CANDEPRES 16 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Candepres, 8 mg, tablets
3. Candepres, 16 mg, tablets
4. Candepres, 32 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
5. What is Candepres and what is it used for
6. Important information before taking Candepres
   1. When not to take Candepres
   2. Warnings and precautions
   3. Before starting treatment with Candepres, the patient should discuss it with their doctor or pharmacist,
   4. Children and adolescents
   5. Candepres and other medicines
   6. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
   7. Candepres with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Candepres contains lactose
   11. Candepres contains sodium
7. How to take Candepres
   1. Taking a higher dose of Candepres than recommended
   2. Missing a dose of Candepres
   3. Stopping treatment with Candepres
8. Possible side effects
   1. In case of any of the following allergic reactions, the patient should stop taking Candepres and seek medical help immediately:
   2. Additional side effects in children and adolescents
   3. Reporting side effects
9. How to store Candepres
10. Contents of the pack and other information
    1. What Candepres contains
    2. What Candepres looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. For more information about the medicine and its names in other European Economic Area countries, please contact:

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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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 aged 6 to <18 years;
treatment of adult patients with heart failure, with reduced heart muscle function, when angiotensin-converting enzyme (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 patient should consult a doctor or pharmacist before taking Candepres.

Warnings and precautions

Before starting treatment with Candepres, the patient should discuss it with their doctor or pharmacist,

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 an 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 used to treat high blood pressure:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease
• aliskiren when taking an ACE inhibitor together with a medicine from the group of so-called mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see "Candepres and other medicines")

If the patient is pregnant (or may become pregnant), they must inform their 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 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 tell their doctor or dentist that they are taking Candepres, as the medicine used in combination with certain anesthetics may cause excessive lowering of blood pressure.
If, after taking Candepres, the patient experiences abdominal pain, nausea, vomiting, or diarrhea, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Candepres on their own.

Children and adolescents

The effect of candesartan cilexetil in children has been studied. The 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 the developing kidneys.

Candepres and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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.
In particular, the patient should mention if they are taking 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 (medicines that relieve pain and inflammation);
acetylsalicylic acid, if taken in a dose greater than 3 g per day (a medicine that relieves pain and inflammation);
potassium supplements or salt substitutes containing potassium (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 together with certain other medicines used to treat heart failure, so-called 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 dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
If the patient suspects that they are (or may be) pregnant, they must inform their doctor. The doctor will usually advise stopping Candepres before becoming pregnant or as soon as possible after finding out about the pregnancy and recommend taking another medicine instead. Using 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 patient should inform their doctor about breastfeeding or intending to breastfeed. Taking 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, the patient should not drive vehicles, use tools, or operate machines.

Candepres contains lactose

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 the medicine 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 patient should consult their doctor or pharmacist. It is essential to take the medicine every day.
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 patient's 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 aged 6 to <18 years:
The recommended initial dose is 4 mg once daily.

• Patients with a body weight <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 ≥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 patient should immediately consult their doctor or pharmacist.

Missing a dose of Candepres

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment with Candepres

If the patient stops taking Candepres, their blood pressure may rise again.
Therefore, the patient should not stop taking the medicine without consulting their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Candepres can cause side effects, although not everybody gets them.
It is essential for the patient to know which side effects can 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 patient should contact their doctor, 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, 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 liver inflammation. 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 angioedema of the intestine: intestinal swelling 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 they occur more frequently. Sore throat, as a side effect, occurs very frequently in children, and runny nose, fever, and rapid heart rate occur frequently. These side effects were not reported in adults.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their 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 gather more information on the safety of the medicine.

5. How to store Candepres

The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 a PP cap, 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 the medicine and its names in other European Economic Area 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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