Indications:
Treatment of essential hypertension in patients whose blood
pressure is not adequately controlled on anti-hypertensive monotherapy.

Contraindications:
- Hypersensitivity to Amlodipine or Valsartan.
- Pregnancy, breast-feeding.

Precautions/Warnings:
- Risk of hypotension in sodium - and/or volume-depleted patients.
- Beta-blocker withdrawal should be gradual.
- Severe renal impairment (creatinine clearance < 10 mL/min) and dialysis.
- No data available in patients with unilateral or bilateral renal artery stenosis, stenosis to a solitary kidney or after recent kidney transplantation.
- Caution in patients with hepatic impairment or biliary obstructive disorders.
- As with all other vasodilators, special caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
- Caution when driving or operating machines.

Use during pregnancy and breast-feeding:
Exforge must not be used during pregnancy or in women planning to become pregnant and while breast-feeding.

Use in children:
Not recommended in patients below 18 years of age.

Dosage and administration:
The recommended daily dose is one film-coated tablet (5 mg amlodipine and 80 mg valsartan, or 5 mg amlodipine and 160 mg valsartan, or 10 mg amlodipine and 160 mg valsartan).
Both amlodipine and valsartan can be taken with or without food. It is recommended to take Exforge with some water.

Drug Interactions:
- Caution and monitoring of serum potassium levels when used concomitantly with potassium supplements, potassium sparing diuretics, salt substitutes containing potassium, or other drugs that may increase potassium level.

Adverse reactions:
The most common adverse reactions are: Nasopharyngitis, influenza, headache, oedema peripheral, oedema, fatigue, flushing, asthenia, vertigo, tachycardia, palpitations, orthostatic hypotension, cough, pharyngolaryngeal pain, diarrhoea, nausea, abdominal pain, constipation, rash, erythema, joint swelling, back pain, arthralgia.
Rare adverse reactions but potentially serious are: Hypersensitivity.
Additional potentially serious adverse experiences reported in clinical trials with amlodipine monotherapy are: Gastritis, gingival hyperplasia, gynaecomastia, leucopenia, myalgia, pancreatitis, hepatitis, thrombocytopenia, vasculitis.
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo. Myocardial infarction or increased angina and arrhythmia (including ventricular tachycardia and atrial fibrillation) have also been reported.
These adverse events may not be distinguishable from the natural history of the underlying disease.
Additional potentially serious adverse experiences reported in clinical trials with valsartan monotherapy are: Neutropenia.
Heart failure patients: > 50 % increase in creatinine value in 3.9% of treated patients compared to 0.9% of placebo-treated patients.
>20% increase in serum potassium in 10% of valsartan treated patients compared to 6.3% of placebo-treated patients.
Post-myocardial infarction patients: doubling of serum creatinine in 4.2% of valsartan-treated patients and 3.4% of captopril-treated patients.

Presentation:
14 tablets