PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN RANBAXY 2/4/8/16 mg tablets

Candesartan cilexetil

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

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

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. 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 CANDESARTAN RANBAXY is and what it is used for

2.    What you need to know before you take CANDESARTAN RANBAXY

3.    HowtotakeCANDESARTAN RANBAXY

4.    Possible side effects

5.    Howto store CANDESARTAN RANBAXY

6.    Contents of the pack and other information

can have an effect on CANDESARTAN RANBAXY. 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 forthinning the blood).

« Water tablets (diuretics).

•    Lithium (a medicine for mental health problems).

CANDESARTAN RANBAXY with food and drink (in particular alcohol)

needs to be increased to 8 mg once daily and to 16 mg once daily.

For Heart Failure:

« The usual starting dose of CANDESARTAN RANBAXY 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 RANBAXY can betaken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

Method of Administration:

You can take CANDESARTAN RANBAXY 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.

DON'T    DO

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 CANDESARTAN RANBAXY

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT CANDESARTAN RANBAXY IS AND WHAT IT IS USED FOR

The name of your medicine is CANDESARTAN RANBAXY. 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 foryour heart to pump blood to all parts of your body.

This medicine is used for:

•    treating high blood pressure (hypertension) in adult patients and in childeren and adolescents aged 6 to <18 years.

•    treating adult heart failure patients with reduced heart muscle function, in addition to 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDESARTAN RANBAXY

DO NOT take CANDESARTAN RANBAXY

•    if you are allergic to candesartan or any of the other ingredients of this medicine (listed in section 6).

•    If you are more than 3 months pregnant, (it is also better to avoid CANDESARTAN RANBAXY 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).

•    ifthe patient is a child under 1 yearofage.

If you are not sure if any of these apply to you, talk

to your doctor or pharmacist before taking

CANDESARTAN RANBAXY.

. You can take CANDESARTAN RANBAXY with or without food.

• When you are prescribed CANDESARTAN RANBAXY, 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 RANBAXY before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of CANDESARTAN RANBAXY. CANDESARTAN RANBAXY 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 if you are breast-feeding or about to start breast-feeding. CANDESARTAN RANBAXY is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was bom prematurely.

Driving and using machines

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

CANDESARTAN RANBAXY contains lactose

CANDESARTAN RANBAXY 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.

If you take more CANDESARTAN RANBAXY than you should

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

If you forget to take CANDESARTAN RANBAXY

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

If you stop taking CANDESARTAN RANBAXY

If you stop taking CANDESARTAN RANBAXY, your blood pressure may increase again. Therefore do not stop taking CANDESARTAN RAN BAXY without first talking to you r doctor.

If you have any furtherquestionson the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Warnings and precautions

Talk to your doctor or pharmacist before taking CANDESARTAN RANBAXY.

•    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.

•    ifyouhaveeverhadastroke.

•    you must tell your doctor if you think you are (or might become! pregnant. CANDESARTAN RANBAXY 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 RANBAXY. This is because CANDESARTAN RANBAXY, when combined with some anaesthetics, may cause a drop in blood pressure.

Children and adolescents

Candesartan has been studied in children. For more information, talk to your doctor.

Candesartan must not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Other medicines and CANDESARTAN RANBAXY

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

CANDESARTAN RANBAXY can affect the way some other medicines work and some medicines

3. HOWTOTAKE CANDESARTAN RANBAXY

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important to keep taking CANDESARTAN RANBAXY every day.

You can take CANDESARTAN RANBAXY 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.

For dosages, which cannot be achieved with CANDESARTAN RANBAXY tablets other strengths of candesartan cilexetil containing medicinal products are available.

For High blood pressure:

•    The usual dose of CANDESARTAN RANBAXY 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.

Use in children and adolescents with high blood pressure:

Children 6 to <18 years of age:

The recommended starting dose is 4 mg once daily.

For patients weighing < 50 kg: In some patients whose    blood    pressure    is    not    adequately

controlled, your doctor may decide the dose needs to be increased to a maximum of 8 mg once daily.

For patients weighing > 50 kg: In some patients whose    blood    pressure    is    not    adequately

controlled, your doctor may decide the dose

Like all medicines, CANDESARTAN RANBAXY can cause side effects, although not everybody gets them.

It is important that you are aware of what these side effects may be.

Serious side effects

Stop taking CANDESARTAN RANBAXY 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 RANBAXY 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 RANBAXY has had any effect on your blood (agranulocytosis).

Otherside effects

Common (may affect up to 1 inlOpeople)

« 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.

What CANDESARTAN RANBAXY contains

-    The active substance is candesartan cilexetil. Each tablet contains either 2 mg, 4 mg, 8 mg or 16 mg of candesartan cilexetil.

-    The other ingredients are:

CANDESARTAN RAN BAXY 2 ma:

Carmellose calcium, Hyprolose, Lactose monohydrate, Magnesium stearate, Maize starch, Macrogol 6000.

CANDESARTAN RANBAXY 4 mo. 8 mo and 16 ma:

Carmellose calcium, Hyprolose, Iron oxide red (E172), Lactose monohydrate, Magnesium stearate, Maize starch, Macrogol 6000

What CANDESARTAN RANBAXY looks like and contents of the pack

CANDESARTAN RANBAXY2 ma:

White capsule-shaped tablets debossed with 'C8' on one side and deep breakline on the otherside.

CANDESARTAN RANBAXY4 ma:

Pink capsule-shaped tablets debossed with 'C9' on one side and deep breakline on the otherside.

CANDESARTAN RANBAXY8 ma:

Pink capsule-shaped tablet with 'C' & '10' debossed on either side of breakline on one side and breakline on otherside.

CANDESARTAN RANBAXY 16 ma:

Pink capsule-shaped tablet with 'C' & '1T debossed on either side of breakline on one side and breakline on otherside.

CANDESARTAN RANBAXY tablets are available jn:

plastic blister pack

packsizes: 7,14,15,20,28,30,50,56,90,98,100

Not all packsizes maybe marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder: Ranbaxy (UK) Limited, Building 4, Chiswick Business Park, 566 Chiswick High Road, London W4 5YE, United Kingdom

Manufacturer:

Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co. Tipperary, Ireland

Basics GmbH, Hemmelratherweg 201, D-51377 Leverkusen, Germany

Terapia SA, 124 Fabricii Street, 400 632 Cluj Napoca, Romania

This leaflet was last revised in February 2014.

Very rare (may affect up to 1 in 10,000 people)

•    Swelling of the face, lips, tongue and/orthroat.

« A reduction in your red or white blood cells. You

may notice tiredness, an infection ora 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.

Additional side effects in children and adolescents

In children treated for high blood pressure, side effects appear to be similar to those seen in adults, but they happen more often. Sore throat is a very common side effect in children but not reported in adults and runny nose, fever and increased heart rate are common in children but not reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible

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

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

-    If you have any further questions, askyour doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if Iheirsigns 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.