Atacand

Package Leaflet: Information for the Patient

Atacand, 8 mg, tablets

Atacand, 16 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. See section 4.

Table of Contents of the Leaflet:

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

1. What is Atacand and what is it used for

The medicine is called Atacand. The active substance is candesartan cilexetil. It belongs to a group of medicines called angiotensin II receptor antagonists. It causes relaxation and widening of blood vessels. This helps to lower blood pressure. Atacand also makes it easier for the heart to pump blood to all parts of the body.
Atacand can be used:

• to treat high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to 18 years of age
• to treat adult patients with heart failure, with reduced heart muscle function, if ACE inhibitors cannot be used or as a supplement to ACE inhibitor therapy, if symptoms of heart failure persist despite treatment, and mineralocorticoid receptor antagonists (MRAs) cannot be used (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. Important information before taking Atacand

When not to take Atacand

• after the third month of pregnancy (it is also recommended to avoid taking Atacand in early pregnancy, see "Pregnancy and breastfeeding");
• in children under 1 year of age;

In case of doubt whether any of the above situations apply to you, consult your doctor or pharmacist before taking Atacand.

Warnings and precautions

Before taking or during treatment with Atacand, consult your doctor:

• you should inform your doctor if you suspect or plan to become pregnant. It is not recommended to take Atacand in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy");
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren;

If you experience stomach pain, nausea, vomiting, or diarrhea after taking Atacand, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Atacand on your own.
Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the section "When not to take Atacand"
If any of the above conditions apply to you, your doctor may recommend more frequent checks and tests.
If you are going to have surgery, inform your doctor or dentist that you are taking Atacand. This is because Atacand, in combination with certain anesthetics, may cause a drop in blood pressure.

Children and adolescents

The use of Atacand has been studied in children. For more information, talk to your doctor. Atacand should not be given to children under 1 year of age due to potential risk to kidney development.

Atacand and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.
Atacand may affect the action of other medicines, and other medicines may affect the action of Atacand. If you are taking certain medicines, your doctor may periodically recommend blood tests.
Particularly, inform your doctor if you are taking any of the following medicines, as your doctor may recommend a dose change and/or take 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 and inflammation relievers);
• Aspirin (in doses greater than 3 g per day) (pain and inflammation reliever);
• Potassium supplements, potassium-containing salt substitutes (medicines that increase potassium levels in the blood);
• Heparin (a medicine that reduces blood clotting);
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole;
• Diuretics;
• Lithium (a medicine used to treat mental disorders).
• If you are taking an ACE inhibitor or aliskiren (see also sections "When not to take Atacand" and "Warnings and precautions").
• If you are taking an ACE inhibitor at the same time as certain medicines used to treat heart failure, called mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Atacand with food, drink, and alcohol:

• Atacand can be taken with or without food.
• Before planned alcohol consumption, consult your doctor. Alcohol consumption may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Atacand before planned pregnancy or as soon as pregnancy is confirmed, and recommend taking a different medicine instead of Atacand. It is not recommended to take Atacand in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Atacand during breastfeeding, especially if breastfeeding a newborn or premature baby. Your doctor may recommend a different medicine.

Driving and using machines

While taking Atacand, some patients may feel tired and dizzy.
If such symptoms occur, do not drive, use tools, or operate machinery.

Atacand contains lactose

Lactose is a type of sugar. If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Atacand

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. It is important to take Atacand every day.
Atacand can be taken with or without food.
Swallow the tablet with water.
Take the tablets at the same time every day. This will help you remember to take your dose.
High blood pressure:

• The recommended dose of Atacand 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 your response to treatment (lowering of blood pressure).
• Your doctor may recommend a lower starting dose for certain patients, e.g., patients with liver or kidney problems, and patients who have lost a lot of fluid, e.g., due to vomiting, diarrhea, or diuretic use.
• In black patients, the response to treatment may be weaker if Atacand is used as monotherapy. A higher dose may be necessary.

