Product Details

Product Information of Exforge 5/160mg Tablets

What you need to know before you take Exforge
Do not take Exforge
 if you are allergic to amlodipine or to any other calcium channel blockers. This may involve
itching, reddening of the skin or difficulty in breathing.
 if you are allergic to valsartan or any of the other ingredients of this medicine (listed in
section 6). If you think you may be allergic, talk to your doctor before taking Exforge.
 if you have severe liver problems or bile problems such as biliary cirrhosis or cholestasis.
 if you are more than 3 months pregnant. (It is also better to avoid Exforge in early pregnancy,
see Pregnancy section).
 if you have severe low blood pressure (hypotension).
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 if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition
where your heart is unable to supply enough blood to the body).
 if you suffer from heart failure after a heart attack.
 if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.
If any of the above applies to you, do not take Exforge and talk to your doctor.
Warnings and precautions
Talk to your doctor before taking Exforge:
 if you have been sick (vomiting or diarrhoea).
 if you have liver or kidney problems.
 if you have had a kidney transplant or if you had been told that you have a narrowing of your
kidney arteries.
 if you have a condition affecting the renal glands called “primary hyperaldosteronism”.
 if you have had heart failure or have experienced a heart attack. Follow your doctor’s
instructions for the starting dose carefully. Your doctor may also check your kidney function.
 if your doctor has told you that you have a narrowing of the valves in your heart (called “aortic
or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called
“obstructive hypertrophic cardiomyopathy”).
 if you have experienced swelling, particularly of the face and throat, while taking other
medicines (including angiotensin converting enzyme inhibitors). If you get these symptoms,
stop taking Exforge and contact your doctor straight away. You should never take Exforge
again.
 if you are taking any of the following medicines used to treat high blood pressure:
 an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have
diabetes-related kidney problems.
 aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also information under the heading “Do not take Exforge”.
If any of these apply to you, tell your doctor before taking Exforge.
Children and adolescents
The use of Exforge in children and adolescents is not recommended (aged below 18 years old).
Other medicines and Exforge
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Your doctor may need to change your dose and/or to take other precautions. In some cases
you may have to stop taking one of the medicines. This applies especially to the medicines listed
below:
 ACE inhibitors or aliskiren (see also information under the headings “Do not take Exforge” and
“Warnings and precautions”);
 diuretics (a type of medicine also called “water tablets” which increases the amount of urine you
produce);
 lithium (a medicine used to treat some types of depression);
 potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and
other substances that may increase potassium levels;
 certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or
selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also check your
kidney function;
 anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
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 St. John’s wort;
 nitroglycerin and other nitrates, or other substances called “vasodilators”;
 medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
 medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
 medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin,
talithromycin);
 verapamil, diltiazem (heart medicines);
 simvastatin (a medicine used to control high cholesterol levels);
 dantrolene (infusion for severe body temperature abnormalities);
 medicines used to protect against transplant rejection (ciclosporin).
Exforge with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are taking Exforge. This is
because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active
substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect
of Exforge.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
advise you to stop taking Exforge before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of Exforge. Exforge is not
recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months
pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Amlodipine has been shown
to pass into breast milk in small amounts. Exforge is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if
your baby is newborn, or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may make you feel dizzy. This can affect how well you can concentrate. So, if you are
not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.

How to store Exforge
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use any Exforge pack that is damaged or shows signs of tampering.