Indapen Sr

Package Leaflet: Information for the Patient

Indapen SR, 1.5 mg, Prolonged-Release Tablets

Indapamide

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

• 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 leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Indapen SR is a diuretic that lowers blood pressure.
The mechanism of action involves increased urine excretion and direct vasodilation.
The effect of the medicine lasts for 24 hours.
Indapen SR is indicated for the treatment of primary hypertension.

2. Important information before taking Indapen SR

When not to take Indapen SR:

• 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;
• 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 the blood (hypokalemia).

Warnings and precautions

Before starting treatment with Indapen SR, discuss it with your doctor or pharmacist.
Be particularly cautious when taking Indapen SR:

• if you have liver failure;
• if you have kidney failure;
• if you have diabetes;
• if you have gout;
• if you are at risk of developing 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 developing 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 SR. 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 in athletes.
If you think any of the above applies to you, or if you are unsure, consult your doctor or pharmacist.
Your doctor may recommend tests to check if your potassium or sodium levels have decreased or if your calcium levels have increased in the blood.

Children and adolescents

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

Elderly patients

Indapen SR may be used in elderly patients only if kidney function is normal or slightly impaired. The doctor will adjust the dose according to the patient's age, weight, and sex.

Indapen SR 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.
It is possible that indapamide may interact with other medicines.
Medicines that should not be taken with indapamide:

• lithium salts (used to treat depression).

Medicines that may increase the effect of Indapen SR or the risk of side effects:

• 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, trifluperazine), 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 effects (e.g., ibuprofen) or high doses of acetylsalicylic acid;
• orally administered 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);
• osmotic laxatives;
• metformin (used to treat diabetes);
• iodine-containing contrast agents (used during diagnostic tests with X-rays);
• 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).

Indapen SR with food and drink

Food does not affect the absorption of the medicine.

Pregnancy and breastfeeding

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

Driving and using machines

During treatment with Indapen SR, especially at the beginning of treatment or when taking another 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.

Indapen SR contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Indapen SR

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor.
Usually, 1.5 mg (1 tablet) is taken orally once a day, preferably in the morning.
The tablets should be swallowed whole with water. Do not crush or chew them.
At higher doses, indapamide does not show a stronger blood pressure-lowering effect.

Overdose of Indapen SR

Acute overdose may 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 of this medicine than you should, contact your doctor or pharmacist immediately. Gastric lavage or other appropriate treatment may be necessary in a hospital setting.

Missed dose of Indapen SR

If you miss a dose, take the next dose as usual. Do not take a double dose to make up for the missed dose.
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.
The following side effects may occur during treatment with this medicine:

• Frequent(occurring in 1 to 10 people in 100):
• low potassium levels in the blood, which can cause muscle weakness;
• rash.

Uncommon(occurring in 1 to 10 people in 1,000):

• nausea and 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(occurring in 1 to 10 people in 10,000):

• dizziness, fatigue, headache, tingling (paresthesia);
• nausea, constipation, dry mouth; low chloride levels in the blood; low magnesium levels in the blood.

Very rare(occurring in 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 (rash and blistering of the skin and mucous membranes, leading to peeling of large areas of skin), Stevens-Johnson syndrome (blisters that progress to ulcers, on the mucous membranes of the mouth, eyes, genitals);
• hypercalcemia.

Frequency not known(frequency 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 - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma);
• fainting;
• severe heart rhythm disorders (torsades de pointes);
• in patients with liver failure, the possibility of developing hepatic encephalopathy (a brain disease), hepatitis;
• increased liver enzyme activity;
• exacerbation of 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 any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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 SR

Keep this medicine out of the sight and reach of children.
Store in a temperature below 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.
The inscription 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 SR contains

• The active substance is indapamide. Each tablet contains 1.5 mg of indapamide.
• The other ingredients are:
• tablet core: lactose monohydrate, carbomer, hydroxypropylcellulose, magnesium stearate, colloidal silica anhydrous, talc;
• Opadry II pink 33G24509 coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 3000, glycerol triacetate, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Indapen SR looks like and contents of the pack

Indapen SR is a pink, round, biconvex tablet.
The pack contains 28, 30, 56, or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Date of last revision of the package leaflet: