Candesartan cilexetil 16 mg tablets

• 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.

1. What Candesartan cilexetil is and what it is used for
2. What you need to know before you take Candesartan cilexetil
3. How to take Candesartan cilexetil
4. Possible side effects
5. How to store Candesartan cilexetil
6. Contents of the pack and other information

• if you are allergic to candesartan cilexetil 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 cilexetil 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).
• if the patient is a child under 1 year of age.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

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

Talk to your doctor or pharmacist before taking Candesartan cilexetil.

• 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,
• if you have ever had a stroke,
• you must tell your doctor if you think that you are (or might become) pregnant. Candesartan cilexetil 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).
• if you are taking any of the following medicines used to treat high blood pressure:
  • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
  • aliskiren
• if you are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptors antagonists (MRA). These medicines are for the treatment of heart failure (see “Other medicines and Candesartan cilexetil”).

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in yourblood at regular intervals.

See also information under the heading “Do not take Candesartan cilexetil

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 cilexetil.

This is because Candesartan cilexetil, when combined with some anaesthetics, may cause a drop in blood pressure.

Candesartan cilexetil has been studied in children. For more information, talk to your doctor. Candesartan cilexetil must not be given to children under 1 year of age due to the potential risk to the developing kidneys.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Candesartan cilexetil can affect the way some other medicines work and some medicines can have an effect on Candesartan cilexetil. 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 or 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).

Your doctor may need to change your dose and/or to take other precautions:

• If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Candesartan cilexetil ” and “Warnings and precautions”)
• If you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone).

Candesartan cilexetil can be taken with or without food.

When you are prescribed Candesartan cilexetil, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 cilexetil before you become pregnant or as soon as you know you are pregnant and will advise you to take other medicines instead of Candesartan cilexetil. Candesartan cilexetil 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. Candesartan cilexetil 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.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

The recommended dose of Candesartan cilexetil 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.

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

The recommended starting dose of Candesartan cilexetil 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 cilexetil 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 Candesartan cilexetil than prescribed by your doctor, contact a doctor or a pharmacist immediately for advice.

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

If you stop taking Candesartan cilexetil your blood pressure may increase again. Therefore do not stop taking Candesartan cilexetil without first talking to your doctor.

• 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 cilexetil 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 cilexetil 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.
• Cough.
• 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.

Not known (frequency cannot be estimated from the available data)

• Diarrhoea.

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.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is candesartan cilexetil. Each tablet contains 4 mg, 8 mg, 16 mg or 32 mg candesartan cilexetil.
• The other ingredients are lactose monohydrate, maize starch, dibutyl sebacate, sodium laurilsulfate, hydroxypropylcellulose, carmellose calcium, magnesium stearate and iron oxide red (E172) – (8 mg, 16 mg and 32 mg tablets only)

4 mg tablets are round, white, biconvex tablets, scored on one side, engraved with mark 4.

8 mg tablets are round, pinkish-white, biconvex tablets, scored on one side.

16 mg tablets are round, slightly pink, biconvex tablets, scored on one side. One side of the score line is marked with 1, the other side of the score line is marked with 6.

32 mg tablets are round, slightly pink, biconvex tablets, scored on one side. One side of the score line is marked with 3, the other side of the score line is marked with 2.

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

Boxes of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets in blisters are available.

Not all pack sizes may be marketed.