INDAPAMIDE TARBIS 1.5 mg PROLONGED-RELEASE FILM-COATED TABLETS

2. Before taking INDAPAMIDE TARBIS 1.5 mg

• if you are allergic to indapamide or any other sulfonamide, or to any of the other components of INDAPAMIDE 1.5 mg,
• 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 low blood potassium levels.

Be careful 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 problems or kidney problems,
• if you need to undergo any tests to check if your parathyroid gland is working properly.

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 increased pressure in the eye and can occur within a few hours to a week after taking Indapamide 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 think 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 that Indapamide Tarbis 1.5 mg contains an active ingredient that can test positive in a doping test.

Use of other medications:

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

Do 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 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, digitalis),
• 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),
• esparfloxacino, moxifloxacino (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),
• 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),
• 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 agent (used for X-ray tests),
• calcium tablets or other calcium supplements,
• cyclosporin, 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.

It is not recommended to take this medication during pregnancy. When pregnancy is planned or confirmed, a change to an alternative treatment should be made as soon as possible. Inform your doctor if you are pregnant or want to become pregnant.

The active ingredient is excreted in breast milk. If you are taking this medication, breastfeeding is not recommended.

Driving and using machines:

This medication may cause side effects due to the lowering of blood pressure, such as dizziness or fatigue (see section 4). The occurrence of these side effects is more likely after starting treatment and after dose increases.

It is unlikely that indapamide will affect your ability to drive or use machines. However, like other medications 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 when consuming alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.

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

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

3. How to take INDAPAMIDE TARBIS 1.5 mg

Instructions for correct use:

One tablet a 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. Do not break or chew them.

Treatment for high blood pressure is usually for life.

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, phone: 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 forgot to take a dose of Indapamide Tarbis 1.5 mg, take the next dose at the usual time. Do not take a double dose to make up for the missed doses.

If you stop taking Indapamide 1.5 mg:

Since treatment for high blood pressure is usually for life, you should talk to your doctor before stopping this medication.

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

4. Possible side effects

Like all medications, Indapamide Tarbis 1.5 mg can have side effects, although not everyone gets them.

These can include:

• Frequent (less than 1 in 10 patients, but more than 1 in 100):low blood potassium levels, which can cause muscle weakness.
• Uncommon (less than 1 in 100 patients, but more than 1 in 1,000):low blood sodium levels that can cause dehydration and low blood pressure, impotence (inability to have or maintain an erection), vomiting, allergic reactions, mainly skin-related, such as skin rashes, purpura (red spots on the skin) in people with a predisposition to allergic and asthmatic reactions.
• Rare (less than 1 in 1,000 patients, but more than 1 in 10,000):
• • Feeling of 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 blood chloride levels;
  • Low blood magnesium levels.
• Very rare (less than 1 in 10,000 patients):
• • Irregular heart rhythms, low blood pressure;
  • Kidney disease;
  • Pancreatitis (inflammation of the pancreas that causes pain in the upper abdomen), altered liver function. 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 platelet count, which favors the appearance of hematomas and nosebleeds), leukopenia (decrease in white blood cells, which can 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).
  • 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 throat or respiratory tract mucosa that causes difficulty breathing or 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 reports of photosensitivity reactions (change in skin appearance) after exposure to sunlight or artificial UVA rays.

Some changes may be observed in your analytical tests, so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your analytical 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 blood calcium levels.

Other possible side effects:

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

If you think any of the side effects you are experiencing is serious or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

5. Storing INDAPAMIDE TARBIS 1.5 mg

Keep out of the reach and sight of children.

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

Store at a temperature below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Further information

Composition of Indapamide Tarbis

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

The other components (excipients) are:

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

Appearance of the product and packaging content

Film-coated tablets with prolonged release, pale pink in color, round, and biconvex.

Indapamide Tarbis 1.5 mg tablets are packaged in AL/PVC/PVDC blisters.

Packaging 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 updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es /