Candesartan Almus 8 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Candesartán Almus 8 mg tablets EFG

Candesartán cilexetilo

Read this entire 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 pass it on to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

The name of this medicine is Candesartán Almus. The active substance is candesartán cilexetilo. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels. This helps lower blood pressure. This makes it easier for the heart to pump blood to all parts of the body.

This medicine is 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 (MRA) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Candesartán Almus

Do not take Candesartán Almus:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are more than 3 months pregnant (this medicine is also best avoided in early pregnancy; see section on pregnancy);
• if you have severe liver disease or biliary obstruction (a condition affecting bile drainage 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 the above apply to you, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you have heart, liver or kidney problems, or are on dialysis;

• if you have recently had a kidney transplant;

• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhoea;

• if you have a disease of the adrenal glands called "Conn's syndrome" (also known as primary hyperaldosteronism);

• if you have very low blood pressure;

• if you have ever had a stroke;

• you must inform your doctor if you suspect you are (or may become) pregnant. Candesartán is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to the unborn baby if used at this stage (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 together with a medicine belonging to a class of drugs known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see “Other medicines and Candesartán Almus”).

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

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

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

If you are in any of these situations, 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 this medicine. This is because candesartan, when combined with certain anaesthetics, may excessively lower blood pressure.

Children and adolescents

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

Other medicines and Candesartán Almus

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

Candesartán may affect how other medicines work, and certain medicines may affect how this medicine works. If you are taking certain medicines, your doctor may need to perform 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 adjust your dose and/or take other precautions:

• other medicines to help lower your blood pressure, including beta-blockers, diazoxide, and 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 you take 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 the blood);

• heparin (an anticoagulant medicine);

• cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole;

• diuretic medicines;

• lithium (a medicine used to treat mental health conditions).

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Candesartán Almus” and “Warnings and precautions”);

• If you are being treated with an ACE inhibitor together with other specific medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g. spironolactone, eplerenone).

Taking Candesartán Almus with food, drinks and alcohol

• You may take this medicine with or without food.
• When this medicine is prescribed for you, discuss with your doctor whether you may drink alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to start. Use of this medicine is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you intend to breast-feed, especially if your baby is a newborn or was premature.

Driving and using machines

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

Candesartán Almus contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Candesartán Almus

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 take this medicine every day.

You may take this medicine with or without food.

Swallow the tablet with 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 this medicine is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and subsequently to 32 mg once daily, depending on how your blood pressure responds.
• Your doctor may prescribe lower starting doses for some patients, such as those with liver or kidney problems, or those who have recently lost body fluids, for example due to vomiting, diarrhoea, or use of diuretics.
• Some patients of black racial origin may have a reduced response to this type of medicine when used as monotherapy and may require higher doses.

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 recommended starting dose of this medicine is 4 mg once daily. Your doctor may double this dose 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; your doctor will decide which treatment is most suitable for you.

If you take more Candesartán Almus than you should

If you take more candesartán than prescribed, contact your doctor or pharmacist immediately for advice.

If you forget to take Candesartán Almus

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

Take the next dose as usual.

If you stop taking Candesartán Almus

If you stop taking this medicine, your blood pressure may rise again. Therefore, do not discontinue treatment with this medicine without first talking to 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 can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects may involve.

Stop taking this medicine and consult 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 that may cause difficulty swallowing;
• Severe itching of the skin (with appearance of lumps).

Candesartan may reduce the number of white blood cells in the blood. Your resistance to infections may decrease, and you may experience fatigue, infections, or fever. If this occurs, contact your doctor. Your doctor may occasionally request blood tests to check whether this medicine has affected your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 people)

• Dizziness/vertigo.

• Headache.

• Respiratory infection.

• Low blood pressure. This may make you feel weak or dizzy.

• Changes in blood test results:

• Increase in blood potassium levels, especially if you have had kidney problems or heart failure. If the increase is severe, you may feel tired, weak, have irregular heartbeats, or tingling sensations.

• Effects on kidney function, especially if you have had kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect up to 1 in 10,000 people)

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

• Reduction in the number of red or white blood cells. You may feel tired, suffer infections, or have a fever.

• Skin rash, hives.

• Itching.

• Back, muscle, and joint 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 tired, lack energy, or have muscle cramps.

• Cough.

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

Frequency not known (cannot be estimated from available data)

• Diarrhea.

Other adverse effects in children and adolescents

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 rhinorrhea, 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, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartan Almus

Keep out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Candesartán Almus

The active substance is candesartan cilexetil. Each Candesartán Almus 8 mg tablet contains 8 mg of candesartan cilexetil.

The other components are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, maize starch, diethylene glycol monoethyl ether (Transcutol), and red iron oxide (E172).

Appearance of Candesartán Almus and contents of the pack

The 8 mg tablets are bevelled, round, pink in colour, and scored on one side.

Candesartán Almus 8 mg tablets EFG are supplied in: transparent ALU/PVC blisters containing 7, 14, 15, 20, 28, 30, 50, 50x1 (unit-dose packs), 56, 98, 98x1 (unit-dose packs), 100 and 300 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

This medicinal product is authorised in EEA Member States under the following names:

NL: Candesartán cilexetil Liconsa 8 mg tabletten

ES: Candesartán Almus 8 mg comprimidos EFG

Date of the latest revision of this leaflet: 03/2025

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