Candepres

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Candepres (Candesartan 1A Pharma 32 mg Tablets)

32 mg, tablets

Candesartan cilexetil
Candepres and Candesartan 1A Pharma 32 mg Tablets are different trade names for the same medicine.

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Candepres and what is it 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 is Candepres and what is it used for

The medicine is called Candepres. It contains the active substance - candesartan cilexetil, which belongs to a group of so-called angiotensin II receptor antagonists. Candepres causes relaxation and dilation of blood vessels, which 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 (hypertension) in adults and children and adolescents from 6 to <18 years of age;< li>
• treatment of adult patients with heart failure, with reduced heart muscle function, when ACE inhibitors cannot be used or as adjunctive therapy during treatment with ACE inhibitors, when symptoms of the disease persist despite treatment, and mineralocorticoid receptor antagonists (MRA) cannot be used. ACE inhibitors and MRA are medicines used to treat heart failure.

2. Important information before taking Candepres

When not to take Candepres

• 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 better not to take Candepres in early pregnancy - see the section on "Pregnancy and breastfeeding");
• if the patient has severe liver disease or bile duct obstruction (a disorder of 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.

In case of doubt as to whether any of the above situations apply to the patient, the doctor or pharmacist should be consulted before taking Candepres.

Warnings and precautions

Before starting treatment with Candepres, the doctor or pharmacist should be consulted,

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 diarrhea;
• has adrenal gland disease (Conn's syndrome, also known as primary hyperaldosteronism);
• has low blood pressure;
• has had a stroke in the past;
• is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease
• aliskiren
• is taking an ACE inhibitor along with a mineralocorticoid receptor antagonist (MRA) for heart failure treatment (see "Candepres and other medicines")

If the patient is pregnant (or may become pregnant), the doctor should be informed.
Candepres is not recommended in early pregnancy and is contraindicated after the 3rd month of pregnancy, as its use at this time may be very harmful to the fetus.
The doctor may recommend regular checks of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also the information in the section "When not to take Candepres".
If any of the above points apply to the patient, the doctor may recommend more frequent check-ups and performance of certain tests.
If the patient is to undergo surgery, they should inform their doctor or dentist about taking Candepres, as the medicine used in combination with certain anesthetics may cause excessive lowering of blood pressure.

Children and adolescents

The action of candesartan cilexetil in children has been studied. Further information will be provided by the doctor.
Candepres should not be used in children under 1 year of age due to the risk of harmful effects on the developing kidneys.

Candepres and other medicines

The doctor or pharmacist should be informed 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 it necessary to perform periodic blood tests.
Particular attention should be paid to informing about the use of any of the following medicines, as the doctor may need to change the dose of the medicine and/or recommend 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-relieving and anti-inflammatory medicines);
• acetylsalicylic acid, if taken in a dose greater than 3 g per day (a pain-relieving and anti-inflammatory medicine);
• potassium supplements or potassium-containing salt substitutes (medicines that increase the amount of potassium in the blood);
• heparin (a medicine that prevents blood clotting);
• cotrimoxazole (an antibiotic), also known as trimethoprim with sulfamethoxazole;
• diuretics;
• lithium (a medicine used to treat mental disorders);
• an ACE inhibitor or aliskiren (see also the information in the sections "When not to take Candepres" and "Warnings and precautions");
• an ACE inhibitor along with certain other medicines used to treat heart failure, such as mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone).

Candepres with food, drink, and alcohol

• Candepres can be taken with or without food.
• If the patient is taking Candepres, they should consult their doctor before consuming alcohol. Alcohol may cause fainting or dizziness.

Pregnancy and breastfeeding

Pregnancy
If the patient suspects that she is (or may be) pregnant, she must inform her doctor.
The doctor will usually advise stopping Candepres before becoming pregnant or as soon as possible after becoming pregnant and recommend taking another medicine instead. The use of Candepres in early pregnancy is not recommended, and it should not be used after the 3rd month of pregnancy, as it may be very harmful to the fetus.
Breastfeeding
The doctor should be informed about breastfeeding or the intention to start breastfeeding.
The use of Candepres is not recommended during breastfeeding. For patients planning to breastfeed, especially newborns or premature babies, the doctor may choose another suitable medicine.

Driving and using machines

Some people taking Candepres may feel tired or dizzy. In such cases, they should not drive vehicles, use tools, or operate machines.

