Indapamide prolonged-release tablets ViatriS 1.5 mg EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Indapamida 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 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

It is a prolonged-release tablet containing indapamide as the active substance.

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 taking Indapamida Retard Viatris

Do not take Indapamida Retard Viatris:

• If you are allergic to indapamide or to 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 (degenerative brain disease).
• If you have abnormally low levels of potassium in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking Indapamida Retard Viatris:

• 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 any test to check whether your parathyroid gland is functioning 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 eye pressure, which may occur within a few hours to one week after taking indapamide. This may lead to permanent worsening of vision if not treated. If you have previously had an allergy to penicillins or sulfonamides, you may be at increased risk of developing such a reaction.
• If you have muscle disorders, including muscle pain, tenderness, weakness, or cramps.

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

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 conditions may apply to you or if you have any doubts about how to take this medicine, consult your doctor or pharmacist.

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.

Other medicines and Indapamida Retard Viatris

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

You must 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 glycosides, 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 condition causing chest pain).

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

• Sparfloxacin, moxifloxacin, intravenous erythromycin (antibiotics used to treat infections).

  • Intravenous vincamine (used to treat symptomatic cognitive disorders in elderly patients, including memory loss).

• Halofantrine (an 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 (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).

• Intravenous amphotericin B (antifungal medicines).

• 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).

• Allopurinol (for the treatment of gout).

• Potassium-sparing diuretics (amiloride, spironolactone, triamterene).

• Metformin (for the treatment of diabetes).

• Iodinated contrast agents (used in X-ray tests).

• 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).

• Methadone (used to treat addiction).

Pregnancy and breastfeeding

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

This medicine may cause adverse effects due to low blood pressure, such as dizziness or fatigue (see section 4). These adverse effects are more likely to occur when treatment is first started or after dose increases. If this happens, you must not drive or operate machinery.

Indapamida Retard Viatris contains lactose

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

3. How to take Indapamida Retard Viatris

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily, preferably in the morning. Tablets may be taken with or without food. The tablets must be swallowed whole with a glass of water and must not be chewed or broken.

Treatment for high blood pressure is usually lifelong.

If you take more Indapamida Retard Viatris 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 medicine and the amount ingested.

A very high dose of indapamide may 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 Viatris

If you forget to take your dose of indapamide, 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 Viatris

Since treatment for high blood pressure is usually long-term, you must speak with your doctor before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• Angioedema and/or urticaria. Angioedema is characterized by swelling of the skin in the limbs or face, swelling of the lips or tongue, swelling of the mucous membranes in the throat or airways causing difficulty breathing or difficulty swallowing.
• Severe skin reactions including intense rash, redness of the skin all over the body, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome).
• Inflammation of the pancreas (pancreatitis), which may cause severe abdominal and back pain accompanied by intense malaise.

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

• Inflammation of the liver (hepatitis), with symptoms such as fatigue, loss of appetite, malaise, swelling of the limbs, 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, tenderness or pain, especially if accompanied by malaise or high fever, which may be due to abnormal muscle breakdown.

Other adverse effects may include:

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

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

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

• Vomiting.
• Small red spots on the skin (purpura).
• Low blood sodium levels, which may 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 of tiredness, dizziness (dizziness), headache, tingling (paresthesia).
• Gastrointestinal disorders (such as nausea, constipation), dry mouth.
• Low blood chloride levels.
• Low blood magnesium levels.

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

• Changes in blood cells, such as thrombocytopenia (decreased number of platelets, leading to bruising and nosebleeds), leucopenia and agranulocytosis (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 anemia (decrease in red blood cells).
• High levels of calcium in the blood.
• Irregularities in heart rhythm (causing palpitations, awareness of heartbeat), low blood pressure.
• Kidney disease (causing symptoms such as fatigue, increased need to urinate, skin itching, feeling unwell, swelling of the limbs).
• Abnormal liver function.

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

• Fainting.
• 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.
• Changes in blood test results may be observed, so your doctor may prescribe blood tests to monitor your condition. The following changes may be seen in your blood tests:
  • Increased uric acid levels, a substance that may 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 of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Indapamide Retard Viatris

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

Do not use this medicine after the expiry date stated on the packaging following CAD or EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Indapamida Retard Viatris

• The active substance is indapamide.
• The other components are:

Monohydrate lactose, hypromellose, povidone, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), macrogol 6000, pregelatinized maize starch. See section 2; Indapamida Retard Viatris contains lactose.

Appearance of Indapamida Retard Viatris and contents of the pack

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

For further information on this medicine, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised 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 the most recent review of this leaflet: April 2023

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