Indapamide Mabo 1.5 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

INDAPAMIDE RETARD MABO 1.5 mg prolonged-release tablets EFG

Read this entire leaflet carefully before you start taking this medicine, because 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.

Leaflet contents:

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

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

This medicine is used to lower 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 causes a slight increase in the amount of urine formed.

2. What you need to know before taking Indapamida retard Mabo

Do not take Indapamida retard Mabo

• if you are allergic (hypersensitive) to indapamide, sulfonamides, or any of the other components of Indapamida 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 levels of potassium in your blood.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Indapamida retard Mabo

• if you have liver problems,
• if you have diabetes,
• if you have gout,
• if you have any heart rhythm disorders or kidney problems,
• if you need to undergo tests to check whether your parathyroid gland is functioning properly,
• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to one week after taking indapamide. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing such a reaction.

You should inform your doctor if you have previously experienced photosensitivity reactions.

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

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

Interaction of Indapamida retard Mabo with other medicines

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

You must not take Indapamida 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 causing chest pain),
• cisapride, difemethilene (used to treat gastrointestinal problems),
• sparfloxacin, moxifloxacin (antibiotics used to treat infections),
• halofantrine (an antiparasitic used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as hay fever),
• non-steroidal anti-inflammatory drugs (NSAIDs) 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 occurring in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (for the treatment of diabetes),
• iodinated contrast agents (used in X-ray examinations),
• calcium tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other immunosuppressants used after transplantation, or for the treatment of autoimmune diseases, or severe dermatological or rheumatological conditions,
• tetracosactide (for the treatment of Crohn's disease).

Pregnancy, breastfeeding, and fertility

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

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

The active substance is excreted in breast milk. Breastfeeding is not recommended if you are taking this medicine.

Driving and using machines

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

Important information about some of the components of Indapamida retard Mabo

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

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

3. How to take Indapamida retard Mabo

Follow exactly the administration instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Remember to take your medicine.

The usual dose is one tablet daily, preferably in the morning. The tablets may be taken with or without food.

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

Your doctor will determine the duration of your treatment with Indapamida retard Mabo.

If you take more Indapamida retard Mabo than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Indapamida retard Mabo

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

If you stop taking Indapamida retard Mabo

Since treatment for high blood pressure is usually lifelong, you must speak with your doctor before stopping this medication.

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

4. Possible adverse effects

Like all medicines, Indapamida retard Mabo may produce adverse effects, although not everyone experiences them.

These may include:

• Frequent (at least 1 in 100 patients): low blood potassium levels, which may cause muscle weakness.

• Uncommon (at least 1 in 1,000 patients): vomiting, allergic reactions, mainly dermatological, such as skin rashes, purpura (red spots on the skin) in people with a predisposition to allergic reactions and those with asthma. Low blood sodium levels, which may cause dehydration and low blood pressure. Impotence (inability to achieve or maintain an erection).

• Rare (at least 1 in 10,000 patients):

  A feeling of tiredness, dizziness, headache, tingling (paraesthesia);

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

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

  Low blood chloride levels.

  Low blood magnesium levels.

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

  Irregular heart rhythm, low blood pressure;

  Kidney disease;

  Pancreatitis (inflammation of the pancreas causing pain in the upper abdomen), liver function abnormalities. In cases of liver failure, there is a possibility of developing hepatic encephalopathy (a degenerative brain disorder).

  Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets, which increases the risk of bruising and nosebleeds), leucopenia (decrease in white blood cells, which may cause fever without apparent cause, sore throat, or other flu-like symptoms – if this occurs, contact your doctor), and anaemia (decrease in red blood cells).

  Angioedema and/or urticaria, severe skin reactions. Angioedema is characterised by swelling of the skin of the limbs or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways causing difficulty breathing or difficulty swallowing. If this occurs, contact your doctor immediately.

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

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Indapamide Mabo Retard

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

Do not use this medicine after the expiry date stated on the packaging following
Exp. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Indapamida retard MABO

• The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other components (excipients) are: Core: colloidal silicon dioxide, hypromellose, lactose monohydrate, pregelatinized maize starch, magnesium stearate. Coating: hypromellose, macrogol 6000, titanium dioxide.

Appearance of the product and contents of the pack

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

Indapamida 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 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/