INDAPAMIDE RETARD MABO 1.5 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

INDAPAMIDE retard MABO 1.5 mg prolonged-release tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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.

Contents of the pack and other information

1. What is Indapamide retard Mabo and what is it used for
2. What you need to know before you take Indapamide retard Mabo
3. How to take Indapamide retard Mabo
4. Possible side effects
5. Storing Indapamide retard Mabo
6. Pack contents and further information

1. What is Indapamide retard Mabo and what is it used for

This medication is used to lower high blood pressure (hypertension).

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only produces a slight increase in the amount of urine formed.

2. What you need to know before you take Indapamide retard Mabo

Do not take Indapamide retard Mabo

• if you are allergic (hypersensitive) to indapamide, sulfonamides, or any of the other ingredients of Indapamide retard Mabo,
• if you have severe kidney disease,
• if you have severe liver disease or suffer from a disorder called hepatic encephalopathy (degenerative brain disease)
• if you have abnormally low potassium levels in your blood.

Warnings and precautions

Consult your doctor or pharmacist before taking Indapamide retard Mabo

• if you have liver problems
• if you have diabetes
• if you have gout
• if you have any heart rhythm problems or kidney problems
• if you need to undergo any tests to check if your parathyroid gland is working properly.
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking indapamide. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it

You should inform your doctor if you have had photosensitivity reactions.

Your doctor may prescribe blood tests to check if you have low sodium or potassium levels, or high calcium levels.

If you think any of the above situations may apply to you or have any doubts about how to take this medicine, consult your doctor or pharmacist.

Interaction of Indapamide retard Mabo with other medicines

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

Do not take Indapamide retard Mabo with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.

Make sure to inform your doctor if you are taking any of the following medicines, as special care may be required:

• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a condition that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• esparfloxacino, moxifloxacino (antibiotics used to treat infections),
• halofantrine (antiparasitic used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as pollen allergy),
• non-steroidal anti-inflammatory drugs for pain relief (e.g., ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat high blood pressure and heart failure),
• oral corticosteroids used in various treatments, including severe asthma and rheumatoid arthritis,
• stimulant laxatives,
• baclofen (for the treatment of muscle stiffness that occurs in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (for the treatment of diabetes),
• iodinated contrast agent (used for X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressive drugs used after a transplant, for the treatment of autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (for the treatment of Crohn's disease).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine is not recommended during pregnancy. When pregnancy is planned or confirmed, an alternative treatment should be initiated as soon as possible. Inform your doctor if you are pregnant or wish to become pregnant.

The active ingredient is excreted in breast milk. If you are taking this medicine, breastfeeding is not recommended.

Driving and using machines

It is unlikely that Indapamide retard Mabo will affect your ability to drive or use machines. However, like other medicines used to treat high blood pressure, Indapamide retard Mabo may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

Important information about some of the ingredients of Indapamide retard Mabo

Athletes are informed that this medicine contains a component that may result in a positive doping test.

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

3. How to take Indapamide retard Mabo

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Remember to take your medicine.

The usual dose is one tablet a day, preferably in the morning. The tablets can be taken with or without food.

The tablets should be swallowed whole with a glass of water and should not be chewed. Treatment for high blood pressure is usually for life.

Your doctor will tell you how long to take Indapamide retard Mabo.

If you take more Indapamide retard Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

A very high dose of Indapamide retard Mabo could cause nausea, vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, changes in the amount of urine produced by the kidneys.

If you forget to take Indapamide retard Mabo

If you forget to take your dose of Indapamide retard Mabo, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Indapamide retard Mabo

Since treatment for high blood pressure is usually for life, you should talk to your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, Indapamide retard Mabo can cause side effects, although not everybody gets them.

These can include:

• Frequent (at least 1 in 100 patients): low potassium levels in the blood, which can cause muscle weakness.
• Uncommon (at least 1 in 1,000 patients): vomiting, allergic reactions, mainly skin-related, such as skin rashes, purpura (red spots on the skin) in people with a predisposition to allergic and asthmatic reactions. Low sodium levels in the blood that can cause dehydration and low blood pressure. Impotence (inability to have or maintain an erection).
• Rare (at least 1 in 10,000 patients):

Feeling of tiredness, dizziness, headache, tingling (paresthesia);

Gastrointestinal disorders (such as nausea, constipation), dry mouth;

Increased risk of dehydration in the elderly and in patients with heart failure.

Low chloride levels in the blood.

Low magnesium levels in the blood

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

Irregular heart rhythms, low blood pressure;

Kidney disease;

Pancreatitis (inflammation of the pancreas that causes pain in the upper abdomen), liver function changes. In cases of liver failure, there is a possibility of developing hepatic encephalopathy (degenerative brain disease).

Changes in blood cells, such as thrombocytopenia (decrease in platelet count, which favors the appearance of hematomas and nosebleeds), leukopenia (decrease in white blood cells, which can cause fever without apparent cause, sore throat, or other flu-like symptoms - if this happens, contact your doctor) and anemia (decrease in red blood cells).

Angioedema and/or urticaria, severe skin manifestations. Angioedema is characterized by inflammation of the skin of the extremities or face, inflammation of the lips or tongue, inflammation of the mucous membranes of the throat or respiratory tract that causes difficulty breathing or swallowing. If this happens, contact your doctor immediately.

If you have systemic lupus erythematosus (a type of collagen disease), it may worsen. There have also been reports of photosensitivity reactions (change in skin appearance) after exposure to sunlight or artificial UVA rays.

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

Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Some changes may be observed in your laboratory tests, so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:

• low potassium levels in the blood,
• low sodium levels in the blood that can cause dehydration and low blood pressure,
• increased uric acid, a substance that can cause or worsen gout (joint pain, especially in the feet),
• increased glucose levels in the blood in diabetic patients,
• increased calcium levels in the blood.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storing Indapamide retard Mabo

Keep out of the reach and sight of children. No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after

EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Pack contents and further information

Composition of Indapamide retard MABO

• The active ingredient is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other ingredients (excipients) are: Core: colloidal silicon dioxide, hypromellose, lactose monohydrate, pregelatinized corn starch, magnesium stearate. Coating: hypromellose, macrogol 6,000, titanium dioxide.

Appearance of the product and pack contents

Prolonged-release tablets, white, round, and biconvex.

Indapamide Retard MABO tablets are packaged in PVC/Aluminum blisters. Each pack contains 30 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares

Madrid, Spain

This leaflet was approved in November 2021

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/