Taking Atacand in children and adolescents with high blood pressure:
Children from 6 to 18 years of age:
The recommended starting dose is 4 mg once daily.
Patients weighing less than 50 kg: in some patients with insufficient blood pressure control, the doctor may decide to increase the dose to a maximum of 8 mg once daily.
Patients weighing 50 kg or more: in some patients with insufficient blood pressure control, the doctor may decide to increase the dose to 8 mg once daily and then to 16 mg once daily.
Heart failure in adults:

• The recommended starting dose of Atacand is 4 mg once daily. Your doctor may increase the dose by doubling it, at intervals of at least 2 weeks, to 32 mg once daily. Atacand can be taken with other medicines used to treat heart failure, and your doctor will decide which therapy is most suitable for you.

Taking a higher dose of Atacand than recommended

If you have taken more Atacand than prescribed by your doctor, contact your doctor or pharmacist immediately.

Missing a dose of Atacand

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

Stopping treatment with Atacand

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

4. Possible side effects

Like all medicines, Atacand can cause side effects, although not everybody gets them.
It is important that you know about the possibility of these effects.

Stop taking Atacand and seek medical help immediately if you experience any of the following allergic reactions:

• 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 raised bumps)

Atacand may cause a decrease in the number of white blood cells. This may lead to a reduced ability to fight infections, and you may experience fatigue, infection, or fever. If you experience such symptoms, contact your doctor. Your doctor may periodically recommend blood tests to check if Atacand is causing any blood disorders (agranulocytosis).
Other possible side effects include:

Common (affecting 1 to 10 patients in 100)

• Dizziness/spinning sensation
• Headache
• Respiratory tract infection
• Low blood pressure. This may cause fainting or dizziness.
• Changes in blood test results:
• increased potassium levels in the blood, especially if you have kidney problems or heart failure. If potassium levels become very high, you may experience fatigue, weakness, irregular heartbeat, or tingling.
• effects on kidney function, especially if you have existing kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affecting less than 1 patient in 10,000)

• Angioedema of the intestine: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat
• Decreased number of red or white blood cells. You may experience fatigue, infection, or fever.
• Rash, hives (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. You may experience fatigue, yellowing of the skin and eyes, and flu-like symptoms.
• Nausea
• Changes in blood test results:
• decreased sodium levels in the blood; if sodium levels become very low, you may experience weakness, lack of energy, or muscle cramps.
• Cough.

Frequency not known (cannot be estimated from available data)

• Diarrhea

Additional side effects observed in children

Side effects in children treated for high blood pressure appear to be similar to those seen in adult patients, but occur more frequently. Very common in children are pharyngitis, rhinitis, fever, and increased heart rate, but these were not observed in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or 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:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atacand

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, blister, or bottle after "EXP". The expiry date refers to the last day of the month.
• This medicinal product does not require any special storage conditions.

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 Atacand contains

• The active substance is candesartan cilexetil. Each tablet contains 8 mg or 16 mg of candesartan cilexetil (Candesartanum cilexetilum).
• The other ingredients are: calcium carboxymethylcellulose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, and macrogol. The 8 mg and 16 mg tablets also contain iron oxide (E172).

What Atacand looks like and contents of the pack

• The 8 mg tablets are pale pink, round, with a score line, marked A/CG on one side and 008 on the other.
• The 16 mg tablets are pink, round, with a score line, marked A/CH on one side and 016 on the other.

The tablets can be divided into two equal doses by breaking them along the score line.
The tablets are supplied in plastic containers (bottles) containing 100 tablets or in blisters containing 7, 14, 28, 30, 56, 90, or 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer

Klocke Pharma-Service GmbH
Straßburger Str. 77
77767 Appenweier
Germany
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24

For more detailed information, please contact:
Komtur Polska Sp. z o.o.
phv@komtur.com

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:January 2025

Other sources of information

Detailed information on this product is available on the website: www.urpl.gov.pl