INDAP 2.5 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. INDAP
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the package leaflet:
3. What is INDAP and what is it used for
4. Important information before taking INDAP
   1. When not to take INDAP
   2. Warnings and precautions
   3. Children
   4. INDAP and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. INDAP contains lactose
5. How to take INDAP
   1. If you take more INDAP than you should
   2. If you forget to take INDAP
   3. If you stop taking INDAP
6. Possible side effects
   1. If you experience any of the following side effects, stop taking INDAP and contact your doctor immediately:
   2. Reporting side effects
7. How to store INDAP
8. Contents of the pack and other information
   1. What INDAP contains
   2. What INDAP 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

INDAP

2.5 mg, hard capsules
indapamide

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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, tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

1. What is INDAP and what is it used for

INDAP is a hard capsule containing the active substance indapamide.
Indapamide is a diuretic.
Most diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics as it only causes a slight increase in urine production.
INDAP is used to treat high blood pressure in adults.

2. Important information before taking INDAP

When not to take INDAP

• if you are allergic to indapamide, sulfonamides, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney disease;
• if you have severe liver disease or liver encephalopathy (a brain condition caused by liver disease);
• if you have low potassium levels in your blood.

Warnings and precautions

Before taking INDAP, discuss with your doctor or pharmacist:

• if you have liver problems;
• if you have diabetes;
• if you have gout;
• if you have any heart rhythm problems or kidney problems;
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye or increased pressure in the eye, which can occur within a few hours to a few weeks after starting INDAP. Untreated symptoms can lead to complete vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at increased risk of developing these symptoms;

if you have muscle disorders, including pain, tenderness, weakness, or cramps;

• if you are to undergo a test to assess parathyroid function.

Tell your doctor if you experience a light-sensitive reaction.
Your doctor may recommend tests to check for low potassium or sodium levels, or high calcium levels.
If you think any of the above applies to you, or if you have any doubts about taking INDAP, consult your doctor or pharmacist.
Athletes should be aware that INDAP contains an active substance that can cause a false positive result in anti-doping tests.

Children

Do not take INDAP if you are under 18 years old.

INDAP and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, including those obtained without a prescription.
Do not take INDAP with lithium (used to treat depression) due to the risk of increased lithium levels in your blood.
Make sure your doctor knows if you are taking any of the following medicines:

• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, digitalis preparations, bretylium);
• medicines for mental disorders, such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• bepridil (used to treat angina pectoris, a condition that causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• sparfloxacin, moxifloxacin, erythromycin injection (antibiotics used to treat bacterial infections);
• vinkamine injection (used to treat cognitive disorders in the elderly, including memory loss);
• halofantrine (an antiparasitic medicine 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 medicines, with pain-relieving properties (e.g., ibuprofen) or high doses of acetylsalicylic acid;
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure);
• amphotericin B injection (an antifungal antibiotic);
• oral corticosteroids, used to treat various diseases, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate peristalsis;
• baclofen (used to treat muscle stiffness, such as in multiple sclerosis);
• allopurinol (used to treat gout);
• potassium-sparing diuretics (amiloride, spironolactone, triamterene);
• metformin (an anti-diabetic medicine);
• iodine-containing contrast agents (used in diagnostic tests with X-rays);
• calcium supplements or other calcium supplements;
• cyclosporine, tacrolimus, or other immunosuppressive medicines used after organ transplantation or to treat autoimmune diseases, severe rheumatic diseases, or skin diseases;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat addiction).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not recommended to take this medicine during pregnancy. If you are planning a pregnancy or have confirmed pregnancy, you should start alternative treatment as soon as possible.
The active substance passes into breast milk. Do not take indapamide during breastfeeding.

Driving and using machines

INDAP may cause side effects such as dizziness or fatigue (see section 4). These side effects are more common at the start of treatment or when taking another blood pressure-lowering medicine.
In such cases, do not drive or operate machinery.
However, these symptoms are rare if treatment is well controlled.

INDAP contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take INDAP

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one capsule (2.5 mg) per day, taken preferably in the morning. The capsules can be taken with or without food. Swallow the capsule whole with water. Do not chew or crush it.
Treatment of high blood pressure is usually long-term.

If you take more INDAP than you should

If you have taken too many capsules, contact your doctor or pharmacist immediately.
Very high doses of indapamide may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in urine production.

If you forget to take INDAP

If you miss a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking INDAP

Since high blood pressure treatment usually lasts for the rest of your life, consult your doctor before stopping treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking INDAP and contact your doctor immediately:

• angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs, face, lips, tongue, mucous membranes of the throat or respiratory tract, which can cause difficulty breathing or swallowing. If you experience such symptoms, seek medical attention immediately (very rare, may occur in up to 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare, may occur in up to 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition (very rare, may occur in up to 1 in 10,000 patients);
• liver disease caused by liver disease (hepatic encephalopathy; frequency not known);
• hepatitis (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which can be caused by abnormal muscle breakdown (frequency not known).

Other side effects, grouped by frequency of occurrence:
Common side effects (may occur in up to 1 in 10 patients):

• red, raised rash;
• allergic reactions, mainly affecting the skin, in people prone to allergies and asthmatic reactions;
• low potassium levels in the blood.

Uncommon side effects (may occur in up to 1 in 100 patients):

• nausea and vomiting;
• red spots on the skin (petechiae);
• low sodium levels in the blood, which can cause dehydration and low blood pressure;
• impotence (inability to achieve or maintain an erection).

Rare side effects (may occur in up to 1 in 1,000 patients):

• feeling tired, headache, tingling, and numbness (paresthesia), dizziness;
• gastrointestinal disorders (such as nausea, constipation), dry mouth;
• low chloride levels in the blood;
• low magnesium levels in the blood.

Very rare side effects (may occur in up to 1 in 10,000 patients):

• changes in blood cell counts, such as thrombocytopenia (reduced platelet count, which can cause easy bruising and bleeding from the nose), leukopenia (reduced white blood cell count, which can cause unexplained fever, sore throat, or flu-like symptoms - if you experience these, contact your doctor), and anemia (reduced red blood cell count);
• heart rhythm disorders, low blood pressure;
• high calcium levels in the blood;
• kidney disease;
• abnormal liver function.

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

• fainting;
• in the case of systemic lupus erythematosus (a type of collagen disease), symptoms may worsen;
• there have also been reports of light-sensitive reactions (skin changes) after exposure to sunlight or artificial UVA radiation;
• myopia;
• blurred vision;
• vision disturbances;
• vision loss or eye pain due to increased pressure in the eye (possible symptoms of fluid accumulation in the vascular layer of the eye or acute angle-closure glaucoma);
• changes in laboratory test results (blood tests) and your doctor may recommend a blood test. The following changes in laboratory test results may occur:
• increased uric acid levels, which can cause or worsen gout (joint pain or swelling, especially in the feet);
• increased glucose levels in the blood in patients with diabetes;
• increased liver enzyme activity;
• abnormal electrocardiogram (ECG) tracing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 INDAP

Keep this medicine out of the sight and reach of children.
Store in a temperature 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 month.
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 INDAP contains

• The active substance is indapamide. One capsule contains 2.5 mg of indapamide.
• The other ingredients (excipients) are: capsule contents - microcrystalline cellulose, lactose monohydrate, cornstarch, magnesium stearate, colloidal silica; 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.
INDAP is available in PVC/Aluminum blisters in a cardboard box.
The pack contains 30 capsules (3 blisters of 10 capsules each).

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s.
Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic
For more information about this medicine, contact your local representative of the marketing authorization holder:
PRO.MED.PL Sp. z o.o.
[email protected]

Date of last revision of the leaflet: