Package leaflet: Information for the patient

Indapres 2.5 mg, coated 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, 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 as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Leaflet contents

What Indapres is and what it is used for
What you need to know before taking Indapres
How to take Indapres
Possible side effects
How to store Indapres
Contents of the pack and other information

1. What Indapres is and what it is used for

Indapres contains the active substance – indapamidum.
Indapres is used in the treatment of high blood pressure (hypertension) in adults.
Indapamidum is a diuretic medicine. Most diuretics increase the volume of urine produced by the kidneys. However, indapamidum differs from other diuretics in that it causes only a slight increase in urine volume.
Additionally, indapamidum dilates blood vessels, allowing blood to flow more easily. This helps lower arterial blood pressure.

2. Important information before using Indapres

When not to use Indapres

If the patient is allergic to indapamide, other sulphonamides, or any of the other ingredients of this medicine (listed in section 6).
If the patient has severe kidney disease.
If the patient has severe liver disease or a condition called hepatic encephalopathy (liver disease affecting brain and central nervous system function).
If the patient has low blood potassium levels.

Warnings and precautions
Before starting Indapres, discuss with the doctor, pharmacist, or nurse if the patient:

has liver diseases;
has diabetes;
has gout;
has any heart rhythm disorders or kidney function disorders;
is scheduled for a test assessing parathyroid function;
experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive accumulation of fluid between choroid and sclera) or increased intraocular pressure – they may occur from several hours to weeks after taking Indapres. If untreated, they may lead to permanent vision loss. If the patient previously had light sensitivity allergy, they may be at increased risk of developing these adverse effects.

Inform the doctor if the patient has previously experienced photosensitivity reactions.
The doctor may recommend blood tests to assess whether sodium and potassium levels are reduced or calcium levels are elevated. Severe reduction in potassium levels may lead to rhabdomyolysis (breakdown of skeletal muscles).
If the patient believes any of the above situations apply, or has any questions or doubts about using this medicine, they should contact their doctor or pharmacist.
Athletes should be aware that this medicine contains an active substance which may cause positive results in anti-doping tests.

Indapres and other medicines
Tell the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not take Indapres together with lithium (used to treat depression) due to the risk of increased lithium blood levels.
Inform the doctor if taking any of the following medicines, as special precautions may be necessary:

medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, bretylium, dofetilide, digitalis preparations),
medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
pimozide (used to treat Tourette's syndrome),
bepridil (used to treat angina pectoris causing chest pain),
cisapride (used in cases of abnormally slow peristalsis of the oesophagus and stomach),
difemanil (used to treat gastrointestinal disorders such as peptic ulcers, hyperacidity, gastrointestinal hyperreactivity),
sparfloxacin, moxifloxacin, intravenous erythromycin (antibiotics used to treat infections),
intravenous vinpocetine (used to treat symptomatic cognitive disorders in elderly people, including memory loss),
halofantrine (an antiparasitic drug used to treat certain types of malaria),
pentamidine (used to treat certain types of pneumonia),
antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, pentamidine, terfenadine, astemizole),
non-steroidal anti-inflammatory drugs with analgesic effect (e.g. ibuprofen) or high doses of acetylsalicylic acid,
synthetic opioids used for pain relief or in addiction treatment (methadone),
angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure),
intravenous amphotericin B (an antifungal medicine),
oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis,
stimulant laxatives,
baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis),
allopurinol (used to treat gout),
potassium-sparing diuretics (amiloride, spironolactone, triamterene),
metformin (used to treat diabetes),
iodinated contrast agents (used during radiological examinations),
calcium tablets or other calcium supplements,
cyclosporine, tacrolimus, or other immunosuppressive drugs used after organ transplantation or to treat autoimmune diseases, or severe rheumatic or dermatological diseases,
tetracosactide (used to treat Crohn's disease).

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.
Use of this medicine during pregnancy is not recommended. If pregnancy is planned or confirmed, the doctor will switch to an alternative treatment as soon as possible. Inform the doctor about pregnancy, suspected or planned pregnancy.
The active substance passes into human milk. Breastfeeding should be avoided while taking this medicine.

Driving and operating machinery
Indapres may cause adverse effects related to low blood pressure, such as dizziness or fatigue (see section 4). These symptoms are more common at the beginning of treatment and after dose increases. If they occur, do not drive or perform other activities requiring concentration. However, these symptoms are rare if treatment is followed according to instructions.

