Product Details

Product Information of Diovan 80mg

What do you need to know before you take Diovan 80mg
Do not take Valsartan
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in
section 6).
• if you have severe liver disease.
• if you are more than 3 months pregnant (it is also better to avoid Valsartan in early
pregnancy – see pregnancy section).
• if you have diabetes or impaired kidney function and you are treated with a blood pressurelowering medicine containing aliskiren.
If any of these apply to you, do not take Valsartan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan if any of the following apply to you.
• If you have liver disease.
• If you have severe kidney disease or if you are undergoing dialysis.
• If you are suffering from a narrowing of the kidney artery.
• If you have recently undergone kidney transplantation (received a new kidney).
• If you are treated after a heart attack or for heart failure, your doctor may check your kidney
function.
• If you have severe heart disease other than heart failure or heart attack.
• If you have ever experienced swelling of the tongue, throat and face caused by an allergic
reaction called angioedema when taking another drug (including ‘ACE inhibitors’), tell your
doctor. If these symptoms occur when you are taking valsartan, stop taking valsartan
immediately and do not take it again. See also section 4 of this leaflet ‘Possible side effects’.
• If you are taking medicines that increase the amount of potassium in your blood. These
include potassium supplements or salt substitutes containing potassium, potassium-sparing
medicines and heparin.
• If you suffer from aldosteronism. This is a disease in which your adrenal glands make too
much of the hormone aldosterone. If this applies to you, the use of Valsartan is not
recommended.
• If you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of
water tablets (diuretics).
• 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.

If you are being treated with an ACE inhibitor together with certain other medicines to treat
your heart failure, which are known as mineralocorticoid receptor antagonists (MRA) (for
example spironolactone, eplerenone) or beta-blockers (for example matoprolol).
• You must tell your doctor if you think you are (or might become) pregnant. Valsartan is not
recommended in early pregnancy, and must not be taken if you are more than 3 months
pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy
section).
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 Valsartan’.
Children and adolescents
If you are below 18 years of age and you take Valsartan in combination with other medicines that
inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor
may check your kidney function and the amount of potassium in your blood at regular intervals.
Other medicines and Valsartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The effect of the treatment can be influenced if Valsartan is taken together with certain other
medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop
taking one of the medicines. This applies to both prescription and non-prescription medicines,
especially:
• other medicines that lower blood pressure, especially water tablets (diuretics), ACE
inhibitors or aliskiren.
• medicines that increase the amount of potassium in your blood. These include potassium
supplements or salt substitutes containing potassium, potassium-sparing medicines and
heparin.
• certain type of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).
• some antibiotics (rifamycin group), a drug used to protect against transplant rejection
(ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These
drugs may increase the effect of Valsartan.
• lithium, a medicine used to treat some types of psychiatric illness.
In addition:
• if you are being treated after a heart attack, a combination with ACE inhibitors (a
medication to treat heart attack) is not recommended.
• if you are being treated for heart failure, a triple combination with ACE inhibitors and
beta blockers (medications to treat heart failure) is not recommended.
Your doctor may need to change your dose and/or to take other precautions:
• if you are taking an ACE inhibitor or aliskiren (see also information under the headings ‘Do
not take Valsartan’ and ‘Warnings and precautions’)
• if you are being treated with an ACE inhibitor together with certain other medicines to treat
your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for
example spironolactone, eplerenone) or beta-blockers (for example metoprolol).
Valsartan with food and drink
You can take Valsartan with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking this medicine.
• You must tell your doctor if you think that you are (or might become) pregnant. Your
doctor will normally advise you to stop taking Valsartan before you become pregnant or as
soon as you know you are pregnant, and will advise you to take another medicine instead of
Valsartan. Valsartan is not recommended in early pregnancy, and must not be taken when
more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the
third month of pregnancy.
• Tell your doctor if you are breast-feeding or about to start breast-feeding. Valsartan is
not recommended for mothers who are breast-feeding, 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.
Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require
concentration, make sure you know how Valsartan affects you. Like many other medicines used to
treat high blood pressure, Valsartan may in rare cases cause dizziness and affect the ability to concentrate