Candepres

Package Leaflet: Information for the Patient

Candepres, 8 mg, tablets

Candepres, 16 mg, tablets

Candepres, 32 mg, tablets

Candesartan cilexetil

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package 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 old;
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 you are allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6);
if you are 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 you have severe liver disease or cholestasis (bile flow disorder);
if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
in children under 1 year of age.
If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking Candepres.

Warnings and precautions

Before starting treatment with Candepres, discuss it with your doctor or pharmacist,

if you:
have heart, liver, or kidney problems, or are undergoing dialysis;
have recently undergone a kidney transplant;
have vomiting or have recently had severe vomiting or diarrhea;
have adrenal gland disease (Conn's syndrome, also known as primary hyperaldosteronism);
have low blood pressure;
have had a stroke in the past;
are taking any of the following blood pressure-lowering medicines:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease
• aliskiren when taking an ACE inhibitor together with a mineralocorticoid receptor antagonist (MRA) for the treatment of heart failure (see "Candepres and other medicines")

If you are pregnant (or think you may be pregnant), you must inform your doctor. 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 baby.
Your 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 these points apply to you, your doctor may recommend more frequent check-ups and some tests.
If you are going to have surgery, tell your doctor or dentist that you are taking Candepres, as the medicine may cause excessive lowering of blood pressure when used with certain anesthetics.
If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candepres, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Candepres on your own.

Children and adolescents

The effect of candesartan cilexetil in children has been studied. Your doctor will provide further information.
Candepres should not be used in children under 1 year of age due to the risk of harmful effects on developing kidneys.

Candepres and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Candepres may affect the action of some other medicines, and some medicines may affect the action of Candepres. If you are taking certain medicines, your doctor may need to perform periodic blood tests.
Especially tell your doctor if you are taking any of the following medicines, as your doctor may need to change the dose 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 medicines (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 (pain-relieving and anti-inflammatory medicine);
potassium supplements or potassium-sparing diuretics (medicines that increase potassium levels in the blood);
heparin (a medicine that prevents blood clotting);
co-trimoxazole (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 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 can be taken with or without food.
If you are taking Candepres, consult your doctor before consuming alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
If you think you are (or may be) pregnant, inform your doctor. Your doctor will usually advise you to stop taking Candepres before becoming pregnant or as soon as possible after finding out you are pregnant, and recommend taking another medicine instead. Taking Candepres in early pregnancy is not recommended, and it is contraindicated after the 3rd month of pregnancy, as it may be very harmful to the baby.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding. Taking Candepres during breastfeeding is not recommended. For breastfeeding mothers, especially those with 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 this case, do not drive, use tools, or operate machinery.

Candepres contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your 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

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. It is important to take the medicine every day.
Candepres can be taken with or without food.
Swallow the tablets with water.
Take the tablets at about the same time every day. This will help you remember to take the medicine.
Dividing the tablet
If necessary, the tablet can be divided into equal doses. To do this, place the tablet on a hard, flat surface (e.g., a table or plate) with the dividing line facing up, then briefly and firmly press on it with two index fingers (or thumbs) on either side of the dividing line.

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 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 lot of fluid (due to vomiting or diarrhea, or taking diuretics), may need a lower initial dose.
In black patients, the response to this type of medicine may be weaker when used alone (in 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 old:
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 up 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. Your doctor may double the dose of Candepres 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 your doctor will decide which treatment is most suitable for you.

Taking a higher dose of Candepres than recommended

If you take a higher dose of Candepres than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Candepres

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment with Candepres

If you stop taking Candepres, your blood pressure may increase again. Therefore, do not stop taking the medicine without consulting your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

If you experience any of the following allergic reactions, 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. You may feel tired, and an infection or fever may occur. In this case, contact your doctor, who will order blood tests to check if Candepres is affecting your blood (agranulocytosis).
Other possible side effects
Common(may affect up to 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, you 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.

Rare(may affect up to 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. You may feel tired, and an infection or fever may occur.
skin rash, hives
itching
back pain, joint or muscle pain
changes in liver function, including hepatitis. You may feel tired, and yellowing of the skin and whites of the eyes, as well as flu-like symptoms, may occur.
nausea
changes in blood test results:

• decreased sodium levels in the blood. If the sodium level is very low, you may feel weak, lack energy, or have muscle cramps. cough angioedema intestinal: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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 you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

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 carton, blister, and bottle label after EXP. The expiry date refers to the last day of the month.
Store in the original package to protect from moisture.
Shelf life after first opening the bottle: 3 months.
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 pack and other information

What Candepres contains

The active substance is candesartan cilexetil.
Each tablet contains 8 mg, 16 mg, or 32 mg of candesartan cilexetil.
The other ingredients are: lactose monohydrate, cornstarch, povidone K-30, carrageenan, sodium croscarmellose, magnesium stearate, red iron oxide (E172), titanium dioxide (E171).

What Candepres looks like and contents of the pack

Candepres, 8 mg
Pink, speckled, round, biconvex tablet with the symbol "8" embossed on one side and a dividing line on the other side.
Candepres, 16 mg
Pink, speckled, round, biconvex tablet with the symbol "16" embossed on one side and a dividing line on the other side.
Candepres, 32 mg
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: 28, 30, 56, 60 tablets.
HDPE bottles with PP caps, with a desiccant: 30 tablets.
Note! The HDPE container contains a desiccant. Do not swallow it.
Not all pack sizes and types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, 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 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For more information about this medicine and its names in other EU countries, please contact:

Sandoz Polska Sp. z o. o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:01/2025
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