Patient Information Leaflet

Atacand 16 mg Tablets

candesartán cilexetilo

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1.What is Atacand and what it is used for

2.What you need to know before starting Atacand

3.How to take Atacand

4.Possible side effects

5Storage of Atacand

6.Contents of the pack and additional information

Your medication is called Atacand. The active ingredient is candesartan cilexetilo. This belongs to a group of medications called angiotensin II receptor antagonists. It works by causing blood vessels to relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

Atacand can be used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years old
• treatment of adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACEIs), or added to ACEIs when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACEIs and MRAs are medications used to treat heart failure)

Do not take Atacand:

• if you are allergic to candesartan cilexetilo or any of the other components of this medication (listed in section6).
• if you are more than 3months pregnant. (It is also best to avoid this medication during the first months of pregnancy – see section Pregnancy).
• if you have severe liver disease or bile duct obstruction (problem with the bile flowing out of the gallbladder).
• if the patient is under 1 year of age.
• if you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure if you fall into any of these situations, consult your doctor or pharmacist before taking Atacand.

Warnings and precautions

Consult your doctor before starting to take Atacand

• if you have heart, liver, or kidney problems or are undergoing dialysis.
• if you have recently had a kidney transplant.
• ifyou have vomiting, have recently had severe vomiting, or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism) affecting the adrenal gland.
• if you have low blood pressure.
• ifyou have ever had a stroke.
• if you are pregnant (or, if you suspect you may be). Atacand is not recommended for use at the beginning of pregnancy (first 3months) andshould not be administered if you are more than three months pregnant,as it may cause serious harm to your baby when administered from that point on (see section Pregnancy).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):
• 1. - an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  2. - aliskirén.
• if you are taking an ACEI along with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see “Taking Atacand with other medications”)

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 electrolyte levels in your blood (e.g., potassium) at regular intervals.

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

If you fall into any of these situations, your doctor may want to see you more frequently and perform some tests.

If you are undergoing surgery, inform your doctor or dentist that you are taking Atacand. This is because Atacand, in combination with some anesthetics, may cause a drop in blood pressure.

Children and adolescents

Atacand has been studied in children. For more information, consult your doctor. Atacand should not be administered to children under 1 year of age due to a potential risk to the developing kidneys.

Taking Atacand with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

Atacand may affect how some medications work and some medications may influence the effect of Atacand. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medications, asyour doctor may need to modify your dose and/or take other precautions:

• Other medications to lower your blood pressure, including beta-blockers, diazoxide, and the so-called ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medications to relieve pain and inflammation).
• Aspirin (if you take more than 3g per day) (medication to relieve pain and inflammation).
• Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).
• Heparin (a medication to increase blood fluidity).
• Cotrimoxazol (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medications to promote urine elimination).
• Lithium (a medication for mental health problems).
• If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Atacand” and “Warnings and precautions”)
• If you are being treated with an ACEI along with other specific medications for 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 you are prescribed Atacand, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Atacand is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. It is essential that you continue to 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 every 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 up to 16 mg once a day and then up to 32 mg once a day, depending on the blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids, for example, due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may present a reduced response to this type of medication, when given as a single treatment, and these patients may need 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 a day.

For patients weighing <50 kg:

For patients weighing ≥ 50 kg: 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 initial normal dose of Atacand is 4 mg once a day. Your doctor may increase this dose by doubling the dose in intervals of at least 2 weeks up to 32 mg once a day. Atacand can be taken with other medications 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 call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atacand

Do not take a double dose to compensate for the missed doses. Simply take the next dose.

If you interrupt treatment with Atacand

If you stop taking Atacand, your blood pressure may increase again. Therefore, do not stop taking Atacand before consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is important that you know which side effects could occur.

Stop taking Atacand and see your 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 skin itching (with skin rash)

Atacand can cause a decrease in white blood cells. Your resistance to infections may decrease and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. It is possible that your doctor will perform a blood test at regular intervals to check that Atacand is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 of every 100 patients)

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

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

• 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 10,000 patients)

• Intestinal angioedema: swelling in the intestine that presents 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 fever.
• Skin rash, hives.
• Itching.
• Back pain, joint and muscle pain.
• Changes in liver function, including inflammation of the liver (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to the flu.
• Nausea.
• Changes in blood test results:
• • A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.

• Cough.

Frequency unknown (cannot be estimated from available data)

• Diarrhea

Other side effects in children

In children treated for hypertension, side effects appear to be similar to those seen in adults, but occur more frequently. Throat pain is a very frequent side effect in children but has not been reported in adults, and runny nose, fever, and increased heart rate are frequent in children but have not been reported in adults.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

• Do not use this medication after the expiration date that appears on the packaging or blister. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAtacand

Appearance of the product and contents of the package

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

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

Not all package sizes may be available in all countries.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 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 authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 01/2025

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/