IPRES 1.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Please read this leaflet carefully before taking this medicine, as it contains important information for you.
   2. Contents of the pack:
2. What is Ipres long 1.5 and what is it used for
3. Important information before taking Ipres long 1.5
   1. When not to take Ipres long 1.5:
   2. Warnings and precautions
   3. Special patient groups
   4. Use of Ipres long 1.5 in athletes
   5. Use of Ipres long 1.5 in patients with kidney function disorders
   6. Use of Ipres long 1.5 in patients with liver function disorders
   7. Use of Ipres long 1.5 in children
   8. Use of Ipres long 1.5 in elderly patients (over 65 years of age)
   9. Ipres long 1.5 and other medicines
   10. Use of Ipres long 1.5 with food and drink
   11. Pregnancy and breastfeeding
   12. Driving and using machines
   13. Ipres long 1.5 contains lactose
4. How to take Ipres long 1.5
   1. Overdose of Ipres long 1.5
   2. Missed dose of Ipres long 1.5
5. Possible side effects
   1. Very common: occurs in more than 1 in 10 patients
   2. Common: occurs in 1 to 10 in 100 patients
   3. Uncommon: occurs in 1 to 10 in 1,000 patients
   4. Rare: occurs in 1 to 10 in 10,000 patients
   5. Very rare: occurs in less than 1 in 10,000 patients
   6. Reporting side effects
6. How to store Ipres long 1.5
7. Contents of the pack and other information
   1. What Ipres long 1.5 contains
   2. What Ipres long 1.5 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

Ipres long 1.5; 1.5 mg, prolonged-release tablets
Indapamide

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• You should 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.

Contents of the pack:

• 1. What is Ipres long 1.5 and what is it used for
• 2. Important information before taking Ipres long 1.5
• 3. How to take Ipres long 1.5
• 4. Possible side effects
• 5. How to store Ipres long 1.5
• 6. Contents of the pack and other information

1. What is Ipres long 1.5 and what is it used for

Ipres long 1.5 is a prolonged-release tablet containing 1.5 mg of indapamide.
The active substance, indapamide, acts in the kidneys, increasing sodium and chloride excretion, and to a lesser extent, potassium and magnesium, thereby increasing urine output. This reduces blood volume and blood pressure.
Ipres long 1.5 also has a vasodilating effect, which reduces peripheral vascular resistance. Long-term treatment reduces left ventricular hypertrophy in patients with hypertension.
In patients with hypertension, long-term treatment does not affect lipid and carbohydrate levels in the blood.
Ipres long 1.5 is a diuretic used to treat primary hypertension.

2. Important information before taking Ipres long 1.5

When not to take Ipres long 1.5:

Do not take Ipres long 1.5 if you have:

• hypersensitivity to indapamide, sulfonamides, or any other component of this medicine (listed in section 6);
• hepatic encephalopathy (disorders of consciousness leading to coma) or severe liver disease;
• severe kidney disease;
• hypokalemia (low potassium levels in the blood).

Warnings and precautions

Before starting treatment with Ipres long 1.5, discuss it with your doctor.

• In patients with water and electrolyte balance disorders

Sodium levels
Before starting treatment and regularly during treatment, your doctor should order a blood test to check sodium levels, as any diuretic can cause hyponatremia (low sodium levels in the blood). Initially, it may be asymptomatic, so regular monitoring of sodium levels is necessary, especially in elderly patients and those with liver cirrhosis, where monitoring should be more frequent.
Potassium levels
Taking thiazide diuretics and diuretics with similar effects is associated with an increased risk of hypokalemia (low potassium levels in the blood). Hypokalemia can cause muscle disorders. Cases of rhabdomyolysis (muscle breakdown) have been reported, mainly in association with severe hypokalemia. Potassium levels in the blood should be checked every 4-6 weeks, especially in elderly patients, malnourished patients, and those taking other medications, patients with liver cirrhosis, edema, and ascites, and patients with coronary heart disease and heart failure. In these disorders, hypokalemia increases the risk of digitalis toxicity and the risk of arrhythmias. Patients with a prolonged QT interval on the electrocardiogram are also at increased risk. Hypokalemia, like bradycardia (excessive slowing of heart rate), can predispose to severe arrhythmias, particularly the dangerous torsade de pointes type. Potassium level monitoring should be performed in the first week of treatment. After diagnosing hypokalemia, the doctor will take appropriate action.
Calcium levels
Thiazide diuretics and diuretics with similar effects can reduce calcium excretion, contributing to a slight and transient increase in its levels in the blood. Significant hypercalcemia (high calcium levels in the blood) can also be caused by unrecognized hyperparathyroidism (overactive parathyroid glands). If it is necessary to examine parathyroid function, the doctor will recommend temporary discontinuation of indapamide treatment.