Candepres contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Candepres contains sodium

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

3. How to take Candepres

This medicine should always be taken as directed by the doctor. In case of doubt, the doctor or pharmacist should be consulted. It is important to take the medicine every day.
Candepres is available in the following doses: 8 mg, 16 mg, and 32 mg.
Candepres can be taken with or without food.
The tablets should be swallowed with water.
The tablets should be taken daily at about the same time. This will help the patient remember to take the medicine.
Dividing the tablet
If necessary, the tablet can be divided into equal doses. To do this, the tablet should be placed on a hard, smooth surface (e.g., a table or plate) with the dividing line facing up, then briefly and firmly pressed with two index fingers (or thumbs) on both sides of the dividing line.

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 then to 32 mg once daily, depending on the response to treatment.
• Some patients, e.g., those with liver or kidney problems, or those who have recently lost a large amount of fluid (due to vomiting or diarrhea, or taking diuretics), may be prescribed a lower initial dose by their doctor.
• In patients of black race, the response to this type of medicine may be weaker if it is used alone (in so-called monotherapy). A higher dose of the medicine may be necessary.

Use in children and adolescents with high blood pressure
Children from 6 to <18 years of age:
The recommended initial dose is 4 mg once daily.

• Patients with a body weight of <50 kg: in patients who do not achieve adequate blood pressure control, the doctor may increase dose to a maximum of 8 mg once daily.< li>
• Patients with a body weight of ≥50 kg: in patients who do not achieve adequate blood pressure control, the doctor may increase the dose to 8 mg once daily, and then to 16 mg once daily if necessary.

Heart failure

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

Taking a higher dose of Candepres than recommended

In case of taking a higher dose of Candepres than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of Candepres

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.

Stopping treatment with Candepres

If the patient stops taking Candepres, blood pressure may rise again.
Therefore, the treatment should not be stopped without consulting the doctor.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is important for the patient to know which side effects may occur.

In case of any of the following allergic reactions, the patient should stop taking Candepres 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).

Candepres may cause a decrease in the number of white blood cells, which can weaken the body's resistance to infections. The patient may feel tired, and an infection or fever may occur. In such cases, the doctor should be consulted, who will order blood tests to check if Candepres is affecting the patient's blood (agranulocytosis).
Other possible side effects
Common(may occur in less than 1 in 10 people taking the medicine):

• dizziness, feeling 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 kidney problems or heart failure. If the potassium level is very high, the patient may feel tired, weak, have irregular heartbeat, or tingling.
• effect on kidney function, especially in patients with kidney problems or heart failure. Very rarely, kidney failure may occur.

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

• swelling of the face, lips, tongue, and/or throat
• decrease in the number of red or white blood cells. The patient may feel tired, and an infection or fever may occur.
• skin rash, hives
• itching
• back pain, joint and muscle pain
• changes in liver function, including hepatitis. The patient may feel tired, and jaundice or flu-like symptoms may occur.
• nausea
• changes in blood test results:
• decreased sodium levels in the blood. If the sodium level is very low, the patient may feel weak, lack energy, or have muscle cramps.
• cough

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

• diarrhea

Additional side effects in children and adolescents

It appears that the side effects in children treated for high blood pressure are similar to those observed in adults, but occur more frequently.
Sore throat, as a side effect, occurs very frequently in children, and runny nose, fever, and rapid heartbeat occur frequently. These side effects were not reported in adults.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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 side effects, more information can be collected on the safety of the medicine.

5. How to store Candepres

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The medicine should be stored in its original packaging to protect it from moisture.

Translation of some abbreviations on the immediate packaging:

Ch.-B./Verwendbar bis: see imprint - Batch number/expiry date: see imprint.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This 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.
• The other ingredients are: lactose monohydrate, cornstarch, povidone K 30, carrageenan, sodium croscarmellose, magnesium stearate, red iron oxide (E 172), titanium dioxide (E 171).

What Candepres looks like and what the pack contains

Pink, speckled, round, biconvex tablet with the symbol "32" embossed on one side and a dividing line on the other side.
Aluminum/Aluminum foil blisters in a cardboard box, containing 30 or 60 tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Austria, the country of export:

1A Pharma GmbH
1020 Vienna, Austria

Manufacturer:

Lek Pharmaceuticals d.d.
Verovśkova 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Austrian export license number: 1-28445

Parallel import license number: 389/22 Date of leaflet approval: 24.10.2022

[Information about the trademark]