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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The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.

Exforge 5mg/80mg film coated tablets

Interactions linked to valsartan Concomitant use not recommended Lithium 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. In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin, digoxin, warfarin or ciclosporin.

Very limited clinical data are available regarding amlodipine administration in patients with hepatic impairment. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.

The safety packkage amlodipine in human pregnancy has not been established. In animal studies, reproductive toxicity was observed at high doses see section 5. Similar changes were exfore seen in the valsartan alone group exposure 8. packagge


The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone. Sign Up Log In Cancel. In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, Elderly age 65 years or over Time to peak plasma amlodipine concentrations is similar in young and elderly patients. No data are available. Reproductive system and breast disorders.

All medicines and poisons in Australia are categorised by how they are made available to the public. Pregnancy Amlodipine The safety of amlodipine in human pregnancy has not been established. If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised. Uncommon 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.

Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0. Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by eexforge channel blockers.

Patients taking Exforge and driving vehicles or using machines should take into account that dizziness or weariness may occasionally occur. In paackage studies with amlodipine have shown that approximately At higher exposures, there were ulceration and erosion of the stomach mucosa in both females and males.

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

In elderly patients, amlodipine clearance tends to decline, causing increases in the area under the curve AUC and inserg half-life. Amlodipine Reversible biochemical changes in the head of spermatozoa have been edforge in some patients treated by calcium channel blockers.


Tabulated list of adverse reactions Adverse reactions have been ranked under headings of frequency using the following convention: Find out more here. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.

Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function. Special populations Paediatric population age below 18 years No pharmacokinetic data are available in the lnsert population. When switching eligible hypertensive patients see section 4.


Exfodge film-coated tablet contains 10 mg of amlodipine as amlodipine besylate and mg of valsartan. ONTARGET was a study conducted in patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage. When switching eligible elderly hypertensive patients see section 4. Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.

In marmosets at comparable doses, the changes were similar though more severe, particularly in the kidney where the changes developed paxkage a nephropathy including raised blood urea nitrogen and creatinine.