Candesartan cilexetil Pluspharma 16 mg, tabletten

Do not take Candesartan +pharma

• if you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Candesartan +pharma (see section 6).
• if you are more than 3 months pregnant (it is also better to avoid Candesartan +pharma in early pregnancy – see pregnancy section).

• if you have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Candesartan +pharma.

Take special care with Candesartan +pharma

Before you take, or whilst you are taking Candesartan +pharma, tell your doctor.

• if you have heart, liver or kidney problems, or are on dialysis.
• if you have recently had a kidney transplant.
• if you are vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• you must tell your doctor if you think you are (or might become) pregnant. Candesartan +pharma 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 want to see you more often and do some tests if you have any of these conditions.

If you are going to have an operation, tell your doctor or dentist that you are taking Candesartan +pharma. This is because Candesartan +pharma, when combined with some anaesthetics, may cause a drop in blood pressure.

Use in children

There is no experience with the use of Candesartan +pharma in children (below the age of 18 years). Therefore Candesartan +pharma should not be given to children.

Using other medicines

Please tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including medicines obtained without a prescription.

Candesartan +pharma can affect the way some other medicines work and some medicines can have an effect on Candesartan +pharma. If you are using certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell your doctor if you are using any of the following 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).

Taking Candesartan +pharma with food and drink (in particular alcohol)

• You can take Candesartan +pharma with or without food.
• When you are prescribed Candesartan +pharma, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

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 Candesartan +pharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan +pharma. Candesartan +pharma 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 used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candesartan +pharma 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

Some people may feel tired or dizzy when taking Candesartan +pharma. If this happens to you, do not drive or use any tools or machines.

Important information about some of the ingredients of Candesartan +pharma

Candesartan +pharma contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Candesartan +pharma exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important to keep taking Candesartan +pharma every day.

You can take Candesartan +pharma with or without food. Swallow the tablet with a drink of water.

Try to take the tablet at the same time each day. This will help you to remember to take it.

High blood pressure:

• The usual dose of Candesartan +pharma 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.
• In some patients, such as those with liver problems, kidney problems or those who recently have lost body fluids, e.g., through vomiting or diarrhoea or by using water tablets, the doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine, when given as the only treatment, and these patients may need a higher dose.

Heart failure:

• The usual starting dose of Candesartan +pharma is 4 mg once a day. Your doctor may increase your dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Candesartan +pharma can be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

If you take more Candesartan +pharma than you should

If you take more Candesartan +pharma than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take Candesartan +pharma

Do not take a double dose to make up for a forgotten tablet. Just take the next dose as normal.

If you stop taking Candesartan +pharma

If you stop taking Candesartan +pharma, your blood pressure may increase again. Therefore do not stop taking Candesartan +pharma without first talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Candesartan +pharma can cause side effects, although not everybody gets them. It is important that you are aware of what these side effects may be.

Stop taking Candesartan +pharma and seek medical help immediately if you have any of the following allergic reactions:

• difficulties in breathing, with or without swelling of the face, lips, tongue and/or throat
• swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing
• severe itching of the skin (with raised lumps)

Candesartan +pharma may cause a reduction in 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. Your doctor may occasionally do blood tests to check whether Candesartan +pharma has had any effect on your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• 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 heart beat 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 (affects less than 1 user in 10,000)

• 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.
• Cough.
• 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.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Keep out of the reach and sight of children.
• Do not use Candesartan +pharma after the expiry date which is stated on the carton box and blister. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Candesartan +pharma contains

• The active substance is 4 mg, 8 mg, 16 mg, 32 mg candesartan cilexetil per tablet
• The other ingredients are maize starch, lactose monohydrate, triethyl citrate (E 1505), hydroxypropylcellulose (E 463), croscarmellose sodium (E 468), magnesium stearate (E 572).

What Candesartan +pharma looks like and contents of the pack

Candesartan +pharma tablets are white, round, biconvex tablets with a notch on one side and embossed on the same side. The tablets can be divided into equal halves.

The tablets are provided in a carton box with blisters containing 14, 28 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorization Holder +pharma arzneimittel GmbH Hafnerstraße 211

8054 Graz

Oostenrijk

Manufacturer 1

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate

BBG 3000 Hal Far

Malta

Manufacturer 2

Genericon Pharma Gesellschaft mbH

Hafnerstrasse 211, 8054 Graz

Oostenrijk

This medicinal product is authorised in the Member States of the EEA under the following names:

Deze bijsluiter is goedgekeurd in februari 2012