KANDESAR 16 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Kandesar, 8 mg, tablets
3. Kandesar, 16 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
4. What is Kandesar and what is it used for
5. Important information before taking Kandesar
   1. When not to take Kandesar
   2. Warnings and precautions
   3. Children and adolescents
   4. Kandesar and other medicines
   5. Kandesar with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Pregnancy
   8. Breastfeeding
   9. Driving and using machines
   10. Kandesar contains lactose
   11. Other excipients
6. How to take Kandesar
   1. High blood pressure
   2. Use in children and adolescents
   3. Heart failure
   4. Taking a higher dose of Kandesar than recommended
   5. Missing a dose of Kandesar
   6. Stopping Kandesar
7. Possible side effects
   1. In case of any of the following allergic reactions, the patient should stop taking Kandesar and seek medical help:
   2. Other possible side effects
   3. Additional side effects in children
   4. Reporting side effects
8. How to store Kandesar
9. Contents of the packaging and other information
   1. What Kandesar contains
   2. What Kandesar looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Kandesar, 8 mg, tablets

Kandesar, 16 mg, tablets

Candesartan cilexetil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a 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 the symptoms of their illness 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 in:

• treatment of high blood pressure in adults and in children and adolescents from 6 to 18 years of age,
• 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

Warnings and precautions

Before starting to take Kandesar, the patient should discuss it with their doctor or pharmacist:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren.
• 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 taking 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 in case of 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. The patient should not stop taking Kandesar on their own.

Children and adolescents

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

Kandesar and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

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

• 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 taking 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 in case of mental disorders).

Kandesar with food, drink, and alcohol

• Kandesar can be taken with or without food.
• In case of taking Kandesar, the patient should consult their 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 baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The doctor will usually recommend stopping Kandesar before planned pregnancy or as soon as pregnancy is confirmed, 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

The patient should inform their doctor about breastfeeding or planning 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, drowsiness or dizziness may occur. In such cases, the patient should 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 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, the patient should consult their doctor or pharmacist. It is important to take Kandesar every day.

Kandesar can be taken with or without food.

The tablet should be swallowed with water.

The patient should try to take the tablets at the same time every day. This will help them 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., those with liver or kidney disease, or those 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 of age: 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, the patient should immediately contact their doctor or pharmacist for advice.

Missing a dose of Kandesar

The patient should not take a double dose to make up for a missed tablet. They should take the next dose at the usual time.

Stopping Kandesar

If the patient stops taking Kandesar, their blood pressure may increase again. Therefore, the patient should not stop taking Kandesar without consulting their 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, the patient should stop taking Kandesar and seek medical help:

• difficulty breathing, with swelling of the face, lips, tongue, and/or throat, 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 patient's resistance to infections may be reduced, and they may experience fatigue, infection, or fever. If such symptoms occur, the patient should contact their doctor. The doctor may recommend periodic blood tests to check if Kandesar is affecting the patient's blood parameters (agranulocytosis).

Other possible side effects

Common ( may occur in 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 occur in 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.
• 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 they are not observed in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Kandesar

The medicine should be stored 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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.
• The other ingredients are: lactose monohydrate, corn starch, hypromellose 2910, calcium stearate, hydroxypropyl cellulose, 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 speckling, 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, the patient should 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