Indapres

Package Leaflet: Information for the Patient

Indapres 2.5 mg, coated tablets
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.

Table of Contents of the Leaflet

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

1. What is Indapres and what is it used for

Indapres contains the active substance indapamide.
Indapres is used to treat high blood pressure in adults.
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. Indapamide, however, only slightly increases the amount of urine produced.
In addition, indapamide dilates blood vessels, making it easier for blood to flow through them.
This helps to lower blood pressure.

2. Important information before taking Indapres

When not to take Indapres

• If you are allergic to indapamide, other 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 a condition called hepatic encephalopathy (a liver disease that affects brain function and the central nervous system).
• If you have low potassium levels in your blood.

Warnings and precautions

Before taking Indapres, discuss with your doctor, pharmacist, or nurse if you have:

• liver disease;
• diabetes;
• gout;
• any heart rhythm disorders or kidney function disorders;
• a planned test to assess parathyroid function;
• blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they may occur within a few hours to weeks after taking Indapres. If left untreated, they can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing these side effects.

Tell your doctor if you have had allergic reactions to light.
Your doctor may recommend blood tests to check if your sodium and potassium levels are not decreased or if your calcium level is not increased. In case of a significant decrease in potassium levels, muscle breakdown may occur.
If you think any of the above situations apply to you, or if you have questions or doubts about taking this medicine, you should contact your doctor or pharmacist.
Athletes should be aware that this medicine contains an active substance that can cause positive doping test results.

Indapres and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Indapres with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.
Tell your doctor if you are taking any of the following medicines, as special caution 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 mental 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, which causes chest pain),
• cisapride (used in cases of slow esophageal and gastric peristalsis),
• difemanil (used to treat gastrointestinal disorders, such as ulcers, hyperacidity, hyperreactivity of the digestive system),
• sparfloxacin, moxifloxacin, erythromycin injected (antibiotics used to treat infections),
• winkamine injected (used to treat symptomatic 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),
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, pentamidine, terfenadine, astemizole),
• non-steroidal anti-inflammatory medicines with analgesic effects (e.g., ibuprofen) or high doses of acetylsalicylic acid,
• synthetic opioids used to relieve pain or treat addiction (methadone),
• angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure),
• amphotericin B injected (an antifungal medicine),
• orally administered corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis,
• laxatives that stimulate peristalsis,
• baclofen (used to treat muscle stiffness, which occurs in diseases such as multiple sclerosis),
• allopurinol (used to treat gout),
• potassium-sparing diuretics (amiloride, spironolactone, triamterene),
• metformin (used to treat diabetes),
• iodine-based contrast agents (used during radiological examinations),
• calcium-containing tablets or other calcium supplements,
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation or used to treat autoimmune diseases, severe rheumatic diseases, or dermatological diseases,
• tetracosactide (used to treat Crohn's disease).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 that you are pregnant, your doctor will prescribe a different treatment as soon as possible. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
The active substance passes into breast milk. Do not breastfeed while taking this medicine.

Driving and using machines

Indapres may cause side 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 increase. If they occur, do not drive or operate machinery. However, these symptoms are rare if the treatment is carried out according to the recommendations.

Indapres contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Indapres

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet once a day, preferably in the morning.
The tablet can be taken with or without food, swallow it whole with a glass of water.
Treatment of high blood pressure is usually long-term.

If you take more Indapres than you should

If you have taken too many tablets, contact your doctor or go to the nearest hospital emergency department immediately.
A very high dose of Indapres may cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, disorientation, and changes in urine output.

If you forget to take Indapres

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 Indapres

Since the treatment of high blood pressure usually lasts for the rest of your life, consult your doctor before stopping the treatment.
If you have any further questions about the use of 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 the medicine and contact your doctor immediately:

• angioedema and (or) urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips, tongue, mucous membranes of the throat or respiratory tract, which can cause shortness of breath or difficulty swallowing. If such symptoms occur, seek medical attention immediately (very rare - may occur less frequently than 1 in 10,000 people);
• severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare - may occur less frequently than 1 in 10,000 people);
• 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 less frequently than 1 in 10,000 people);
• liver disease caused by liver disease (encephalopathy); (frequency not known);
• hepatitis (frequency not known).

Other side effects are grouped by frequency of occurrence.

Common side effects (may occur in less than 1 in 10 people):

• red, raised rash;
• allergic reactions, mainly affecting the skin, such as rashes, in people with a predisposition to allergic reactions and asthma;
• low potassium levels in the blood.

Uncommon side effects (may occur in less than 1 in 100 people):

• 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 less than 1 in 1,000 people):

• fatigue, headache, tingling, and numbness (paresthesia), dizziness of labyrinthine origin;
• gastrointestinal disorders (such as nausea, constipation), dryness of the mucous membrane of the mouth;
• low chloride levels in the blood;
• low magnesium levels in the blood.

Very rare side effects (may occur in less than 1 in 10,000 people):

• changes in blood cell counts, such as thrombocytopenia (decreased platelet count, which can cause easy bruising and nosebleeds), leukopenia (decreased white blood cell count, which can cause fever of unknown origin, sore throat, or other flu-like symptoms - if such symptoms occur, contact your doctor) and anemia (decreased red blood cell count);
• increased calcium levels in the blood;
• heart rhythm disorders (palpitations - feeling of heart activity), low blood pressure;
• kidney disorders (causing symptoms such as fatigue, increased need to urinate, itching, nausea, swelling of the limbs);
• abnormal liver function.

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

• fainting;
• possibility of exacerbating symptoms in patients with systemic lupus erythematosus (a type of collagen disease);
• reported cases of hypersensitivity reactions to light (changes in skin appearance) after exposure to sunlight or artificial UVA radiation;
• myopia;
• blurred vision;
• vision disturbances;
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma);
• blood changes - your doctor may recommend a blood test to assess them. The following changes in blood test results may occur:
• increased uric acid levels, a substance that can cause gout (joint pain or swelling, especially in the feet),
• increased glucose levels in the blood in patients with diabetes,
• increased liver enzyme activity;
• abnormal ECG tracing
• muscle cramps, muscle weakness, muscle pain, rhabdomyolysis (breakdown of striated muscle).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this 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 month.
Do not store above 25°C.
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 Indapres contains

The active substance is indapamide. Each coated tablet contains 2.5 mg of indapamide.
Other ingredients: lactose monohydrate (type 200), cornstarch, 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 score line on one side.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
The pack contains 30 tablets.

Marketing authorization 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
To obtain more detailed information on this medicine, 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
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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