INDAPAMIDE RETARD VIATRIS 1.5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Indapamide Retard Viatris 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. See section 4.

Contents of the pack

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

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

This medicine is used to lower high blood pressure in adults.

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

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 Viatris

Do not take Indapamide Retard Viatris

• If you are allergic to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney disease.
• If you have severe liver disease or suffer from a disorder called hepatic encephalopathy (a degenerative brain disease).
• If you have abnormally low levels of potassium in your blood.

Warnings and precautions

Consult your doctor or pharmacist before taking Indapamide 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 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 impairment if left untreated. 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 think any of the above situations may apply to you, or if you have any doubts about taking this medicine, consult your doctor or pharmacist.

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

Other medicines and Indapamide Retard Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Do 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 medicines, as special care may be required:

• Medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium).
• Medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)
• Bepridil (used to treat angina pectoris, a disorder that causes chest pain).
• Cisapride, difemanil (used to treat gastrointestinal problems).
• Esparfloxacino, moxifloxacino, 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).
• 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).
• Amphotericin B intravenous (antifungal medications).
• Oral corticosteroids used in various treatments, including severe asthma and rheumatoid arthritis.
• 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 agent (used for X-ray tests).
• Calcium tablets or other calcium supplements.
• Cyclosporin, 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 to treat addiction).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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

This medicine may cause side effects such as dizziness or fatigue (see section 4) due to the lowering of blood pressure. The appearance of these side effects is more likely to occur when treatment is first started and after dose increases. If this happens, do not drive or use machines.

Indapamide Retard Viatris contains lactose

This medicine contains lactose monohydrate. 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 Viatris

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

The recommended dose is one tablet per 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 or broken.

Treatment for high blood pressure is usually for life.

If you take more Indapamide Retard Viatris than you should

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

A very high dose of indapamide 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 Viatris

If you forget to take your dose of indapamide, 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 Viatris

Since treatment for high blood pressure is usually long-term, 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, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience any of the following side effects:

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

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of 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, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome).
• Pancreatitis that can cause severe abdominal and back pain accompanied by severe discomfort.

Frequency not known (cannot be estimated from the available data):

• Hepatitis (inflammation of the liver) with symptoms such as fatigue, loss of appetite, discomfort, swelling of the extremities, yellowing of the skin.
• Brain disease caused by liver disease (Hepatic Encephalopathy).
• Life-threatening irregular heartbeat (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, and especially if you also feel discomfort or high fever, may be due to abnormal muscle breakdown.

Other side effects may be:

Common (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.

Uncommon (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 have or maintain an erection).

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

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

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

• Changes in blood cells, such as thrombocytopenia (decrease in platelet count, which favors the appearance of hematomas and nosebleeds), leucopenia, and agranulocytosis (decrease in white blood cells, which can produce fever without apparent cause, sore throat, or other flu-like symptoms - if this happens, contact your doctor) and anemia (decrease in red blood cells).
• High calcium levels in the blood.
• Irregular heart rhythms (causing palpitations, perception of heartbeats), low blood pressure.
• Kidney disease (causing symptoms of fatigue, increased need to urinate, itching, feeling of discomfort, swelling of the extremities).
• Abnormal liver function.

Frequency not known (cannot be estimated from the available data):

• Fainting.
• If you suffer from "systemic lupus erythematosus" (an immune system disorder), it may worsen.
• Cases of photosensitivity reactions (change in skin appearance) after sun exposure or artificial UVA radiation.
• Short-sightedness (myopia), blurred vision, decreased vision.
• Changes may be observed in your laboratory tests (blood tests), 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 glucose levels in the blood in diabetic patients.
  • Increased liver enzyme levels.

Abnormal electrocardiogram.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Indapamide Retard Viatris

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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. Contents of the pack and other information

Composition of Indapamide Retard Viatris

• The active ingredient is indapamide.
• The other ingredients are:

Lactose monohydrate, hypromellose, povidone, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), macrogol 6000, pregelatinized corn starch. See section 2, Indapamide Retard Viatris contains lactose.

Appearance of Indapamide Retard Viatris and pack contents

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Indapamida Retard Viatris 1.5 mg prolonged-release tablets EFG

France Indapamide Viatris LP 1.5 mg prolonged-release film-coated tablet

Italy Indapamide Mylan Generics Italia

United Kingdom Tensaid XL 1.5 mg prolonged-release film-coated tablet

Date of last revision of this leaflet: April 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/