Exforge 5/160 mg 14 tablets

Exforge 5/160 mg 14 tablets

Composition

Active ingredients:

Amlodipine (as amlodipine besylate): 5 mg

Valsartan: 160 mg

Description

Exforge is a combination of a calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (valsartan). It is used to lower blood pressure in adults whose condition is not adequately controlled with either agent alone.

Mechanism of action:

Amlodipine prevents calcium from entering the blood vessel walls, reducing vessel constriction.

Valsartan blocks the effect of angiotensin II, preventing blood vessel tightening.

Together, they help relax blood vessels and reduce blood pressure.

Indications for Use

Treatment of high blood pressure in adults not adequately controlled by monotherapy with amlodipine or valsartan.

Dosage and Administration

Usual dose: One tablet per day.

Take at the same time daily with water. May be taken with or without food.

Avoid grapefruit or grapefruit juice.

Elderly patients: caution when increasing the dose.

Do not exceed prescribed dose.

If you miss a dose, take it as soon as possible. Do not double the next dose.

Do not stop taking Exforge® unless advised by your doctor.

Contraindications

Allergy to amlodipine, valsartan, or any ingredients

Severe liver disease, including biliary cirrhosis or cholestasis

Pregnancy over 3 months

Severe hypotension

Aortic stenosis, cardiogenic shock

Post-MI heart failure

Diabetes or impaired kidney function treated with aliskiren

Precautions

Liver or kidney disease

Kidney transplant or renal artery stenosis

Primary hyperaldosteronism

Heart failure or prior heart attack

Aortic/mitral stenosis or hypertrophic cardiomyopathy

Swelling of face/throat (angioedema) with other medications

Concomitant use with ACE inhibitors or aliskiren

Monitor potassium, renal function, blood pressure during therapy

Side Effects

Serious (rare, up to 1 in 1,000):

Anaphylaxis, angioedema, hypotension, breathing difficulties — seek emergency care

Common (up to 1 in 10):

Flu, nasal congestion, sore throat

Headache, swelling in limbs, fatigue, weakness, flushing

Uncommon (up to 1 in 100):

Dizziness, dry mouth, nausea, sleepiness, palpitations

Joint pain, back pain, skin rash, constipation

Rare (up to 1 in 1,000):

Anxiety, tinnitus, fainting, urinary frequency, erectile dysfunction

Hypotension, sweating, muscle cramps

Amlodipine-specific rare effects:

Myocardial infarction, arrhythmia

Pancreatitis, hepatitis, jaundice

Severe skin reactions (e.g., Stevens-Johnson syndrome)

Pregnancy and Breastfeeding

Pregnancy: contraindicated after the first trimester; switch to safer alternatives

Breastfeeding: not recommended, especially in newborn or premature infants, due to amlodipine excretion into milk

Storage Conditions

Keep out of reach of children

Do not use past expiry date (see carton/blister)

Package:

A carton box containing a blisters, total 14 tablets and insert leaflet.