• In patients with diabetesDuring treatment with Ipres long 1.5, blood glucose levels should be monitored, especially in diabetic patients, particularly if hypokalemia (low potassium levels in the blood) is detected.
• In patients with goutIn patients with hyperuricemia (high uric acid levels in the blood) treated with thiazide diuretics, there is an increased risk of gout attacks.
• In patients with impaired vision or eye painImpaired vision or eye pain may occur. These can 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 Ipres long 1.5. If left untreated, they can lead to complete vision loss. In patients allergic to penicillin or sulfonamides, the risk of such disorders is higher.

You should inform your doctor if you experience a photosensitive reaction.

Special patient groups

Use of Ipres long 1.5 in athletes

In athletes, the drug may give a positive result in a doping test.

Use of Ipres long 1.5 in patients with kidney function disorders

Ipres long 1.5, like thiazide diuretics, is effective only in patients with normal or slightly impaired kidney function (creatinine levels below 25 mg/L).
At the beginning of diuretic treatment, a transient increase in blood urea and creatinine levels may occur. This temporary disorder does not cause any consequences in patients with normal kidney function, but it may worsen existing kidney failure.

Use of Ipres long 1.5 in patients with liver function disorders

In case of liver failure, Ipres long 1.5, like thiazide diuretics, may cause hepatic encephalopathy, especially in the case of water and electrolyte balance disorders, which can lead to hepatic coma. If symptoms of hepatic encephalopathy (disorders of consciousness leading to coma) occur, the use of these diuretics should be discontinued immediately and medical attention should be sought as soon as possible.

Use of Ipres long 1.5 in children

The drug should not be given to children.

Use of Ipres long 1.5 in elderly patients (over 65 years of age)

In elderly patients, there is no need to change the dosage. However, the drug should be used with caution.

Ipres long 1.5 and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ipres long 1.5 should not be taken with lithium salts.
Medicines that should be used with caution with Ipres long 1.5:

• Certain anti-arrhythmic drugs (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium), as they increase the risk of severe arrhythmias in the case of low potassium levels in the blood. Certain antipsychotic drugs (e.g., tricyclic antidepressants, antipsychotic drugs, neuroleptics, such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol), as they enhance the hypotensive effect, which can cause orthostatic hypotension, manifested by dizziness when getting up from bed.
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen), as they may reduce the antihypertensive effect.
• Ambotericin B administered intravenously, systemic corticosteroids, tetracosactide, certain laxatives (e.g., sodium phosphate), as they increase the risk of excessive potassium loss from the body.
• Baclofen, as it enhances the hypotensive effect.
• Digitalis glycosides, as they may cause digitalis toxicity.
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene). During such combination therapy, the doctor usually recommends regular monitoring of potassium levels in the blood.
• Angiotensin-converting enzyme inhibitors (e.g., enalapril, captopril), as they may cause excessive hypotension.
• Metformin, as it may cause lactic acidosis.
• Iodine-containing contrast agents (used in some radiological examinations), as they may increase the risk of acute kidney failure in the case of dehydration that may occur in patients taking diuretics. The administration of such contrast agents is always decided by the doctor.
• Calcium salts, as they cause an increase in calcium levels in the blood.
• Cyclosporine - a drug used, for example, in transplantation, as it may increase creatinine levels in the blood.
• Corticosteroids, tetracosactide (administered systemically), as they reduce the antihypertensive effect of indapamide.
• Allopurinol (used in the treatment of gout)
• Bepridil (used in the treatment of coronary heart disease, causing chest pain);
• Cyzapride, difemanil (used in the treatment of gastrointestinal disorders);
• Erythromycin administered intravenously;
• Vincomycin administered intravenously (used in the treatment of cognitive disorders in elderly patients, including memory loss);
• Halofantrine (an antiparasitic drug used in the treatment of certain types of malaria);
• Pentamidine (used in the treatment of certain types of pneumonia);
• Antihistamine drugs used in the treatment of allergic reactions, such as hay fever (e.g., astemizole, terfenadine);

Use of Ipres long 1.5 with food and drink

Taking the drug before, during, or after a meal does not significantly affect its action.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor.
Ipres long 1.5 should not be used in pregnant women. If you are pregnant or plan to become pregnant, inform your doctor. Alternative treatment should be used as soon as possible.
Indapamide passes into breast milk. Women treated with indapamide should not breastfeed.

