Valsartan

• Lowers blood pressure
• Used to treat patients after a recent heart attack and heart failure
• Also used to treat high blood pressure in children and adolescents
• Not to be used while pregnant or breastfeeding

Valsartan belongs to a class of medicines known as angiotensin II receptor antagonist, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.

Valsartan is used treat:

• High blood pressure in children and adolescents aged 6 to 18 years.
• Adult patients after a recent heart attack (‘recent’ here means between 12 hours and 10 days).
• Symptomatic heart failure in adult patients.

Always take this medicine exactly as your doctor or pharmacist has told you. Valsartan should be taken with a drink of water. The tablet should be taken at the same time each day. This will help you to remember to take it. Valsartan can be taken with or without food.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

Use in children and adolescents (6 to 18 years of age) with high blood pressure:

• In patients who weigh less than 35 kg the usual dose is 40 mg of valsartan once daily.
• In patients who weigh 35 kg or more the usual starting dose is 80 mg of valsartan once daily.

In some cases, your doctor may prescribe higher doses. Valsartan oral solution is recommended for children with difficulty swallowing.

Use in adult patients after a recent heart attack:

After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. If necessary, the doctor may decide to increase this dose (see the package leaflet).

Use in adult patients with heart failure:

Treatment starts generally with 40 mg twice daily. If necessary, the doctor may decide to increase this dose (see the package leaflet).

Alcohol/driving

This medicine does not interact with alcohol.

Valsartan may in rare cases cause dizziness and affect the ability to concentrate. 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.

If you use too much/forget to use/stop using Valsartan

If you accidentally take more Valsartan than you were told to, contact your doctor, pharmacist or hospital immediately.

If you miss a dose, take it as soon as you remember. 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 one.

Do not stop using Valsartan without talking to your doctor.

Valsartan is not suitable for everyone. Do not take this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Valsartan contains').
• You have a severe liver disease.
• You are more than three months pregnant (it is also better to avoid Valsartan in early pregnancy).
• You have diabetes or impaired kidney function and you are treated with a blood pressurelowering medicine containing aliskiren.

When should this medicine be used with caution?

There are situations in which this medicine should be used with caution. These include:

• You have a liver disease.
• You have severe kidney disease or if you are undergoing dialysis.
• You are suffering from a narrowing of the kidney artery.
• You have recently undergone kidney transplantation (received a new kidney).
• You are treated after a heart attack or for heart failure.
• You have severe heart disease other than heart failure or heart attack.
• You are taking medicines that increase the amount of potassium in your blood.
• You are below 18 years of age and take Valsartan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure).
• 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.
• You have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of
• water tablets (diuretics).

See the package leaflet for a full list of situations in which Valsartan should not be used or used with caution. Talk to your doctor or pharmacist before taking Valsartan if any of the above apply to you.

Pregnancy and breastfeeding

Valsartan is not recommended in early pregnancy and must not be taken when more than three months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.

Valsartan is not recommended in breastfeeding mothers.

Other medicines and Valsartan

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. The following medicines are known to interact with Valsartan:

• Other medicines that lower blood pressure, especially water tablets (diuretics).
• Medicines that increase the amount of potassium in your blood.
• Certain type of pain killers called nonsteroidal anti-inflammatory medicines (NSAIDs).
• Lithium.
• Some antibiotics (rifamycin group).
• Medicines used to protect against transplant rejection (e.g., ciclosporin).
• Certain medicines used to treat HIV/AIDS infection (e.g., ritonavir).
• If you are being treated after a heart attack, a combination with ACE inhibitors is not recommended.
• If you are being treated for heart failure, a triple combination with ACE inhibitors and beta blockers is not recommended.
• ACE inhibitors or 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 receptors antagonists (MRA) (e.g., spironolactone, eplerenone) or betablockers (e.g., metoprolol), your doctor may need to change your dose and/or to take other precautions.

See the package leaflet for more information.

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Get emergency medical help if you notice severe side effects, such as signs of an allergic reaction or heart failure (see the package leaflet for symptoms).

Other side effects that are known to be associated with Valsartan include:

Common (may affect up to 1 in 10 people):

• Dizziness.
• Low blood pressure with or without symptoms such as dizziness and fainting when standing up.
• Decreased kidney function (signs of renal impairment).

Uncommon (may affect up to 1 in 100 people):

• Sudden loss of consciousness (syncope).
• Spinning sensation (vertigo).
• Severely decreased kidney function (signs of acute renal failure).
• Muscle spasms, abnormal heart rhythm (signs of hyperkalaemia).
• Headache.
• Coughing.
• Abdominal pain.
• Nausea.
• Diarrhoea.
• Tiredness.
• Weakness.

For a complete list of side effects, see the package leaflet. Consult a doctor if you experience these or other side effects.

The active substance is valsartan. Each film-coated tablet contains 40 mg valsartan.

Read the package leaflet before use. The official package leaflet of Valsartan is available for download here.