CANDESARTAN CILEXETIL JUBILANT 8 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CANDESARTAN CILEXETIL JUBILANT 8 MG TABLETS

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, 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. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What Candesartan cilexetil tablets is and what it is used for

2. What you need to know before you take Candesartan cilexetil tablets

3. How to take Candesartan cilexetil tablets

4. Possible side effects

5. How to store Candesartan cilexetil tablets

6. Contents of the pack and other information

1. what candesartan cilexetil tablets is and what it is used for

The name of your medicine is Candesartan cilexetil tablets. The active ingredient is candesartan cilexetil. It 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.

Candesartan cilexetil tablets can be used to:

treat high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to 18 years.
treat adult heart failure in 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 when mineralocorticoid receptor antagonists (MRA) cannot be used (ACE-inhibitors and MRAs are medicines used to treat heart failure).

2. what you need to know before you take candesartan cilexetil tablets 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 this medicine in early pregnancy – see “Pregnancy” paragraph).
if you have severe liver disease or biliary obstruction (a problem with 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 tablets.

Warnings and precautions

Talk to your doctor before taking Candesartan cilexetil tablets:

if you have heart, liver or kidney problems;
if you are on dialysis or 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. Candesartan cilexetil tablets 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” paragraph).
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 (see also information under the headings “Other medicines and Candesartan cilexetil tablets” and “Do not take Candesartan cilexetil tablets”);

if you are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRA). These medicines are for the treatment of heart failure (see “Other medicines and Candesartan cilexetil tablets”).

Your doctor may want to see you more often and do some tests if you have any of these conditions. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

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

If you are going to have an operation, tell your doctor or dentist that you are taking Candesartan cilexetil tablets. This is because this medicine, when combined with some anaesthetics, may cause an excessive drop in blood pressure.

Children and adolescents

This medicine can be used in children from the age of 6. For more information, talk to your doctor.

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

Other medicines and Candesartan cilexetil tablets

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

Candesartan cilexetil tablets can affect the way some other medicines work and some medicines can affect Candesartan cilexetil tablets. If you are taking certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell your doctor if you are taking any of the following medicines as your doctor may need to change your dose and/or take other precautions:

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 (aspirin), 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);
Co-trimoxazole (an antibiotic medicine) also known as trimethoprim/sulfamethoxazole;
Water tablets (diuretics);
Lithium (a medicine for mental health problems);
Aliskiren (see also information under the headings “Do not take Candesartan cilexetil tablets” and “Warnings and precautions”);
ACE-inhibitor together with other medicines to treat your heart failure, which are known as mineralocorticoid receptor antagonists (MRA), for example spironolactone or eplerenone.

Candesartan cilexetil tablets with food, drink and alcohol

You can take Candesartan cilexetil tablets with or without food.
When you are prescribed Candesartan cilexetil tablets, 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 cilexetil tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candesartan cilexetil tablets. Candesartan cilexetil tablets 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 tablets 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 Candesartan cilexetil tablets. If this happens to you, do not drive or use any tools or machines.

Candesartan cilexetil tablets contains lactose

Lactose 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.

3. how to take candesartan cilexetil tablets

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 cilexetil tablets every day.

You can take this medicine 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.

The recommended dose

Heart failure in adults:

The recommended starting dose 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 tablets can be taken together with other medicines for heart failure. Your doctor will decide which treatment is suitable for you.

High blood pressure in adults:

The recommended dose 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 your blood pressure response.
In some patients, such as those with liver problems, kidney problems or those who have recently lost body fluids, e.g. through vomiting or diarrhoea or by taking 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 and adolescents aged 6 to 18 years:

The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg: In some patients whose blood pressure is not adequately controlled, the doctor may decide the dose needs to be increased to a maximum of 8 mg once daily.

For patients weighing 50 kg and more: In some patients whose blood pressure is not adequately controlled, the doctor may decide the dose needs to be increased to 8 mg or to 16 mg once daily.

If you take more Candesartan cilexetil tablets than you should

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

If you forget to take Candesartan cilexetil tablets

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 cilexetil tablets

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

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

4. possible side effects

Like all medicines, this medicine 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 Candesartan cilexetil tablets 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 cilexetil tablets 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 Candesartan cilexetil tablets has had any effect on your blood (agranulocytosis).

Other possible side effects:

Common (may affect up to 1 in 10 people)

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

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

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

Diarrhoea

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.
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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store candesartan cilexetil tablets

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, blister pack or bottle. 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 protect the environment.

6. contents of the pack and other information

What Candesartan cilexetil tablets contains

The active ingredient is candesartan cilexetil. The tablets contain 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil.
The other ingredients are hydroxypropyl cellulose, lactose monohydrate, lactose anhydrous, mono and diglycerides, silica colloidal anhydrous, magnesium stearate, maize starch, iron oxide (E172) and carmellose calcium.

What Candesartan cilexetil tablets looks like and contents of the pack

4 mg tablets are pink coloured with white to off white mottled, round shaped, biconvex, uncoated tablets, debossed with ‚D7‘ on one side and breakline on other side having approximate dimensions of diameter 5 mm (±0.2 mm) and thickness 2.30 mm (± 0.50 mm).
8 mg tablets are pink coloured with white to off white mottled, round shaped, biconvex, uncoated tablets, debossed with ‚D8‘ on one side and breakline on other side having approximate dimensions of diameter 6 mm (±0.2 mm) and thickness 3.10 mm (± 0.50 mm).
16 mg tablets are pink coloured with white to off white mottled, round shaped, biconvex, uncoated tablets, debossed with ‚D9‘ on one side and breakline on other side having approximate dimensions of diameter 7.5 mm (±0.3 mm) and thickness 4.20 mm (± 0.50 mm).
32 mg tablets are pink coloured with white to off white mottled, round shaped, biconvex, uncoated tablets, debossed with ‚D10‘ on one side and breakline on other side having approximate dimensions of diameter 9.5 mm (±0.3 mm) and thickness 5.00 mm (± 0.50 mm).

The tablet can be divided into equal doses by breaking along the score line.

Alu-PVC/PVDC blister packs of 7, 14, 28, 56 and 70 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Jubilant Pharmaceuticals nv

Axxes Business Park

Guldensporenpark 22 – Block C

9820 Merelbeke

Belgium

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

PT: Candesartan Jubilant

UK: Candesartan cilexetil tablets

This leaflet was last revised in 06/2018

Detailed and updated information on this product is available by scanning the QR Code included on the inner lid of the carton with a smartphone. The same information is also available on the following URL:.