Document: leaflet CONSILIENT HEALTH (UK)_PL 01656-0102 change

• leaflet CONSILIENT HEALTH (UK)_PL 01656-0102
• leaflet MAH GENERIC_PL 01656-0102

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CONSILIENT HEALTH ta.

Candesartan/Hydrochlorothiazide 8mg/12.5 mg tablets Candesartan/Hydrochlorothiazide 16mg/12.5 mg tablets Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets

Candesartan cilexetil/Hyd rochlorothiazide

Read all of this leaflet carefully before you start taking

this medicine.

•    Keep this leaflet.You may need to read it again.

•    Ifyou have any further guestions,ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Candesartan/Hydrochlorothiazide is and what it is used for

2.    Before you take Candesartan/Hydrochlorothiazide

3.    How to take Candesartan/Hydrochlorothiazide

4.    Possible side effects

5.    How to store Candesartan/Hydrochlorothiazide

6.    Further information

The name of your medicine is Candesartan/Hydrochlorothiazide. 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 Candesartan/Hydrochlorothiazide if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone.

Do not take Candesartan/Hydrochlorothiazide

•    ifyou are allergic (hypersensitive) to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of Candesartan/Hydrochlorothiazide (see section 6).

•    ifyou are allergic to sulphonamide medicines. Ifyou are not sure if this applies to you, please ask your doctor.

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

•    ifyou have severe kidney problems.

•    ifyou have ever had gout.

•    if you have persistently low levels of potassium in your blood,

•    ifyou have persistently high levels of calcium in your blood.

•    ifyou are more than 3 months pregnant (it is also better to avoid Candesartan/Hydrochlorothiazide in early pregnancy -see pregnancy section).

Ifyou are not sure if any of these apply to you, talk to your doctor

or pharmacist before taking Candesartan/Hydrochlorothiazide.

Take special care with Candesartan/Hydrochlorothiazide

•    ifyou have diabetes.

•    ifyou have heart, liver or kidney problems.

•    ifyou have recently had a kidney transplant.

•    ifyou are vomiting, have recently been vomiting a lot, or have diarrhoea.

•    ifyou have a disease of the adrenal gland called Conn's syndrome (also called primary hyperaldosteronism).

•    if you have ever had a disease called systemic lupus erythematosus (SLE).

•    if you have low blood pressure.

•    if you have ever had a stroke.

•    if you have ever had allergy or asthma.

Your doctor may want to see you more often and do some tests if you have any of these conditions.

You must tell your doctor if you think you are (or might become) pregnant. Candesartan/Hydrochlorothiazide 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).

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

Candesartan/Hydrochlorothiazide may cause increased sensitivity oftheskinto sun.

Use in children

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

Taking other medicines

Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription. Candesartan/Hydrochlorothi-azide can affect the way some other medicines work and some medicines can have an effect on Candesartan/Hydrochlorothi-azide tablets. Ifyou are using certain medicines, your doctor may need to do blood tests from time to time.

It particularly, tell your doctor ifyou are taking 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 (ifyou 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).

•    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 (antiarrhythmic agents) such as digoxin and beta-blockers.

•    Heparin (a medicine for thinning the blood).

•    Water tablets (diuretics).

•    Laxatives.

•    Penicillin (an antibiotic).

•    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 esophageal 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 Candesartan/Hydrochlorothiazide with food and

drink (in particular alcohol)

•    You can take Candesartan/Hydrochlorothiazide with or without food.

•    Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

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

Pregnancy

You must tell your doctor ifyou think you are (or might become) pregnant.Your doctor will normally advise you to stop taking Candesartan/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan/Hydrochlorothi-azide. Candesartan/Hydrochlorothiazide 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.

Breastfeeding

Tell your doctor ifyou are breast-feeding or about to start breast-feeding. Candesartan/Hydrochlorothiazide is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you ifyou 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/ Hydrochlorothiazide. If this happens to you, do not drive or use any tools or machines.

Important information about some of the ingredients of Candesartan/Hydrochlorothiazide

Candesartan/Hydrochlorothiazide 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 medicinal product.

Always take Candesartan/Hydrochlorothiazide 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/Hydrochlorothiazide every day.

The usual dose of Candesartan/Hydrochlorothiazide 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 Candesartan/Hydrochlorothiazide than you should

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

If you forget to take Candesartan/Hyd rochlorothiazide

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/Hydrochlorothiazide

If you stop taking Candesartan/Hydrochlorothiazide, your blood pressure may increase again.Therefore do not stop taking Candesartan/Hyd rochlorothiazide without first talking to your doctor.

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

Like all medicines,Candesartan/Hydrochlorothiazide 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 Candesartan/Hydrochlorothiazide are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

These side effects may occur with certain freguencies, which are defined as follows:

Stop taking Candesartan/Hydrochlorothiazide 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/Hydrochlorothiazide 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 tell your doctor. Your doctor may occasionally do blood tests to check whether Candesartan/Hydrochlorothiazide has had any effect on your blood (agranulocytosis).

Other possible side effects include:

Common

•    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

•    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

•    Jaundice (yellowing of your 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 already 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.

•    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 guickly, with blistering or peeling of the skin and possibly blistering in the mouth.

•    Worsening of existing lupus erythematosus like reactions or appearance of unusual skin reactions.

Very rare

•    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.

Keep out of the reach and sight of children.

Do not use Candesartan/Hydrochlorothiazide after the expiry date which is stated on the packaging.The expiry date refers to the last day of that month.

Tablets packaged in blisters of PVC/PVDC film and aluminium foil:

Do not store above 30°C.

Tablets packaged in blisters of laminated OPA/AI/PVC foil and aluminium foil:

This medicinal product does not reguire 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 reguired.These measures will help to protect the environment.

WhatCandesartan/Hydrochlorothiazide contains

•    The active substances are candesartan cilexetil and hydrochlorothiazide.

Each tablet contains 8 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.

Each tablet contains 16 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.

Each tablet contains 32 mg candesartan cilexetil and 25 mg hydrochlorothiazide.

Each tablet contains 32 mg candesartan cilexetil and 12.5 mg hydrochlorothiazide.

•    The other ingredients are lactose monohydrate, maize starch, macrogol 8000, hydroxypropylcellulose, carmellose calcium, magnesium stearate, red iron oxide (E172) only for

16 mg/12.5 mg and 32 mg/25 mg and yellow iron oxide (E172) only for 32 mg/12.5 mg.

WhatCandesartan/Hydrochlorothiazide looks like and contents of the pack

Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets are white, biconvex, oval, with a score on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into egual doses. Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets are pale pink, biconvex, oval, with a score on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into egual doses.

Candesartan/Hyd rochlorothiazide 32 mg/12.5 mg tablets are yellowish white, biconvex, oval, with a score on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into egual doses. Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets are pale pink, biconvex, oval, with a score on one side.

The tablet can be divided into egual halves.

Boxes of 14,15,28,30,56,60,84,90,98 tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Krka d.d.,Smarjeska cesta 6,8501 Novo mesto, Slovenia

Distributed by: Consilient Health (UK) Ltd, 500 Chiswick High Road, London, W45RG

This leaflet was last revised in March 2011