PATIENT INFORMATION LEAFLET

INDAPAMIDE retard MABO 1.5 mg prolonged-release tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they do not appear in this leaflet.

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

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

Do not take Indapamida retard Mabo

• if you are allergic (hypersensitive) to indapamida, sulfamidas, 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 condition 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 problems or kidney problems
• if you need to undergo a test to check if your parathyroid gland is functioning correctly.
• if you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking indapamida. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a 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 consider that any of the above situations may affect you or have any doubts about how to take this medication, consult your doctor or pharmacist.

Interaction of Indapamida retard Mabo with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any medication.

You should 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 using any of the following medications, as special care may be required:

• medications for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals),
• medications used to treat mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a disorder that causes chest pain),
• cisapride, difemanil (used to treat gastrointestinal problems),
• esparfloxacine, moxifloxacine (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),
• nonsteroidal 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 (used to treat muscle stiffness that occurs in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (used to treat diabetes),
• iodinated contrast agents (used for X-ray tests),
• calcium tablets or other calcium supplements,
• ciclosporin, tacrolimus, or other immunosuppressive medications used after a transplant, to treat autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (used to treat Crohn's disease).

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and operating machinery

It is unlikely that Indapamida retard Mabo will affect your ability to drive or operate machinery. However, like other medications 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 engaging in these activities.

Important information about one of the components of Indapamida retard Mabo

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

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 provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medication.

The usual dose is one tablet per day, preferably in the mornings. Tablets can be taken with or without food.

Tablets should be swallowed whole with a glass of water and should not be chewed. Treatment for high blood pressure is lifelong.

Your doctor will inform you of 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 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, muscle cramps, dizziness, drowsiness, confusion, 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 the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Indapamida retard Mabo

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

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

Like all medications, Indapamida retard Mabo may cause side effects, although not everyone will experience them.

These may include:

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

Feeling tired, 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 levels of chloride in the blood.

Low levels of magnesium in the blood

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

Irregular heart rhythm, low blood pressure;

Renal disease;

Pancreatitis (inflammation of the pancreas that produces pain in the upper abdomen), liver function alteration. 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 the number of platelets, which favors the appearance of bruises and nasal bleeding), leucopenia (decrease in white blood cells, which may cause fever without apparent cause, sore throat, or other symptoms similar to the flu – if this occurs, 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 difficulty swallowing. If this occurs, contact your doctor immediately.

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

• Unknown frequency (cannot be estimated from available data)

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

You may notice some changes 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 levels of potassium in the blood,
• low levels of sodium in the blood that may cause dehydration and low blood pressure,
• increased levels of uric acid, a substance that may cause or worsen gout (pain in the joints, especially in the feet),
• increased levels of glucose in the blood in diabetic patients,
• increased levels of calcium in the blood.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Do not use this medication after the expiration date that appears on the packaging after

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of 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.

Composition of Indapamida retard MABO

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

Appearance of the product and contents of the packaging

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

The Indapamida Retard MABO tablets are packaged in PVC/Aluminum blisters. Each package contains 30 tablets

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada Madrid, Spain

Responsible for manufacturing

MEIJI PHARMA SPAIN, S.A.

Avda. de Madrid, 94,

28802, Alcalá de Henares

Madrid, Spain

This leaflet was approved in November 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/