Atacand 4 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atacand 4 mg tablets

candesartan cilexetilo

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Atacand is and what it is used for

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

Atacand can be used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to <18 years.
• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or added to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Atacand

Do not take Atacand:

• if you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is also better to avoid this medicine during the first months of pregnancy – see Pregnancy section.)
• if you have severe liver disease or biliary obstruction (a problem with bile leaving the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor before starting to take Atacand

• if you have heart, liver or kidney problems, or are on dialysis.
• if you have recently received a kidney transplant.
• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhoea.
• if you have a disease of the adrenal gland called Conn’s syndrome (also known as primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant (or think you might be pregnant). Use of Atacand is not recommended during early pregnancy (first 3 months) and must not be used at all if you are more than three months pregnant, as it may cause serious harm to your baby from that stage onwards (see Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  1. • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  2. • aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to a class of drugs called mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Taking Atacand with other medicines”).

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Atacand. Your doctor will decide whether to continue treatment. Do not stop taking Atacand on your own.

Your doctor may monitor your kidney function, blood pressure and blood levels of electrolytes (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Atacand”.

If any of these situations apply to you, your doctor may want to see you more frequently and carry out certain tests.

If you are scheduled for surgery, tell your doctor or dentist that you are taking Atacand. This is because Atacand, in combination with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents

Atacand has been studied in children. For further information, consult your doctor. Atacand must not be given to children under 1 year of age due to potential risk to developing kidneys.

Taking Atacand with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Atacand may affect how some medicines work, and some medicines may influence the effect of Atacand. If you are taking certain medicines, your doctor may need to carry out blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medicines, as your doctor may need to adjust your dose and/or take other precautions:

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and angiotensin-converting enzyme (ACE) inhibitors such as enalapril, captopril, lisinopril or ramipril.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib or etoricoxib (medicines used to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine used to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
• Heparin (a medicine used to increase blood fluidity).
• Cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that promote urine elimination).
• Lithium (a medicine used for mental health conditions).
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Atacand” and “Warnings and precautions”).
• If you are being treated with an ACE inhibitor together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking Atacand with food, drinks and alcohol

• You may take Atacand with or without food.
• When prescribed Atacand, consult your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Breast-feeding

Inform your doctor if you are breast-feeding or are planning to breast-feed. The use of Atacand is not recommended during breast-feeding, and your doctor will choose another treatment for you if you intend to breast-feed, especially if your baby is newborn or premature.

Driving and use of machines

Some patients may feel tired or dizzy when taking Atacand. If this happens to you, do not drive or operate tools or machinery.

Atacand contains lactose. Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Atacand

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. It is important that you continue taking Atacand every day.

You may take Atacand with or without food.

Swallow the tablet with a glass of water.

Try to take the tablet at the same time each day. This will help you remember to take it.

High blood pressure:

• The recommended dose of Atacand is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then up to 32 mg once daily depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (e.g., due to vomiting, diarrhea, or diuretic use), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine when used as monotherapy, and may require a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:

The recommended starting dose is 4 mg once daily.

For patients with body weight < 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose up to a maximum of 8 mg daily.

For patients with body weight ≥ 50 kg: in some patients whose blood pressure is not adequately controlled, 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 usual starting dose of Atacand is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to 32 mg once daily. Atacand may be taken together with other heart failure medications, and your doctor will decide which treatment is appropriate for you.

If you take more Atacand than you should

If you have taken more Atacand than prescribed by your doctor, contact your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atacand

Do not take a double dose to make up for missed doses. Simply take the next dose as scheduled.

If you stop taking Atacand

If you stop taking Atacand, your blood pressure may rise again. Therefore, do not stop taking Atacand without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects might be.

Stop taking Atacand and see a doctor immediately if you experience 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
• Severe itching of the skin (with skin rash)

Atacand may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, have an infection, or develop a fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to check that Atacand is not affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 in every 100 patients)

• Dizziness
• Headache
• Respiratory infection
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results:
  • Increased blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling.
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (affects less than 1 in every 10,000 patients)

• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.
• Swelling of the face, lips, tongue and/or throat.
• Decrease in red blood cells or white blood cells. You may feel tired, or have an infection or fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including liver inflammation (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Nausea.
• Changes in blood test results:
  • Reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.
• Cough.

Frequency not known (cannot be estimated from available data)

• Diarrhoea

Other adverse effects in children

In children treated for hypertension, adverse effects appear to be similar to those seen in adults, but occur more frequently. Sore throat is a very common adverse effect in children but has not been reported in adults, and rhinorrhoea (runny nose), fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atacand

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the packaging or blister. The expiry date refers to the last day of the month indicated.

• This medicine does not require any special storage temperature conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atacand

• The active substance is candesartan cilexetilo. The tablets contain 4 mg of candesartan cilexetilo.
• The other components are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch, and macrogol.

Appearance of the product and contents of the pack

• Atacand 4 mg tablets are white, round, scored tablets, engraved with "A/CF" on one side and "004" on the other.

The tablet can be divided into equal doses by breaking it along the score line.

Atacand 4 mg tablets are marketed in plastic bottles containing 100 tablets, or in blisters containing 7, 14, 28, 30, 56, 90 or 98 tablets.

Not all pack sizes may be marketed in all countries.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturers:

Klocke Pharma-Service GmbH
Straßburger Str. 77
77767 Appenweier
Germany

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

AstraZeneca AB, S-152 57, Södertälje, Sweden

Local Representative:

Laboratorios Rubió, S.A.
Industria, 29
Pol. Ind. Comte de Sert
08755 Castellbisbal (Barcelona)
Spain

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

Date of the most recent review of this leaflet: 01/2025

Other sources of information

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/