Kandesar

Leaflet accompanying the packaging: patient information

Kandesar, 8 mg, tablets

Kandesar, 16 mg, tablets

Candesartan cilexetil

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4. Table of contents of the leaflet:
• 1. What is Kandesar and what is it used for
• 2. Important information before taking Kandesar
• 3. How to take Kandesar
• 4. Possible side effects
• 5. How to store Kandesar
• 6. Contents of the packaging and other information

1. What is Kandesar and what is it used for

The name of the medicine is Kandesar. It contains the active substance candesartan cilexetil, which belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and dilation of blood vessels. This helps to lower blood pressure. It also makes it easier for the heart to pump blood to all parts of the body.

This medicine is used for:

• treatment of high blood pressure in adults and in children and adolescents from 6 to 18 years old,
• treatment of adult patients with heart failure, with reduced heart muscle function, when angiotensin-converting enzyme inhibitors (ACE) cannot be used or as an addition to ACE inhibitor therapy, when symptoms of heart failure persist despite treatment, and mineralocorticoid receptor antagonist (MRA) drugs cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. Important information before taking Kandesar

When not to take Kandesar

• if the patient is allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Kandesar in early pregnancy, see the section "Pregnancy and breastfeeding"),
• if the patient has severe liver disease or bile duct obstruction (impaired bile flow from the gallbladder),
• if the patient is a child under 1 year of age,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren. In case of doubt, whether any of the above situations apply to the patient, before taking Kandesar, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Kandesar, discuss it with your doctor or pharmacist:

• if the patient has heart, liver, or kidney disease or is undergoing dialysis,
• if the patient has recently had a kidney transplant,
• if the patient has vomiting or has recently had severe vomiting or has diarrhea,
• if the patient has a disease of the adrenal glands called Conn's syndrome (also known as primary hyperaldosteronism),
• if the patient has low blood pressure,
• if the patient has had a stroke,
• in case of suspected or planned pregnancy. It is not recommended to take Kandesar in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may be very harmful to the fetus (see the section "Pregnancy and breastfeeding"),
• if the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• if the patient is taking an ACE inhibitor at the same time as certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone). Kandesar may affect the action of some other medicines, and some medicines may affect the action of Kandesar. In the case of certain medicines, the doctor may recommend periodic blood tests. In particular, inform your doctor about taking any of the following medicines:
• other blood pressure-lowering medicines, 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 (pain and inflammation relievers);
• acetylsalicylic acid (in case of a dose greater than 3 g per day) (pain and inflammation relievers);
• potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
• heparin (a medicine used to thin the blood);
• diuretics;
• lithium (a medicine used for mental disorders).

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Kandesar, they should discuss it with their doctor. The doctor will decide on further treatment. Do not stop taking Kandesar on your own.

Children and adolescents

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

Kandesar and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking now or has taken recently, as well as any medicines the patient plans to take.

The doctor may need to change the dose and/or take other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Kandesar" and "Warnings and precautions"),
• if the patient is taking an ACE inhibitor at the same time as certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone). Kandesar may affect the action of some other medicines, and some medicines may affect the action of Kandesar. In the case of certain medicines, the doctor may recommend periodic blood tests.

Kandesar with food, drink, and alcohol

• Kandesar can be taken with or without food.
• When taking Kandesar, consult a doctor before consuming alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

The doctor will usually recommend stopping Kandesar before planned pregnancy or immediately after confirmation of pregnancy and recommend taking another medicine instead of Kandesar. It is not recommended to take Kandesar in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.

Breastfeeding

Inform your doctor about breastfeeding or intending to breastfeed. It is not recommended to take Kandesar during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may recommend taking another medicine.

Driving and using machines

In some people taking Kandesar, fatigue or dizziness may occur. In such cases, do not drive vehicles, use tools, or operate machines.

Kandesar contains lactose

Kandesar 8 mg tablets contain 105.8 mg of lactose monohydrate, and 16 mg tablets contain 74.1 mg of lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Kandesar

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. It is important to take Kandesar every day.

Kandesar can be taken with or without food.

Swallow the tablet with water.

Try to take the tablets at the same time every day. This will help you remember to take them.

High blood pressure

• The recommended dose of Kandesar is 8 mg once a day. The doctor may increase the dose to 16 mg once a day, and then to 32 mg once a day, depending on the blood pressure values obtained.
• In some patients, e.g., with liver or kidney disease, or who have recently lost a lot of fluid, e.g., due to vomiting or diarrhea, or taking diuretics, the doctor may recommend a lower initial dose.
• In some patients of black race, the response to this type of medicine may be weaker, when used alone. In these patients, a higher dose may be necessary.

