Candesartan Mabo 16 mg Tablets

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Candesartan Mabo 16 mg tablets EFG

candesartan cilexetil

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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 pack:

1. What Candesartan Mabo is and what it is used for
2. Before you take Candesartan Mabo
3. How to take Candesartan Mabo
4. Possible side effects

5 Storage of Candesartan Mabo

1. Further information

1. What CANDESARTAN MABO is and what it is used for

Your medicine is called Candesartan Mabo. The active ingredient is candesartan cilexetil. This belongs to a group of medicines called angiotensin II receptor antagonists. It works by making your blood vessels relax and dilate. This helps to lower your blood pressure. It 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.

treatment of adult patients with heart failure with a reduced muscular function of the heart when it is not possible to use angiotensin-converting enzyme inhibitors (ACE inhibitors), or added to ACE inhibitors when symptoms persist despite treatment and it is not possible to use mineralocorticoid receptor antagonists (MRAs). (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. BEFORE YOU TAKE CANDESARTAN MABO

Do not take Candesartan Mabo:

• if you are allergic (hypersensitive) to candesartan cilexetil or 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 section Pregnancy).
• if you have severe liver disease or biliary obstruction (problem with the release of bile from the gallbladder).
• 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 you are in one of these situations, consult your doctor or pharmacist before taking Candesartan Mabo.

Be particularly cautious with Candesartan Mabo

Before taking, or while taking Candesartan 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 recently had vomiting, severe vomiting, or have diarrhea.
• if you have a disease of the adrenal gland 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, think you may be pregnant, or plan to become pregnant, you must inform your doctor. It is not recommended to use Candesartan Mabo at the beginning of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancybecause it can cause serious harm to your baby, see section Pregnancy.

• 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), 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 "Use of other medicines").

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 Mabo".

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

If you are going to have surgery, inform your doctor or dentist that you are taking Candesartan Mabo. This is because Candesartan 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 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). Therefore, Candesartan Mabo should not be administered to children.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, even those obtained without a prescription. Candesartan Mabo may affect the way some medicines work and some medicines may affect the effect of Candesartan Mabo. If you are using certain medicines, your doctor may need to perform blood tests from time to time.

In particular, inform your doctor if you are using any of the following medicines, as your doctor may need to change your dose and/or take other precautions:

• • Other medicines for lowering your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril.
  • Non-steroidal anti-inflammatory medicines (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 your blood).
  • Heparin (a medicine to increase blood fluidity).
  • Diuretics (medicines to promote urine elimination).
  • Lithium (a medicine for mental health problems).
• An angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Candesartan Mabo" and "Be particularly cautious with Candesartan Mabo")
• • 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 Mabo with food and drinks (especially with alcohol)

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

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. In general, your doctor will advise you to stop taking Candesartan Mabo before you become pregnant or as soon as you become pregnant, and will recommend taking another anti-hypertensive medicine instead. It is not recommended to use Candesartan Mabo at the beginning of pregnancy and in no case should it be administered from the third month of pregnancybecause it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as it is not recommended to administer Candesartan Mabo to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

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

Candesartan Mabo contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. HOW TO TAKE CANDESARTAN MABO

Follow exactly the administration instructions of Candesartan Mabo indicated by your doctor.

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

You can take Candesartan 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.

High blood pressure:

• The normal dose of Candesartan 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 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, diarrhea, or because they are taking diuretics, the doctor may prescribe a lower initial dose.
• Some patients of black race may have a reduced response to this type of medicine when given as sole treatment, and these patients may need a higher dose.

Heart failure:

• The initial normal dose of Candesartan Mabo 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 Mabo can be taken with other medicines for heart failure, and your doctor will decide what 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.

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 before consulting your doctor.

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

4. Possible side effects

Like all medicines, Candesartan Mabo can cause side effects, although not everybody gets them. It is important that you know what these side effects may be.

Stop taking Candesartan Mabo and go to the doctor immediately if you have 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 can cause difficulty swallowing
• severe skin itching (with rash)

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

Candesartan Mabo is not affecting your blood (agranulocytosis).

Other possible side effects include:

Frequent (affects 1 to 10 in every 100 patients)

• Dizziness sensation.
• Headache.
• Respiratory infection.
• Low blood pressure. This can cause you to feel dizzy or faint.
• 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 notice fatigue, weakness, irregular heartbeats, 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 every 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 have a 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 color of the skin and the white of the eyes, and symptoms similar to those of 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 reduction in sodium levels in the blood. If it is severe, you may feel weak, lack energy, or have muscle cramps.

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

• Diarrhea

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 expiration date stated on the packaging or blister.

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

• This medicine does not require special storage temperature conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE Collection Point (or any other system for collecting medicinal waste) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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6. FURTHER INFORMATION

Composition of Candesartan Mabo

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

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

Appearance of the product and packaging contents

The tablets of Candesartan Mabo 16 mg are white, round, biconvex with a notch on one face.

Candesartan Mabo 16 mg is available in blister packs of 28 tablets.

Marketing authorization holder and manufacturer

Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

LABORATORIOS ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

This leaflet was approved in February 2025

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