DIURESIN 1.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. DIURESIN SR, 1.5 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Diuresin SR and what is it used for
4. Important information before taking Diuresin SR
   1. When not to take Diuresin SR:
   2. Warnings and precautions
   3. Children
   4. Diuresin SR and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Diuresin SR contains lactose
5. How to take Diuresin SR
   1. Overdose of Diuresin SR
   2. Missed dose of Diuresin SR
   3. Stopping treatment with Diuresin SR
6. Possible side effects
   1. Reporting side effects
7. How to store Diuresin SR
8. Contents of the pack and other information
   1. What Diuresin SR contains
   2. What Diuresin SR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

DIURESIN 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 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Diuresin SR is a diuretic. Indapamide is a non-thiazide derivative of sulfonamides with pharmacological properties similar to those of thiazide diuretics. The antihypertensive effect is due to the direct, vasodilating action of indapamide on the smooth muscle of blood vessels, which results in decreased peripheral resistance. The drug does not have an adverse effect on lipid metabolism and carbohydrates, even in patients with diabetes. It reduces left ventricular hypertrophy caused by arterial hypertension. Indapamide is rapidly and completely absorbed from the gastrointestinal tract. The biological half-life is approximately 18 hours. The drug is excreted in the urine (about 70%) and feces (about 20%) in the form of inactive metabolites. About 5% of the dose is excreted unchanged. Diuresin SR is indicated for:

• primary arterial hypertension, in monotherapy or in combination with other antihypertensive drugs.

2. Important information before taking Diuresin SR

When not to take Diuresin SR:

• if the patient has had a recent cerebral ischemic stroke;
• if the patient is allergic to the active substance (indapamide), sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe renal impairment (glomerular filtration rate (GFR) <10 ml min);< li>
• if the patient has severe liver impairment with disturbances of water and electrolyte balance (pre-coma and coma hepaticum);
• if the patient has hypokalemia.

Warnings and precautions

Before starting treatment with Diuresin SR, discuss it with your doctor or pharmacist. The occurrence of visual disturbances 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 may occur within a few hours to a week after taking Diuresin SR. If left untreated, they can lead to permanent vision loss. If the patient has a history of allergy to sulfonamides or penicillin, the risk of occurrence may be increased. Particular caution should be exercised when using Diuresin SR in combination with digitalis products, lithium, astemizole, terfenadine, erythromycin (given intravenously) in patients with water and electrolyte balance disorders (hypokalemia - decreased potassium levels in the blood, hyponatremia - decreased sodium levels in the blood, hypercalcemia - increased calcium levels in the blood), gout (including past), hyperuricemia (increased uric acid levels in the blood), liver and (or) kidney function disorders. In case of worsening renal failure or occurrence of consciousness disorders caused by liver failure during treatment, Diuresin SR should be discontinued and contact your doctor. Particular caution should be exercised when using indapamide and angiotensin-converting enzyme (ACE) inhibitors. Especially in the first week of concomitant use of ACE inhibitors and indapamide, the doctor may recommend monitoring kidney function (creatinine levels). Caution should be exercised in patients with systemic lupus erythematosus (SLE), as indapamide may exacerbate symptoms or cause a relapse of the disease. During treatment with the drug, periodic monitoring of blood pressure and periodic monitoring of potassium levels in the blood serum are recommended, especially in patients treated concomitantly with digitalis glycosides or systemic corticosteroids, as well as in patients with liver failure. In these patients, it is recommended to enrich the diet with products high in potassium or use products containing potassium (also in case of normal potassium levels).

Children

Diuresin SR should not be given to children.

Diuresin 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. Diuretics may increase lithium levels in the blood and increase the risk of lithium overdose symptoms. Drugs that prolong the QT interval (astemizole, bepridil, erythromycin (given intravenously), halofantrine, pentamidine, sultopride, terfenadine, vincamine): indapamide increases the risk of cardiac arrhythmias. Calcium salts: thiazides and thiazide-like drugs slow down the excretion of calcium in the urine and may cause hypercalcemia (excessive calcium levels in the serum). Digitalis glycosides: there is an increased risk of digitalis glycoside poisoning (including nausea, vomiting, arrhythmia), especially if there is a decreased potassium level in the serum. Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid) may weaken the antihypertensive effect of indapamide. Amphotericin B (given intravenously), systemic corticosteroids may increase the risk of hypokalemia. Baclofen may enhance the antihypertensive effect of indapamide. Potassium-sparing diuretics used concomitantly with indapamide do not exclude the possibility of hypokalemia and, in patients with renal failure or diabetes, increase the risk of hyperkalemia. Anti-arrhythmic drugs (quinidine, disopyramide, amiodarone, bretylium, sotalol) increase the risk of life-threatening cardiac arrhythmias in patients with hypokalemia. Iodine-containing contrast agents: dehydration that may occur during diuretic treatment increases the risk of acute renal failure, especially when large doses of contrast are used. Angiotensin-converting enzyme inhibitors: in patients treated with diuretics, the administration of an angiotensin-converting enzyme inhibitor increases the risk of hypotension and (or) severe renal failure. Metformin given with indapamide increases the risk of metabolic acidosis, especially in patients with renal failure. It is not recommended to use metformin in patients with a serum creatinine level greater than 15 mg/l (men) or 12 mg/l (women). Tricyclic antidepressants enhance the antihypertensive effect of indapamide and increase the risk of excessive blood pressure lowering after sudden verticalization. Cyclosporine: increased risk of increased serum creatinine levels without changes in cyclosporine levels and with normal water and electrolyte balance. You should inform your doctor about other medicines you are taking, including those available without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. The drug passes into breast milk. Women taking indapamide should not breastfeed.