Use in children and adolescents

Children from 6 to 18 years old: the recommended initial dose is 4 mg once a day.

Patients with a body weight of less than 50 kg: in patients who do not achieve adequate blood pressure control, the doctor may decide to increase the dose to a maximum of 8 mg once a day.

Patients with a body weight of 50 kg or more: in patients who do not achieve adequate blood pressure control, the doctor may decide to increase the dose to 8 mg once a day and then to 16 mg once a day.

Heart failure

The recommended initial dose of Kandesar is 4 mg once a day. The doctor may increase the dose by doubling it, at intervals of at least 2 weeks, to a dose of 32 mg once a day. Kandesar can be taken with other medicines used to treat heart failure; the doctor will decide which treatment is suitable for the patient.

Taking a higher dose of Kandesar than recommended

In case of taking a higher dose of Kandesar than recommended, consult a doctor or pharmacist immediately for advice.

Missing a dose of Kandesar

Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time.

Stopping Kandesar

If the patient stops taking Kandesar, blood pressure may increase again. Therefore, do not stop taking Kandesar without consulting a doctor first.

4. Possible side effects

Like all medicines, Kandesar can cause side effects, although not everybody gets them.

It is important for the patient to know which side effects can occur.

In case of any of the following allergic reactions, stop taking Kandesar and seek medical help immediately:

• difficulty breathing, with swelling of the face, lips, tongue, and/or throat, with or without swelling;
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing;
• severe itching of the skin (with a rash). Kandesar may cause a decrease in the number of white blood cells. The body's resistance to infections may be reduced, and the patient may experience fatigue, infection, or fever. If such symptoms occur, consult a doctor. The doctor may recommend periodic blood tests to check if Kandesar affects blood parameters (agranulocytosis).

Other possible side effects

Common (may affect up to 1 in 10 people):

• Dizziness, feeling of spinning.
• Headache.
• Respiratory tract infection.
• Low blood pressure, which may cause fainting or dizziness.
• Abnormal blood test results:
• Increased potassium levels in the blood, especially if the patient has kidney problems or heart failure. In case of a significant increase in potassium levels, the patient may experience fatigue, weakness, heart rhythm disturbances, or a feeling of tingling and numbness.
• Affecting kidney function, especially if the patient has previously had kidney problems or heart failure. Very rarely, kidney failure may occur.

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

• Swelling of the face, lips, tongue, and/or throat.
• Decrease in the number of red or white blood cells. The patient may experience fatigue, infection, or fever.
• Skin rash, hives (urticaria).
• Itching.
• Back pain, joint and muscle pain.
• Liver function disorders, including hepatitis. The patient may experience fatigue, yellowing of the skin and eyes, and flu-like symptoms.
• Nausea.
• Abnormal blood test results:
• Decreased sodium levels in the blood. In case of a significant decrease in sodium levels, the patient may experience weakness, loss of energy, or muscle cramps.
• Cough
• Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea. Unknown (frequency cannot be estimated from the available data):
• Diarrhea.

Additional side effects in children

In children treated for high blood pressure, side effects seem to be similar to those observed in adults, but they occur more frequently. Sore throat is a very common side effect in children, but it is not observed in adults. Also, runny nose, fever, and increased heart rate are common in children, but not observed in adults.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Kandesar

Keep the medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.

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

6. Contents of the packaging and other information

What Kandesar contains

• The active substance of Kandesar is candesartan cilexetil. Kandesar 8 mg: each film-coated tablet contains 8 mg of candesartan cilexetil. Kandesar 16 mg: each film-coated tablet contains 16 mg of candesartan cilexetil.
• Other ingredients are: lactose monohydrate, cornstarch, hypromellose 2910, calcium stearate, hydroxypropylcellulose, disodium edetate, microcrystalline cellulose, red iron oxide (E 172).

What Kandesar looks like and contents of the pack

Kandesar 8 mg tablets:

Uncoated tablets are pink to reddish-brown with a white speckle, round, biconvex, with a score line on one side and smooth on the other. The tablets can be divided into equal doses.

Kandesar 16 mg tablets:

Uncoated tablets are light pink to pale red, round, biconvex, with a score line on one side and smooth on the other. The tablets can be divided into equal doses.

Package sizes: 10, 14, 28, 30, 50, 56, 60, 98, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark, Finland, Norway, Sweden:

Candesartan Orion

Poland:

Kandesar

Date of last revision of the leaflet:20/01/2025