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

Read all of this leaflet carefully before you start taking 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 Candesarstad is and what it is used for 
2. What you need to know before you use Candesarstad 
3. How to use Candesarstad 
4. Possible side effects 
5. How to store Candesarstad 
6. Contents of the packaging and other information 

1. What Candesarstad is and what it is used for

The name of your medicine is Candesartan. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II 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.

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

2. What you need to know before using Candesarstad

Do not use Candesarstad

  • if you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant for more than three months (it is also best to avoid Candesarstad during early pregnancy – see the section on pregnancy)
  • if you have severe liver disease or gallbladder 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 Candesarstad.

Warnings and cautions

Talk to your doctor or pharmacist before taking Candesarstad

  • if you have heart, liver, or kidney problems, or are undergoing dialysis .
  • if you have had a recent 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 before.
  • You must tell your doctor if you think you are (or might become) pregnant. Candesartan is not recommended during early pregnancy and you should not take Candesarstad if you are pregnant after the third month, as it can 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 with medicine that belongs to the group of medicines MR antagonist (mineral corticoid receptor antagonist ) These medicines are for the treatment of heart failure (see “Other medicines and Candesarstad”).

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

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

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

Tell your doctor or dentist that you are taking Candesarstad if you are having surgery, as Candesarstad can cause a drop in blood pressure when combined with certain anesthetics.

Children and young people

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 possible risk to the developing kidneys.

Other medicines and Candesarstad

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

Candesartan may affect the way other medicines work, and some medicines may also affect the effect of Candesarstad. Your doctor may need to take blood samples from time to time if you are taking certain medicines.

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

  • 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 that contain 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 Candesarstad” 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 MRagon antagonists (mineral corticoid receptor) (eg spironolactone, eplerenone).

Candesartan with food, drinks, and alcohol

  • You can take Candesarstad with or without food.
  • If you are prescribed Candesarstad, talk to your doctor before drinking alcohol. Alcohol can make you feel dizzy and dizzy.

Pregnancy, breastfeeding, and fertility

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 Candesarstad before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Candesarstad. Candesartan 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. Candesartan is not recommended for breastfeeding mothers and your doctor may choose another treatment for you if you want to breast-feed, especially if your baby is a newborn or born prematurely.

Driving and using machines

Some people may feel tired or dizzy when taking Candesarstad. 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.

Candesartan contains lactose and sodium

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

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

3. How to use Candesarstad

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 Candesarstad every day. You can take Candesarstad with or without food.

Swallow the tablet with a glass of water. The tablet can be divided into equal doses.

Try to take the tablet at the same time each day. It will help you remember to take it.

For dosages that cannot be obtained by Candesarstad, there are more strengths of other drugs available that contain candesartan cilexetil.

Hypertension:

  • The recommended dose of Candesarstad 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 the use of diuretic tablets, your doctor may prescribe a lower starting dose.
  • Some black patients may experience a worse effect of this type of medicine when given as a single treatment and may need a higher dose.

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 and to 16 mg once daily.

Heart failure in adults:

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

Use for children and adolescents

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 and to 16 mg once daily.

If you forget to use Candesarstad

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

If you stop using Candesarstad

If you stop taking Candesarstad, your blood pressure may rise again. Therefore, do not stop taking Candesarstad 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 what these side effects may be.

Stop taking Candesarstad and seek medical help 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 itching of the skin (with raised rash).

Candesartan 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, consult a doctor as soon as possible. Your doctor may take blood samples from time to time to check if Candesarstad 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:
    • An increased amount of potassium in your blood, especially if you already have kidney problems or heart failure. If it is severe, 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.
  • A decrease in red or white blood cell count. You may notice tiredness, infection, or fever.
  • Skin rash, lumpy rash ( hives ).
  • Itching.
  • Back pain, joint pain, and muscle aches.
  • Changes in liver function, including hepatic inflammation ( hepatitis ). You may feel tired, have yellow skin and whites of the eyes, and flu-like symptoms. Cough.
  • Nausea.
  • Changes in blood test results:
    • A reduced amount of sodium in your blood. If it is severe, you may notice weakness, lack of energy, or muscle cramps.

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

  • Diarrhea.

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 Candesarstad

  • 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 or blister after EXP. The expiration date is the last day of the specified month.
  • Do not store above 25 ° C.

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. Each 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 contents of the pack

Candesartan 4 mg tablets are white, biconvex tablets with a scoreline on one side and C4 printed on the same side.

Candesartan 8 mg tablets are white, biconvex tablets with a scoreline on one side and C8 printed on the same side.

Candesartan 16 mg tablets are white, biconvex tablets with a score line on one side and C16 printed on the same side.

Candesartan 32 mg tablets are white, biconvex tablets with a score line on one side and C32 printed on the same side.

The tablet can be divided into two equal doses .

Pack sizes:

4 mg : 7, 10, 14, 28, 30, 50, 56, 90, 98, 100 tablets.

8, 16, 32 mg : 7, 10, 14, 28, 30, 50, 56, 90, 98, 100, 112, 126, 140, 154, 168, 182, 196 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Other manufacturers

Siegfried Malta Ltd, HHF 070 Hal Far Industrial Estate, BBG 3000 Hal Far, Malta.

Centrafarm Services BV, Nieuwe Donk 9, 4879 Etten-Leur, The Netherlands.

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria.

Eurogenerics NV / SA, Heizel Esplanade Heysel b22, 1020 Brussels, Belgium.

Lamp San Prospero SpA, Via Della Pace 25 / A, 41030 Modena, San Prospero, Italy.

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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