Candesartan

• Used to treat high blood pressure and heart failure
• Can cause dizziness
• Avoid drinking alcohol while taking this medicine
• Not to be used while pregnant or breastfeeding

Candesartan contains the active ingredient candesartan cilexetil, which belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening your blood vessels. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

This medicine is used for high blood pressure and to treat adult heart failure patients with reduced heart muscle function, sometimes in combination with another medicine.

Always take this medicine exactly as your doctor has told you. Candesartan tablets should be swallowed whole with a drink of water, without chewing. You can take Candesartan with or without food. Try to take the tablet at the same time each day. This will help you to remember to take it.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The recommended dose in adults is:

For high blood pressure:

• The recommended dose is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and further up to 32 mg once a day depending on blood pressure response.

For heart failure:

• The recommended starting dose is 4 mg once a day. Your doctor may increase your dose by doubling the dose at intervals of at least two weeks up to 32 mg once a day.

Candesartan can be taken together with other medicines for heart failure. Your doctor will decide which treatment is suitable for you.

See the package leaflet for more information. This medicine is not suitable for use in children.

Alcohol/driving

Candesartan can cause dizziness and sleepiness. Do not drive if you experience these side effects.

Avoid drinking alcohol while taking this medicine as this is likely to trigger or worsen the side effects.

Taken too much/forgot to take/stop taking Candesartan

If you take more Candesartan tablets than prescribed by your doctor, contact your doctor or pharmacist.

If you have forgotten to take a dose, do not take a double dose to make up for a forgotten tablet. Skip the missed dose and take the next dose as normal.

If you stop taking Candesartan, your blood pressure may increase again. Therefore, do not stop taking Candesartan without consulting your doctor first.

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

• You are allergic to candesartan cilexetil or any of the ingredients in this medicine (see section 'What Candesartan contains').
• You are more than three months pregnant. It is also better to avoid Candesartan in early pregnancy (see section ‘Pregnancy and breastfeeding’).
• You have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).

When should this medicine be used with caution?

Regular check-ups by your doctor may be necessary in some cases. Talk to your doctor before taking Candesartan if:

• You have heart, liver or kidney problems, or are on dialysis.
• You have recently had a kidney transplant.
• You are vomiting, have recently vomited, or have diarrhoea.
• You have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
• You have low blood pressure.
• You have ever had a stroke.
• You are going to have an operation. Tell your doctor or dentist that you are taking Candesartan. This is because Candesartan, when combined with some anaesthetics, may cause an excessive drop in blood pressure.

Pregnancy and breastfeeding

You must tell your doctor if you think that you are (or might become) pregnant. Candesartan is not recommended in early pregnancy and must not be taken if you are more than three months pregnant. This medicine may cause serious harm to your baby if used after the third month of pregnancy.

Candesartan is not recommended for mothers who are breastfeeding. Your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely. Tell your doctor if you are breastfeeding.

Other medicines and Candesartan

Candesartan and some medicines may interfere with each other. Talk to your doctor if you are taking any of these medicines:

• Other medicines to help lower your blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines to relieve pain and inflammation).
• Acetylsalicylic acid if you are taking more than 3 g each day (medicine to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine for thinning the blood).
• Water tablets (diuretics).
• Lithium (a medicine for mental health problems).

Please tell your doctor or pharmacist if you are taking or have recently taken any of these or other medicines, including herbal remedies and medicines obtained without a prescription.

Medicines can cause side effects, although some people may not experience any. The side effects that are known to be associated with Candesartan include:

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

• Feeling dizzy/spinning sensation.
• Headache.
• Respiratory infection.
• Low blood pressure. This may make you feel faint or dizzy.
• Changes in blood test results (an increased amount of potassium in your blood, especially if you already have kidney problems or heart failure. If this is severe you may notice tiredness, weakness, irregular heartbeat or pins and needles.
• Effects on how your kidneys work, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect less than 1 in 10,000 users):

• Swelling of the face, lips, tongue and/or throat.
• A reduction in your red or white blood cells. You may notice tiredness, an infection or a fever.
• Skin rash, lumpy rash (hives), itching.
• Back pain, pain in joints and muscles.
• Changes in how your liver is working, including inflammation of the liver (hepatitis). You may notice tiredness, yellowing of your skin and the whites of your eyes and flu-like symptoms.
• Nausea.
• Changes in blood test results (a reduced amount of sodium in your blood). If this is severe then you may notice weakness, lack of energy, or muscle cramps.
• Coughing.

Candesartan may cause a reduction in the number of white blood cells. Your resistance to infection may be decreased and you may notice tiredness, an infection or a fever. If this happens contact your doctor.

If the side effects are severe or if you get any side effects that are not listed in the package leaflet, talk to your doctor or pharmacist. Stop taking Candesartan and seek medical help immediately if you have an allergic reaction (see the package leaflet for more information).

The active substance in Candesartan Cilexetil Actavis is candesartan cilexetil. Each tablet contains 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil. The other ingredients are: lactose monohydrate, maize starch, hydroxypropyl cellulose, carmellose calcium, magnesium stearate, triethyl citrate.

The manufacturers of Candesartan Cilexetil Actavis are:

Siegfried Malta Ltd HHF070 Hal Far Industrial Estate
P.O. Box 14
Hal Far BBG 3000
Malta

Actavis Group PTC ehf. Reykjavíkurvegi 76-78
IS-220 Hafnarfjörður
Iceland

Read the package leaflet before use.