PATIENT INFORMATION LEAFLET

Candesartán Mabo16mg film-coated tablets

candesartán cilexetilo

Read this leaflet carefully before you start to take 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

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

2.Before taking Candesartán Mabo

3.How to take Candesartán Mabo

4.Possible side effects

5Storage of Candesartán Mabo

6.Further information

Your medication is called Candesartán Mabo. The active ingredient is candesartán cilexetilo. This belongs to a group of medications called angiotensin II receptor antagonists. It works by causing blood vessels to relax and dilate. This facilitates a decrease in blood pressure. It also facilitates your heart pumping blood to all parts of your body.

This medication is used for:

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

treatment of adult patients with heart failure and reduced cardiac muscle functionwhen 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 Mabo:

• if you are allergic (hypersensitive) to candesartán cilexetilo or to any of the other components of Candesartán Mabo (see section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section).
• if you have a severe liver disease or biliary obstruction (problem with the bile flow from the gallbladder).
• If you havediabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If you are unsure whether you fall into any of these situations, consult your doctor or pharmacist before taking Candesartán Mabo.

Be especially careful with Candesartán Mabo

Before taking, or while taking Candesartán Mabo, inform your doctor:

• if you have heart, liver, or kidney problems or are undergoing dialysis.
• if you have recently had a kidney transplant.
• if you have vomiting, have recently had severe vomiting, or have diarrhea.
• if you have a condition called Conn's syndrome (also known as primary aldosteronism) affecting the adrenal gland.
• if you have low blood pressure.
• if you have ever had a stroke.
• if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Candesartan Mabo is not recommended for use at the beginning of pregnancy (first 3 months) andmust not be administered after the third month of pregnancybecause it can cause serious harm to your baby, see Pregnancy section.

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

• if you are taking an ACEI together with a medication belonging to the class of drugs called mineralocorticoid receptor antagonists (MRAs). These medications are for the treatment of heart failure (see "Use of other medications").

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

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

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

If you are to undergo surgery, inform your doctor or dentist that you are taking Candesartán Mabo. This is because Candesartán Mabo, in combination with some anesthetics, can cause a drop in blood pressure.

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

Use in children

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Candesartán Mabo may affect how some medications work, and some medications may influence the effect of Candesartán Mabo. If you are using certain medications, your doctor may need to perform blood tests at regular intervals.

Especially, inform your doctor if you are using any of the following medications, asyour doctor may need to modify your dose and/or take other precautions:

• • Other medications to lower your blood pressure, including beta-blockers, diazoxide, and the so-called 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).
  • Acetylsalicylic acid (if you take more than 3 g per day) (medication to relieve pain and inflammation).
  • Potassium supplements or salt substitutes containing potassium (medications that increase the amount of potassium in your blood).
  • Heparin (a medication to increase blood fluidity).
  • Diuretics (medications to promote urine elimination).
  • Lithium (a medication for mental health problems).
• a converting enzyme inhibitor (ACEI) or aliskirén (see also the information under the headings “Do not take Candesartán Mabo” and “Be especially careful withCandesartán Mabo”)
• • if you are being treated with an ACEI together with other medications specifically for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example, spironolactone, eplerenone).

Taking Candesartán Mabo with food and drinks (especially with alcohol)

• You can take Candesartán Mabo with or without food.
• When Candesartán Mabo is prescribed, consult your doctor before taking alcohol. Alcohol may make you feel dizzy or lightheaded.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Candesartán Mabo before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Candesartán Mabo is not recommended for use at the beginning of pregnancy and must not be administered after the third month of pregnancy because it can cause serious harm to your baby when administered from that point on.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, asCandesartán Mabo is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

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

Candesartán Mabo contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for Candesartán Mabo indicated by your doctor.

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

You can take Candesartán Mabo with or without food.

Swallow the tablet with a little water.

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

Hypertension:

• The normal dose of Candesartán Mabo is 8 mg once a day. Your doctor may increase this dose up to 16 mg once a day and then up to 32 mg once a day, depending on the 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, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.

• Some black patients may present a reduced response to this type of medication, when given as a single treatment, and these patients may need a higher dose.

Heart failure:

• The initial normal dose of Candesartán Mabo is 4 mg once a day. Your doctor may increase this dose by doubling it in intervals of at least 2 weeks up to 32 mg once a day. Candesartán Mabo can be taken with other medications for heart failure, and your doctor will decide what treatment is suitable for you.

If you take more Candesartán Mabo than you should

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

If you forget to take Candesartán Mabo

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

If you interrupt the treatment with Candesartán Mabo

If you stop taking Candesartán Mabo, your blood pressure may increase again. Therefore, do not stop taking Candesartán Mabo before consulting your doctor.

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

Like all medications, Candesartán Mabo may have side effects, although not everyone will experience them. It is essential that you know which side effects could occur.

Stop taking Candesartán Mabo and see 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 skin itching (with skin rash)

Candesartán Mabo may cause a decrease in white blood cells. Your resistance to infections may decrease, and you may feel tired, have an infection, or fever. If this occurs, inform your doctor. Your doctor may perform a blood test from time to time to check that

Candesartán Mabo is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 of every 100 patients)

• Dizziness sensation.

• Headache.

• Respiratory infection.

• Low blood pressure. This may cause dizziness or fainting.

• Changes in blood test results:

– An increase in potassium levels in the blood, especially if you already have kidney problems or heart failure. If this situation is severe, you will feel tired, weak, have irregular heartbeats, or numbness.

• 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.

• A decrease in red or white blood cells. You may feel tired, have an infection, or fever.

• Skin rash, hives.

• Itching.

• Back pain, joint and muscle pain.

• Changes in liver function, including liver inflammation (hepatitis). You will feel tired, have a yellowish discoloration of the skin and the white of the eyes, and symptoms similar to the flu.

• Nausea.

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• Changes in blood test results:

– A decrease in sodium levels in the blood. If severe, you may feel weak, lack energy, or have muscle cramps.

Unknown frequency (cannot be estimated from available data)

• Diarrhea

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep out of reach and sight of children.

• Do not use Candesartán Mabo after the expiration date that appears on the packaging or blister.

The expiration date is the last day of the month indicated.

• This medication does not require special storage temperature conditions.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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Composition of Candesartán Mabo

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

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

Appearance of the product and contents of the package

The Candesartán Mabo 16 mg tablets are white, round, biconvex with a notch on one of the faces.

Candesartán Mabo 16 mg is available in a blister pack with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada, Madrid

Spain

Responsible for Manufacturing

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

This leaflet was approved in February 2025

The 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/