Exforge 5/80, 5/160 and 10/160 mg film-coated tablets – amlodipine and valsartan for high blood pressure

Exforge film-coated tablets contain two active substances that help control high blood pressure. Amlodipine is a calcium channel blocker – it stops calcium from entering the blood vessel wall and thus prevents the vessels from narrowing. Valsartan is an angiotensin II receptor antagonist – it blocks the action of angiotensin II, a substance that narrows blood vessels and raises blood pressure.

Together they prevent narrowing of the blood vessels, so the vessels relax and blood pressure falls. According to the leaflet, Exforge is used in adults whose blood pressure is not adequately controlled with amlodipine alone or valsartan alone. It is authorised in three strengths: 5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg.

What is Exforge used for and how should it be taken correctly?

Key facts about the medicine

What is Exforge used for?

• High blood pressure (hypertension) in adults – when blood pressure is not adequately controlled with amlodipine alone or valsartan alone.

The doctor chooses the strength (5/80, 5/160 or 10/160 mg) according to previous treatment and response.

How is it used and dosed?

• Usual dose: one tablet a day, preferably at the same time each day.
• How to take: swallow the tablet with a glass of water, with or without food – but not with grapefruit or grapefruit juice.
• Depending on your response, the doctor may suggest a lower or higher dose. Do not exceed the prescribed dose.
• Older people (65 years and over): the doctor must be careful when increasing the dose.

Special patient groups

• Children and adolescents under 18: use is not recommended.
• Older people: the dose is increased cautiously.
• Liver and kidney disease: severe liver disease and bile problems (biliary cirrhosis, cholestasis) are contraindications; other liver or kidney problems, a kidney transplant or narrowing of the kidney arteries require caution, and the doctor may check kidney function and potassium.
• Heart failure or previous heart attack: follow your doctor's instructions carefully when starting treatment.

Contraindications – when the medicine must not be used

Do not take Exforge if you:

• are allergic to amlodipine or other calcium channel blockers, to valsartan or any of the ingredients;
• have severe liver disease or bile problems such as biliary cirrhosis or cholestasis;
• are more than 3 months pregnant (it is also better to avoid it in early pregnancy);
• have severely low blood pressure (hypotension);
• have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock;
• have heart failure after a heart attack;
• have diabetes or impaired kidney function and take a blood pressure medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking the medicine if you:

• are vomiting or have diarrhoea;
• have liver or kidney problems, a kidney transplant or narrowing of the kidney arteries;
• have primary hyperaldosteronism;
• have heart failure or have had a heart attack;
• have narrowing of the heart valves (aortic or mitral stenosis) or obstructive hypertrophic cardiomyopathy;
• have previously had swelling, especially of the face and throat, with other medicines (including ACE inhibitors);
• take an ACE inhibitor (e.g. enalapril, lisinopril, ramipril) – especially with diabetes-related kidney problems – or aliskiren.

The doctor may regularly check your kidney function, blood pressure and blood electrolytes (e.g. potassium).

Interactions with other medicines, food and drink

Tell your doctor about all medicines you take – the dose may need to be changed or one of the medicines stopped. According to the leaflet, this is especially important if you take:

• ACE inhibitors or aliskiren; diuretics;
• lithium;
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes and other substances that raise potassium;
• non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors – the doctor may check kidney function;
• anticonvulsants (carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St John's wort;
• nitroglycerin and other nitrates or vasodilators;
• HIV medicines (ritonavir, indinavir, nelfinavir) and antifungals (ketoconazole, itraconazole);
• antibiotics (rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem; simvastatin; dantrolene; tacrolimus; ciclosporin.

Grapefruit: people taking Exforge should not consume grapefruit or grapefruit juice, as they may increase amlodipine levels in the blood and unpredictably increase the lowering of blood pressure.

Pregnancy and breast-feeding

• Pregnancy: the doctor will normally advise stopping the medicine before pregnancy or as soon as you know you are pregnant and prescribe another medicine. Exforge is not recommended in the first three months of pregnancy and must not be taken after the third month, as it may seriously harm the baby.
• Breast-feeding: amlodipine passes into breast milk in small amounts; Exforge is not recommended for breast-feeding mothers, especially if the baby is newborn or premature.

