Ipres long 1,5

Package leaflet: Information for the user

Ipres long 1.5; 1.5 mg, prolonged-release tablets
Indapamidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Package leaflet contents:

1. What Ipres long 1.5 is and what it is used for
2. What you need to know 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 Ipres long 1.5 is and what it is used for

Ipres long 1.5 is a prolonged-release tablet containing 1.5 mg of indapamide.
The active substance, indapamide, acts on the kidneys, increasing the excretion of sodium and chloride, and to a lesser extent, potassium and magnesium, thereby increasing the volume of urine excreted. As a result, plasma volume and blood pressure are reduced.
An additional effect of Ipres long 1.5 is arterial dilation and reduction of peripheral vascular resistance. When used long-term, the drug reduces left ventricular hypertrophy.
In patients with arterial hypertension, long-term treatment with this medicine does not alter blood lipid and carbohydrate levels.
Ipres long 1.5 is a diuretic used in the treatment of essential (primary) hypertension.

2. Important information before using the medicine Ipres long 1.5

When not to use Ipres long 1.5:
Do not use Ipres long 1.5 if the patient has:

• Hypersensitivity to indapamide, sulfonamides, or any of the other components of this medicine (listed in section 6);
• Hepatic encephalopathy (disturbances of consciousness leading to coma) or other severe liver disease;
• Severe kidney disease;
• Hypokalaemia (low potassium levels in the blood).

Warnings and precautions
Before starting treatment with Ipres long 1.5, discuss this with your doctor.

• In patients with fluid and electrolyte imbalance

Sodium levels
Before starting treatment and regularly during therapy, your doctor should order blood sodium level tests, as any diuretic may cause hyponatraemia (reduced sodium concentration in the blood). Initially, it may be asymptomatic, hence regular monitoring of sodium levels is necessary. In elderly patients and patients with liver cirrhosis, monitoring should be more frequent.
Potassium levels
Taking thiazide diuretics and diuretics with similar action is associated with an increased risk of hypokalaemia (reduced potassium levels in the blood).
Hypokalaemia may cause muscle disorders. Cases of rhabdomyolysis (muscle breakdown) have been reported, mainly in connection with severe hypokalaemia. Blood potassium levels should be measured every 4–6 weeks, especially in elderly, malnourished and (or) patients taking other medications, patients with liver cirrhosis, oedema and ascites, and patients with ischaemic heart disease and heart failure. In the above conditions, hypokalaemia increases the risk of toxic effects of cardiac glycosides on the heart and increases the likelihood of cardiac arrhythmias. Patients at higher risk include those with prolonged QT interval on electrocardiogram. Hypokalaemia, as well as bradycardia (excessive slowing of the heartbeat), may predispose to the development of severe cardiac arrhythmias, particularly the life-threatening torsade de pointes tachycardia. Blood potassium levels should be checked during the first week of treatment. If hypokalaemia is diagnosed, the doctor will initiate appropriate management.
Calcium levels
Thiazide diuretics and drugs with similar action may reduce calcium excretion, leading to a slight and transient increase in blood calcium levels.
Significant hypercalcaemia (increased blood calcium levels) may also be caused by undiagnosed hyperparathyroidism (overactivity of the parathyroid glands). If parathyroid function tests are required, the doctor may recommend temporary discontinuation of indapamide treatment.

• In patients with diabetes
  During treatment with Ipres long 1.5, blood glucose levels should be monitored, especially in diabetic patients, particularly if hypokalaemia (low potassium levels in the blood) is detected.
• In patients with gout
  In patients with hyperuricaemia (elevated blood uric acid levels) treated with thiazide diuretics, there is an increased risk of gout attacks.
• In patients with visual disturbances or eye pain
  Visual disturbances or eye pain may occur. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure. These symptoms may appear from several hours to weeks after taking Ipres long 1.5. If untreated, they may lead to complete loss of vision. The risk of such disorders is higher in patients with hypersensitivity to penicillin or sulfonamides.

Patients should inform their doctor if they experience photosensitivity reactions.
Special patient groups
Use of Ipres long 1.5 in athletes
In athletes, this medicine may lead to a positive result in anti-doping tests.
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 mildly impaired kidney function (creatinine concentration below 25 mg/L).
At the beginning of diuretic treatment, a transient increase in blood urea and creatinine levels may occur. This transient disturbance has no consequences in patients with normal kidney function, but may worsen pre-existing kidney failure.
Use of Ipres long 1.5 in patients with liver function disorders
In liver failure, Ipres long 1.5, like thiazide diuretics, may, particularly in the presence of fluid and electrolyte imbalances, cause hepatic encephalopathy, which may lead to hepatic coma. If symptoms of hepatic encephalopathy (disturbances of consciousness leading to coma) occur, treatment with these diuretics should be stopped immediately and the patient should contact a doctor as soon as possible.
Use of Ipres long 1.5 in children
This medicine should not be given to children.
Use of Ipres long 1.5 in elderly patients (aged over 65 years)
In elderly patients, dosage adjustment is not necessary. However, the medicine should be used with caution.
Ipres long 1.5 and other medicines
Tell your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Ipres long 1.5 should not be administered simultaneously with lithium salts.
Medicines that should be used with caution together with Ipres long 1.5:

• Some antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium), as they increase the risk of severe cardiac arrhythmias in case of low serum potassium levels. Some antipsychotics (e.g. tricyclic antidepressants, antipsychotics, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol), as they intensify blood pressure lowering, which may cause orthostatic hypotension manifested, among others, by dizziness upon rapid standing (e.g. during morning rising from bed).
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen), as they may reduce the blood pressure-lowering effect.
• Intravenous amphotericin B, systemic corticosteroids, tetracosactide, some laxatives (e.g. sodium phosphate), as they increase the risk of excessive potassium loss from the body.
• Baclofen, as it enhances the blood pressure-lowering effect.
• Cardiac glycosides, as symptoms of digitalis toxicity may develop.
• Potassium-sparing diuretics (amiloride, spironolactone, triamterene). During combined treatment, the doctor usually recommends regular monitoring of blood potassium levels.
• Angiotensin-converting enzyme inhibitors (e.g. enalapril, captopril), as excessive blood pressure reduction may occur.
• Metformin, as it may cause lactic acidosis.
• Iodine-containing contrast agents (used in certain radiological examinations), as in case of dehydration that may occur in patients taking diuretics, the risk of acute kidney failure increases. The decision to administer such contrast agents is always made by a doctor.
• Calcium salts, as they cause increased blood calcium levels.
• Cyclosporine – a drug used, for example, in transplantation, as it may increase blood creatinine levels.
• 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 ischaemic heart disease causing chest pain);
• Cisapride, difenoxin (used in the treatment of gastrointestinal disorders);
• Erythromycin administered by intravenous injection;
• Vinpocetine administered by intravenous injection (used in the treatment of symptomatic 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);
• Antihistamines used in the treatment of allergic reactions such as hay fever (e.g. astemizole, terfenadine);

Taking Ipres long 1.5 with food and drink
Taking the medicine before, during or after meals does not significantly affect its action.
Pregnancy and breastfeeding
Before taking any medicine, consult a doctor.
Ipres long 1.5 is not recommended for use in pregnant women. If a patient is pregnant or planning to become pregnant, she should inform her doctor. Alternative treatment should then be initiated as quickly as possible.
Indapamide passes into human milk. Women treated with indapamide should not breastfeed.
Driving and operating machinery
After taking Ipres long 1.5, symptoms related to reduced blood pressure (e.g. headaches and dizziness, weakness, drowsiness, visual disturbances) may occur, especially at the beginning of treatment or when another antihypertensive medicine is used concomitantly.
In such cases, the ability to drive and operate machinery may be impaired.
If in doubt, consult a doctor.
Ipres long 1.5 contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.

3. How to use Ipres long 1,5

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor.
The recommended dose is one tablet (1.5 mg of indapamide) once daily, regardless of the severity of arterial hypertension.
The tablets should be swallowed whole, without chewing, with a drink.

Taking a higher than recommended dose of Ipres long 1,5
If a higher than recommended dose of the medicine has been taken, seek immediate medical advice from a doctor or pharmacist.
Symptoms of overdose may include: disturbances in water and electrolyte balance (reduced blood concentrations of sodium and potassium), nausea, vomiting, muscle cramps, weakness, dizziness, drowsiness, polyuria or oliguria. After a significant overdose, respiratory disturbances and hypotension may occur.
If necessary, the doctor will initiate appropriate treatment.

Missed dose of Ipres long 1,5
A missed dose should be taken as soon as possible, except when it is almost time for the next dose. Do not take a double dose to make up for a missed dose. In case of doubt, consult the doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following frequency criteria have been used to assess adverse effects:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects less than 1 in 10,000 patients
Not known: frequency cannot be estimated from the available data

The following adverse effects have been observed during use of the medicine:
Common: papular-rash, hypersensitivity reactions, low blood potassium levels;
Uncommon: vomiting, purpura, low blood sodium levels, which may lead to dehydration and low blood pressure, impotence (inability to achieve or maintain an erection);
Rare: dizziness, feeling of fatigue, headache, paresthesia, nausea, constipation, dry mouth, low blood chloride levels, low blood magnesium levels;
Very rare: thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), agranulocytosis (reduced granulocyte count), aplastic anemia, hemolytic anemia, cardiac arrhythmias, hypotension, pancreatitis, renal failure, hepatic function disorders, angioedema and (or) urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hypercalcemia;
Frequency not known: fainting, prolonged QT interval on electrocardiogram, torsade de pointes tachycardia, possible development of hepatic encephalopathy in the course of liver failure, hepatitis, possible exacerbation of symptoms of coexisting systemic lupus erythematosus, bullous pemphigoid, cases of photosensitivity reported, hyponatremia with hypovolemia causing dehydration and orthostatic hypotension, increased blood uric acid and glucose levels, increased liver enzyme activity in blood, myopia (short-sightedness), visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye — excessive fluid accumulation between choroid and sclera — or acute angle-closure glaucoma), blurred vision, visual disturbances, muscle weakness, cramps, tenderness or muscle pain, particularly when the patient simultaneously feels unwell or has a high temperature, which may be caused by abnormal muscle breakdown.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ipres long 1.5

Keep this medicine out of sight and reach of children.
Store below 25°C.
Store in the original packaging 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 specified month.
Do not use this medicine if the tablet appears damaged.
Medicines must 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 packaging and other information

What Ipres long 1.5 contains

• The active substance is indapamide. One prolonged-release tablet contains 1.5 mg of indapamide.
• Other ingredients are:
  Core composition: lactose, gum arabic, hypromellose 4000 cP, hypromellose 15000 cP, magnesium stearate;
  Coating composition (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.
Pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
VEDIM Sp. z o.o.
8 Kruczkowskiego Street
00-380 Warsaw
Tel.: +48 22 696 99 20

Manufacturer:
Orifarm Manufacturing Poland Sp. z o.o.
12 Księstwa Łowickiego Street
99-420 Łyszkowice