcinogenesis, mutagenesis Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0. Exforge should be used with caution to treat hypertension in patients with unilateral or bilateral renal artery stenosis or stenosis to a solitary kidney since blood urea and serum creatinine may increase in pavkage patients.


In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed to a nephropathy including raised blood urea nitrogen and creatinine. Exforge combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: Following administration of therapeutic doses inseet patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.

When switching eligible elderly hypertensive patients see section 4. Amlodipine elimination from plasma is biphasic, with a terminal elimination half-life of approximately 30 to 50 hours. Aortic and mitral valve stenosis As with all other vasodilators, special caution is indicated in patients suffering from mitral stenosis or significant aortic stenosis that is not high grade.

Please enter your name Please enter your email Your email exdorge invalid. The steady-state volume of distribution of valsartan after intravenous administration is about 17 litres, indicating that valsartan does not distribute into tissues extensively.

Healthdirect 24hr 7 days a week hotline 24 hour health advice you can count on Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase packsge levels heparin, etc. Very limited clinical data are available indert amlodipine administration in patients with hepatic impairment.