Indix Sr

Package Leaflet: Information for the Patient

INDIX SR

1.5 mg, prolonged-release tablets

Indapamide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Indix SR and what is it used for
• 2. Important information before taking Indix SR
• 3. How to take Indix SR
• 4. Possible side effects
• 5. How to store Indix SR
• 6. Package contents and other information

1. What is Indix SR and what is it used for

Indix SR 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 differs from other diuretics in that it causes only a slight increase in urine production. Indix SR is used to treat high blood pressure (hypertension).

2. Important information before taking Indix SR

When not to take Indix SR:

• if you are allergic to indapamide, sulfonamides, or 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 liver dysfunction, including hepatic encephalopathy;
• if you have low potassium levels in your blood.

Warnings and precautions

Before taking Indix SR, discuss with your doctor or pharmacist:

• 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 have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after starting Indix SR. Untreated symptoms can lead to complete vision loss. Patients with a history of penicillin or sulfonamide allergy are at higher risk of developing such disorders.

If you experience a hypersensitivity reaction to light, tell your doctor. Your doctor may recommend tests to check for low potassium or sodium levels, or high calcium levels. If you are concerned about any of the above, or have questions or doubts about taking this medicine, you should consult your doctor or pharmacist. Athletes should note that Indix SR contains an active substance that may give a positive result in anti-doping tests.

Indix SR and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any you plan to take. Do not take Indix SR with lithium (used to treat depression) due to the risk of increased lithium levels in the blood. Make sure your doctor knows about the following medicines, as special caution may be necessary:

• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• medicines for 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 coronary heart disease, which causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, erythromycin injection);
• vincamine injection (used to treat cognitive disorders in the elderly, including memory loss);
• halofantrine (an antiparasitic medicine 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 medicines with analgesic properties (e.g., ibuprofen) or high doses of acetylsalicylic acid;
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure);
• amphotericin B injection (a medicine used to treat fungal infections);
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate peristalsis;
• baclofen (used to treat muscle stiffness, which occurs in diseases such as multiple sclerosis);
• allopurinol (used to treat gout);
• potassium-sparing diuretics (e.g., amiloride, spironolactone, triamterene);
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used in diagnostic tests with X-rays);
• calcium supplements or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or to treat autoimmune diseases, severe rheumatic diseases, or dermatological diseases;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat addiction).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Indix SR is not recommended during pregnancy. If pregnancy is planned or confirmed, alternative treatment should be started as soon as possible. Tell your doctor if you are pregnant or plan to become pregnant. Indapamide passes into breast milk. This medicine is not recommended during breastfeeding.

Driving and using machines

Indix SR may cause side effects such as dizziness or fatigue (see section 4). These side effects are more common at the beginning of treatment or after a dose increase. In such cases, you should avoid driving or operating machinery. However, these symptoms are rare if treatment is well controlled.

Indix SR contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Indix SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet per day, taken preferably in the morning. The tablets can be taken with or without food. Swallow the tablet whole with water. Do not break or chew it. Treatment of high blood pressure is usually lifelong. Patients with kidney problems: Indix SR is not recommended for patients with kidney problems. Patients with liver problems: Indix SR is not recommended for patients with liver problems. Elderly patients: Indix SR can be used in elderly patients, provided they do not have kidney problems. Children and adolescents (up to 18 years): Indix SR is not recommended for children and adolescents.

If you take more Indix SR than you should

If you have taken too many tablets, contact your doctor or pharmacist immediately. Very high doses of indapamide may cause: nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in urine production.

If you forget to take Indix SR

If you miss a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Indix SR

Since treatment of high blood pressure usually lasts for the rest of your life, consult your doctor before stopping treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Indix SR and contact your doctor immediately:

• -angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, lips or tongue, mucous membranes of the throat or respiratory tract, which can cause difficulty breathing or swallowing. If you experience such symptoms, seek medical attention immediately (very rare, may occur in up to 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare, may occur in up to 1 in 10,000 patients);
• life-threatening heart rhythm disorders (very rare, may occur in up to 1 in 10,000 patients);
• -pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition (very rare, may occur in up to 1 in 10,000 patients);
• -hepatic encephalopathy (frequency not known);
• hepatitis (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Other side effects, grouped by frequency of occurrence:

Common side effects (may occur in up to 1 in 10 patients):

• red, raised rash;
• allergic reactions, mainly affecting the skin, in patients with a history of allergies and asthma;
• low potassium levels in the blood.

Uncommon side effects (may occur in up to 1 in 100 patients):

• nausea and vomiting;
• red spots on the skin (purpura);
• low sodium levels in the blood, which can cause dehydration and low blood pressure;
• impotence (inability to achieve or maintain an erection).

Rare side effects (may occur in up to 1 in 1,000 patients):

• dizziness, excessive fatigue, tingling (paresthesia), headaches;
• gastrointestinal disorders (such as nausea, constipation), dry mouth;
• low chloride levels in the blood;
• low magnesium levels in the blood.

Very rare side effects (may occur in up to 1 in 10,000 patients):

• changes in blood cell counts, such as thrombocytopenia (reduced platelet count, which can cause easy bruising and bleeding from the nose), leukopenia (reduced white blood cell count, which can cause unexplained fever, sore throat, or flu-like symptoms - if you experience these, contact your doctor), agranulocytosis (lack of granulocytes in the blood), aplastic or hemolytic anemia (reduced red blood cell count);
• heart rhythm disorders, low blood pressure;
• kidney failure;
• liver dysfunction;
• toxic epidermal necrolysis;
• hypercalcemia (elevated calcium levels in the blood).

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

• fainting;
• -possibility of exacerbating pre-existing systemic lupus erythematosus;
• photosensitivity reactions (changes in skin appearance) after exposure to sunlight or artificial UVA radiation;
• myopia;
• blurred vision;
• visual disturbances;
• worsening vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye - choroidal effusion - or acute angle-closure glaucoma);
• changes in laboratory test results (blood tests) and your doctor may recommend a blood test. The following changes in laboratory test results may occur:
• increased uric acid levels, which can cause or worsen gout (joint pain or swelling, especially in the feet);
• increased glucose levels in the blood in patients with diabetes;
• increased liver enzyme activity;
• abnormal electrocardiogram (ECG) tracing.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Indix SR

Do not store above 30°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP (expiry date). The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Indix SR contains

• The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: lactose monohydrate, copovidone, hypromellose, magnesium stearate, colloidal anhydrous silica.

What Indix SR looks like and contents of the pack

Indix SR is a white or almost white, round, biconvex tablet. The tablets are packaged in blisters placed in a cardboard box. Pack sizes: 30, 60, or 90 tablets.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków

Date of last revision of the package leaflet: