Ficha técnica de Candesartan cinfa 8 mg comprimidos efg – Espanha

Como usar Candesartan cinfa 8 mg comprimidos efg

Introduction

Leaflet: information for the user

candesartán cinfa 8 mg EFG tablets

candesartán cilexetilo

Read this 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What iscandesartán cinfaand what it is used for

2. What you need to know before you start takingcandesartán cinfa

3. How to takecandesartán cinfa

4. Possible side effects

5. Storage ofcandesartán cinfa

6. Contents of the pack and additional information

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

The name of this medicine is candesartán cinfa. The active ingredient is candesartán cilexetilo. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by making blood vessels relax and widen. This helps to lower blood pressure. This also makes it easier for the heart to pump blood to all parts of the body.

This medicine is used for:

treatment of high blood pressure (hypertension) in adult patients and in children and adolescents between 6 years and less than 18 years of age.
treatment of adult patients with heart failure, in which the heart muscle function is decreased, when 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 a group of medicines used to treat heart failure).

2. What you need to know before starting candesartán cinfa

Do not take candesartán cinfa

if you are allergic to candesartán cilexetilo or any of the other ingredients of this medicine (listed in section 6);
if you are more than 3 months pregnant (it is also recommended to avoid this medicine at the beginning of pregnancy; see the "Pregnancy" section);
if you have a severe liver disease or biliary obstruction (a problem related to the drainage of bile from the gallbladder);
if the patient is less than one year old;
if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication that contains aliskirén.

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult 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 undergone a kidney transplant;
if you experience vomiting, have recently had severe vomiting, or have diarrhea;
if you have a condition 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 blood pressure-lowering medications (hypertension):

an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

aliskirén.
- if you are taking an ACE inhibitor together with a medication belonging to the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Other medicines and candesartán cinfa");
- You should inform your doctor if you suspect that you are (or could become) pregnant. This medicine is not recommended at the beginning of 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 at this stage (see the "Pregnancy" section).

Your doctor may want to see you more frequently and perform some tests if you have any of these conditions.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take candesartán cinfa".

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

Children and adolescents

Candesartán cilexetilo has been studied in children. For more information, consult your doctor; candesartán should not be administered to children under one year old due to potential risks of developing renal abnormalities.

Other medicines and candesartán cinfa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Candesartán may affect how other medicines work, and certain medicines may affect how candesartán works. If you are using certain medicines, your doctor may want to perform blood tests at regular intervals.

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;
nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines to relieve pain and inflammation);
aspirin, 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 the blood);
heparin (blood thinner);
diuretics;
litium (medicine for mental health problems);
co-trimoxazole (antibiotic known as trimethoprim/sulfamethoxazole).

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

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings "Do not take candesartán cinfa" and "Warnings and precautions").
If you are being treated with an ACE inhibitor together with other specific medications for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone).

Taking candesartán cinfa with food and alcohol

You can take candesartán with or without food.
When prescribed candesartán, consult your doctor if 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 plan 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 that you take another medicine instead of candesartán.

This medicine is not recommended at the beginning of 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 after the third month of pregnancy.

Candesartán is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is a newborn or premature.

Driving and operating machinery

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

candesartán cinfa contains lactose.If your doctor has told 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 administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is essential to take this medication every day.

You can take candesartan with or without food.

Swallow the tablet with the help of water.

The tablet can be divided into equal doses.

Try to take the tablet at the same time every day. This will help you remember to take it.

The recommended dose is:

Hypertension:

The recommended dose of candesartan is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and subsequently to 32 mg once a day, depending on how your blood pressure responds.

Your doctor may prescribe lower initial 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 diarrhea, or due to the use of diuretics.
Some black patients may have a reduced response to this type of medication when used as a single treatment and may require higher doses.

Use in children and adolescents with high blood pressure:

Children aged 6 to less than 18 years:

The initial recommended 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 to a maximum of 8 mg once a 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 16 mg once a day.

Heart failure:

The initial recommended dose of candesartan is 4 mg once a day. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to a maximum of 32 mg once a day. Candesartan can be taken with other medications for heart failure; your doctor will decide on the most suitable treatment for you.

If you take more candesartan cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take candesartan cinfa

Do not take a double dose to compensate for the missed doses. Take the next dose normally.

If you interrupt treatment with candesartan cinfa

If you interrupt treatment with candesartan, your blood pressure may increase again. Therefore, do not stop taking this medication without first talking to your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

It is important that you know what these side effects may consist of.

Stop taking candesartan 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 the appearance of blisters).

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 ask you to undergo tests to check if candesartan has affected your blood (agranulocytosis).

Other possible side effects include:

Frequent (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:

-Increased levels of potassium in the blood, especially if you have kidney problems or heart failure. Ifthis situation is severe,you may notice fatigue, weakness, irregular heartbeats, or tingling.

Effects on kidney function, especially if you have kidney problems or heart failure. In very rare cases, it may cause kidney failure.

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 notice fatigue, suffer an infection, or have fever.
Skin rash, hives.
Itching.
Back, muscle, and joint pain.
Changes in liver function, including hepatitis. You may feel fatigue, yellowing of the skin and white of the eyes, and flu-like symptoms.
Nausea.
Changes in blood test results:
Reduction in sodium levels in the blood. If severe, you may notice fatigue, lack of energy, or muscle cramps.
Cough.
Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency (cannot be estimated from available data):

Diarrhea.

Other side 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 side 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of candesartán cinfa

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of candesartan cinfa

The active ingredient is candesartan cilexetilo. Each tablet contains 8 mg of candesartan cilexetilo.

The other components are: hydroxypropylcellulose (E-463), lactose monohydrate, magnesium stearate, cornstarch, diethylglycol monoethyl ether (Transcutol), and iron oxide red (E-172).

Appearance of the product and contents of the package

The 8 mg tablets are bisected, cylindrical, pink in color, scored on one face, and have the logo “8” on the other.

candesartan cinfa 8 mg tablets are presented in blisters of PVC/ALU, available in packages of 7, 14, 15, 20, 28, 30, 50, 56, 98, 100, and 300 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

LICONSA Laboratories, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo (Azuqueca de Henares (Guadalajara)) - 19200 - Spain

This medicine is authorized in the EEA member states with the following names:

Spain: candesartan cinfa 8 mg tablets EFG

Portugal: candesartan cinfa 8 mg tablets

Last review date of this leaflet:February 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/75656/P_75656.html

QR code to:https://cima.aemps.es/cima/dochtml/p/75656/P_75656.html

Quanto custa o Candesartan cinfa 8 mg comprimidos efg em Espanha em 2025?

O preço médio do Candesartan cinfa 8 mg comprimidos efg em julho de 2025 é de cerca de 5.25 EUR. Os valores podem variar consoante a região, a farmácia e a necessidade de receita. Confirme sempre com uma farmácia local ou fonte online para obter informações atualizadas.