Indapen

Package Leaflet: Information for the Patient

Indapen, 2.5 mg, Film-Coated Tablets

Indapamide

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

• Keep this 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Indapen and what is it used for
• 2. Important information before taking Indapen
• 3. How to take Indapen
• 4. Possible side effects
• 5. How to store Indapen
• 6. Contents of the pack and other information

1. What is Indapen and what is it used for

These are film-coated tablets containing indapamide as the active substance. Indapamide is a diuretic. Most diuretics increase the amount of urine excreted by the kidneys. Indapamide differs from other diuretics in that it causes only a slight increase in urine volume. Indapen is used to treat high blood pressure (essential hypertension).

2. Important information before taking Indapen

When not to take Indapen

• if you are allergic to indapamide, other sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney failure (anuria);
• if you have severe liver dysfunction or a condition called hepatic encephalopathy (a brain disorder caused by liver damage);
• if you have low potassium levels in your blood (hypokalemia).

Warnings and precautions

Before taking Indapen, discuss it with your doctor or pharmacist. You should be particularly careful when taking Indapen:

• if you have liver failure;
• if you have kidney failure;
• if you have diabetes;
• if you have gout;
• if you are at risk of hypokalemia (low potassium levels in the blood, which can cause muscle weakness, tremors, or heart rhythm disturbances);
• if you have water and electrolyte balance disorders;
• if you are sensitive to light;
• if you are at risk of hypercalcemia (elevated calcium levels in the blood, which can cause loss of appetite, nausea, vomiting, or heart rhythm disturbances);
• if you are to undergo a test to assess parathyroid function;
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they can occur within a few hours to weeks after taking Indapen. Without treatment, these symptoms can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at increased risk of developing these symptoms.

The medicine may cause positive results in doping tests for athletes. If you think any of the above applies to you, or if you are in doubt, you should consult your doctor or pharmacist before taking this medicine. Your doctor may recommend tests to check if your potassium or sodium levels have decreased or if your calcium levels have increased in your blood.

Children and adolescents

Due to the lack of clinical trials, the use of Indapen is not recommended in children and adolescents.

Elderly patients

Indapen can be used in elderly patients only if kidney function is normal or slightly impaired. Your doctor will adjust the dose of the medicine, taking into account your age, body weight, and sex.

Indapen and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Medicines that should not be taken with indapamide:

• lithium salts (used to treat depression).

Medicines that may increase the effect of Indapen or the risk of side effects: You should make sure your doctor is informed about your use of the following medicines, as special caution may be necessary:

• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations);
• antipsychotic medicines used to treat mental disorders such as depression, anxiety, schizophrenia: phenothiazine derivatives (e.g., chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamide derivatives (amisulpride, sulpiride, sultopride, tiapride), butyrophenone derivatives (droperidol, haloperidol);
• bepridil (used to treat coronary heart disease, which causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• sparfloxacin, moxifloxacin, intravenous vincamine, amphotericin B, or erythromycin (antibiotics used to treat infections);
• halofantrine (an antiparasitic medicine used to treat certain types of malaria);
• mizolastine (used to treat allergic reactions, such as high fever);
• pentamidine (used to treat certain types of pneumonia);
• non-steroidal anti-inflammatory medicines with analgesic properties (e.g., ibuprofen) or high doses of acetylsalicylic acid;
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• baclofen (used to treat muscle stiffness, which occurs in diseases such as multiple sclerosis);
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure);
• potassium-sparing diuretics (amiloride, spironolactone, triamterene);
• laxatives with osmotic effects;
• metformin (used to treat diabetes);
• contrast agents containing iodine (used during diagnostic tests with X-rays);
• tablets containing calcium 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).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Diuretics should be avoided in pregnant women. Diuretics can cause fetal hypoperfusion with a risk of fetal growth restriction. Indapamide can be used during pregnancy only if absolutely necessary. Indapamide passes into breast milk. Therefore, it is not recommended to take this medicine during breastfeeding.

Driving and using machines

While taking Indapen, especially at the beginning of treatment or when taking an additional antihypertensive medicine, symptoms related to decreased blood pressure may occur. In such a situation, the ability to drive vehicles and operate machines may be impaired.

3. How to take Indapen

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. The usual dose for adults is 1 tablet (2.5 mg) per day, in the morning. The tablets can be taken with or without food. Indapen should be taken orally. Treatment of hypertension is usually long-term.

Take more Indapen than prescribed

Acute poisoning can cause water and electrolyte balance disorders (decreased sodium and potassium levels in the blood), nausea, vomiting, hypotension, muscle cramps, dizziness, drowsiness, confusion, polyuria, or oliguria up to anuria (due to decreased circulating blood volume). If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately, as gastric lavage or other measures may be necessary in a hospital setting.

Miss a dose of Indapen

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

Stop taking Indapen

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

4. Possible side effects

Like all medicines, Indapen can cause side effects, although not everybody gets them. Frequent (affect 1 to 10 people in 100): low potassium levels in the blood; papular rash (especially in people prone to allergic reactions or with asthma). Uncommon (affect 1 to 10 people in 1,000): vomiting; purpura (a disease characterized by a rash, abdominal pain, and joint pain); low sodium levels in the blood, which can cause dehydration and decreased blood pressure; impotence (inability to achieve or maintain an erection); Rare (affect 1 to 10 people in 10,000): feeling tired, dizziness, headache, tingling (paresthesia); nausea, constipation, dry mouth; low chloride levels in the blood; low magnesium levels in the blood. Very rare (affect less than 1 person in 10,000): thrombocytopenia (decreased platelet count, which can increase the risk of bleeding and bruising), leukopenia (decreased total white blood cell count), agranulocytosis (complete or almost complete disappearance of granulocytes in the blood), aplastic anemia (decreased blood cell count due to bone marrow failure), hemolytic anemia (decreased red blood cell count); heart rhythm disorders, decreased blood pressure; pancreatitis, kidney failure, liver dysfunction; angioedema (swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing or breathing) and/or urticaria, toxic epidermal necrolysis (skin changes with blisters and peeling, leading to large areas of skin loss); Stevens-Johnson syndrome (blisters that turn into ulcers on the mucous membranes of the mouth, genitals, and eyes); hypercalcemia. Frequency not known (cannot be estimated from the available data): vision loss or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or increased intraocular pressure); fainting; severe heart rhythm disorders (torsade de pointes); in patients with liver failure, the possibility of developing hepatic encephalopathy (a disease that damages the brain), hepatitis; increased liver enzyme activity; possibility of exacerbating symptoms of systemic lupus erythematosus; photosensitivity reactions (skin changes after exposure to sunlight or artificial UVA radiation); abnormal ECG; increased uric acid and glucose levels in the blood. In patients with diabetes or gout, the doctor should consider the appropriateness of using diuretics.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Indapen

Keep this medicine out of the sight and reach of children. Store in a temperature not exceeding 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number. 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. Contents of the pack and other information

What Indapen contains

• The active substance is indapamide. Each tablet contains 2.5 mg of indapamide.
• The other ingredients are:
• tablet core: microcrystalline cellulose, crospovidone, magnesium stearate;
• coating: hypromellose, stearic acid, microcrystalline cellulose, titanium dioxide (E 171).

What Indapen looks like and contents of the pack

Indapen is a round, white, biconvex film-coated tablet. The pack contains 20, 30, or 60 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Date of last revision of the leaflet: