Leaflet: information for the user

Indapamida Retard pensa 1.5 mg film-coated prolonged-release tabletsEFG

Read this leaflet carefully before you start taking the 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 you think you have suffered a side effect you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1. What isIndapamida Retard Pensaand what it is used for

2. Before takingIndapamida Retard Pensa

3. How to takeIndapamida Retard Pensa

4. Possible side effects

5. Storage ofIndapamida Retard Pensa

6. Further information

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.

This medication is indicated for the treatment of high blood pressure (hypertension).

Do not take Indapamida Retard Pensa

-if you are allergic (hypersensitive) to indapamide, sulfonamides, or any of the other components of Indapamida Retard Pensa.

• if you have severe kidney disease.
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (alteration of brain function that occurs when the liver is no longer able to remove toxic substances from the blood).
• if you have abnormally low levels of potassium in your blood.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Indapamida Retard Pensa

• if you have liver problems
• if you have diabetes
• if you have gout
• if you have any heart problems or kidney problems
• if you are undergoing a test to check if your parathyroid gland is functioning correctly
• 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 an increase in eye pressure, which can occur within a few hours to a week after taking Indapamida Retard Pensa.

You should inform your doctor if you have had photoallergic reactions.Avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA), while using this medication.

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.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

You should not take Indapamida Retard Pensa 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 arrhythmia (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 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),
• mizolastina (used to treat allergic reactions, such as pollen allergy),
• nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief (e.g., ibuprofen) or high doses of acetylsalicylic acid.
• angiotensin-converting enzyme inhibitors (ACEIs) (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 agents (used for X-ray tests)
• calcium tablets or other calcium supplements,
• ciclosporin, tacrolimus, or other immunosuppressive medications used after a transplant, for the treatment of autoimmune diseases, or severe dermatological or rheumatological diseases,
• tetracosactide (for the treatment of Crohn's disease).

Taking Indapamida Retard Pensa with food and drinks

Indapamida Retard Pensa can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

It is not recommended to take this medication during pregnancy. When pregnancy is planned or confirmed, the treatment should be changed to an alternative 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 medication, breastfeeding is not recommended.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

It is unlikely that Indapamida Retard Pensa will affect your ability to drive or operate machinery. However, like other medications used to treat high blood pressure, Indapamida Retard Pensa may cause dizziness or drowsiness in some people, especially at the start of treatment, when changing doses, or if alcohol is consumed. If you experience dizziness or drowsiness, consult your doctor before engaging in these activities.

Important information about some of the components of Indapamida Retard Pensa

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 Indapamida Retard Pensa as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Dosage

The usual dose is one tablet per day, preferably in the mornings.

The treatment for high blood pressure is lifelong.

Your doctor will inform you of the duration of your treatment with Indapamida Retard Pensa.

Administration Form

This medication is administered orally.

Tablets can be taken with or without food. They must be swallowed whole with a glass of water and should not be chewed.

If you take more Indapamida Retard Pensa 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 Pensa 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 Pensa

If you forget to take your dose of Indapamida Retard Pensa 1.5 mg tablets, 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 Pensa

Since high blood pressure treatment 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 Pensa may cause side effects, although not everyone will experience them.

These may include:

Frequent (affecting between 1 and 10 out of every 100 patients):

• Low levels of potassium in the blood, which may cause muscle weakness.

Infrequent (affecting between 1 and 10 out of every 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 and asthmatic reactions.
• Low sodium levels in the blood that may cause dehydration and low blood pressure.
• Impotence (inability to have or maintain an erection).

Rare (affecting between 1 and 10 out of every 10,000 patients):

• Feeling tired, dizziness, headaches, 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 (affecting fewer than 1 out of every 10,000 patients):

• Irregular heart rhythms, 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 platelet count, which favors the appearance of hematomas and nasal bleeding), leucopenia (decrease in white blood cell count, 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 cell count).
• 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) after exposure to the sun or artificial UVA rays have also been reported.

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:

• 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.

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]

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 Indapamida Retard Pensa after the expiration date that appears on the packaging. 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 the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Indapamida Retard Pensa

• The active ingredient is indapamida. Each tablet contains 1.5 mg of indapamida.
• The other components (excipients) are: lactose monohydrate, cornstarch pregelatinized, hypromellose, colloidal silicon dioxide, magnesium stearate. Components of the coating: hypromellose, macrogol 6000, and titanium dioxide.

Appearance of the product and contents of the package

Indapamida Retard Pensa are coated tablets with prolonged release film, round, biconvex, white or off-white in color.

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

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50, 90449 Nürnberg (Germany)

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19,

Venda Nova 2700-487 Amadora

Portugal

Last review date of this leaflet: September 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/