4 mg, 8 mg, 16 mg and 32 mg tablets 
candesartan cilexetil

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Candexetil is and what it is used for 
2. What you need to know before you take Candexetil 
3. How to take Candexetil 
4. Possible side effects 
5. How to store Candexetil 
6. Contents of the packaging and other information 

1. What Candexetil is and what it is used for

The name of your medicine is Candexetil. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It causes your blood vessels to relax and dilate. This will help you lower your blood pressure. It also makes it easier for the heart to pump blood to all parts of the body.

Candexetil can be used to:

  • treat high blood pressure ( hypertension ) in adult patients and in children and adolescents aged 6 to 18 years.
  • treat adult patients with heart failure and reduced heart muscle function when ACE inhibitors (angiotensin-converting enzyme inhibitors) can not be used or in addition to ACE inhibitors when symptoms persist despite treatment and the MR antagonist s (mineralkortikoidreceptor- antagonist s) can not be used. ( ACE inhibitors and MR antagonists are medicines used to treat heart failure ).

Candesartan cilexetil contained in Candexetil may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Candexetil

Do not take Candexetil

  • 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 three months pregnant (it is also best to avoid Candexetil during early pregnancy – see the section on pregnancy).
  • if you have severe liver disease or bile obstruction (problems with bile drainage from the gallbladder).
  • if the patient is a child under 1 year of age.
  • if you have diabetes or renal impairment and are being 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 Candexetil.

Warnings and cautions

Talk to your doctor or pharmacist before taking Candexetil

  • if you have heart, liver, or kidney problems, or are undergoing dialysis.
  • if you have recently had a kidney transplant.
  • if you have vomiting or have recently had severe vomiting or have diarrhea.
  • if you have an adrenal disease called Conn’s syndrome (also called primary hyperaldosteronism).
  • if you have low blood pressure.
  • if you have had a stroke ( stroke ).
  • You must tell your doctor if you think you are (or might become) pregnant. Candexetil is not recommended during early pregnancy and you should not take Candexetil if you are pregnant after the third month, as it may seriously harm your baby if used during this stage of pregnancy (see the section on pregnancy).
  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
    • aliskiren.
  • if you are taking an ACE inhibitor together with a medicine that belongs to the group of medicines MR antagonist er (mineral corticoid receptor antagonist er). These medicines are for the treatment of heart failure (see “Other medicines and Candexetil”).

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

See also the information under the heading “Do not take Candexetil”.

Your doctor may want to see you more often and take some samples if you have any of the above conditions.

Tell your doctor or dentist that you are taking Candexetil if you are going to have surgery. Candexetil, which is taken at the same time as some anesthetics, may lower your blood pressure.

Children and young people

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

Other medicines and Candexetil

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Candexetil may affect the way other medicines work, and some medicines may also affect the way Candexetil works. Your doctor may need to take blood samples from time to time, change your dose, or take other precautions if you are taking certain medicines.

If you are taking any of the following medicines, tell your doctor in particular:

  • Other medicines that help you lower your blood pressure such as 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 that relieve pain and inflammation).
  • Acetylsalicylic acid (if you take more than 3 g per day) (medicines that relieve pain and inflammation ).
  • Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood).
  • Heparin (a blood thinner).
  • Trimethoprim/sulfamethoxazole (a combination of antibiotics ).
  • Diuretics ( diuretics ).
  • Lithium (a medicine for mental health problems).
  • If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Candexetil” and “Warnings and precautions”).
  • If you are being treated with an ACE inhibitor together with certain other medicines that you are taking to treat your heart failure, which is called MR antagonists (mineral corticoid receptor) (eg spironolactone, eplerenone).

Candexetil with food, drink, and alcohol

You can take Candexetil with or without food.

If you are being prescribed Candexetil, talk to your doctor before drinking alcohol. Some people who drink alcohol and take Candexetil may experience fainting and dizziness.

Pregnancy and breastfeeding

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 usually advise you to stop taking Candexetil before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Candexetil. Candexetil is not recommended during early pregnancy and should not be taken if you are pregnant after the third month, as it can seriously harm your baby if used after the third month of pregnancy.

Breast-feeding 
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Candexetil is not recommended for breastfeeding mothers and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn or born prematurely.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Candexetil contains lactose

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

Candexetil contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Candexetil

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

It is important to take Candexetil every day. 
You can take Candexetil with or without food. 
Swallow the tablet with a glass of water. 
Try to take the tablet at the same time each day. It will help you remember to take it.

