Candesartan Mabo 16 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Candesartán Mabo 16 mg tablets EFG

candesartan cilexetil

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Candesartán Mabo is and what it is used for
2. Before you take Candesartán Mabo
3. How to take Candesartán Mabo
4. Possible side effects
5. How to store Candesartán Mabo
6. Further information

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

Your medicine is called Candesartán Mabo. The active substance is candesartán cilexetilo. It belongs to a group of medicines called angiotensin II receptor antagonists. It works by relaxing and widening the blood vessels, which helps lower blood pressure. It also helps the heart pump blood more easily to all parts of the body.

This medicine is used for:

• the treatment of high blood pressure (hypertension) in adult patients.

• the treatment of adult patients with heart failure and reduced heart muscle function when angiotensin-converting enzyme inhibitors (ACE inhibitors) cannot be used, or as an addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. BEFORE TAKING CANDESARTAN MABO

Do not take Candesartan Mabo:

• if you are allergic (hypersensitive) to candesartan cilexetil or to any of the other ingredients of Candesartan Mabo (see section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy – see Pregnancy section).
• if you have severe liver disease or biliary obstruction (a problem with bile outflow from the gallbladder).
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Candesartan Mabo.

Take special care with Candesartan Mabo

Before taking, or while you are taking Candesartan Mabo, inform your doctor:

• if you have heart, liver or kidney problems or are undergoing dialysis.

• if you have recently received a kidney transplant.

• if you are experiencing vomiting, have recently had severe vomiting, or have diarrhea.

• if you have an adrenal gland disorder called Conn's syndrome (also known as primary hyperaldosteronism).

• if you have low blood pressure.

• if you have ever had a stroke.

• if you are pregnant, suspect you might be pregnant, or plan to become pregnant, you must inform your doctor. Use of Candesartan Mabo is not recommended during early pregnancy (first 3 months), and must not be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby – see Pregnancy section.

• if you are taking any of the following medicines used 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 the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Use with other medicines").

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 Candesartan Mabo”.

If any of these situations apply to you, your doctor may wish to see you more frequently and carry out certain tests.

If you are due to undergo surgery, inform your doctor or dentist that you are taking Candesartan Mabo. This is because Candesartan Mabo, in combination with certain anaesthetics, may cause a drop in blood pressure.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Candesartan Mabo. Your doctor will decide whether to continue treatment. Do not stop taking Candesartan Mabo on your own.

Use in children

There is no experience with the use of Candesartan Mabo in children (under 18 years of age). Therefore, Candesartan Mabo should not be administered to children.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription. Candesartan Mabo may affect how some medicines work, and some medicines may influence the effect of Candesartan Mabo. If you are taking certain medicines, your doctor may need to perform blood tests periodically.

In particular, inform 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 your blood pressure, including beta-blockers, diazoxide, and so-called 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 your blood).
  • Heparin (a medicine used to increase blood fluidity).
  • Diuretics (medicines that promote urine elimination).
  • Lithium (a medicine used for mental health conditions).
• An angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Candesartan Mabo” and “Take special care with Candesartan Mabo”).
  • 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).

Taking Candesartan Mabo with food and drinks (especially alcohol)

• You may take Candesartan Mabo with or without food.
• When prescribed Candesartan Mabo, consult your doctor before consuming alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, suspect you might be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Candesartan Mabo before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Candesartan Mabo is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from that point onward.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Candesartan Mabo is not recommended for women during this period. Your doctor may choose a treatment more suitable for you if you intend to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

Candesartan Mabo contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

3. HOW TO TAKE CANDESARTAN MABO

Follow exactly the administration instructions for Candesartan Mabo given by your doctor.

Consult your doctor or pharmacist if you have any doubts. It is important that you continue taking Candesartan Mabo every day.

You may take Candesartan Mabo with or without food.

Swallow the tablet with some water.

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

High blood pressure:

• The usual dose of Candesartan Mabo is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily, and then to 32 mg once daily, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or those who have recently lost body fluids (for example, due to vomiting, diarrhoea, or use of diuretics), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this type of medicine when used as monotherapy, and may require a higher dose.

Heart failure:

• The usual starting dose of Candesartan Mabo 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 Mabo may be taken together with other medicines for heart failure, and your doctor will decide which treatment is suitable for you.

If you take more Candesartan Mabo than you should

If you have taken more Candesartan Mabo than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Candesartan Mabo

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

If you stop taking Candesartan Mabo

If you stop taking Candesartan Mabo, your blood pressure may rise again. Therefore, do not stop taking Candesartan Mabo without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, Candesartán Mabo can have adverse effects, although not everyone experiences them. It is important that you are aware of what these adverse effects could be.

Stop taking Candesartán Mabo and contact your 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 skin rash)

Candesartán Mabo may cause a decrease in white blood cells. Your resistance to infections may be reduced, and you may feel tired, develop an infection or fever. If this occurs, inform your doctor. Your doctor may perform blood tests periodically to check whether
Candesartán Mabo is affecting your blood (agranulocytosis).

Other possible adverse effects include:

Common (affects 1 to 10 out of every 100 patients)

• Dizziness
• Headache
• Respiratory infection
• Low blood pressure. This may cause dizziness or fainting
• Changes in blood test results:
  • Increased levels of potassium in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may experience fatigue, weakness, irregular heartbeat, or tingling
• Effects on kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur

Very rare (affects less than 1 in 10,000 patients)

• Swelling of the face, lips, tongue and/or throat
• Decrease in red blood cells or white blood cells. You may feel tired, or develop an
  infection or fever
• Skin rash, hives
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including inflammation of the liver (hepatitis). You may feel tired, have yellowing of the skin and whites of the eyes, and flu-like symptoms
• Nausea
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• Changes in blood test results:
  • Reduction in levels of sodium in the blood. If severe, you may feel weak, lack energy, or experience muscle cramps

Frequency not known (cannot be estimated from available data)

• Diarrhea

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance 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 MABO

• Keep out of the reach and sight of children.
• Do not use Candesartan Mabo after the expiry date stated on the packaging or blister.

The expiry date refers to the last day of the month indicated.

• This medicine does not require special storage temperature conditions.

Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their packaging to the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Candesartán Mabo

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

-The other components are monohydrate lactose, pregelatinized corn starch, hydroxypropylcellulose, calcium carboxymethylcellulose, triethyl citrate, magnesium stearate.

Appearance of the medicinal product and contents of the pack

Candesartán Mabo 16 mg tablets are white, round, biconvex, with a score line on one side.

Candesartán Mabo 16 mg is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Building 6, 28033, Madrid,

Spain.

Manufacturer

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

This leaflet was approved in February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/