Candesartan Combix 32 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Candesartán Combix 32 mg tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Candesartán Combix is and what it is used for

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

This medicine can be used for:

• the treatment of high blood pressure (hypertension) in adult patients and in children and adolescents aged 6 to less than 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 in addition 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 Candesartán Combix

Do not take Candesartán Combix

• 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 advisable 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 flow from 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 situations apply to you, consult your doctor or pharmacist before taking candesartan.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine

• if you have heart, liver, or kidney problems or are undergoing dialysis,
• if you have recently received a kidney transplant,
• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhea,
• if you have an adrenal gland disorder 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 suspect you might be pregnant). Candesartan is not recommended during early pregnancy (first 3 months) and must under no circumstances be administered after the third month of pregnancy, as it may cause serious harm to your baby from that point onward (see section “Pregnancy”),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.
• if you are taking an ACE inhibitor together with a medicine belonging to a class of drugs called mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see “Other medicines and Candesartán Combix”).

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

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

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

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, inform your doctor or dentist that you are taking candesartan. This is because this medicine, in combination with certain anesthetics, may cause a drop in blood pressure.

Children and adolescents

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

Other medicines and Candesartán Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Candesartan may affect how some medicines work, and some medicines may influence the effect of candesartan. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

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 potassium levels in your blood).
• Heparin (a medicine to increase blood fluidity).
• Cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines that increase urine output).
• Lithium (a medicine used for mental health conditions).
• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also information under the headings “Do not take Candesartán Combix” 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 (MRA) (e.g., spironolactone, eplerenone).

Taking Candesartán Combix with food, drinks, and alcohol

• You may take candesartan with or without food.
• When prescribed candesartan, consult your doctor before drinking alcohol. Alcohol may cause dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking candesartan before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine. Candesartan is not recommended during early pregnancy and must under no circumstances be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Candesartan is not recommended during breastfeeding. Your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartán Combix contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Candesartán Combix

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

It is important that you continue taking this medicine every day. Candesartán can be taken with or without food. Swallow the tablet with a little water. The tablet may be divided into equal doses.

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 candesartán is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and then to 32 mg once daily, 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, diarrhoea, or use of diuretics), 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 less than 18 years:

The recommended starting dose is 4 mg once daily.

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 up to a maximum of 8 mg per 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 daily and then to 16 mg once daily.

Heart failure in adults:

• The usual initial dose of candesartán is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks up to a maximum of 32 mg once daily. Candesartán may be taken together with other medicines for heart failure, and your doctor will decide which treatment is appropriate for you.

If you take more Candesartán Combix than you should

If you have taken more candesartán than prescribed by your doctor, contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Candesartán Combix

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

If you stop taking Candesartán Combix

If you stop taking candesartán, your blood pressure may rise again. Therefore, do not stop taking this medicine 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 this medicine and go to your 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 skin itching (with skin rash).

This medicine may 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. Your doctor may carry out blood tests from time to time to check whether candesartan is affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 out 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 blood potassium levels, especially if you already have kidney problems or heart failure. If this condition is serious, you may notice 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 10,000 patients)

• Swelling of the face, lips, tongue and/or throat.

• A 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 inflammation of the liver (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:

• A reduction in blood sodium levels. If severe, you may feel weak, lack energy, or have muscle cramps.

• Cough.

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

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, 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 or pharmacist, 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 Candesartán Combix

Keep this medicine out of sight and reach of children.

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

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and any leftover packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Candesartán Combix

• The active substance is candesartan cilexetil. The tablets contain 32 mg of candesartan cilexetil.
• The other components (excipients) are: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, calcium stearate, disodium edetate, and red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

Uncoated, round, biconvex tablets, light pink to pale red in colour, with a score line on both sides. The tablets have a diameter of approximately 9.52 mm.

Candesartán Combix is available in aluminum-aluminum or PVC/PVDC-aluminum blisters containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France
ZAC Les Hautes Patures
Parc d'activités des Peupliers
25 Rue des Peupliers
92000 Nanterre
France

Or

Centre Specialites Pharmaceutiques
Z.A.C. des Suzots
35 Rue de la Chapelle
63450 Saint Amant Tallende
France

Or

Laboratori Fundacio DAU
C/De la letra C, 12-14,
Polígono Industrial de la Zona Franca,
08040 Barcelona,
Spain

Or

Netpharmalab Consulting Services S.L.
Carretera de Fuencarral 22,
Alcobendas,
28108 Madrid
Spain

Or

Flavine Pharma France
3 Voie d’Allemagne
13127 Vitrolles
France

Date of the latest revision of this leaflet: February 2025

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