Candesartan CombiX 32 mg Tablets

Introduction

Package Leaflet:information for the patient

Candesartan Combix 32 mg tablets EFG

candesartan cilexetil

Read all of this leaflet carefullybefore you start taking thismedicine,because it contains important informationfor you.

• Keep this leaflet, as 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

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

5 Storage of Candesartan Combix

1. Contents of the pack and other information

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

Your medicine is called Candesartan Combix. 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 lowers your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

This medicine can be used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to less than 18 years of age.
• treatment of adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or 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 Candesartan Combix

Do not take Candesartan 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 better to avoid this medicine during the first months of pregnancy – see section Pregnancy),
• if you have severe liver disease or biliary obstruction (problem with bile leaving the gallbladder),
• if the patient is a child under 1 year of age,
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if you are in one of these situations, consult your doctor or pharmacist before taking candesartan.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• if you have heart, liver or kidney problems or are undergoing 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 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). You should not take candesartan during the first few months of pregnancy, and in no case should it be administered if you are more than three months pregnant,as it may cause serious harm to your baby when administered from that time on (see section “Pregnancy”),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.
• if you are taking an ACE inhibitor along with a medicine belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see “Other medicines and Candesartan Combix”).

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

Consult 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 Candesartan Combix”.

If you are in one of these situations, your doctor may want to see you more frequently and perform some tests.

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

Children and adolescents

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

Other medicines and Candesartan Combix

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

Candesartan may affect the way some medicines work and some medicines may affect the effect of candesartan. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

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

• Other medicines to lower your blood pressure, including beta-blockers, diazoxide, and the so-called 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).
• Acetylsalicylic acid (if you take more than 3 g per day) (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 medicine) also known as trimethoprim/sulfamethoxazole.
• Diuretics (medicines to promote urine elimination).
• 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 Candesartan Combix” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor along with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Taking Candesartan Combixwith food,drinks and alcohol

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

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

You should tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking candesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of this one. Candesartan should not be used during the first few months of pregnancy, and in no case should it be administered if you are more than three months pregnant,as it may cause serious harm to your baby when administered from that time on (see section “Pregnancy”).

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Candesartan is not recommended during 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 candesartan. If this happens to you, do not drive or use tools or machines.

Candesartan Combix contains lactose and sodium

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

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

3. How to take Candesartan Combix

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is important that you continue to take this medicine every day. You can take candesartan with or without food. Swallow the tablet with a little water. The tablet can 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 candesartan 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, for example due to vomiting, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some black patients may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Use in children and adolescents with high blood pressure:

Children from 6 to less than 18 years of age:

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 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 a day and to 16 mg once a day.

Heart failure in adults:

• The initial dose of candesartan is normally 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. Candesartan can be taken with other medicines for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartan Combix than you should

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

If you forget to take Candesartan Combix

Do not take a double dose to make up for forgotten doses. Simply take the next dose.

If you stop taking Candesartan Combix

If you stop taking candesartan, your blood pressure may rise again. Therefore, do not stop taking this medicine before consulting your doctor.

If you have any other questions about 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 this medicine and go to the 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 can cause difficulty swallowing,
• severe itching of the skin (with 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 have a fever. If this happens, tell your doctor. Your doctor may perform a blood test from time to time to check that candesartan is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 in every 100 patients)

• Dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This can cause you to feel dizzy or faint.
• 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 may feel tired, weak, have irregular heartbeats, or have 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)

• 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 symptoms similar to those of 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.
• Intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Diarrhea

Other side effects in children

In children treated for high blood pressure, the side effects seem to be similar to those seen in adults, but they 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 experience 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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Combix

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 after “EXP”. The expiry date is the last day of the month stated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. If you have any further questions, ask your pharmacist. By doing this, you will help to protect the environment.

6. Contents of the pack and other information

Composition of Candesartan Combix

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

Appearance of the product and contents of the pack

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

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus FranceZAC Les Hautes PaturesParc d'activités des Peupliers25 Rue des Peupliers92000 NanterreFrance

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 last revision of this leaflet: February 2025

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