Kandesar

Package leaflet: Information for the patient

Kandesar, 8 mg, tablets
Kandesar, 16 mg, tablets
candesartan cilexetil
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of the leaflet:
  1. What Kandesar is and what it is 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 package and other information

1. What Kandesar is and what it is used for

The name of the medicine is Kandesar. It contains the active substance candesartan cilexetil, which belongs to a group of medicines known as angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This helps lower blood pressure and makes it easier for the heart to pump blood to all parts of the body.
This medicine is used for:

• treating high blood pressure (hypertension) in adults and in children and adolescents aged 6 to <18 years,
• treating adult patients with heart failure and reduced heart muscle function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on to ACE inhibitor therapy when heart failure symptoms persist despite treatment, and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used in the treatment of heart failure).

2. Important information before using Kandesar

When not to use 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 more than 3 months pregnant (Kandesar should also be avoided in early pregnancy; see section "Pregnancy and breastfeeding"),
• if the patient has severe liver disease or biliary 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.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before taking Kandesar.

Warnings and precautions

Talk to your doctor or pharmacist before starting Kandesar:

• if the patient has heart, liver or kidney disease, or is undergoing dialysis,
• if the patient has recently received a kidney transplant,
• if the patient is experiencing vomiting, has recently had severe vomiting, or has diarrhoea,
• 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 ever had a stroke,
• if pregnancy is suspected (or planned). Kandesar is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may be highly harmful to the unborn child (see section "Pregnancy and breastfeeding"),
• if the patient is taking any of the following medicines used to treat 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 together with a medicine belonging to a group known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Kandesar with other medicines").

Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Kandesar". If any of the above conditions apply, your doctor may recommend more frequent check-ups and specific tests.

If the patient is scheduled for surgery, inform the doctor or dentist about taking Kandesar. This is necessary because Kandesar, when used in combination with certain anaesthetic medicines, may cause low blood pressure.

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Kandesar, discuss this with a doctor. The doctor will decide on further treatment. Do not stop taking Kandesar without medical advice.

Children and adolescents

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

Kandesar with other medicines

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

Your doctor may need to adjust the dose and/or take other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also information under "When not to use Kandesar" and "Warnings and precautions"),
• if the patient is taking an ACE inhibitor together with certain other medicines used to treat heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Kandesar may affect the action of certain other medicines, and some medicines may affect the action of Kandesar. When certain medicines are used, your doctor may recommend periodic blood tests. Especially inform your doctor if the patient is taking any of the following medicines:

• other medicines that lower 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 that relieve pain and inflammation);
• acetylsalicylic acid (if taken at doses above 3 g per day) (medicines that relieve pain and inflammation);
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels);
• heparin (a medicine used to thin the blood);
• diuretics (water tablets);
• lithium (a medicine used for psychiatric disorders).

Kandesar, food, drink and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

The doctor will usually advise stopping Kandesar before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Kandesar is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform the doctor if the patient is breastfeeding or intends to breastfeed. Kandesar is not recommended during breastfeeding. For women planning to breastfeed, especially a newborn or premature infant, the doctor may recommend an alternative medicine.

Driving and using machines

Some people taking Kandesar may experience fatigue or dizziness. In such cases, do not drive, use tools, or operate machinery.

Kandesar contains lactose

Kandesar 8 mg tablets contain 105.8 mg of monohydrated lactose, and 16 mg tablets contain 74.1 mg of monohydrated lactose. If the patient has been previously diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Other excipients

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

3. How to take Kandesar

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. It is important to take Kandesar every day.
Kandesar may be taken during or independently of meals.
Swallow the tablet with water.
Try to take the tablets at the same time each day. This will help you remember to take them.

Hypertension

• The recommended dose of Kandesar is 8 mg once daily. Your doctor may increase the dose to 16 mg once daily, and subsequently to 32 mg once daily, depending on your blood pressure response.
• In some patients, e.g. those with liver or kidney disease, or who have recently lost a large amount of fluid (e.g. due to vomiting, diarrhoea or diuretic therapy), your doctor may prescribe a lower starting dose.
• In some patients of black race, response to this type of medicine may be weaker when used alone. In such patients, a higher dose may be required.

Use in children and adolescents
Children aged 6 to <18 years: the recommended starting dose is 4 mg once daily.
Patients with body weight <50 kg: if adequate blood pressure control is not achieved, your doctor may decide to increase the dose up to a maximum of 8 mg once daily.
Patients with body weight ≥50 kg: if adequate blood pressure control is not achieved, your doctor may decide to increase the dose to 8 mg once daily and subsequently to 16 mg once daily.

Heart failure
The recommended starting dose of Kandesar is 4 mg once daily. Your doctor may increase the dose by doubling it at intervals of at least 2 weeks, up to a dose of 32 mg once daily. Kandesar
may be taken together with other medicines used to treat heart failure; your doctor will decide which treatment is appropriate for you.

Taking more Kandesar than prescribed
If you take more Kandesar than prescribed, contact your doctor or pharmacist immediately for advice.

If you miss a dose of Kandesar
Do not take a double dose to make up for a missed tablet. Take the next dose at your usual time.

Stopping Kandesar
If you stop taking Kandesar, your blood pressure may rise again. Therefore, do not stop taking Kandesar without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur.
If any of the following allergic reactions occur, treatment with Kandesar must be stopped immediately and medical advice must be sought:

• 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 cause difficulty in swallowing;
• Severe skin itching (with rash or hives).

Kandesar may cause a reduction in the number of white blood cells. The body's immunity to infections may be reduced, and the patient may experience fatigue, infection, or fever. If such symptoms occur, the patient should contact a doctor. The doctor may recommend periodic blood tests to monitor whether Kandesar affects blood parameters (agranulocytosis).

Other possible adverse reactions

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

• Dizziness, sensation 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, particularly in patients with impaired kidney function or heart failure. If potassium levels increase significantly, the patient may experience fatigue, weakness, heart rhythm disturbances, or tingling and numbness.
• Effects on kidney function, particularly in patients with pre-existing kidney impairment or heart failure. Renal failure may very rarely occur.

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

• Swelling of the face, lips, tongue, and (or) throat.
• Decreased number of red or white blood cells. The patient may experience fatigue, infection, or fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Liver function disorders, including hepatitis. The patient may experience fatigue, yellowing of the skin and eyes (jaundice), and flu-like symptoms.
• Nausea.
• Abnormal blood test results:
• Decreased sodium levels in the blood. If sodium levels decrease significantly, the patient may experience weakness, loss of energy, or muscle cramps.
• Cough.
• Angioedema of the intestine: intestinal swelling causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (cannot be estimated from available data):

• Diarrhea.

Additional adverse reactions in children
In children treated for high blood pressure, adverse reactions appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common adverse reaction in children, but is not observed in adults. Nasal congestion, fever, and increased heart rate are also common in children, but not observed in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Kandesar

Keep this 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Kandesar contains

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

What Kandesar looks like and contents of the pack
Kandesar 8 mg tablets: Uncoated tablets, pink to reddish-brown in colour with a whitish mosaic pattern, round, biconvex, with a division line on one side and smooth on the other. The tablets can be divided into equal doses.
Kandesar 16 mg tablets: Uncoated tablets, light pink to pale red in colour, round, biconvex, with a division line on one side and smooth on the other. The tablets can be divided into equal doses.

Pack sizes: 10, 14, 28, 30, 50, 56, 60, 98 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Denmark, Finland, Norway, Sweden: Candesartan Orion
Poland: Kandesar