ATACAND 16 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Atacand 16mg tablets

candesartan cilexetil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Atacand and what is it used for
2. What you need to know before you take Atacand
3. How to take Atacand
4. Possible side effects

5 Storage of Atacand

1. Contents of the pack and other information

1. What is Atacand and what is it used for

Your medicine is called Atacand. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your 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.< li>
• the treatment of adult patients with heart failure with reduced cardiac function when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or when added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before you take Atacand

Do not take Atacand:

• if you are allergic to candesartan cilexetil or 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 Atacand during the first months of pregnancy – see section Pregnancy).
• if you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you have diabetes or kidney problems and you are treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Atacand.

Warnings and precautions

Talk to your doctor before you start taking Atacand

• if you have heart, liver or kidney problems, or if you are on dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting or have diarrhea.
• if you have a condition affecting 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 if you think you might be). Your doctor will normally advise you to stop taking Atacand before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Atacand.
• if you are taking any of the following medicines used to treat high blood pressure:
• 1. an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  2. aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to the class of medicines known as mineralocorticoid receptor antagonists (MRAs) for the treatment of heart failure (see “Taking Atacand with other medicines”)

Talk to your doctor if you get any of the following symptoms: abdominal pain, nausea, vomiting, or diarrhea after taking Atacand. Your doctor will decide whether you should continue treatment. Do not stop taking Atacand without talking to your doctor.

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

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

If you are in any of these situations, your doctor may want to see you more often and do some tests.

If you are going to have surgery, tell your doctor or dentist that you are taking Atacand. This is because Atacand, in combination with some anesthetics, can cause a drop in blood pressure.

Children and adolescents

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 a potential risk to the developing kidneys.

Taking Atacand with other medicines

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

Atacand may affect the way some medicines work and some medicines may affect the way Atacand works. If you are taking certain medicines, your doctor may need to do blood tests from time to time.

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

• Other medicines for lowering your blood pressure, 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 (medicines to relieve pain and inflammation).
• Aspirin (if you take more than 3 g a day) (a medicine 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 to increase blood fluidity).
• Cotrimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to increase urine production).
• Lithium (a medicine for mental health problems).
• If you are taking an ACE inhibitor or aliskiren (see also the 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 the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Atacand with food, drinks, and alcohol

• You can take Atacand with or without food.
• When Atacand is prescribed, talk to your doctor before drinking alcohol. Alcohol can make you feel faint or dizzy.

Pregnancy and breastfeeding

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Atacand should not be used while breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

Atacand contains lactose. Lactose is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Atacand

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. It is important that you take Atacand every day.

You can take Atacand with or without food.

Swallow the tablet with a little water.

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

Hypertension:

• The recommended dose of Atacand is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and then to 32 mg once a day depending on your blood pressure response.
• In some patients, such as those with liver or kidney problems, or those who have recently lost body fluids (e.g. due to vomiting, diarrhea, or because they are taking diuretics), your doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine, when given as the only treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children aged 6 to <18 years:< p>

The recommended starting dose is 4 mg once a day.

For patients weighing less than 50 kg: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to a maximum of 8 mg a day.

For patients weighing 50 kg or more: in some patients whose blood pressure is not adequately controlled, your doctor may decide to increase the dose to 8 mg once a day and then to 16 mg once a day.

Heart failure in adults:

• The usual starting dose of Atacand is 4 mg once a day. Your doctor may increase this dose by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Atacand can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable 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 can also contact the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Atacand

Do not take a double dose to make up for a forgotten dose. Just take the next dose as normal.

If you stop taking Atacand

If you stop taking Atacand, your blood pressure may increase again. Therefore, do not stop taking Atacand without talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking Atacand and see a doctor immediately if you have 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 rash)

Atacand may cause a decrease in white blood cells. Your resistance to infection may be decreased and you may become tired, have an infection, or have a fever. If this happens, talk to your doctor. Your doctor may need to do regular blood tests to check that Atacand is not affecting your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may cause dizziness or fainting.
• Changes in blood test results:

• An increase in blood potassium levels, especially if you already have kidney problems or heart failure. If this is severe, you may feel tired, weak, have irregular heartbeats, or have tingling.

• Affecting kidney function, especially if you already have kidney problems or heart failure. In rare cases, kidney failure may occur.

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

• Intestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• Swelling of the face, lips, tongue, and/or throat.
• A decrease in red or white blood cells. You may feel tired, have an infection, or have a fever.
• 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 the whites of the eyes, and flu-like symptoms.
• Nausea.
• Changes in blood test results:
• • A decrease in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

• Cough.

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

• Diarrhea

Other side effects in children

In children treated for high blood pressure, side effects seem to be similar to those seen in adults but occur more frequently. Sore throat is a very common side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are common in children but have not been reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaram.es. By reporting side 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 which is stated on the carton or blister. The expiry date is the last day of the month stated.
• This medicine 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

Composition of Atacand

• The active substance is candesartan cilexetil. The tablets contain 16 mg of candesartan cilexetil.
• The other ingredients are: calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch, and macrogol. The 16 mg tablets also contain iron oxide (E172).

Appearance and packaging

• Atacand 16 mg tablets are round, pink, scored, and marked A/CH on one side and 016 on the other.

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

Atacand 16 mg tablets are available in plastic bottles of 100 tablets or in blisters of 7, 14, 28, 30, 56, 90, or 98 tablets.

Not all pack sizes may be marketed in all countries.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

CHEPLAPHARM Arzneimittel GmbHZiegelhof 2417489 Greifswald

Germany

Manufacturer:

KlockePharma-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 medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: 01/2025

Other sources of information

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