The name of your medicine is Candeza. 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 for your heart to pump blood to all parts of your body.

This medicine is used to:

·         Treat high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years.

·         Treat adult heart failure patients with reduced heart muscle function when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE-inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE-inhibitors and MRAs are medicines used to treat heart failure).

a.      Do not take Candeza:

·    If you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Candeza (see section 6).

·    If you are more than 3 months pregnant (it is also better to avoid Candeza 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).

·         Candeza should not be administered with aliskiren in patients with diabetes mellitus or renal impairment.

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

b.      Take special care with Candeza:

Before you take, or whilst you are taking Candeza, tell your doctor.

·         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 you are (or might become) pregnant. Candeza 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).

Dual blockade of the renin-angiotensin-aldosterone system (RAAS):

Combination therapy of ACEI (Angiotensin Converting Enzyme inhibitors) and ARB (Angiotensin II Receptor Blocker) drugs may cause an increased risk of hyperkalemia, worsening of the kidney function and hypotension. Therefore, this combination should not be used, especially in patients with kidney problems.

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

Use in children

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

c.       Other medicines and Candeza:

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

Candeza can affect the way some other medicines work and some medicines can have an effect on Candeza. 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).

·         Acetyl salicylic 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).

·         Heparin (a medicine for thinning the blood).

·         Water tablets (diuretics).

·         Lithium (a medicine for mental health problems).

·         Dual Renin-Angiotensin-Aldosterone System (RAAS) blockade:

-        The combination of aliskiren with ARBs (Angiotensin II Receptor Blockers) or ACEIs (Angiotensin Converting Enzyme inhibitors) is contraindicated in patients with diabetes mellitus or renal impairment.

-        Dual blockade (e.g. by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should not be used, especially in patients with kidney problems.

d.      Taking Candeza with food and drink (in particular alcohol)

·    You can take Candeza with or without food.

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

e.       Pregnancy and breast-feeding

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Candeza 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 new-born, or was born prematurely.

f.        Driving and using machines

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

g.      Important information about some of the ingredients of Candeza

Candeza contains lactose which is a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Always take Candeza 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 Candeza every 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.

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

·    High blood pressure:

·    The usual dose of Candeza 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 whorecently 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.

Heart failure:

·    The usual starting dose of Candeza 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. Candeza 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 Candeza than you should

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

If you forget to take Candeza

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

If you stop taking Candeza

If you stop taking Candeza, your blood pressure may increase again. Therefore do not stop taking Candeza 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, Candeza can cause side effects, although not everybody gets them. It is important that you are aware of what these side effects may be.

Stop taking Candeza 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)

Candeza may cause a reduction in the 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 Candeza 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.

•        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.

•        Cough.

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 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 this medicine out of the sight and reach of children.

·                                Store below 30°C. Store in the original pack.

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

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