ATACAND 8 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Atacand, 8 mg, tablets
3. Atacand, 16 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
4. What is Atacand and what is it used for
5. Important information before taking Atacand
   1. When not to take Atacand
   2. Warnings and precautions
   3. Children and adolescents
   4. Atacand and other medicines
   5. Atacand with food, drink, and alcohol:
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Atacand contains lactose
6. How to take Atacand
   1. Taking more Atacand than prescribed
   2. Missing a dose of Atacand
   3. Stopping Atacand treatment
7. Possible side effects
   1. Stop taking Atacand and seek medical help immediately if you experience any of the following allergic reactions:
   2. Common (affecting 1 to 10 patients in 100)
   3. Very rare (affecting less than 1 patient in 10,000)
   4. Frequency not known (cannot be estimated from the available data)
   5. Additional side effects seen in children
   6. Reporting side effects
8. How to store Atacand
9. Contents of the pack and other information
   1. What Atacand contains
   2. What Atacand looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Other sources of information

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.

Contents of the package 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 works by relaxing and widening the 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 function, if ACE inhibitors cannot be used or as an addition 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 during early pregnancy, see section "Pregnancy and breastfeeding");
• in children under 1 year of age;

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking Atacand.

Warnings and precautions

Before taking or while taking Atacand, consult your doctor:

• you should inform your doctor if you think you might be pregnant. It is not recommended to take Atacand during early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "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. Your doctor will decide on further treatment. Do not stop taking Atacand on your own.

Your doctor may recommend regular checks 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 the potential risk to kidney development.

Atacand and other medicines

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

Atacand may affect the way other medicines work, and other medicines may affect the way Atacand works. 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 need to adjust the dose 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 medicines (NSAIDs), such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (pain-relieving and anti-inflammatory medicines);
• Aspirin (in doses greater than 3 g per day) (pain-relieving and anti-inflammatory medicine);
• Potassium supplements, potassium-sparing diuretics, or 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 a medicine used to treat heart failure, called a mineralocorticoid receptor antagonist (MRA) (e.g., spironolactone, eplerenone).

Atacand with food, drink, and alcohol:

• Atacand can be taken with or without food.
• Before consuming alcohol while taking Atacand, consult your doctor. Drinking alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping Atacand before planned pregnancy or as soon as possible after confirming pregnancy, and will recommend taking a different medicine instead of Atacand. It is not recommended to take Atacand during early pregnancy and it must 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 while 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 or dizzy. If you experience these symptoms, 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 unsure, consult your doctor or pharmacist. It is important to take Atacand every day.

Atacand can be taken with or without food.

Swallow the tablet with a glass of water.

Take the tablets at the same time each day to 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 (blood pressure reduction).
• Your doctor may recommend a lower starting dose for certain patients, e.g., patients with liver or kidney problems, or patients who have lost a lot of fluid, e.g., due to vomiting, diarrhea, or diuretic therapy.
• In black patients, the response to treatment may be reduced 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, your 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, your 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, up 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 more Atacand than prescribed

If you take more Atacand than prescribed, 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 Atacand treatment

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 what these side effects are.

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 patches)

Atacand may cause a decrease in white blood cells. This may lead to a reduced ability to fight infections, and you may experience fatigue, infection, or fever. If you experience these 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 infections
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results:
• increased potassium levels in the blood, especially if you have kidney problems or heart failure. If potassium levels become too 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)

• Intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
• Swelling of the face, lips, tongue, and/or throat
• Decreased red or white blood cell count. You may experience fatigue, infection, or fever.
• Rash, hives (urticaria)
• Itching
• Back pain, joint or 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 too low, you may experience weakness, lack of energy, or muscle cramps.
• Cough.

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

• Diarrhea

Additional side effects seen in children

Side effects in children treated for high blood pressure are similar to those seen in adult patients, but they occur more frequently. Very common side effects in children include pharyngitis, rhinitis, fever, and increased heart rate, but these were not seen 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. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C

PL-02 222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

You can also report side effects 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.
• The other ingredients are calcium carboxymethylcellulose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch, 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, and scored, marked A/CG on one side and 008 on the other.
• The 16 mg tablets are pink, round, and scored, 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 available 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 information, contact:

Komtur Polska Sp. z o.o.

[email protected]

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