Candesartan Cinfa 16 mg Tablets

Introduction

Package Leaflet: Information for the User

candesartan cinfa 16 mg tablets EFG

candesartan cilexetil

Read all of this 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 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 package leaflet

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

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

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

This medicine is used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 years to less than 18 years of age.
• treatment of adult patients with heart failure, in whom the function of the heart muscle 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 (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 you take candesartan cinfa

Do not take candesartan cinfa

• 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 recommended to avoid this medicine at the start of pregnancy; see section “Pregnancy”);
• if you have 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 problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take candesartan cinfa:

• if you have heart, liver or kidney problems or are on dialysis;
• if you have recently had a kidney transplant;
• if you are vomiting, have recently had severe vomiting or have diarrhea;
• if you have a disease of the adrenal glands called "Conn's syndrome" (also called 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 (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially 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 called mineralocorticoid receptor antagonists (MRAs). These medicines are for the treatment of heart failure (see "Other medicines and candesartan cinfa");
  • you must inform your doctor if you suspect that you are (or may be) pregnant. This medicine is not recommended at the start of pregnancy, and you must not take it if you are more than 3 months pregnant, because it may cause serious harm to your baby if used at this stage (see section “Pregnancy”).

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

Talk to 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.

Your doctor may check 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 candesartan cinfa”.

If you are scheduled for surgery, inform your doctor or dentist that you are taking candesartan. This is because this medicine, when combined with certain anesthetics, can excessively lower your blood pressure.

Children and adolescents

The use of candesartan cilexetil has been studied in children. For more information, consult your doctor; candesartan should not be given to children under one year of age due to potential kidney damage risks.

Other medicines and candesartan cinfa

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

Candesartan may affect the way other medicines work and certain medicines may affect the way candesartan works. If you are using certain medicines, your doctor may want to perform blood tests from time to time.

In particular, tell 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 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 the blood);
• heparin (anticoagulant medicine);
• diuretic medicines;
• lithium (medicine to treat mental health problems);
• cotrimoxazole (an antibiotic known as trimethoprim/sulfamethoxazole).

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take candesartan cinfa” 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 cinfa with food and alcohol

• You can take candesartan with or without food.
• When your doctor prescribes candesartan, ask your doctor if you can drink alcohol. Alcohol can 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, ask your doctor or pharmacist for advice before taking this medicine.

Usually, your doctor will 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 candesartan.

This medicine is not recommended during the first trimester of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

The use of candesartan is not recommended in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed, 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 vehicles or use tools or machines.

candesartan cinfa contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take candesartan cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

It is important that you take this medicine every day.

You can take candesartan with or without food.

Swallow the tablet with some 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.

The recommended dose is:

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 how your blood pressure responds.

• 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, the doctor may prescribe lower initial doses.
• Some black patients may have a reduced response to this type of medicine when used as the only treatment and may need higher doses.

Use in children and adolescents with high blood pressure:

Children from 6 to less than 18 years of age:

The recommended initial 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 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 recommended initial 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 32 mg once a day. Candesartan can be taken with other medicines for heart failure; the doctor will decide what treatment is most suitable 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take candesartan cinfa

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

If you stop taking candesartan cinfa

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

If you have any further questions on 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 candesartan cinfa and see 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 hives).

This medicine may reduce the number of white blood cells in your blood. Your resistance to infections may be decreased and you may experience fatigue, infections, or fever. If this happens, contact your doctor. Your doctor may occasionally ask you to have blood tests to check if candesartan has affected your blood (agranulocytosis).

Other possible side effects include:

Common (may affect up to 1 in 10 people)

• dizziness.
• headache.
• respiratory infection.
• low blood pressure. This can make you feel weak or dizzy.
• changes in blood test results:

• increased levels of potassium in the blood, especially if you have had kidney problems or heart failure. If this situation is severe, you may notice 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 notice fatigue, infection, or fever.
• skin rash, hives.
• itching.
• back pain, muscle and joint pain.
• changes in liver function, including liver inflammation (hepatitis). You may feel tired, yellowing of the skin and the whites 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.

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

• diarrhea.

Other side effects in children

In children treated for high blood pressure, side effects seem to be similar to those observed in adults, but occur more frequently. Sore throat is a very common side effect in children, but not usually in adults, and runny nose, fever, or increased heart rate are also common in children, but not 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 via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of candesartan cinfa

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

• The other ingredients 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 pack contents

The 16 mg tablets are cylindrical, pink, scored on one side, and have the logo “16” on the other.

candesartan cinfa 16 mg tablets are available in PVC/ALU blister packs, in packs of 7, 14, 15, 20, 28, 30, 50, 56, 98, 100, and 300 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the EEA under the following names:

Spain: candesartan cinfa 16 mg tablets EFG

Portugal: candesartan cinfa 16 mg tablets

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 Healthcare Products (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/75655/P_75655.html

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