Candesartan CINFA 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

candesartán cinfa 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 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What candesartán cinfa is and what it is used for

The name of this medicine is candesartán cinfa. The active substance is candesartán cilexetilo. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This helps lower blood pressure. It also 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 years and less than 18 years of age.
• the treatment of adult patients with heart failure, in whom heart muscle function is reduced, 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 groups of medicines used to treat heart failure).

2. What you need to know before starting to take candesartán cinfa

Do not take candesartán cinfa

• if you are allergic to candesartan cilexetil 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 “Pregnancy”);
• if you have severe liver disease or biliary obstruction (a condition affecting bile drainage from the gallbladder);
• if the patient is under one 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 candesartán cinfa:

• 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 disorder 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;

• 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 ACEI 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 cinfa");
  • you must inform your doctor if you suspect you are (or might be) pregnant. This medicine is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if used during this stage (see section “Pregnancy”).

Your doctor may want to see you more frequently and carry out certain tests if you have any of these conditions.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking candesartán. Your doctor will decide whether to continue treatment. Do not stop taking candesartán 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 cinfa”.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartán. This is because this medicine, when combined with certain anaesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

The use of candesartan cilexetil has been studied in children. For further information, consult your doctor. Candesartán must not be given to children under one year of age due to the potential risk of developing kidney problems.

Other medicines and candesartán cinfa

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 candesartán works. If you are taking certain medicines, your doctor may want to carry out blood tests from time to time.

In particular, inform your doctor if you are taking any of the following medicines:

• 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 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 the blood);
• heparin (an anticoagulant medicine);
• diuretic medicines;
• lithium (a medicine used to treat mental health conditions);
• cotrimoxazole (an antibiotic also known as trimethoprim/sulfamethoxazole).

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskiren (see also information under the headings “Do not take candesartán cinfa” and “Warnings and precautions”).
• If you are being treated with an ACEI together with other specific medicines for heart failure, known as mineralocorticoid receptor antagonists (MRA) (e.g., spironolactone, eplerenone).

Taking candesartán cinfa with food and alcohol

• You may take candesartán with or without food.
• When you are prescribed candesartán, consult your doctor about whether you can drink 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.

Generally, your doctor will advise you to stop taking candesartán before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

This medicine is not recommended during early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.

Use of candesartán is not recommended in breastfeeding mothers, and your doctor may choose another treatment for you if you plan to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

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

candesartán cinfa contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take candesartan cinfa

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

It is important that you take this medicine every day.

You may take candesartan with or without food.

Swallow the tablet with 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.

The recommended dose is:

High blood pressure:

• The recommended dose of candesartan 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.

• For some patients, such as those with liver or kidney problems, or those who have recently lost body fluids (e.g., due to vomiting, diarrhea, or use of diuretics), your doctor may prescribe lower initial doses.

• 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 less than 18 years:

The recommended initial 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 once daily.

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:

• The recommended starting dose of candesartan 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 candesartan cinfa than you should

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 candesartan cinfa

Do not take a double dose to make up for forgotten doses. Take the next dose as usual.

If you stop taking candesartan cinfa

If you stop taking candesartan, 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 candesartán cinfa 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 skin itching (with appearance of lumps).

This medicine 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 candesartán has affected your blood (agranulocytosis).

Other possible adverse effects include:

Common (may affect up to 1 in 10 people)

• Dizziness.
• 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 this condition 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, 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 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

In children treated for high blood pressure, side effects appear to be similar to those observed in adults, but occur more frequently. Sore throat is a very common effect in children, but does not usually occur in adults, and nasal discharge, fever, or increased heart rate are also common in children, but not in adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects 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 candesartan cinfa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. 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 unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of candesartán cinfa

• The active substance is candesartan cilexetil. Each tablet contains 16 mg of candesartan cilexetil.

• The other components are: hydroxypropylcellulose (E-463), lactose monohydrate, magnesium stearate, corn starch, diethylene glycol monoethyl ether (Transcutol), and red iron oxide (E-172).

Appearance of the product and contents of the pack

The 16 mg tablets are cylindrical, pink in colour, with a score line on one side and the logo “16” on the other.

candesartán cinfa 16 mg tablets are available in PVC/ALU blisters, in pack sizes of 7, 14, 15, 20, 28, 30, 50, 56, 98, 100 and 300 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

LABORATORIOS LICONSA, S.A.

Avda. Miralcampo, Nº 7, Pol. Ind. Miralcampo (Azuqueca de Henares (Guadalajara)) - 19200 - Spain

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

Spain: candesartán cinfa 16 mg tablets EFG

Portugal: candesartan cinfa 16 mg tablets

Date of the most recent review of this leaflet: February 2025

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

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75655/P_75655.html

QR code link: https://cima.aemps.es/cima/dochtml/p/75655/P_75655.html