Indapres contains monohydrate 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 Indapres

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The usual dose is one tablet once daily, preferably in the morning.
The tablet may be taken with or without food and should be swallowed whole with a glass of water.
Treatment of high blood pressure is usually long-term.
Taking more Indapres than prescribed
If you take too many tablets, seek medical advice immediately or go to the nearest hospital emergency department.
A very large dose of Indapres may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, and changes in the amount of urine passed.
Missing a dose of Indapres
If you miss a dose, take the next dose as scheduled. Do not take a double dose to make up for the missed dose.
Stopping Indapres
Since treatment of high blood pressure is usually lifelong, you should consult your doctor before stopping the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following adverse symptoms, the medicine must be discontinued immediately and the doctor must be contacted without delay:

Angioedema and (or) urticaria. Angioedema is characterised by swelling of the skin of the limbs or face, swelling of the lips, tongue, mucous membranes of the throat or airways, causing shortness of breath or difficulty swallowing. If such symptoms occur, medical advice must be sought immediately (very rare – may occur in fewer than 1 in 10,000 people);
Severe skin reactions, including severe rash, redness of the entire body surface, intense itching, formation of blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare – may occur in fewer than 1 in 10,000 people);
Life-threatening heart rhythm disorders (frequency unknown);
Pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in fewer than 1 in 10,000 people);
Brain disease caused by liver disorder (hepatic encephalopathy); (frequency unknown);
Inflammation of the liver (frequency unknown).

Other adverse reactions, grouped by decreasing frequency of occurrence.
Common adverse reactions (may occur in fewer than 1 in 10 people):

Red, raised skin rash;
Allergic reactions, mainly affecting the skin, such as rashes, in individuals with predisposition to allergic and asthmatic reactions;
Low blood potassium levels.

Uncommon adverse reactions (may occur in fewer than 1 in 100 people):

Vomiting;
Red spots on the skin (purpura);
Low blood sodium levels, which may lead to dehydration and low blood pressure;
Impotence (inability to achieve or maintain an erection).

Rare adverse reactions (may occur in fewer than 1 in 1,000 people):

Fatigue, headache, tingling and numbness (paraesthesia), vertigo;
Gastrointestinal disturbances (such as nausea, constipation), dryness of the oral mucosa;
Low blood chloride levels;
Low blood magnesium levels.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):

Changes in blood cell counts, such as thrombocytopenia (reduced number of platelets, leading to easy bruising and nosebleeds), leukopenia (reduced number of white blood cells, which may cause fever of unknown origin, sore throat or other flu-like symptoms – if such symptoms occur, contact a doctor), and anaemia (reduced number of red blood cells);
Increased blood calcium levels;
Heart rhythm disturbances (palpitations – awareness of heartbeat), low blood pressure;
Kidney disorders (causing symptoms such as fatigue, increased need to urinate, skin itching, nausea, limb swelling);
Abnormal liver function.

Frequency unknown (cannot be estimated from available data):

Fainting;
Possible exacerbation of symptoms in patients with systemic lupus erythematosus (a type of collagenosis);
Cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation have also been reported;
Myopia;
Blurred vision;
Visual disturbances;
Visual impairment or eye pain due to elevated 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);
Blood-related changes – the doctor may recommend blood tests to monitor these. The following changes in blood test results may occur:
- increased blood uric acid levels, a substance which may cause or exacerbate gout (pain in one or more joints, particularly in the feet),
- increased blood glucose levels in patients with diabetes,
- increased liver enzyme activity;
Abnormal electrocardiogram (ECG) findings;
Muscle cramps, muscle weakness, muscle pain, rhabdomyolysis (breakdown of skeletal muscle).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Indapres

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Indapres contains
The active substance is indapamide. Each coated tablet contains 2.5 mg of indapamide.
Other ingredients: monohydrate lactose (type 200), corn starch, Povidone (K-25), magnesium stearate, hypromellose, Macrogol 6000, titanium dioxide.

What Indapres looks like and contents of the pack
Indapres is a white, round, biconvex coated tablet with a break line on one side.
The break line on the tablet is intended only to facilitate breaking for ease of swallowing, and does not ensure equal dose division.
The pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: (22) 755 50 81

For more detailed information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]

((logo of the Marketing Authorisation Holder))
((pharmacode))