Candesartan cilexetil/Hydrochloorthiazide Orion 16 mg/12,5 mg tabletten

1. WHAT IS AND WHAT IT IS USED FOR

The name of your medicine is <Product name>. It is used for treating high blood pressure (hypertension) in adult patients. It contains two active ingredients: candesartan cilexetil and hydrochlorothiazide. These work together to lower your blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blood pressure.

Your doctor may prescribe <Product name> if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. BEFORE YOU TAKE

Do not take <Product name> if:

• you are allergic (hypersensitive) to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of <Product name> (see section 6).
• you are allergic to sulphonamide medicines. If you are not sure if this applies to you, please ask your doctor.
• you are more than 3 months pregnant (it is also better to avoid <Product name> in early pregnancy – see pregnancy section).
• you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gall bladder).
• you have severe kidney problems.
• you have ever had gout.
• you have persistently low levels of potassium in your blood.
• you have persistently high levels of calcium in your blood.

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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 diabetes.
• you have heart, liver or kidney problems.
• you have recently had a kidney transplant.
• you are vomiting, have recently had severe vomiting or have diarrhoea.
• you have a disease of the adrenal gland called Conn’s syndrome (also called primary hyperaldosteronism).
• you have ever had a disease called systemic lupus erythaematosus (SLE).
• you have low blood pressure.
• you have ever had a stroke.
• you have ever had allergy or asthma.
• you must tell your doctor if you 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.

<Product name>may cause increased sensitivity of the skin to sun.

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.

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.

<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 Angiotensin Converting Enzyme (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 3g 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).
• Calcium or Vitamin D supplements.
• Medicines to lower your cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (tablets or insulin).
• Medicines to control your heart beat (antiarryhthmic agents) such as digoxin and beta-blockers.
• Medicines that can be affected by potassium blood levels such as some antipsychotic medicines.
• Heparin (a medicine for thinning the blood).
• Water tablets (diuretics).
• Laxatives.
• Penicillin (an antibiotic).

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• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Steroids such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines to treat cancer.
• Amantadine (for the treatment of Parkinson’s disease or for serious infections caused by viruses).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Carbenoxolone (for treatment of oesophageal disease, or oral ulcers).
• Anticholinergic agents such as atropine and biperiden
• Cyclosporine, a medicine used for organ transplant to avoid organ rejection.
• Other medicines that may lead to enhancement of the antihypertensive effect such as baclofen (a medicine for relief of spasticity), amifostin (used in cancer treatment) and some antipsychotic medicines.

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

Pregnancy

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 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. <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.

Ask your doctor or pharmacist for advice before taking any medicine.

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 which is a type of sugar. If you have been told by doctor that you have an intolerance to some sugars, 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. The usual dose of <Product name> is one tablet once a day.

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.

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.

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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.

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. Some of the side effects of <Product name> are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking <Product name> and seek medical help immediately if you have any of the following allergic reactions

1. difficulties in breathing, with or without swelling of the face, lips, tongue and/or throat
2. swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing
3. 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 less than 1 in 10 patients)

• 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.
  • An increased or reduced 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.
  • An increased amount of cholesterol, sugar, or uric acid in your blood.
• Sugar in your urine.
• Feeling dizzy/spinning sensation or weak.
• Headache.
• Respiratory infection.

Uncommon (affects less than 1 user in 100)

• Low blood pressure. This may make you feel faint or dizzy.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, lumpy rash (hives), rash caused by sensitivity to sunlight.

Rare (affects less than 1 user in 1,000)

• Jaundice (yellowing of the skin or the whites of your eyes). If this happens to you, contact your doctor immediately.
• Effects on how your kidneys work, especially if you have kidney problems or heart failure.
• Difficulty in sleeping, depression, being restless.
• Tingling or prickling in your arms or legs.
• Blurred vision for a short time.
• Abnormal heart beat.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe pain in the stomach.

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• Muscle cramps.
• Damage to blood vessels causing red or purple dots in the skin.
• A reduction in your red or white blood cells or platelets. You may notice tiredness, an infection, fever or easy bruising.
• A severe rash, that develops quickly, with blistering or peeling of the skin and possibly blistering in the mouth.
• Worsening of existing lupus erythaematosus-like reactions or appearance of unusual skin reactions.

Very rare (affects less than 1 user in 10,000)

• Swelling of the face, lips, tongue and/or throat.
• 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.
• Cough.
• Nausea.

If any of the side effects gets 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.

Do not store above 30°C.

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 ingredients in <Product name> are candesartan cilexetil and hydrochlorothiazide.

<Product name> 8 mg/12.5 mg:

One <Product name> tablet contains 8 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

<Product name> 16 mg/12.5 mg:

One <Product name> tablet contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide.

The other ingredients are:

Lactose monohydrate

Maize starch

Hypromellose 2910 (E464)

Calcium stearate

Hydroxypropyl cellulose (E463)

Disodium edetate

Microcrystalline cellulose (E460)

For <Product name> 16 mg/12.5 mg additionally: ferric oxide red (E172), ferric oxide yellow (E172).

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

<Product name> 8 mg/12.5 mg:

White to off white, oval, biconvex, 9.5 x 4.5 mm, bevel edged uncoated tablets with breakline on both sides.

<Product name> 16 mg/12.5 mg:

Peach colored to light orange colored, oval, biconvex, 9.5 x 4.5 mm, bevel edged 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

Manufacturer

Orion Corporation, Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Marketing authorisation numbers

Candesartan cilexetil/Hydrochloorthiazide Orion 8 mg/12,5 mg tabletten: 107850 Candesartan cilexetil/Hydrochloorthiazide Orion 16 mg/12,5 mg tabletten: 107851

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

This leaflet was last approved in July 2011

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