Candesartan Almus 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartan Almus 16 mg tablets EFG

Candesartan cilexetil

Read the entire 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Candesartan Almus is and what it is used for
2. What you need to know before taking Candesartan Almus
3. How to take Candesartan Almus
4. Possible side effects
5. How to store Candesartan 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 making the blood vessels relax and widen. This helps lower blood pressure. As a result, it becomes 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 (MRAs) 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 (it is also preferable to avoid this medicine in early pregnancy; see section on pregnancy);
• if you have severe liver disease or biliary obstruction (a problem related to bile drainage from the gallbladder);
• if the patient is a child under 1 year of age;
• if you have diabetes or renal impairment 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 undergone a kidney transplant;

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

• if you suffer from an adrenal gland disorder 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 in early pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to the baby if used during this period (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 the 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 blood levels of electrolytes (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 candesartán, 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 a 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 want to carry out 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, also known as trimethoprim/sulfamethoxazole (an antibiotic medicine);

• 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 can consume alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 are planning to breast-feed. Use of this medicine is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you plan 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 informed you that you have an intolerance to certain sugars, consult with 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 or diarrhoea, or due to diuretic use.
• Some patients of black 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 initial 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. Candesartan 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 candesartan 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 your next dose as usual.

If you stop taking Candesartán Almus

If you stop treatment with 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 experiences 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, which 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 experience fatigue, weakness, irregular heartbeat, or tingling.

• 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 experience fatigue, infections or fever.

• Skin rash, urticaria.

• Itching.

• Back, muscle and joint pain.

• Changes in liver function, including liver inflammation (hepatitis). You may feel fatigued, develop yellowing of the skin and whites of the eyes, and experience flu-like symptoms.

• Nausea.

• Changes in blood test results:

• Reduction in blood sodium levels. If severe, you may experience fatigue, lack of energy, or 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 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 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartán Almus

Keep out of the 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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 16 mg tablet contains 16 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 16 mg tablets are round, pink in colour and scored on one side.

Candesartán Almus 16 mg tablets EFG are supplied in: transparent ALU/PVC blisters containing 7, 14, 15, 20, 28, 30, 50, 50x1 (unit-dose), 56, 98, 98x1 (unit-dose), 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 authorized in EEA Member States under the following names:

NL: Candesartán cilexetil Liconsa 16 mg tabletten

ES: Candesartán Almus 16 mg comprimidos EFG

Date of the most recent revision of this leaflet: 03/2025

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