PACKAGE LEAFLET: INFORMATION FOR THE USER

Silardaf HCT 8 mg/12.5 mg tablets Silardaf HCT 16 mg/12.5 mg tablets Silardaf HCT 32 mg/12.5 mg tablets Silardaf HCT 32 mg/25 mg tablets

Candesartan cilexetil/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. Y ou may need to read it again.

-    If you have any further questions, 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 signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4..

What is in this leaflet

1.    What Silardaf HCT is and what it is used for

2.    What you need to know before you take Silardaf HCT

3.    How to take Silardaf HCT

4.    Possible side effects

5    How to store Silardaf HCT

6.    Contents of the pack and other information

1.    What Silardaf HCT is and what it is used for

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

2.    What you need to know before you take Silardaf HCT Do not take Silardaf HCT if:

-    you are allergic (hypersensitive) to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of Silardaf HCT (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 Silardaf HCT in early pregnancy - see pregnancy section).

-    you have severe kidney problems.

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

-    you have persistently low levels of potassium in your blood.

-    you have persistently high levels of calcium in your blood.

-    you have ever had gout.

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

Take special care with Silardaf HCT

Before you take, or whilst you are taking Silardaf HCT, 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. Silardaf HCT 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 Silardaf HCT. This is because Silardaf HCT, when combined with some anaesthetics, may cause a drop in blood pressure.

Silardaf HCT may cause increased sensitivity of the skin to sun.

Use in children

There is no experience with the use of Silardaf HCT in children (below the age of 18 years). Therefore Silardaf HCT 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. Silardaf HCT can affect the way some other medicines work and some medicines can have an effect on Silardaf HCT. 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 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.

•    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).

•    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 Silardaf HCT with food and drink (in particular alcohol)

•    You can take Silardaf HCT with or without food.

•    When you are prescribed Silardaf HCT, 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 Silardaf HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Silardaf HCT. Silardaf HCT 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. Silardaf HCT 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 Silardaf HCT. If this happens to you, do not drive or use any tools or machines.

Important information about some of the ingredients of Silardaf HCT

Silardaf HCT 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 Silardaf HCT

Always take Silardaf HCT 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 Silardaf HCT every day.

The usual dose of Silardaf HCT is one tablet once a day Swallow the tablet with a drink of water.

The score line in 8 mg/12.5 mg tablets, 32 mg/12.5 mg tablets and 32 mg/25 mg tablets is only there to help you break the tablet if you have difficulty swallowing it whole.

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

If you take more Silardaf HCT than you should

If you take more Silardaf HCT than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take use Silardaf HCT

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

If you stop taking Silardaf HCT

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

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

4. Possible side effects

Like all medicines, Silardaf HCT 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 Silardaf HCT are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking Silardaf HCT 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).

Silardaf HCT 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 Silardaf HCT has had any effect on your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

•    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 heartbear 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.

•    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 j oints 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.

Not Known (frecuency cannot be stimated from the available data)

•    Sudden Shortsightedness

•    Sudden eye pain (acute angle-closure glaucoma)

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.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Silardaf HCT

•    Keep this medicine out of the sight and reach of children.

•    This medicinal product does not require any special storage conditions.

•    Do not use Silardaf HCT after the expiry date which is stated on the carton, blister pack or bottle. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What Silardaf HCT contains

The active substances are: Candesartan and Hydrochlorthiazide

The tablets contain either 8 mg, 16 mg or 32 mg of candesartan cilexetil and either 12.5 mg or 25 mg of hydrochlorothiazide.

The other excipients are:

Silardaf    HCT    8 mg/12.5    mg    tablets    Hydroxypropyl    Cellulose    (HPC-L),    Lactose

Monohydrate, Maize Starch, Diethylene glycol monoethyl ether (Transcutol), Magnesium Stearate, Calcium Carmellose.

Silardaf    HCT    16    mg/12.5    mg    tablets    Hydroxypropyl    Cellulose    (HPC-L),    Lactose

Monohydrate, Maize Starch, Diethylene glycol monoethyl ether (Transcutol), Magnesium Stearate, Calcium Carmellose, Ferric Oxid Red (E-172), Ferric Oxid Yellow (E-172).

Silardaf    HCT    32    mg/12.5    mg    tablets    Hydroxypropyl    Cellulose    (HPC-L),    Lactose

Monohydrate, Maize Starch, Diethylene glycol monoethyl ether (Transcutol), Magnesium Stearate, Calcium Carmellose, Ferric Oxid Yellow (E-172).

Silardaf    HCT    32    mg/25    mg    tablets    Hydroxypropyl    Cellulose    (HPC-L),    Lactose

Monohydrate, Maize Starch, Diethylene glycol monoethyl ether (Transcutol), Magnesium Stearate, Calcium Carmellose, Ferric Oxid Red (E-172), Ferric Oxid Yellow (E-172).

What Silardaf HCT looks like and contents of the pack

Candesartan cilexetil/ hydrochlorothiazide 8 mg/12.5 mg tablets are scored oblong tablets with white colour.

Candesartan cilexetil/ hydrochlorothiazide 16 mg/12.5 mg tablets are oblong tablets with orange colour.

Candesartan cilexetil/ hydrochlorothiazide 32 mg/12.5 mg tablets are scored oblong tablets with yellow colour.

Candesartan cilexetil/ hydrochlorothiazide 32 mg/25 mg tablets are scored oblong tablets with orange colour.

Silardaf HCT is supplied in Aluminium-PVC (treated with PE/PVDC).

Pack sizes: 7, 14, 15, 28, 28x1 (single dose unit), 30, 50, 50x1 (single dose unit), 56, 56x1 (single doses unit) 98, 98x1 (single dose unit), 100 and 300 tablets

Not all the pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Laboratorios Liconsa, S.A.

Gran Via Carlos III, 98, 7th floor 08028 - Barcelona, Spain

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, n° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara)

Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

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

The Netherlands:	Silardaf HCT 8/12.5 mg tabletten Silardaf HCT 16/12.5 mg tabletten Silardaf HCT 32/12.5 mg tabletten Silardaf HCT 32/25 mg tabletten
Spain:	Silardaf HCT 16 mg/12,5 mg comprimidos EFG Silardaf HCT 32 mg/12,5 mg comprimidos EFG Silardaf HCT 32 mg/25 mg comprimidos EFG
United Kingdom:	Silardaf HCT 8 mg/12,5 mg tablets Silardaf HCT 16 mg/12,5 mg tablets Silardaf HCT 32 mg/12,5 mg tablets Silardaf HCT 32 mg/25 mg tablets
Germany:	Candesartan/HCT Heumann 8 mg/12,5 mg Tabletten Candesartan/HCT Heumann 16 mg/12,5 mg Tabletten Candesartan/HCT Heumann 32 mg/12,5 mg Tabletten Candesartan/HCT Heumann 32 mg/25 mg Tabletten

This leaflet was last revised in October/2013.

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