Atacand

Package leaflet: Information for the patient

Atacand, 8 mg, tablets
Atacand, 16 mg, tablets
candesartan cilexetil
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet contents:

1. What Atacand is and what it is 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 Atacand is and what it is used for

This medicine is called Atacand. The active substance is candesartan cilexetil. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This helps lower blood pressure. Atacand also helps the heart pump blood more easily to all parts of the body.

Atacand may be used:

• for the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years
• for the treatment of adult patients with heart failure and impaired heart muscle function, if angiotensin-converting enzyme (ACE) inhibitors cannot be used, or as an add-on to ACE inhibitor therapy if heart failure symptoms persist despite treatment, and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE inhibitors and MRAs are medicines used in the treatment of heart failure).

2. Information before using Atacand

When not to use Atacand

• if the patient is allergic to candesartan cilexetil or any of the other ingredients of this medicine (listed in section 6);
• during the third month of pregnancy and later (Atacand should also be avoided in early pregnancy; see section “Pregnancy and breastfeeding”);
• if the patient has severe liver disease or biliary obstruction (impaired bile flow from the gallbladder);
• in children under 1 year of age;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using Atacand.

Warnings and precautions

Before starting or while taking Atacand, consult a doctor:

• if there are heart, liver or kidney problems, or if the patient is undergoing dialysis;
• if the patient has recently undergone a kidney transplant;
• if the patient has or has had severe vomiting or diarrhoea;
• if the patient has a disease of the adrenal glands called Conn’s syndrome (primary hyperaldosteronism);
• if the patient has low blood pressure;
• if the patient has ever had a stroke;
• inform the doctor if pregnancy is suspected or suspected. Use of Atacand is not recommended during early pregnancy and must be avoided after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”);
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
• aliskiren;
• if the patient is taking an ACE inhibitor together with a medicine belonging to a group of medicines called mineralocorticoid receptor antagonists (MRAs), used in the treatment of heart failure (see “Atacand with other medicines”).

If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Atacand, discuss this with the doctor. The doctor will decide whether treatment should continue. Do not stop taking Atacand without medical advice.

The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium).

See also the section “When not to use Atacand”.

If any of the above conditions apply, the doctor may recommend more frequent monitoring and tests.

If the patient is to undergo surgery, inform the doctor or dentist about taking Atacand. This is because Atacand, in combination with certain anaesthetics, may cause low blood pressure.

Children and adolescents

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

Atacand with other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.

Atacand may affect the action of other medicines, and other medicines may affect the action of Atacand. If the patient is taking certain medicines, the doctor may periodically recommend blood tests.

In particular, inform the doctor if the patient is taking any of the following medicines, as the doctor may recommend a dose adjustment and/or additional 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 (in doses exceeding 3 g per day) (a medicine that relieves pain and inflammation);
• Potassium supplements, potassium-containing salt substitutes (medicines that increase blood potassium levels);
• Heparin (a medicine that reduces blood clotting);
• Co-trimoxazole (an antibiotic), also known as trimethoprim/sulfamethoxazole;
• Diuretics (water tablets);
• Lithium (a medicine used to treat psychiatric disorders).
• If the patient is taking an ACE inhibitor or aliskiren (see also sections “When not to use Atacand” and “Warnings and precautions”).
• If the patient is taking an ACE inhibitor together with 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 consuming alcohol while taking Atacand, consult your doctor. Alcohol may cause fainting or dizziness.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Your doctor will usually advise stopping Atacand before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Atacand is not recommended during early pregnancy and must be avoided after the third month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Atacand is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. Your doctor may recommend an alternative medicine.

Driving and using machines

While taking Atacand, some patients may experience fatigue or dizziness. If these symptoms occur, do not drive, use tools or operate machinery.

Atacand contains lactose

Lactose is a type of sugar. If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before using this medicine.

3. How to use Atacand

This medicine should always be taken as directed by the physician. If in doubt, consult the physician or pharmacist again. It is important to take Atacand every day.
Atacand may be taken during meals or independently of meals.
The tablet should be swallowed with water.
Tablets should be taken daily at approximately the same time. This will help the patient remember to take the dose.

