Candesartan Pensa 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Candesartán Pensa 8 mg tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Candesartán Pensa is and what it is used for

The name of this medicine is Candesartán Pensa. The active substance is candesartán cilexetilo. It belongs to a group of medicines known as angiotensin II receptor antagonists. It works by relaxing and widening blood vessels. This helps lower blood pressure and 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 to <18 years.
• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors, or IECA) cannot be used, or as an addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs, or ARM) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you need to know before taking Candesartán Pensa

Do not take Candesartán Pensa:

• If you are allergic (hypersensitive) 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 (Candesartán Pensa is also best avoided at the beginning of pregnancy; see the pregnancy section);
• if you have severe liver disease or biliary obstruction (a condition affecting bile drainage 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 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 Candesartán Pensa.

Warnings and precautions

Talk to your doctor or pharmacist before starting Candesartán Pensa if:

• you have heart, liver, or kidney problems, or are on dialysis;

• you have recently had a kidney transplant;

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

• you suffer from an adrenal gland disorder called "Conn's syndrome" (also known as primary hyperaldosteronism);

• you have very low blood pressure;

• you have ever had a stroke;

• you are pregnant (or think you might be). Candesartán Pensa is not recommended during early pregnancy (first 3 months) and must not be taken if you are more than three months pregnant, as it may cause serious harm to your baby from that stage onward (see Pregnancy section);

• you are taking any of the following medicines for 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 a class known as mineralocorticoid receptor antagonists (MRA). These medicines are used to treat heart failure (see section "Taking Candesartán Pensa with other medicines").

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 levels of electrolytes (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Candesartán Pensa”.

If any of these situations apply to you, 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 Candesartán Pensa. This is because Candesartán Pensa, when combined with certain anaesthetics, may cause excessive lowering of blood pressure.

Children and adolescents

Candesartán Pensa has been studied in children. For further information, consult your doctor. Candesartán Pensa must not be given to children under 1 year of age due to the potential risk to developing kidneys.

Taking Candesartán Pensa with other medicines

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

Candesartán Pensa may affect how other medicines work, and certain medicines may affect how Candesartán Pensa works. If you are taking 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, as your doctor may need to adjust your dose and/or take other precautions:

• other medicines to lower 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 blood potassium levels);

• heparin (an anticoagulant medicine);

• cotrimoxazole (an antibiotic medicine), also known as trimethoprim/sulfamethoxazole;

• 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 information under the headings “Do not take Candesartán Pensa” and “Warnings and precautions”);

• If you are being treated with an ACE inhibitor together with other specific medicines for heart failure known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Candesartán Pensa with food and alcohol

• You may take Candesartán Pensa with or without food.
• When Candesartán Pensa is prescribed for you, discuss with your doctor whether you can drink alcohol. Alcohol may make you feel weak or dizzy.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you suspect you are (or might become) pregnant. Your doctor will usually advise you to stop taking Candesartán Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Candesartán Pensa is not recommended in early pregnancy, and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. The use of Candesartán Pensa is not recommended in breastfeeding mothers. 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 Candesartán Pensa. If this happens to you, do not drive or operate tools or machinery.

Candesartán Pensa contains lactose

Lactose is a type of sugar. 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 Candesartán Pensa

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist. It is important that you take Candesartán Pensa every day.

You may take Candesartán Pensa 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.

The 8 mg tablet may be divided into equal doses.

High blood pressure:

• The recommended dose of Candesartán Pensa 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 your blood pressure response.
• Your doctor may prescribe a lower starting dose 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 race 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 per day.

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 Candesartán Pensa 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. Candesartán Pensa may be taken together with other medications for heart failure; your doctor will decide which treatment is most appropriate 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.

If you forget to take Candesartán Pensa

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

Take the next dose as usual.

If you stop taking Candesartán Pensa

If you stop treatment with Candesartán Pensa, your blood pressure may rise again. Therefore, do not discontinue treatment with Candesartán Pensa 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 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 which may cause difficulty swallowing;
• intense itching of the skin (with appearance of lumps).

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 blood tests to check whether Candesartán Pensa 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 the 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Candesartán Pensa

Keep out of 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 must 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, please 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 Pensa

The active substance is candesartan cilexetil. Each Candesartán Pensa 8 mg tablet contains 8 mg of candesartan cilexetil.

The other components are: hydroxypropylcellulose (E463), lactose monohydrate, magnesium stearate, corn starch, diethylene glycol monoethyl ether (Transcutol), iron oxide red (E172).

Appearance of Candesartán Pensa and contents of the pack

The 8 mg tablets are bevelled, round, pink in colour and scored on one side.

Candesartán Pensa 8 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 some pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible for manufacturing:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, No. 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

This medicinal product is authorized in the Member States of the European Economic Area under 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 up-to-date 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/”.