Label: information for the user

Indapamida Retard Viatris 1.5 mg prolonged-release tablets EFG

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Indapamida Retard Viatris and for what it is used

2.What you need to know before starting totake Indapamida Retard Viatris

3. How to take Indapamida Retard Viatris

4. Possible adverse effects

5. Storage of Indapamida Retard Viatris

6.Contents of the package andadditional information

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

It is a prolonged-release tablet that contains indapamida as the active ingredient.

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 Viatris:

• If you are allergic to indapamide or any other sulfonamide, or to any of the other components of this medication (listed in section 6).
• If you have a severe kidney disease.
• If you have a 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 Viatris:

• 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. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking indapamide. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillins or sulfonamides, you may be at higher risk of developing it.
• If you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps.

You should inform your doctor if you have had sensitivity to sunlight.

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.

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

Other medications and Indapamida Retard Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

You should not take indapamide 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, bretylium).

- Medications used to treat mental disorders such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol).

- Bepridil (used to treat angina pectoris, a condition that causes chest pain).

- Cisapride, difemanil (used to treat gastrointestinal problems).

- Erythromycin intravenous (antibiotics used to treat infections).

• Vincamine intravenous (used to treat cognitive disorders in elderly patients, including memory loss).

- Halofantrine (antiparasitic used to treat certain types of malaria).

- Pentamidine (used to treat certain types of pneumonia).

- Antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, astemizole, terfenadine).

- Nonsteroidal anti-inflammatory drugs for pain relief (e.g., ibuprofen) or high doses of aspirin.

- Angiotensin-converting enzyme inhibitors (ACEIs) (used to treat high blood pressure and heart failure).

- Amphotericin B intravenous (antifungal medications).

- 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).

- Allopurinol (for the treatment of gout).

- 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.

- Cyclosporine, tacrolimus, or other immunosuppressive medications used after transplantation, for the treatment of autoimmune diseases, or severe dermatological or rheumatological diseases.

- Tetracosactide (for the treatment of Crohn's disease).

- Methadone (used for the treatment of addiction).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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

This medication may cause adverse effects due to low blood pressure, such as dizziness or fatigue (see section 4). The occurrence of these adverse effects is more likely to occur when treatment is started for the first time and after dose increases.If this occurs, you should not drive or operate machinery.

Indapamida Retard Viatris contains lactose

This medication contains lactose monohydrate. 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 this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day, preferably in the mornings. Tablets can be taken with or without food. Tablets must be swallowed whole with a glass of water and should not be chewed or broken.

Typically, treatment for high blood pressure is lifelong.

If you take more Indapamida Retard Viatris 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 could cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, changes in the amount of urine produced by the kidneys.

If you forgot to take Indapamida Retard Viatris

If you forgot to take your indapamida dose, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withIndapamida Retard Viatris

Since treatment for high blood pressure is typically long-term, you should talk to your doctor before stopping this medication.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Stop taking this medicine and seek immediate medical attention if you experience any of the following side effects:

Rare (may affect up to 1 in 10,000 people):

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin on the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or respiratory tract, causing difficulty breathing or difficulty swallowing.
• Severe skin reactions including intense skin rash, body-wide skin redness, intense itching, blisters, peeling, and skin swelling, inflammation of the mucous membranes (Stevens-Johnson Syndrome).
• Pancreatitis that can cause severe abdominal and back pain accompanied by intense discomfort.

Unknown frequency (cannot be estimated from available data):

• Liver inflammation (hepatitis) with symptoms such as fatigue, loss of appetite, discomfort, limb inflammation, and yellowing of the skin.
• Brain disease caused by liver disease (Hepatic Encephalopathy).
• Irregular heartbeat with life-threatening risk (Torsade de Pointes).
• Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Muscle weakness, cramps, sensitivity, or pain, especially if accompanied by discomfort or high fever, which may be due to abnormal muscle degradation.

Other side effects may be:

Frequent (may affect up to 1 in 10 people):

• Skin rash with redness
• Allergic reactions,mainly dermatological in individuals with a predisposition to allergic and asthmatic reactions.
• Low potassium levels in the blood.

Infrequent (may affect up to 1 in 100 people):

• Vomiting.
• Red spots on the skin (Purpura).
• Low sodium levels in the blood that can cause dehydration and low blood pressure.
• Impotence (inability to achieve or maintain an erection).

Rare (may affect up to 1 in 1,000 people):

• Feeling tired, dizziness (dizziness), headache, tingling (paresthesia).
• Gastrointestinal disorders (such as nausea, constipation), dry mouth.
• Low chloride levels in the blood.
• Low magnesium levels in the blood.

Rare (may affect up to 1 in 10,000 people):

• Changes in blood cells, such as thrombocytopenia (decreased platelet count, which favors the appearance of bruises and nasal bleeding), leucopenia, and agranulocytosis (decreased white blood cell count, which can cause fever without apparent cause, sore throat, or other symptoms similar to the flu – if this occurs, contact your doctor) and anemia (decreased red blood cell count).
• High calcium levels in the blood.
• Irregular heart rhythm (causing palpitations, perception of heartbeats), low blood pressure.
• Kidney disease (causing symptoms of fatigue, increased need to urinate, skin itching, feeling unwell, limb inflammation).
• Abnormal liver function.

Unknown frequency (cannot be estimated from available data):

• Loss of consciousness.
• If you have "systemic lupus erythematosus" (a disorder of the immune system) it may worsen.
• Cases of photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA radiation.
• Short-sightedness (myopia), blurred vision, decreased vision.
• You may observe changes in your laboratory tests (blood analysis), so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:
• • Increased uric acid, a substance that can cause or worsen gout (joint pain, especially in the feet).
  • Increased blood glucose levels in diabetic patients.
  • Increased levels of liver enzymes.

Abnormal electrocardiogram.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD or 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 the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Indapamida Retard Viatris

• The active ingredient is indapamida.
• The other components are:

Lactose monohydrate, hypromellose, povidone, anhydrous colloidal silicon dioxide, magnesium stearate, titanium dioxide (E171), macrogol 6000, pregelatinized cornstarch. See section 2, Indapamida Retard Viatris contains lactose.

Appearance of Indapamida Retard Viatris and contents of the package

Indapamida Viatris 1.5 mg prolonged-release film-coated tablets are white, round, film-coated tablets. They are available in blister packs of 10, 30, 90, or 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35-36 Industrial Estate

Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft

H-2900 Komarom

Mylan utca 1

Hungary

For more information about this medication, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the European Economic Area member states with the following names:

SpainIndapamida Retard Viatris 1.5 mg prolonged-release tablets EFG

FranceIndapamide Viatris LP 1.5 mg prolonged-release tablet

ItalyIndapamide Mylan Generics Italia

United KingdomTensaid XL 1.5 mg prolonged-release film-coated tablet

Last review date of this leaflet: April 2023

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/