Indapen sr

Package leaflet: Information for the patient

Indapen SR, 1.5 mg, prolonged-release tablets
Indapamidum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

Indapen SR is a diuretic medicine that reduces blood pressure.
Its mechanism of action involves increasing urine excretion and direct vasodilation.
The effect of the medicine lasts up to 24 hours.
Indapen SR is indicated for the treatment of essential arterial hypertension.

2. Important information before using Indapen SR

When not to use Indapen SR:

• if the patient is allergic to indapamide, other sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe renal impairment;
• if the patient has severe liver dysfunction or a condition called hepatic encephalopathy (a nervous system disorder due to liver damage);
• if the patient has low blood potassium levels (hypokalaemia).

Warnings and precautions
Before starting treatment with Indapen SR, discuss this with your doctor or pharmacist.
Exercise particular caution when using Indapen SR:

• if the patient has liver impairment;
• if the patient has kidney impairment;
• if the patient has diabetes;
• if the patient has gout;
• if the patient has an increased risk of hypokalaemia (low blood potassium levels, manifested, among others, by muscle weakness, tremors, or cardiac arrhythmias);
• if the patient has disturbances in water and electrolyte balance;
• if the patient has photosensitivity;
• if the patient has an increased risk of hypercalcaemia (excess calcium in blood serum, manifested, among others, by loss of appetite, nausea, vomiting, or cardiac disturbances);
• if the patient is scheduled for tests assessing parathyroid function;
• if the patient develops blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these symptoms may occur from several hours to weeks after taking Indapen SR. Without treatment, these symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.

The medicine may cause positive results in doping tests in athletes.
If the patient believes any of the above situations apply, or has any doubts about using the medicine, they should contact their doctor or pharmacist.
The doctor may recommend tests to assess whether blood potassium or sodium levels have decreased, or whether blood calcium levels have increased.

Children and adolescents
Due to lack of clinical data, use in children and adolescents is not recommended.

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

Indapen SR and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use. Indapamide may interact with other medicines.

Medicines that must not be used with indapamide:

• lithium salts (used in the treatment of depression).

Medicines that may enhance the effect of Indapen SR or increase the risk of adverse effects:
Ensure that the doctor is informed if the patient is taking any of the following medicines, as special caution may be required:

• medicines used to treat cardiac arrhythmias (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 in the treatment of ischemic heart disease causing chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• sparfloxacin, moxifloxacin, intravenous vinca alkaloids, 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 drugs with analgesic effect (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 occurring 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 X-ray procedures);
• calcium tablets or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or in the treatment of autoimmune diseases or severe rheumatic or dermatological diseases;
• tetracosactide (used in the treatment of Crohn's disease).

Indapen SR with food and drink
Food does not affect the absorption of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Diuretics should be avoided in pregnant women. Diuretics may cause fetoplacental hypoperfusion with a risk of impaired fetal growth.
Indapamide may be used during pregnancy only if strictly necessary.
Indapamide passes into breast milk. Therefore, use of the medicine during breastfeeding is not recommended.

Driving and operating machinery
When using Indapen SR, especially at the beginning of treatment or when adding another antihypertensive medicine, symptoms related to low blood pressure may occur. In such cases, the ability to drive or operate machinery may be impaired.

Indapen SR contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Indapen SR

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.
The usual dose is 1.5 mg (1 tablet) once daily, preferably in the morning.
The tablets should be swallowed whole with water. Do not crush or chew them.
Higher doses of indapamide do not produce a stronger blood pressure-lowering effect.

Taking more Indapen SR than recommended
Acute overdose may lead to disturbances in water and electrolyte balance (reduced blood levels of sodium and potassium), nausea, vomiting, hypotension, muscle cramps, dizziness, drowsiness, confusion, polyuria or oliguria, up to anuria (due to reduced circulating blood volume).
If you have taken more medicine than recommended, inform your doctor or pharmacist immediately. Gastric lavage or other appropriate treatment in a hospital setting may be necessary.

Missing a 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 about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur during treatment with this medicine:

Common (occur in 1 to 10 people out of 100):

• low blood potassium levels, which may cause muscle weakness;
• papular rash.

Uncommon (occur in 1 to 10 people out of 1,000):

• vomiting;
• purpura (a condition characterized by skin rash, abdominal pain and joint pain);
• low blood sodium levels, which may lead to dehydration and low blood pressure;
• impotence (inability to achieve or maintain erection).

Rare (occur in 1 to 10 people out of 10,000):

• dizziness, feeling tired, headache, tingling sensations (paresthesia);
• nausea, constipation, dry mouth; low blood chloride levels; low blood magnesium levels.

Very rare (occur in less than 1 person out of 10,000):

• thrombocytopenia (reduced number of platelets in the blood, causing increased risk of bleeding and bruising), leukopenia (reduced total number of white blood cells in the blood), agranulocytosis (complete or near-complete absence of granulocytes (a type of white blood cells) in the blood), aplastic anemia (reduced number of blood cells due to absent or incomplete bone marrow development), hemolytic anemia (reduced number of red blood cells);
• heart rhythm disorders, low blood pressure;
• pancreatitis, kidney failure, liver function disorders;
• angioedema (swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing) and/or urticaria (hives), toxic epidermal necrolysis (erythematous-bullous skin and mucosal lesions leading to shedding of large areas of the epidermis and exposure of large skin surfaces), Stevens-Johnson syndrome (blisters progressing to erosions affecting the mucous membranes of the mouth, conjunctiva, and genital organs);
• hypercalcemia.

Frequency not known (frequency cannot be estimated from available data):

• visual disturbances or eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the uvea—the membrane surrounding the eye—or excessive accumulation of fluid between the choroid and sclera—or acute angle-closure glaucoma);
• fainting;
• severe heart rhythm disorders (torsade de pointes);
• in patients with liver impairment, possible development of hepatic encephalopathy (a brain disorder caused by liver disease), hepatitis;
• increased liver enzyme activity;
• possible exacerbation of symptoms of pre-existing systemic lupus erythematosus;
• photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation;
• abnormal ECG;
• increased blood uric acid and glucose levels. In patients with diabetes or gout, the physician should consider the appropriateness of using diuretics.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorization Holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Indapen SR

Keep this medicine out of sight and reach of children.
Store 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 indicated.
The label on the packaging shows EXP followed by the expiry date, and LOT/LOT followed by the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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: monohydrate lactose, carbomer, hydroxypropylcellulose, magnesium stearate, colloidal anhydrous silica, talc;
• coating Opadry II pink 33G24509: hypromellose, titanium dioxide (E 171), monohydrate lact游戏副本