High blood pressure:

• The recommended dose of Atacand is 8 mg once daily. The physician may increase the dose to 16 mg once daily, and subsequently to 32 mg once daily, depending on the response to treatment (reduction in blood pressure).
• The physician may prescribe a lower starting dose for certain patients, e.g. in patients with impaired liver or kidney function, as well as in patients who have lost a large amount of fluid, e.g. due to vomiting, diarrhoea, or use of diuretic medicines.
• In patients of Black ethnicity, the response to treatment may be weaker when Atacand is used as monotherapy. Higher doses may therefore 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 body weight <50 kg: in some patients with inadequate blood pressure control, the physician may decide to increase the dose of the medicine up to a maximum of 8 mg once daily.
Patients with body weight ≥50 kg: in some patients with inadequate blood pressure control, the physician may decide to increase the dose of the medicine to 8 mg once daily and up to 16 mg once daily.

Heart failure in adults:

• The recommended initial dose of Atacand is 4 mg once daily. The physician may increase the dose by doubling it at intervals of at least 2 weeks, up to 32 mg once daily. Atacand may be taken together with other medicines used in the treatment of heart failure, and the physician will decide which therapy is most appropriate for the patient.

Taking more Atacand than prescribed
If more Atacand has been taken than prescribed by the physician, contact the physician or pharmacist immediately.
Missing a dose of Atacand
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Atacand
If treatment with Atacand is stopped, blood pressure may rise again. Therefore, do not discontinue treatment with Atacand without first consulting the physician.
If there are any further questions regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
It is important that the patient is aware of the possibility of their occurrence.
The use of Atacand must be stopped immediately and medical help should be sought if
the patient experiences any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue and (or) throat
• Swelling of the face, lips, tongue and (or) throat, which may cause difficulty swallowing
• Intense itching of the skin (with raised rashes)

Atacand may cause a reduction in the number of white blood cells. This may lead to decreased resistance to infections, therefore the patient may experience fatigue, infection and fever. If such symptoms occur, contact a doctor. The doctor may periodically recommend blood tests to check whether Atacand causes any blood disorders (agranulocytosis).
Other possible adverse reactions include:
Common (occur in 1 to 10 patients out of 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, particularly if the patient has impaired kidney function or heart failure. In case of significantly increased potassium levels, symptoms such as fatigue, weakness, irregular heartbeat or tingling sensations may occur.
• Effect on kidney function, especially in case of existing kidney disorders or heart failure. In very rare cases, kidney failure may occur.

Very rare (occur in less than 1 patient out of 10,000)

• Angioedema of the intestine: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
• Swelling of the face, lips, tongue and (or) throat
• Reduction in the number of red or white blood cells. Fatigue, infection or fever may occur.
• Skin rash, papular rash (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including hepatitis. Symptoms such as fatigue, yellowing of the skin and eyes, and flu-like symptoms may occur.
• Nausea
• Changes in blood test results:
• decreased sodium levels in the blood; in case of significantly decreased sodium levels, symptoms such as weakness, lack of energy, or muscle cramps may occur.
• Cough

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

• Diarrhoea

Additional adverse reactions observed in children
Adverse reactions in children treated for high blood pressure appear to be similar to those observed in adult patients, but occur more frequently. Sore throat is very common in children, and colds, fever and increased heart rate are common, although these effects have not been observed in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atacand

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle after EXP. The expiry date refers to the last day of the stated 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. These measures 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, 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 light pink, round, biconvex, film-coated tablets with a breakline on one side, marked A/CG on one side and 008 on the other.
• The 16 mg tablets are pink, round, biconvex, film-coated tablets with a breakline on one side, 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 breakline.
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 Authorisation 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 further information, please contact:
Komtur Polska Sp. z o.o.
[email protected]
This medicinal product is authorized for marketing in the European Economic Area member states under the following names:

Other sources of information
Detailed information about this product is available on the website: www.urpl.gov.pl