Leaflet: information for the user

Candesartán pensa 16 mg tablets EFG

Read this 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, 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 is Candesartán Pensa and what it is used for

2. What you need to know before starting to take Candesartán Pensa

3. How to take Candesartán Pensa

4. Possible side effects

5. Storage of Candesartán Pensa

6. Contents of the pack and additional information

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

This medication is used for:

• treatment of high blood pressure (hypertension) in adult patients and in children and adolescents from 6 to <18 years old
• treatment of adult patients with heart failure with reduced cardiac muscle function when it is not possible to use angiotensin-converting enzyme inhibitors (ACEIs), or added to ACEIs when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACEIs and MRAs are medications used to treat heart failure)

Do not take Candesartán Pensa:

• If you are allergic (hypersensitive) to candesartán cilexetilo or to any of the other components of this medication (including those listed in section 6);
• If you are more than 3 months pregnant (it is also recommended to avoid Candesartán Pensa at the beginning of pregnancy; see the section on pregnancy);
• 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 a child under 1 year of age.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Candesartán Pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Candesartán Pensa.

• 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 intense vomiting, or have diarrhea;
• If you have a condition called "Conn's syndrome" (also known as primary hyperaldosteronism) affecting the adrenal glands;
• If you have very low blood pressure;
• If you have ever had a stroke;
• If you arepregnant (or suspect that you may be). Candesartán Pensa is not recommended at the beginning of pregnancy (first 3 months) and should not be administered if you are more than 3 months pregnant, as it may cause serious harm to your baby when used from that point onwards (see the section on pregnancy).
• If you are taking any of the following medications 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.

- aliskirén

• If you are taking an ACE inhibitor along 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 "Taking Candesartán Pensa with other medications").

Consult 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 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 Pensa”.

If you are in any of these situations, your doctor may want to see you more frequently and perform some tests.

If you have a scheduled procedure, inform your doctor or dentist that you are taking Candesartán Pensa. This is because Candesartán Pensa, when combined with certain anesthetics, may lower blood pressure excessively.

Children and adolescents

Candesartán Pensa has been studied in children. For more information, consult your doctor. Candesartán Pensa should not be administered to children under 1 year of age due to a potential risk to developing kidneys.

Taking Candesartán Pensa with other medications

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

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

In particular, inform your doctor if you are taking any of the following medicationsasyour doctor may need to adjust your dose and/or take other precautions:

• other medications to help you lower your blood pressure, including beta-blockers, diazoxide, ACE inhibitors, such as enalapril, captopril, lisinopril, or ramipril;
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac,

celecoxib or etoricoxib (medications to relieve pain and inflammation);

• aspirin, if you take more than3 gper day (medication to relieve pain and inflammation);
• potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in the blood);
• heparin (blood thinner).
• Cotrimoxazol (anantibiotic) also known as trimetoprima/sulfametoxazol;
• diuretics;
• lithium (medication for mental health problems).

• If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Candesartán Pensa” and “Warnings and precautions”)
• If you are being treated with an ACE inhibitor along with other medications specifically for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Candesartán Pensa with food and alcohol

• You can take Candesartán Pensa with or without food.
• When prescribedCandesartán Pensa, discuss with your doctor if 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Candesartán Pensa is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment for you, especially if your baby is a newborn or premature.

Driving and operating machinery

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

Candesartán Pensa contains lactose

Lactose is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. It is essential that you take Candesartán Pensa every day.

You can take Candesartán Pensa with or without food.

Swallow the tablet with the help of water.

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

The 8 mg tablet can be divided into equal doses.

Hypertension:

• The recommended dose of Candesartán Pensa 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 the use of diuretics.

• Some patients of black race may present 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 hypertension:

Children from 6 to <18>

The recommended starting dose is 4 mg once a day.

For patients weighing <50>

For patients weighing ≥ 50 kg: 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 to 16 mg once a day.

Heart failure in adults:

• The initial recommended dose of Candesartán Pensa 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. Candesartán Pensa can be taken with other medications for heart failure; your doctor will decide on the most suitable treatment for you.

If you take more Candesartán Pensa than you should

If you take more Candesartán Pensa than prescribed, contact your doctor or pharmacist immediately for advice on what to do.

If you forget to take Candesartán Pensa

Do not take a double dose to compensate for the missed tablet.

Take the next dose as usual.

If you interrupt treatment with Candesartán Pensa

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

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

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

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

Stop taking Candesartán Pensa 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;
• Intense itching of the skin (with the appearance of bumps).

Candesartán Pensa 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 that you undergo tests to check if Candesartán Pensa has affected your blood (agranulocytosis).

Other possible side effects include:

Frequent (may affect up to 1 in 10 people)

• Sensation of dizziness/dizziness.
• Headache.
• Respiratory infection.
• Low blood pressure. This may make you feel weak or dizzy.
• Changes in blood test results:

• Increased potassium levels in the blood, especially if you have kidney problems or heart failure. If the increase is intense, 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.

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, suffer an infection, or have a fever.
• Skin rash, urticaria.
• 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:

• Reduced sodium levels in the blood. If it is intense, 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 and adolescents

In children treated for hypertension, side effects appear to be similar to those seen in adults, but occur more frequently. Throat pain is a very frequent side effect in children but has not been reported in adults, and rhinorrhea, fever, and increased heart rate are frequent in children but have not been reported in adults.

Reporting 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 Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and the blister pack. 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 in the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Candesartán Pensa

The active ingredient is candesartan cilexetilo. Each Candesartán Pensa 16 mg tablet contains 16 mg of candesartan cilexetilo.

The other components are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, cornstarch, diethylenglycol monoethyl ether (Transcutol), iron oxide red (E172).

Appearance of Candesartán Pensa and contents of the packaging

The 16 mg tablets are round, pink, and scored on one side.

Candesartán Pensa 16 mg tablets EFG are supplied in: transparent ALU/PVC blisters with 7, 14, 15, 20, 28, 30, 50, 50x1 (single-unit doses), 56, 98, 98x1 (single-unit doses), 100, and 300 tablets.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Portugal: Candesartan toLife

Italy: Candesartan Pensa

Spain: Candesartán Pensa

Netherlands: Silardaf

Germany: Candaxiro

This leaflet has been approved in: January 2025

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