Hypertension:

  • The recommended dose of Candexetil is 8 mg once a day. Your doctor may increase the dose one up to 16 mg once a day and a further up to 32 mg once a day depending on how your blood pressure is affected.
  • For some patients who have liver or kidney problems or those who have recently lost body fluids, for example through vomiting, diarrhea, or those taking diuretic tablets, the doctor may prescribe a lower starting dose.
  • Some black patients may respond less well to this type of medication when given as the only treatment. These patients may therefore need a higher dose.

Heart failure:

  • The recommended starting dose of Candexetil is 4 mg once a day. Your doctor may increase the dose by one by doubling the dose at least 2 weeks apart up to 32 mg once a day. Candexetil can be taken with other medicines for heart failure and your doctor will decide which treatment is right for you.

Use in children and adolescents with high blood pressure

Children aged 6 to 18 years:

The recommended starting dose is 4 mg once daily.

For patients weighing less than 50 kg: In some patients with unsatisfactory blood pressure control, your doctor may decide that your dose needs to be increased to a maximum of 8 mg once daily.

For patients weighing 50 kg or more: In some patients with unsatisfactory blood pressure control, your doctor may decide that your dose needs to be increased to 8 mg once daily or to 16 mg once daily.

The tablet can be divided into two equal doses.

If you forget to take Candexetil

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

If you stop taking Candexetil

If you stop taking Candexetil, your blood pressure may rise again. Therefore, do not stop taking Candexetil without talking to your doctor first.

If you have any further questions on the use of this product, 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 the side effects that may occur.

Stop taking Candexetil and seek medical attention immediately if you get any of the following allergic reactions:

  • difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat
  • swelling of the face, lips, tongue, and/or throat, which may make it difficult to swallow
  • severe skin itching (with swelling of the skin).

Candexetil may cause a decrease in the number of white blood cells. Your resistance to infection may deteriorate and you may feel tired, have an infection or fever. If this happens, you should see a doctor as soon as possible so that blood tests can check whether Candexetil has had any effect on your blood ( agranulocytosis ).

Other possible side effects are:

Common (may affect up to 1 in 10 people)

  • Feeling of dizziness.
  • Headache.
  • Respiratory tract infection.
  • Low blood pressure. This can make you feel dull and dizzy.
  • Changes in blood test results:
    • The increased amount of potassium in your blood, especially if you already have kidney problems or heart failure. If this is a significant change, you may notice fatigue, weakness, irregular heartbeat, or ant crawling.
  • Impact on kidney function, 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)

  • Swelling of the face, lips, tongue, and/or throat.
  • The decrease in red or white blood cell count. You may notice tiredness, infection, or fever.
  • Skin rash, itchy lumpy rash ( hives ).
  • Itching.
  • Back pain, joint pain, and muscle aches.
  • Changes in liver function, including liver inflammation ( hepatitis ). You may feel tired, have yellow skin and whites of the eyes, and flu-like symptoms.
  • Nausea.
  • Cough.
  • Changes in blood test results:
    • A reduced amount of sodium in your blood. If there is a noticeable change, you may notice weakness, lack of energy, or muscle cramps.

Has been reported (occurs in an unknown number of users)

  • Diarrhea.

Additional side effects are in children

The side effects in children treated for high blood pressure appear to be comparable to those observed in adults, but they occur more frequently. 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 side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Candexetil

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 after “EXP” and on the blister after “Exp”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is candesartan cilexetil. One tablet contains 4 mg, 8 mg, 16 mg, or 32 mg candesartan cilexetil
  • The other ingredients are lactose monohydrate, corn starch, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, and triethyl citrate.

What the medicine looks like and the contents of the pack

Candexetil is a white, biconvex tablets with a notch on one side and the embossing C4, C8, C16, or C32 on the same side.

Blister packs Pack sizes 
: 7, 10, 14, 28, 30, 56, 70, 90, 98 tablets.

Jars Pack 
sizes: 100, 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

ratiopharm GmbH 
Graf-Arco Strasse 3 
89079 Ulm 
Germany

Manufacturer

Siegfried Malta Ltd.

HHF070 Hal Far Industrial Estate

BBG 3000 Hal Far

Malta

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany


Muhammad Nadeem

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