EXFORGE PACKAGE INSERT PDF

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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Summary of the safety profile The safety of Exforge has been evaluated in five controlled clinical studies with 5, patients, 2, of whom received valsartan in combination with amlodipine. Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia. Abrupt pacckage of valsartan has not been associated with rebound hypertension or other adverse clinical events. Amlodipine dosage recommendations have not been established in patients with mild to moderate hepatic impairment.

Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported. Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other iinsert that may increase potassium levels. The study was terminated early because of an increased risk of adverse outcomes.

Primary hyperaldosteronism 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. Adverse reactions have been ranked under headings of frequency using the following convention: Others In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: Enter medicine name or pcakage Start typing to retrieve search suggestions.

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Respiratory, thoracic and mediastinal disorders.

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

Hepatic impairment Very ineert clinical data are available regarding amlodipine administration in patients with hepatic impairment. Hepatic impairment Exforge is contraindicated in patients with severe hepatic impairment see section 4.

It acts selectively on the receptor subtype AT 1which is responsible for the known actions of angiotensin II. Adverse reactions previously reported with one of the individual components amlodipine or valsartan may be potential adverse esforge with Exforge as well, even if not observed in clinical trials or during the post-marketing period.

Insomnia, mood changes including anxietydepression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance including diplopiatinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease. Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan.

Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium fxforge blockers.

The effect of amlodipine on infants is unknown.

EXFORGE &amp EXFORGE HCT

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision paackage subject to frequent close monitoring of renal function, electrolytes and blood pressure. Commonly used antihypertensive agents e. Each film-coated tablet contains 5 mg of amlodipine as amlodipine besylate and 80 mg of valsartan.

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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 such patients.

The no-observed-effect-level for developmental effects was observed at 3- valsartan and 4- amlodipine fold the clinical exposure based on AUC. The way to take this medicine: Thank you for sharing our content. Calcium channel blockers, including amlodipine, should be used with caution in patients with congestive heart failure, as they may increase the risk of future cardiovascular events and mortality.

When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered. Find out more here.

Marketing authorisation holder 8. Each film-coated tablet contains 5 mg of amlodipine as amlodipine besylate and mg of valsartan. General disorders and administration site conditions. Reproductive system and breast disorders.

High Blood Pressure Medication | EXFORGE & EXFORGE HCT

Exforge can be used with or without food. Symptoms There is no experience of overdose with Exforge. In one rat study, adverse effects were found on male fertility see section 5. In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve AUC and elimination half-life.

Agents acting on the renin-angiotensin system; angiotensin II antagonists, combinations; angiotensin II antagonists and calcium channel blockers, ATC code: CYP3A4 inducers anticonvulsant agents [e.