PATIENT INFORMATION LEAFLET

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

Indapamida

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered any side effects that have not been listed in this leaflet, tell your doctor or pharmacist.

This medicationis used to lower high blood pressure (hypertension).

It is presented in the form of a coated tablet with a prolonged release film 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.

- If you are allergic to indapamide or any other sulfonamide, or to any of the other components ofINDAPAMIDA1,5mg,

- 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 low blood potassium levels.

Be especially careful with Indapamida Tarbis

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

- 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, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and they can occur within a few hours to a week after taking Indapamida Tarbis.

You should inform your doctor if you have had photosensitivity reactions.

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.

Athletes should be aware thatIndapamida Tarbis1,5mg contains an active ingredient that can give a positive result in a doping test.

Use of other medications:

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

You should not takeIndapamida Tarbis1,5mg 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),

- Medications used to treat mental disorders such as depression, anxiety, schizophrenia... (e.g. tricyclic antidepressants, antipsychotics, neuroleptics),

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

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

- Enoxacin, moxifloxacin (antibiotics used to treat infections),

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

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

- Mizolastine (used to treat allergic reactions, such as pollen allergy),

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

- Angiotensin-converting enzyme inhibitors (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 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,

- Cyclosporine, 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).

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any 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 wish 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 after starting treatment and after dose increases.

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

Important information about some of the components of Indapamida Tarbis1,5mg:

This medication contains lactose monohydrate. If your doctor has told you that you have intolerance to some sugars, inform your doctor before taking this medication.

Instructions for Correct Use:

Take one tablet per day, preferably in the morning. Tablets can be taken with or without food.

Swallow the tablets whole with a glass of water. Do not break or chew them.

The treatment for high blood pressure is usually lifelong.

If you take moreIndapamida1,5mg than you should:

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

A very high dose ofIndapamida Tarbis1,5mg could cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, and changes in urine production by the kidneys.

If you forget to take Indapamida 1,5mg:

If you forget to take a dose ofIndapamida Tarbis1,5mg, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Indapamida 1,5mg:

Since the treatment for high blood pressure 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 Tarbis1,5mg may have adverse effects, although not all people may experience them.

These may include:

• Frequently (less than 1 patient in every 10, but more than 1 in every 100):low levels of potassium in the blood, which may cause muscle weakness.
• Rarely (less than 1 patient in every 100, but more than 1 in every 1,000):low sodium levels in the blood that may cause dehydration and low blood pressure, impotence (inability to have or maintain an erection),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.
• Rarely (less than 1 patient in every 1,000, but more than 1 in every 10,000):
• • fatigue, dizziness, headache, 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 rarely (less than 1 patient in every 10,000):
• • irregular heart rhythms, low blood pressure;
  • kidney 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 the number of platelets, which favors the appearance of bruises and nasal bleeding), leucopenia (decrease in white blood cells, 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 cells).
  • 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 respiratory difficulty or difficulty swallowing. If this occurs, contact your doctor immediately.

If you have systemic lupus erythematosus (a type of collagen disease), it may worsen. There have also been reported cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA rays.

Some changes may be observed 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 uric acid levels, a substance that may cause or worsen gout (joint pain, especially in the feet),

. increased levels of glucose in the blood in diabetic patients,

. increased levels of calcium in the blood.

Other possible adverse effects:

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 adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use this medication after the expiration date that appears on the box and on the blister. The expiration date is the last day of the month indicated.

Store at a temperature below 25°C..

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines.This will help protect the environment.

Composition of Indapamida Tarbis

The active ingredient is indapamida. Each tablet contains 1.5 mg of indapamida.

The other components (excipients) are:

- Core: lactose monohydrate, carbomer, hydroxypropyl cellulose, magnesium stearate, anhydrous colloidal silica, and purified water.

- Pellicular coating Opadry II Pink (33G24509) formed by: hypromellose, titanium dioxide, lactose monohydrate, Macrogol/PEG 3000, triacetin, yellow iron oxide, red iron oxide, and black iron oxide.

Appearance of the product and contents of the package

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

The tablets ofIndapamida Tarbis 1.5 mgare packaged in AL/PVC/PVDC blisters.

Packages containing 30 and 100 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 – Barcelona

Spain

Responsible manufacturer

POLPHARMA S.A. Pharmaceutical Works

83-200 Starogard Gdanski, 19, Pelplinska Street

Poland

This leaflet was approved in December 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 /