Exforge 320 mg Film-Coated Tablets

Your medicine is called EXFORGE and is available as a film-coated tablet. EXFORGE contains amlodipine, a medicine that belongs to the class of calcium channel antagonists and valsartan, which belongs to the class of so-called angiotensin-II receptor antagonists. They both help to control high blood pressure.

What EXFORGE is used for
EXFORGE is used to treat high blood pressure in patients ≥ 18 years old whose blood pressure is not adequately controlled with a single blood pressure lowering medicine. EXFORGE is used in patients whose blood pressure is normalised with the individual components in the same doses as the proposed fixed dose combination of EXFORGE.

How EXFORGE works
Amlodipine blocks calcium channels at the blood vessels. Angiotensin II is a natural substance produced by the body that causes blood vessels to tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result of both mechanisms, blood vessels relax and blood pressure is lowered.

Follow your doctor’s instructions carefully. They may differ from the general instructions contained in this leaflet.

Do not take EXFORGE
• If you have a history of allergies related to taking valsartan, amlodipine and/or other similar types of medicines.
• If you have an unusual sudden onset allergic reaction involving swelling and accumulation of water due to a hereditary or unknown cause.
• If your doctor has diagnosed that you suffer from a narrowing of valves in your heart (called aortic or mitral valve stenosis), or abnormally increased thickness of your heart muscle with narrowing of the left ventricular cavity (called obstructive hypertrophic cardiomyopathy).
• If you suffer from severe liver problems.
• If you have received a kidney transplant or if you had been diagnosed as suffering from a narrowing of your kidney artery or if you are suffering from severe kidney problems.
• If you are taking other medicines or substances, which increase the potassium levels in your blood (such as certain types of diuretics, potassium supplements, etc.).
• If you have porphyria.

• If you are taking lithium (a medicine used to treat some types of depression).
• If you have ever had an unusual or allergic reaction to amlodipine besylate or valsartan or to any other ingredients of EXFORGE listed at the beginning of this leaflet. If you think you may be allergic, ask your doctor for advice.
• If you are pregnant or breastfeeding your baby.
• If you are taking a blood pressure lowering medicine called aliskiren. If either of these apply to you, tell your doctor without taking EXFORGE.

Warnings and precautions
• If you suffer from several episodes of vomiting or diarrhoea or are taking a diuretic (a medicine increasing the amount of urine).
• If you suffer from liver problems.
• If you suffer from mild to moderate kidney problems.
• If you ever had a swelling mainly of the face and throat while taking other medicines (including an ACE-inhibitor). If you get those symptoms, stop taking EXFORGE and contact your doctor immediately. You should never take EXFORGE again.
• If you suffer from heart failure or have experienced a heart attack. Follow your doctor’s instruction for the starting dose carefully. Your doctor may also check your kidney function.

Do not share medicines prescribed for you with any other person. Always take EXFORGE exactly as your doctor has told you. Check with your doctor if you are not sure. It is very important that you take EXFORGE exactly as your doctor tells you in order to get the best results and reduce the risk of side effects. EXFORGE is for oral use only. Do not take more than the recommended dose.

How much EXFORGE to take
Your doctor will tell you exactly how many tablets of EXFORGE to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose. The recommended dose of EXFORGE is one film-coated tablet per day.

When to take EXFORGE
Taking EXFORGE at the same time each day will help you remember when to take your medicine. EXFORGE may be taken with or without food.

How long to take EXFORGE
Continue to take EXFORGE as your doctor tells you. If you have questions about how long to take EXFORGE, talk to your doctor or your pharmacist.

If you take more EXFORGE than you should
If you have accidentally taken too many tablets of EXFORGE, talk to your doctor. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you experience severe dizziness and/or fainting, tell your doctor as quickly as possible.

If you forget to take EXFORGE
Take your medicine at the same time each day, preferably in the morning. If you forget to take EXFORGE, take it as soon as you remember and then take your next dose at its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

If you stop taking EXFORGE
Stopping your treatment with EXFORGE may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.

EXFORGE can have side effects. Not all side effects reported for EXFORGE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EXFORGE, please consult your health care provider for advice.

If any of the following happens, stop taking EXFORGE and tell your doctor immediately or go to the casualty department at your nearest hospital: Some side effects could be serious (frequency unknown: frequency cannot be estimated from the available data)

• swelling of the face, lips, mouth or tongue, which may cause difficulty in swallowing or breathing,
• rash or itching
• Difficulty breathing
• Low blood pressure

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to EXFORGE. You may need urgent medical attention or hospitalisation.

Other possible side effects are:

Frequent:
• Nasal congestion
• Flu-like symptoms
• Sore throat and discomfort when swallowing; swelling of arms, hands, legs, ankles or feet; redness and warm feeling of the face and/or the neck
• Headache
• Tiredness

Less Frequent:
• Anxiety
• Dizziness, tingling or numbness of the hands or feet, vertigo,
• dizziness on standing up

KEEP OUT OF THE REACH OF CHILDREN
Do not store above 30 °C
Store your tablets in the original package
Protect from moisture
Do not use EXFORGE after the expiry date shown on the pack
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).