Indapamide Tarbis 1.5 mg prolonged-release film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Indapamida Tarbis 1.5 mg prolonged-release film-coated tablets EFG

Indapamide

Read the entire leaflet carefully before you start taking this 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Indapamida Tarbis 1.5 mg prolonged-release tablets are and what they are used for
2. Before taking Indapamida Tarbis 1.5 mg prolonged-release tablets
3. How to take Indapamida Tarbis 1.5 mg prolonged-release tablets
4. Possible side effects
5. How to store Indapamida Tarbis 1.5 mg prolonged-release tablets
6. Further information

1. What INDAPAMIDE TARBIS 1.5 mg is and what it is used for

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

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

Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it only causes a slight increase in the amount of urine formed.

2. Before taking INDAPAMIDE TARBIS 1.5 mg

• if you are allergic to indapamide or to any other sulfonamide, or to any of the other ingredients of INDAPAMIDE 1.5 mg,
• if you have severe kidney disease,
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder),
• if you have low levels of potassium in your blood.

Take special care with Indapamide Tarbis

Consult your doctor, pharmacist, or nurse before starting to take Indapamide Tarbis

• 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 tests 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 pressure in the eye, and may occur within a few hours to one week after taking Indapamide Tarbis.

You must inform your doctor if you have ever had photosensitivity reactions.

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 should be aware that Indapamide Tarbis 1.5 mg contains an active ingredient that may result in a positive doping test.

Use of other medicines:

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

You must not take Indapamide Tarbis 1.5 mg 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 taking 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),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia... (e.g. tricyclic antidepressants, antipsychotics, neuroleptics),
• bepridil (used to treat angina pectoris, a condition causing chest pain),
• cisapride, difenamidol (used to treat gastrointestinal problems),
• sparfloxacin, moxifloxacin (antibiotics used to treat infections),
• halofantrine (an antiparasitic used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• mizolastine (used to treat allergic reactions, such as hay fever),
• non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief (e.g. ibuprofen) or high doses of acetylsalicylic acid,
• angiotensin-converting enzyme (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 (for the treatment of muscle stiffness occurring in diseases such as multiple sclerosis),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (for the treatment of diabetes),
• iodinated contrast agents (used in X-ray procedures),
• 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).

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any 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 intend to become pregnant.

The active substance is excreted in breast milk. Breastfeeding is not recommended while taking this medicine.

Driving and use of machines:

This medicine may cause adverse effects due to lowering of blood pressure, such as dizziness or fatigue (see section 4). These adverse effects are more likely to occur at the beginning of treatment and after dose increases.

It is unlikely that indapamide will affect your ability to drive or operate machinery. However, like other medicines used to treat high blood pressure, indapamide 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 performing such activities.

Important information about some of the components of Indapamide Tarbis 1.5 mg:

This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take INDAPAMIDE TARBIS 1.5 mg

Instructions for correct use:

One tablet daily, preferably in the morning. The tablets may be taken with or without food.

The tablets should be swallowed whole with a glass of water. Do not break or chew them.

Treatment for high blood pressure is usually lifelong.

If you take more Indapamide 1.5 mg than you should:

If you have ingested an excessive number of tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20.

A very high dose of Indapamide Tarbis 1.5 mg could 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 Indapamide 1.5 mg:

If you forget to take a dose of Indapamide Tarbis 1.5 mg, take the next dose at your usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Indapamide 1.5 mg:

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

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

4. Possible adverse effects

Like all medicines, Indapamida Tarbis 1.5 mg can have adverse effects, although not everyone experiences them.

These may include:

• Frequently (less than 1 in 10 patients, but more than 1 in 100): low blood potassium levels, which may cause muscle weakness.
• Uncommonly (less than 1 in 100 patients, but more than 1 in 1,000): low blood sodium levels, which may lead to dehydration and low blood pressure, impotence (inability to achieve or maintain an erection), vomiting, allergic reactions, mainly dermatological, such as skin rashes, purpura (small red spots on the skin) in individuals predisposed to allergic and asthmatic reactions.
• Rarely (less than 1 in 1,000 patients, but more than 1 in 10,000):
  • Feeling of fatigue, dizziness, headache, tingling (paraesthesia);
  • Gastrointestinal disorders (such as nausea, constipation), dry mouth;
  • Increased risk of dehydration in elderly patients and in patients with heart failure;
  • Low blood chloride levels;
  • Low blood magnesium levels.
• Very rarely (less than 1 in 10,000 patients):
  • Irregular heart rhythm, low blood pressure;
  • Kidney disease;
  • Pancreatitis (inflammation of the pancreas causing upper abdominal pain), liver function abnormalities. In cases of liver failure, there is a possibility of developing hepatic encephalopathy (a degenerative brain disorder).
  • Changes in blood cells, such as thrombocytopenia (reduced platelet count, which increases the risk of bruising and nosebleeds), leucopenia (reduced white blood cell count, which may cause fever without apparent cause, sore throat or other flu-like symptoms – if this occurs, contact your doctor), and anaemia (reduced red blood cells).
  • Angioedema and/or urticaria, severe skin reactions. Angioedema is characterized by skin swelling 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. 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 (changes in skin appearance) after exposure to sunlight or artificial UVA rays have also been reported.

Some changes in laboratory test results may be observed, so your doctor may prescribe blood tests to monitor your condition. The following changes in laboratory results may occur:

. increased uric acid, a substance which may cause or worsen gout (joint pain, especially in the feet);

. increased blood glucose levels in diabetic patients;

. increased blood calcium levels.

Other possible adverse effects:

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of INDAPAMIDE TARBIS 1.5 mg

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month indicated.

Store below 25°C.

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

6. Additional Information

Composition of Indapamida Tarbis

The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.

The other components (excipients) are:

• Core: monohydrate lactose, carbomer, hydroxypropyl cellulose, magnesium stearate, anhydrous colloidal silica, talc, and purified water.
• Film coating Opadry II Pink (33G24509) consisting of: hypromellose, titanium dioxide, monohydrate lactose, Macrogol/PEG 3000, glycerol triacetate, yellow iron oxide, red iron oxide, and black iron oxide.

Appearance of the product and contents of the container

Prolonged-release film-coated tablets, pale pink in colour, round and biconvex.

Indapamida Tarbis 1.5 mg tablets are packed in AL/PVC/PVDC blisters.

Pack sizes containing 30 and 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 – Barcelona

Spain

Manufacturer

POLPHARMA S.A. Pharmaceutical Works

83-200 Starogard Gdanski, 19, Pelplinska Street

Poland

This leaflet was approved in December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es /