Driving and using machines

After taking Ipres long 1.5, symptoms related to decreased blood pressure (e.g., headache, dizziness, weakness, drowsiness, vision disturbances) may occur, especially at the beginning of treatment or if another antihypertensive drug is used concurrently.
In such a situation, the ability to drive and operate machines may be impaired.
In case of doubt, consult your doctor.

Ipres long 1.5 contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the drug.

3. How to take Ipres long 1.5

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
The recommended dose is one tablet (1.5 mg of indapamide) once a day, regardless of the severity of hypertension.
Swallow the tablets whole, without chewing, with a liquid.

Overdose of Ipres long 1.5

If you have taken more than the recommended dose of Ipres long 1.5, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: water and electrolyte balance disorders (low sodium and potassium levels in the blood), nausea, vomiting, muscle cramps, weakness, dizziness, drowsiness, polyuria or oliguria. After significant overdose, respiratory disorders and hypotension may occur.
If necessary, the doctor will provide appropriate treatment.

Missed dose of Ipres long 1.5

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose. If in doubt, consult your doctor.

4. Possible side effects

Like all medicines, Ipres long 1.5 can cause side effects, although not everybody gets them.
The following criteria have been used to assess the frequency of side effects:

Very common: occurs in more than 1 in 10 patients

Common: occurs in 1 to 10 in 100 patients

Uncommon: occurs in 1 to 10 in 1,000 patients

Rare: occurs in 1 to 10 in 10,000 patients

Very rare: occurs in less than 1 in 10,000 patients

Unknown:
frequency cannot be estimated from available data
The following side effects have been observed during treatment with Ipres long 1.5:
Common: papular rash, hypersensitivity reactions, low potassium levels in the blood;
Uncommon: vomiting, purpura, low sodium levels in the blood, which may cause dehydration and hypotension, impotence (inability to achieve or maintain an erection);
Rare: dizziness, fatigue, headache, paresthesia, nausea, constipation, dry mouth, low chloride levels in the blood, low magnesium levels in the blood;
Very rare: thrombocytopenia (low platelet count), leukopenia (low white blood cell count), agranulocytosis (low granulocyte count), aplastic anemia, hemolytic anemia, arrhythmias, hypotension, pancreatitis, kidney failure, liver function disorders, angioedema and (or) urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hypercalcemia;
Frequency unknown: fainting, prolonged QT interval on the electrocardiogram, torsade de pointes type tachycardia, possibility of developing hepatic encephalopathy in liver failure, hepatitis, possibility of exacerbating symptoms of systemic lupus erythematosus, pemphigus vulgaris, reported cases of photosensitivity, hyponatremia with hypovolemia causing dehydration and orthostatic hypotension, increased uric acid and glucose levels in the blood, increased liver enzyme activity in the blood, myopia (nearsightedness), impaired vision 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), blurred vision, vision disturbances, muscle weakness, cramps, tenderness, or muscle pain, especially when the patient feels unwell or has a high fever, which may be caused by abnormal muscle breakdown.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 Ipres long 1.5

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not use this medicine if you notice that the tablet is damaged.
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 Ipres long 1.5 contains

• The active substance is indapamide. One prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: core: lactose, arabic gum, hypromellose 4000 cP, hypromellose 15000 cP, magnesium stearate; coating (Opadry AMB White OY-B 28920): polyvinyl alcohol, titanium dioxide, talc, soy lecithin, xanthan gum.

What Ipres long 1.5 looks like and contents of the pack

White, round, biconvex tablets.
The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel.: +48 22 696 99 20
Manufacturer:
Orifarm Manufacturing Poland Sp. z o.o.
ul. Księstwa Łowickiego 12
99-420 Łyszkowice

Date of last revision of the leaflet: