Patient Information Leaflet

INDAP
2.5 mg, hard capsules
indapamidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What INDAP is and what it is used for
Important information before taking INDAP
How to take INDAP
Possible side effects
How to store INDAP
Contents of the pack and other information

1. What INDAP is and what it is used for

INDAP is a medicine in the form of hard capsules containing indapamidum as the active substance.
Indapamidum is a diuretic medicine.
Most diuretics increase the volume of urine excreted by the kidneys. However, indapamidum differs from other diuretics in that it causes only a slight increase in the volume of urine produced.
INDAP is used in the treatment of high arterial pressure (hypertension) in adults.

2. Important information before using INDAP

When not to use INDAP

if the patient is allergic to indapamide, sulfonamides, 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 brain disorder caused by liver disease, called hepatic encephalopathy (degenerative brain disease);
if the patient has low blood potassium levels.

Warnings and precautions
Before starting treatment with INDAP, discuss with a doctor or pharmacist:

if the patient has liver problems;
if the patient has diabetes;
if the patient has gout;
if the patient has any heart rhythm disorders or kidney problems;
if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between choroid and sclera) or increased pressure inside the eye – which may occur within a few hours to several weeks after starting treatment with Indap.
Untreated, these symptoms may lead to complete loss of vision. If the patient previously had an allergic reaction to penicillin or sulfonamides, they may be at increased risk of developing these symptoms;
if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;
if the patient is due to undergo tests assessing parathyroid function.

The patient should inform the doctor if they have photosensitivity (allergic reaction to light).
The doctor may recommend tests to monitor decreased potassium or sodium levels, or increased calcium levels.
If the patient believes any of the above situations apply, or has questions or doubts about using this medicine, they should contact their doctor or pharmacist.
Athletes
Athletes should be aware that INDAP contains an active substance which may lead to a false positive result in anti-doping tests.

Children
INDAP must not be used in children and adolescents.

INDAP with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription.
Do not use INDAP together with lithium (used in the treatment of depression) due to the risk of increased lithium blood levels.
Ensure that the doctor has been informed about the use of the following medicines:

medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, digitalis preparations, bretylium);
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);
bepridil (used to treat ischemic heart disease causing chest pain);
cisapride, difenoxin (used to treat gastrointestinal disorders);
sparfloxacin, moxifloxacin, intravenous erythromycin (antibiotics used to treat bacterial infections);
intravenous vinpocetine (used for symptomatic treatment of cognitive disorders in elderly patients, including memory loss);
halofantrine (an antiparasitic drug used to treat certain types of malaria);
pentamidine (used to treat certain types of pneumonia);
mizolastine, astemizole, terfenadine (medicines used to treat allergic reactions such as hay fever);
non-steroidal anti-inflammatory drugs with analgesic effect (e.g. ibuprofen) or high doses of acetylsalicylic acid;
angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure);
intravenous amphotericin B (an antifungal antibiotic);
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 (an antidiabetic medicine);
iodine-containing contrast agents (used in diagnostic X-ray procedures);
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);
methadone (used in addiction treatment).

Pregnancy, breastfeeding, and fertility
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. When pregnancy is planned or confirmed, alternative treatment should be initiated as soon as possible.
The active substance passes into breast milk. Indapamide should not be used during breastfeeding.

Driving and operating machinery
INDAP may cause adverse effects related to lowering of blood pressure, such as dizziness or tiredness (see section 4). These adverse effects occur more frequently especially at the beginning of treatment or when another blood pressure-lowering medicine is added.
In such cases, the patient should refrain from driving or performing other activities requiring concentration.
However, these symptoms are rare when treatment is properly monitored.

INDAP 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 the medicine INDAP

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
The recommended dose is 1 capsule (2.5 mg) daily, preferably taken in the morning. Capsules may
be taken independently of meals. The capsule should be swallowed whole with water. Do not chew
or crush it.
Treatment of hypertension is usually long-term.
Taking more INDAP medicine than recommended
If too many capsules have been taken, seek immediate medical advice from a doctor or pharmacist.
Very high doses of indapamide may cause nausea, vomiting, low blood pressure, muscle cramps,
dizziness, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.
Missing a dose of INDAP medicine
If a dose has been missed, take the next dose as usual. Do not take a double dose to make up for
the missed dose.
Stopping treatment with INDAP medicine
Since treatment of high blood pressure usually lasts for life, contact your doctor before stopping the
medicine.
If you have any further questions regarding 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 any of the following adverse reactions occur in a patient, the medicine must be discontinued immediately and the patient should contact a doctor without delay:

Angioedema and (or) urticaria. Angioedema is characterised by swelling of the skin of the limbs or face, lips or tongue, or of the mucous membranes of the throat or respiratory tract, causing breathing difficulties or problems with swallowing. If such symptoms occur, medical advice must be sought immediately (very rare – may occur in up to 1 in 10,000 patients);
Severe skin reactions, including intense rash, redness of the entire skin surface, severe itching, formation of blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions (very rare – may occur in up to 1 in 10,000 patients);
Life-threatening heart rhythm disturbances (frequency unknown);
Pancreatitis, which may cause severe abdominal pain radiating to the back and a very poor general condition (very rare – may occur in up to 1 in 10,000 patients);
Brain disease caused by liver disorder (hepatic encephalopathy; frequency unknown);
Hepatitis (frequency unknown);
Muscle weakness, cramps, tenderness or muscle pain, particularly if the patient simultaneously feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Other adverse reactions, grouped by decreasing frequency of occurrence:
Common adverse reactions (may occur in up to 1 in 10 patients):

Red, raised rash;
Allergic reactions, mainly affecting the skin, in patients prone to allergies and asthmatic reactions;
Low blood potassium levels.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

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

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

Feeling of fatigue, headache, prickling and tingling sensations (paresthesia), dizziness;
Gastrointestinal disturbances (such as nausea, constipation), dryness of the mouth;
Low blood chloride levels;
Low blood magnesium levels.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

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 lead to unexplained fever, sore throat or other flu-like symptoms – if these occur, contact a doctor) and anaemia (reduced number of red blood cells);
Heart rhythm disturbances, low blood pressure;
Increased blood calcium levels;
Kidney disease;
Abnormal liver function.

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

Fainting;
In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen;
Cases of photosensitivity reactions (skin changes) following exposure to sunlight or artificial UVA radiation have also been reported;
Short-sightedness;
Blurred vision;
Visual disturbances;
Visual impairment or eye pain due to increased intraocular pressure (possible signs of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between the choroid and sclera – or acute angle-closure glaucoma);
Changes may occur in laboratory test results (blood tests), and the doctor may recommend blood testing. The following changes in laboratory test results may occur:
Increased blood uric acid levels, a substance which may cause or exacerbate gout (pain in one or more joints, especially in the feet);
Increased blood glucose levels in patients with diabetes;
Increased liver enzyme activity;
Abnormal electrocardiogram (ECG) findings.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine INDAP

Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
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 pack and other information

What INDAP contains

The active substance is indapamide. One capsule contains 2.5 mg of indapamide.
The other components (excipients) are: capsule contents - microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate, colloidal silicon dioxide; capsule shell - titanium dioxide (E 171), gelatin, indigo carmine (E 132).

What INDAP looks like and contents of the pack
INDAP is a hard, gelatin capsule containing a white powder. The upper part of the capsule is blue, the lower part is white.
The medicine is available in PVC/Aluminium blisters packed in a cardboard box.
The pack contains 30 capsules (3 blisters with 10 capsules each).

Marketing Authorisation Holder and Manufacturer
PRO.MED.CS Praha a.s.
Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:
PRO.MED.PL Sp. z o.o.
[email protected]