Candesartan cilexetil Orion 16 mg tabletten

1. WHAT IS AND WHAT IT IS USED FOR

The name of your medicine is <Product name>. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and widen. 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:

• treating high blood pressure (hypertension) in adult patients.
• treating adult heart failure patients with reduced heart muscle function, when used with Angiotensin Converting Enzyme (ACE) inhibitors or when ACE inhibitors cannot be used (ACE inhibitors are a group of medicines used to treat heart failure).

2. BEFORE YOU TAKE

Do not take <Product name> if you

• are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of <Product name> (see section 6).
• are more than 3 months pregnant (it is also better to avoid <Product name> in early pregnancy – see pregnancy section).
• have severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).

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If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking <Product name>.

Take special care with <Product name>

Before you take, or whilst you are taking <Product name>, tell your doctor if you

• have heart, liver or kidney problems, or are on dialysis.
• have recently had a kidney transplant.
• are vomiting, have recently had severe vomiting, or have diarrhoea.
• have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
• have low blood pressure.
• have ever had a stroke.
• think you are (or might become) pregnant. <Product name> 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 <Product name>. This is because <Product name>, when combined with some anaesthetics, may cause a drop in blood pressure.

Use in children

There is no experience with the use of <Product name> in children (below the age of 18 years). Therefore <Product name> should not be given to children.

Taking 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.

<Product name> can affect the way some other medicines work and some medicines can have an effect on <Product name>. 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 <Product name> with food and drink (in particular alcohol)

• You can take <Product name> with or without food.
• When you are prescribed <Product name>, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breast-feeding

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You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking <Product name> before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of <Product name>. <Product name> 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.

Tell your doctor if you are breast-feeding or about to start breast-feeding. <Product name> 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 <Product name>. If this happens to you, do not drive or use any tools or machines.

Important information about some of the ingredients of <Product name>

<Product name> contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE

Always take <Product name> 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 <Product name> every day.

You can take <Product name> 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 <Product name> 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 <Product name> 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. <Product name> 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 <Product name> than you should

If you take more <Product name> than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take <Product name>

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

If you stop taking <Product name>

If you stop taking <Product name>, your blood pressure may increase again. Therefore do not stop taking <Product name> without first talking to your doctor.

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

Like all medicines, <Product name> 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 <Product name> 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)

<Product name> 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 <Product name> 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.
• 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.

5. HOW TO STORE

Keep out of the reach and sight of children.

<Product name> 4 mg, 8 mg: Do not store above 30°C.

<Product name> 16 mg, 32 mg: This medical product does not require any special temperature storage conditions.

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Do not use <Product name> after the expiry date which is stated on the carton or blister pack. The expiry date refers to the last day of that month.

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 <Product name> contains

The active ingredient is:

Candesartan as candesartan cilexetil.

Each film-coated tablet contains 4 mg candesartan as candesartan cilexetil.

Each film-coated tablet contains 8 mg candesartan as candesartan cilexetil.

Each film-coated tablet contains 16 mg candesartan as candesartan cilexetil.

Each film-coated tablet contains 32 mg candesartan as candesartan cilexetil.

The other ingredients are:

Lactose monohydrate

Maize starch

Hypromellose 2910 (E464)

Calciumstearate

Hydroxypropyl cellulose (E463)

Disodium edetate

Microcrystalline cellulose (E460)

For 8 mg, 16 mg and 32 mg additionally: ferric oxide red (E172).

What <Product name> looks like and contents of the pack

<Product name> 4 mg tablets

White to off-white, round, biconvex, uncoated tablets with breakline on one side and plain on the other side. The tablets can be divided into equal halves.

<Product name> 8 mg tablets

Pink to reddish brown colored with whitish mosaic appearance, round, biconvex, uncoated tablets with breakline on one side and plain on other side. The tablets can be divided into equal halves.

<Product name> 16 mg tablets

Light Pink to pale red colored, round, biconvex, uncoated tablets with breakline on one side and plain on other side. The tablets can be divided into equal halves.

<Product name> 32 mg tablets

Light Pink to pale red colored, round, biconvex, uncoated tablets with breakline on both sides. The tablets can be divided into equal halves.

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98, 100 tablets

Not all pack sizes may be marketed.

Marketing authorisation holder

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

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Manufacturer

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

MARKETING AUTHORISATION NUMBER(S)

4 mg: RVG 107860

8 mg: RVG 107861

16 mg: RVG 107862

32 mg: RVG 107863

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

<To be completed nationally>

This leaflet was last approved in januari 2012.

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