Candepres

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Candepres (Candesartan 1A Pharma 32 mg Tabletten)
32 mg, tablets
Candesartanum cilexetili
Candepres and Candesartan 1A Pharma 32 mg Tabletten are different brand names of the same
medicinal product.
Please read this leaflet carefully before using 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, 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, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Candepres is and what it is used for
2. Important information 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 to ACE inhibitor treatment when symptoms persist despite such 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 during 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 to the patient, consult a doctor or pharmacist before using Candepres.

Warnings and precautions

Talk to a 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 had severe vomiting, or has 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), especially if the patient has kidney disease due to diabetes
  • aliskiren
• is taking an ACE inhibitor together with a medicine from a 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 be highly harmful to the unborn child (see section on pregnancy).
The doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium). See also 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, the patient should 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 effect of candesartan cilexetil in children has been studied. Further information should 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 the developing kidneys.

Candepres with other medicines

Tell the doctor or pharmacist about all medicines currently taken or 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 about 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 salt substitutes containing potassium (medicines that increase blood potassium levels);
• heparin (a medicine that prevents blood clotting);
• co-trimoxazole (an antibiotic), also known as trimethoprim with sulfamethoxazole;
• diuretics (water tablets);
• 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 in the treatment of 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, the patient should 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 the 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 during early pregnancy is not recommended, and must not be used after the 3rd month of pregnancy, as it may be highly harmful to the unborn child.

Breastfeeding
Inform the doctor if the patient is breastfeeding or intends to breastfeed.
Use of Candepres is not recommended during breastfeeding. For patients planning to breastfeed, especially of a newborn or premature infant, the doctor may choose another suitable medicine.

Driving and operating machinery
Some people taking Candepres may experience fatigue or dizziness. In such cases, the patient should not drive, use tools or operate machinery.

Candepres contains lactose monohydrate
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

Candepres contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Candepres

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. It is important to take the medicine every day.
Candepres is available in the following doses: 8 mg, 16 mg and 32 mg.
Candepres may be taken independently of meals.
Tablets should be swallowed with water.
Tablets should be taken daily at approximately the same time. 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, smooth surface (e.g. on a tabletop or on a plate) with the dividing groove facing upwards, then press quickly and firmly 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. Your doctor may increase the dose to 16 mg once daily, and subsequently to 32 mg once daily, depending on the response to treatment.
• Some patients, e.g. those with impaired liver function, impaired kidney function, or those who have recently lost a large amount of fluid (due to vomiting or diarrhoea, or taking diuretics) may be prescribed a lower starting dose by the doctor.
• In black patients, the response to this type of medicine may be weaker when used alone (so-called monotherapy). A higher dose of the medicine may be required.

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: in patients in whom adequate blood pressure control has not been achieved, the doctor may increase the dose up to a maximum of 8 mg once daily.
• Patients with body weight ≥ 50 kg: in patients in whom adequate blood pressure control has not been 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 type of treatment is most suitable for the patient.

Taking more Candepres than prescribed
If you have taken more Candepres than prescribed, seek immediate advice from your doctor or pharmacist.
Missed dose of Candepres
Do not take a double dose to make up for a forgotten 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 this medicine without consulting your doctor.
If you have any further doubts concerning 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 reactions may occur.
If any of the following allergic reactions occur, stop using the medicine 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 in swallowing;
• severe skin itching (with a lumpy rash).

The medicine Candepres may cause a decrease in the number of white blood cells, which weakens 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 is affecting 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
• headache
• 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
• decreased number of red or white blood cells. The patient may feel tired, and may experience infections or fever.
• 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 determined 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, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Candepres

Keep the medicine out of the sight and reach of children.
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.
Store in the original packaging to protect from moisture.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B./Verwendbar bis: siehe Prägung - Batch number/expiry date: see imprint.
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 Candepres contains

• The active substance is candesartan cilexetil. Each tablet contains 32 mg of candesartan cilexetil.
• The other ingredients are: lactose monohydrate, 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
Pink, mottled, round, biconvex tablet with the imprint "32" on one side and a dividing groove on the other side.
Aluminium/Aluminium foil blisters in a cardboard carton containing 30 or 60 tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Austria, the country of export:
1A Pharma GmbH
1020 Vienna, Austria
Manufacturer:
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D, 9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50C, 02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Austria (country of export) marketing authorization number: 1-28445
Parallel import licence number: 389/22