Candepres

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Candepres (Candesartan HEXAL)
32 mg, tablets
Candesartanum cilexetili
Candepres and Candesartan HEXAL are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Candepres is and what it is used for
2. What you need to know before taking Candepres
3. How to take Candepres
4. Possible side effects
5. How to store Candepres
6. Contents of the pack and other information

1. What Candepres is and what it is used for

This medicine is called Candepres. It contains the active substance candesartan cilexetil, which belongs to a group of medicines known as angiotensin II receptor antagonists. Candepres causes relaxation and widening of blood vessels, which helps lower blood pressure. It also helps the heart pump blood to all parts of the body more easily.

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 impaired heart muscle function, when angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as add-on therapy in combination with ACE inhibitors when symptoms persist despite treatment, and mineralocorticoid receptor antagonists (MRA) cannot be used. ACE inhibitors and MRAs are medicines used in the treatment of heart failure.

2. Important information before using Candepres

When not to use Candepres

• if the patient is allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is more than 3 months pregnant (Candepres is also best avoided in early pregnancy – see section “Pregnancy and breastfeeding”);
• if the patient has severe liver disease or biliary obstruction (a condition affecting bile drainage from the gallbladder);
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• in children under 1 year of age.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using Candepres.
Warnings and precautions
Talk to your doctor or pharmacist before taking Candepres if the patient:

• has heart, liver or kidney problems, or is undergoing dialysis;
• has recently undergone a kidney transplant;
• has vomiting or has recently experienced severe vomiting or diarrhoea;
• has an adrenal gland disorder (Conn’s syndrome, also known as primary hyperaldosteronism);
• has low blood pressure;
• has previously had a stroke;
• is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney disease due to diabetes
• aliskiren
• is taking an ACE inhibitor together with a medicine from the group known as mineralocorticoid receptor antagonists (MRAs). These medicines are used in the treatment of heart failure (see “Candepres with other medicines”).

If the patient is pregnant (or might become pregnant), it is essential to inform the doctor.
Candepres is not recommended during early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use during this period may severely harm the unborn child (see section on pregnancy).
The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also the information in the section “When not to use Candepres”.
If any of the above conditions apply, the doctor may recommend more frequent check-ups and certain tests.
If the patient is due to undergo surgery, inform the doctor or dentist about taking Candepres, as the medicine, when used together with certain anaesthetics, may cause excessive lowering of blood pressure.
Children and adolescents
The effects of candesartan cilexetil in children have been studied. Further information can be obtained from the doctor.
Candepres must not be used in children under 1 year of age due to the risk of harmful effects on developing kidneys.
Candepres with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Candepres may affect the action of certain other medicines, and some medicines may affect the action of Candepres. If the patient is taking certain medicines, the doctor may consider periodic blood tests necessary.
Especially inform the doctor if the patient is taking any of the following medicines, as the doctor may need to adjust the dose and/or recommend additional 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 (medicines that relieve pain and inflammation);
• acetylsalicylic acid, if taken at doses exceeding 3 g per day (a medicine that relieves pain and inflammation);
• potassium supplements or potassium-containing salt substitutes (medicines that increase blood potassium levels);
• heparin (a medicine that prevents blood clotting);
• co-trimoxazole, also known as trimethoprim with sulfamethoxazole (an antibiotic);
• diuretics;
• lithium (a medicine used to treat psychiatric disorders);
• an ACE inhibitor or aliskiren (see also information in sections “When not to use Candepres” and “Warnings and precautions”);
• an ACE inhibitor together with certain other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone).

Candepres with food, drink and alcohol

• Candepres may be taken independently of meals.
• If the patient is taking Candepres, consult the doctor before consuming alcohol. Alcohol may cause fainting or dizziness.

Pregnancy and breastfeeding
Pregnancy
If the patient suspects she is (or might be) pregnant, she must inform her doctor. The doctor will usually advise stopping Candepres before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Candepres is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may severely harm the unborn child.
Breastfeeding
Inform the doctor if the patient is breastfeeding or intends to start breastfeeding. Use of Candepres is not recommended during breastfeeding. For patients planning to breastfeed, especially of a newborn or premature infant, the doctor may choose a different suitable medicine.
Driving and using machines
Some people taking Candepres may experience fatigue or dizziness. In such cases, do not drive, use tools or operate machinery.
Candepres contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.
Candepres contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered “sodium-free”.
3. How to take Candepres
Always take this medicine exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist. It is important to take the medicine every day.
Candepres may be taken independently of meals.
Swallow the tablets with water.
Take the tablets at approximately the same time each day. This will help the patient remember to take the medicine.
Tablet splitting
If necessary, the tablet may be divided into equal doses. To do this, place the tablet on a hard, flat surface (e.g. a table top or plate) with the dividing groove facing upwards, then press firmly and briefly with two index fingers (or thumbs) on both sides of the dividing groove.

High blood pressure

• The recommended dose of Candepres is 8 mg once daily. The doctor may increase the dose to 16 mg once daily, and subsequently to 32 mg once daily, depending on the response to treatment.
• For some patients, e.g. those with impaired liver or kidney function, or patients who have recently lost large amounts of fluid (due to vomiting or diarrhoea, or due to diuretic use), the doctor may prescribe a lower starting dose.
• In patients of black race, the response to this type of medicine may be weaker when used alone (in so-called monotherapy). A higher dose may therefore be necessary.

Use in children and adolescents with high blood pressure
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, the doctor may 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, the doctor may increase the dose to 8 mg once daily, and subsequently, if necessary, to 16 mg once daily.

Heart failure

• The recommended starting dose of Candepres is 4 mg once daily. The doctor may double the dose at intervals of at least 2 weeks, up to a dose of 32 mg once daily. Candepres may be taken together with other medicines used in the treatment of heart failure, and the doctor will decide which treatment is most appropriate for the patient.

Taking more Candepres than recommended
If more Candepres than recommended has been taken, seek immediate advice from a doctor or pharmacist.
If a dose of Candepres is missed
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Candepres
If the patient stops taking Candepres, blood pressure may rise again. Therefore, do not stop taking the medicine without consulting the doctor.
If there are any further questions about the use of this medicine, consult the 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 that the patient knows which reactions may occur.
If any of the following allergic reactions occur, stop taking
Candepres and seek immediate 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 skin itching with a rash.

Candepres may reduce the number of white blood cells, weakening the body's resistance
to infections. The patient may feel tired, and infections or
fever may occur. In such a case, contact a doctor who will order blood tests
to check whether Candepres affects the patient's blood (agranulocytosis).
Other possible adverse reactions
Common (may occur in fewer than 1 in 10 people taking the medicine):

• dizziness, sensation of spinning
• headaches
• respiratory tract infections
• low blood pressure (which may cause fainting or dizziness)
• changes in blood test results:
• increased potassium levels in the blood, especially in patients with impaired kidney function or heart failure. If potassium levels are very high, the patient may experience fatigue, weakness, irregular heartbeat, or tingling.
• effects on kidney function, especially in patients with impaired kidney function or heart failure. Very rarely, kidney failure may occur.

Very rare (may occur in fewer than 1 in 10,000 people taking the medicine):

• swelling of the face, lips, tongue and (or) throat
• reduced number of red or white blood cells. The patient may feel tired, and infections or fever may occur.
• skin rash, urticaria
• itching
• back pain, joint and muscle pain
• changes in liver function, including hepatitis. The patient may feel tired, may develop yellowing of the skin and whites of the eyes, and flu-like symptoms.
• nausea
• changes in blood test results:
• decreased sodium levels in the blood. If sodium levels are very low, the patient may experience weakness, lack of energy, or muscle cramps.
• cough.

Frequency not known (frequency cannot be estimated from available data):

• diarrhoea.

Additional adverse reactions in children and adolescents
Adverse reactions in children treated for high blood pressure appear to be
similar to those observed in adults, but occur more frequently. Sore throat as an adverse
reaction occurs very commonly in children, while nasal discharge, fever and increased heart rate occur commonly. These reactions have not been reported in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Candepres

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number / expiry date – see embossing.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Candepres contains

• The active substance is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.
• Other ingredients are: monohydrate lactose, corn starch, povidone K 30, carrageenan, sodium croscarmellose, magnesium stearate, iron oxide red (E 172), titanium dioxide (E 171).

What Candepres looks like and contents of the pack
Candepres is a pink, mottled, round, biconvex tablet, embossed with the symbol “32” on one side and a dividing score line on the other.
Al/Al blisters in a cardboard box: 28, 56 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany
Manufacturer:
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Germany, the country of export: 68566.00.00
Parallel import authorisation number: 110/23