Driving and using machines

The medicine may cause dizziness and affect concentration. If you are not sure how it affects you, do not drive, use machines or do activities requiring concentration.

Possible side effects

Contact your doctor immediately in case of an allergic reaction: rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure with a feeling of faintness (rare).

• common: flu-like symptoms, blocked nose, sore throat or discomfort when swallowing, headache, swelling of the arms, hands, legs, ankles or feet, tiredness, weakness, redness and warmth of the face and/or neck;
• uncommon: dizziness, nausea and abdominal pain, dry mouth, drowsiness, tingling of the hands or feet, vertigo, fast heartbeat and palpitations, light-headedness on standing, cough, diarrhoea, constipation, rash, skin redness, joint swelling and pain, back pain;
• rare: anxiety, ringing in the ears, fainting, increased urination, erection problems, feeling of heaviness, low blood pressure with light-headedness, increased sweating, widespread rash, itching, muscle cramps.

For amlodipine alone, very rare severe reactions have also been described (sudden wheezing, chest pain, swelling of the eyelids, face, tongue and throat, severe skin reactions, heart attack, irregular rhythm, pancreatitis), as well as gum swelling, liver problems and jaundice. For valsartan, low blood cell counts, high potassium, reduced kidney function, swelling of the face and throat and skin blisters have been described. If you notice any of these, contact your doctor immediately.

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor immediately. Excess fluid may build up in the lungs (pulmonary oedema) with shortness of breath, which may develop 24–48 hours after taking the medicine.
• Missed dose: take it as soon as you remember and the next one at the usual time; if it is nearly time for the next dose, skip the missed one. Do not take a double dose.
• Stopping treatment: stopping may worsen your condition – do not stop unless your doctor tells you to.

Related information

For regular home blood pressure monitoring, see also the Blood pressure monitors category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substances: amlodipine (as amlodipine besilate) 5 mg or 10 mg and valsartan 80 mg or 160 mg per film-coated tablet.
• Tablet core: microcrystalline cellulose; crospovidone (type A); colloidal anhydrous silica; magnesium stearate.
• Film coating: hypromellose; macrogol 4000; talc; titanium dioxide (E171); yellow iron oxide (E172); for 10/160 mg also red iron oxide (E172).
• Pack: box with 2 PVC/PVDC/aluminium blisters of 14 film-coated tablets (28 tablets).
• Marketing authorisation holder: Predstavništvo Novartis Pharma Services Inc. Beograd (Novi Beograd), Omladinskih brigada 90a. Manufacturers: Novartis Farmaceutica S.A., Barcelona (Spain); Novartis Pharma GmbH, Nuremberg (Germany); Novartis Farma S.p.A., Torre Annunziata (Italy).

Storage

• Store below 30 °C, in the original package to protect from moisture.
• Do not use if the pack is damaged or shows signs of tampering. Keep out of the sight and reach of children.
• Shelf life is 3 years. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Why must I not eat grapefruit while taking Exforge?

Grapefruit and grapefruit juice may increase amlodipine levels in the blood, which can cause an unpredictable, stronger lowering of blood pressure. The leaflet therefore explicitly excludes them during treatment.

Is swelling of the legs and ankles normal?

Swelling of the arms, hands, legs, ankles or feet is listed among the common side effects. If it bothers you or lasts more than a week, contact your doctor – do not stop treatment yourself, as this may worsen your condition.

When is Exforge taken – with a meal or not?

One tablet a day, preferably at the same time, with a glass of water. It can be taken with or without food, but not with grapefruit.

Can I take Exforge during pregnancy?

It is not recommended in the first three months and must not be taken after the third month of pregnancy, as it may seriously harm the baby. If you are planning a pregnancy or have become pregnant, your doctor will prescribe another medicine.

Sources

• ALIMS – Summary of Product Characteristics, Exforge® 5/80, 5/160 and 10/160 mg film-coated tablets (SmPC, Serbian)
• ALIMS – Package leaflet, Exforge® film-coated tablets (PIL, Serbian, October 2024)

Sources checked on: 25 October 2026.