Driving and using machines

During treatment with the drug, symptoms associated with excessive lowering of blood pressure may occur, such as dizziness and headache, especially at the beginning of treatment or during combination therapy, which can impair psychophysical fitness and the ability to drive vehicles. You should consult your doctor about the possibility of driving a vehicle while taking the drug.

Diuresin SR contains lactose

The drug contains lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the drug. The drug contains 0.12645 g of lactose (0.063225 g of glucose and 0.063225 g of galactose) in one tablet. This should be taken into account in patients with diabetes.

3. How to take Diuresin SR

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist. The dosage of the drug is always determined by the doctor. The recommended initial single daily dose of indapamide is 1.5 mg, which corresponds to 1 prolonged-release tablet of 1.5 mg.

Overdose of Diuresin SR

In case of taking a higher dose than recommended, contact your doctor or pharmacist immediately. After an overdose of indapamide, the following symptoms occur due to the intensification of the diuretic effect: excessive lowering of blood pressure; water and electrolyte balance disorders; decreased potassium levels in the blood; increased uric acid levels in the blood, which can cause an acute attack of gout. Inform your doctor as soon as possible about the overdose. There is no specific antidote. The treatment depends on the patient's condition. Soon after the overdose, inducing vomiting or gastric lavage may be effective in removing the unabsorbed drug from the body.

Missed dose of Diuresin SR

Do not take a double dose to make up for a missed dose.

Stopping treatment with Diuresin SR

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of side effects listed below is defined as follows:

• very common (occurring in more than 1 in 10 people);
• common (occurring in 1 to 10 people in 100);
• uncommon (occurring in 1 to 10 people in 1,000);
• rare (occurring in 1 to 10 people in 10,000);
• very rare (occurring in less than 1 in 10,000 people);
• not known (frequency cannot be estimated from the available data).

Water and electrolyte balance disorders - hyponatremia (in about 3% of patients), hypokalemia (potassium level below 3.4 mmol/l); often observed (in 3 to 7% of patients treated with indapamide at a dose of 2.5-5 mg). In a study evaluating the efficacy and safety of indapamide in the form of prolonged-release tablets (SR) compared to conventional tablets (IR), hypokalemia was observed very often (in 29% of patients taking indapamide 2.5 mg IR and in 11, 18, and 14% of patients taking indapamide SR, respectively, at doses of 1.5, 2.0, and 2.5 mg). In most cases, hypokalemia manifests as ECG changes (prolonged QT interval, arrhythmia), excessive weakness, and muscle cramps. Gastrointestinal disorders: nausea; vomiting; constipation; diarrhea; abdominal pain; loss of appetite. Skin and subcutaneous tissue disorders (common - in less than 5% of patients): rash; urticaria; itching; vasculitis. Cardiac disorders: palpitations; orthostatic hypotension (decrease in systolic blood pressure by more than 20 mmHg or decrease in diastolic blood pressure by more than 10 mmHg after 3 minutes of changing position from lying to standing); premature ventricular contractions. Nervous system disorders: dizziness and headache; mood changes; paresthesia (tingling, burning, numbness of certain skin areas, felt as a result of changes in the nerves). Blood and lymphatic system disorders (rare): thrombocytopenia (low platelet count - thrombocytes); leukopenia (decreased white blood cell count - leukocytes); agranulocytosis (severe decrease in white blood cell count - granulocytes); aplastic anemia (bone marrow failure or atrophy); hemolytic anemia (accelerated breakdown of red blood cells). Visual disturbances or eye pain due to increased 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). Commonside effects (may occur in up to 1 in 10 patients):

• low potassium levels in the blood

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

• low sodium levels in the blood, which may cause dehydration and decreased blood pressure
• impotence (inability to achieve or maintain an erection)

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

• low chloride levels in the blood
• low magnesium levels in the blood

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or 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.: 22 49-21-301, Fax: 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 Diuresin SR

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. There are no special precautions for storing the medicine. 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 Diuresin SR contains

• The active substance of the drug is indapamide. One prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: hypromellose (4000 cP), lactose monohydrate, povidone, colloidal anhydrous silica, magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol (6000).

What Diuresin SR looks like and contents of the pack

The pack contains 30 or 40 or 50 or 60 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno, Poland, Tel.: 24 357 44 44, Fax: 24 357 45 45, e-mail: [email protected]

Date of last revision of the leaflet: