Indix Combi

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Indix Combi (Perindopril/Indapamide Teva)

10 mg + 2.5 mg, film-coated tablets

Perindopril tosilate + Indapamide
Indix Combi and Perindopril/Indapamide Teva are different trade names for the same medicine.

The patient should carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Indix Combi and what is it used for

Indix Combi is a combination medicine that contains two active substances: perindopril and indapamide. It is an antihypertensive medicine used to treat high blood pressure (hypertension). Indix Combi is used in patients who are taking perindopril 10 mg and indapamide 2.5 mg in separate tablets and who can instead take one tablet of Indix Combi, which contains both components.
Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). These medicines widen the blood vessels, making it easier for the heart to pump blood through the vessels.
Indapamide is a diuretic. Diuretics increase the amount of urine excreted by the kidneys. Indapamide differs from other diuretics in that it only slightly increases the amount of urine excreted. Both active substances lower blood pressure and work together to normalize it.

2. Important information before taking Indix Combi

When not to take Indix Combi

• if the patient is allergic to perindopril, indapamide, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other ACE inhibitors or other sulfonamides;
• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash while taking an ACE inhibitor, or if such symptoms have occurred in the patient or a relative in any other circumstances (a condition called angioedema);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has severe liver disease or a condition called hepatic encephalopathy (a disease that damages the brain);
• if the patient has kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Indix Combi may not be suitable for the patient;
• if the patient has low potassium levels in the blood;
• if the patient has untreated, uncontrolled heart failure (significant fluid retention in the body, difficulty breathing);
• after the third month of pregnancy (it is also recommended to avoid taking Indix Combi in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

Warnings and precautions

Before starting treatment with Indix Combi, the patient should discuss it with their doctor or pharmacist:

• if the patient has a narrowing of the aortic valve (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the blood vessel supplying the kidney);
• if the patient has heart failure or any other heart disease;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has muscle disorders, including pain, tenderness, weakness, or cramps;
• if the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism)
• if the patient has liver disease;
• if the patient has collagenosis (a skin disease), such as systemic lupus erythematosus or scleroderma;
• if the patient has atherosclerosis (hardening of the blood vessels);
• if the patient has hyperparathyroidism (a disorder of parathyroid function);
• if the patient has gout;
• if the patient has diabetes;
• if the patient is on a low-salt diet or taking salt substitutes containing potassium;
• if the patient is taking lithium, potassium-sparing diuretics (spironolactone, triamterene), or potassium supplements - it is recommended to avoid taking these medicines while taking Indix Combi (see section "Indix Combi and other medicines");
• if the patient is elderly;
• if the patient has had hypersensitivity reactions to light;
• if the patient has had severe allergic reactions with swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema). Such symptoms can occur at any time during treatment, and if they occur, the patient should stop taking the medicine and seek medical attention immediately.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA) (also called a sartan - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also subsection "When not to take Indix Combi".
• if the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes),
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure.
• if the patient is black, as there is a higher risk of angioedema and the medicine may be less effective in lowering blood pressure compared to patients of other races;
• if the patient is undergoing dialysis using high-flux dialysis membranes;
• if the patient experiences vision loss 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 pressure in the eye - they can occur within a few hours to weeks after taking Indix Combi. If left untreated, they can lead to permanent vision loss. In patients allergic to penicillin or sulfonamides, the risk of such disorders is higher.

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Indix Combi. It can occur at any time during treatment. If such symptoms occur, the patient should stop taking Indix Combi and seek medical attention immediately. See also section 2 "Warnings and precautions".
The patient should inform their doctor about pregnancy, suspected pregnancy, or planning to become pregnant, and the doctor may recommend an alternative medicine.
It is not recommended to take Indix Combi during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken during this period (see section "Pregnancy and breastfeeding").
When taking Indix Combi, the patient should also inform their doctor or medical staff:

• if the patient is to undergo anesthesia and/or surgery;
• if the patient has recently experienced diarrhea or vomiting, or is dehydrated;
• if dialysis or LDL apheresis (removal of cholesterol from the blood using a special device) is to be performed;
• if desensitization treatment is to be performed to reduce allergic reactions to bee or wasp stings;
• if a test requiring the administration of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen in an X-ray examination) is to be performed;
• if vision loss or eye pain occurs while taking Indix Combi. These may be symptoms of glaucoma or increased pressure in the eye. In such cases, the patient should stop taking Indix Combi and seek medical attention.

Athletes should be informed that Indix Combi contains the active substance indapamide, which may cause a positive doping test result.

Children and adolescents

Indix Combi should not be used in children and adolescents.

Indix Combi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking Indix Combi with:

• lithium (used to treat mania or depression);
• aliskiren (used to treat hypertension) in patients other than those with diabetes or kidney problems;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection and treat certain diseases; heparin, a medicine used to thin the blood and prevent blood clots);
• estramustine (used to treat cancer);
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect treatment with Indix Combi. The doctor may recommend changing the dose and/or taking other precautions. The patient should tell their doctor about taking any of the following medicines, as it may require special precautions:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA) or aliskiren (see also subsections "When not to take Indix Combi" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine excreted by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in daily doses of 12.5 mg to 50 mg;
• anesthetics;
• contrast agents containing iodine;
• antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, erythromycin given by injection);
• methadone (used to treat addiction);
• procainamide (used to treat heart rhythm disorders);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, astemizole);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• immunosuppressive medicines used to treat autoimmune diseases or prevent organ rejection (e.g., cyclosporine, tacrolimus);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold salts given by injection (used to treat rheumatoid arthritis);
• vinkamine (used to treat cognitive disorders in the elderly, including memory loss);
• bepridil (used to treat angina pectoris);
• medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• cyzapride, difemanil (medicines used to treat gastrointestinal disorders);
• digoxin or other digitalis glycosides (used to treat heart diseases);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives with a stimulating effect (e.g., senna);
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid (a substance found in many medicines, used as a pain reliever and antipyretic, as well as to prevent blood clots));
• amphotericin B given by injection (used to treat severe fungal infections);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• tetracosactide (used to treat Crohn's disease);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• medicines commonly used to treat diarrhea (racecadotril) or prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of medicines called mTOR inhibitors). See section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Indix Combi" and "Warnings and precautions".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Usually, the doctor will recommend stopping Indix Combi before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend an alternative medicine. It is not recommended to take Indix Combi during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken during this period.
Breastfeeding
It is not recommended to take Indix Combi while breastfeeding, and the doctor may choose an alternative treatment for the patient if they plan to breastfeed, especially if the baby is a newborn or premature.
The patient should contact their doctor immediately.

Driving and using machines

Indix Combi usually does not affect attention, but some patients may experience dizziness or fatigue related to low blood pressure. If such symptoms occur, the ability to drive or operate machines may be impaired.

Indix Combi contains lactose monohydrate

If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Indix Combi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Indix Combi

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is one tablet per day. The tablet should be taken in the morning, before a meal. The tablet should be swallowed with a glass of water.

Overdose of Indix Combi

If the patient has taken too many tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately. The most common symptom of overdose is low blood pressure. If severe low blood pressure occurs (with symptoms such as nausea, vomiting, cramps, dizziness, drowsiness, confusion, and changes in urine output), it may help to lie down with the legs elevated.

Missing a dose of Indix Combi

It is important to take the medicine every day, as regular treatment is most effective.
If a dose of Indix Combi is missed, the next dose should be taken at the usual time.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Indix Combi

Treatment of high blood pressure usually lasts for life, so before stopping treatment with this medicine, the patient should contact their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Indix Combi can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms (which may be severe), they should stop taking the medicine and contact their doctor immediately:

• severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of chest tightness, wheezing, and shortness of breath) (uncommon - may occur in less than 1 in 100 patients);
• swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing (angioedema, see section 2 "Warnings and precautions") (uncommon - may occur in less than 1 in 100 patients);
• severe skin reactions, including erythema multiforme (a skin rash that often starts with red, itchy patches on the face, hands, or feet) or severe skin rash, urticaria, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);
• cardiovascular disorders (heart rhythm disorders, angina pectoris, myocardial infarction) (very rare - may occur in less than 1 in 10,000 patients);
• weakness or paralysis of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may occur in less than 1 in 10,000 patients);
• pancreatitis, which may cause severe abdominal pain, radiating to the back, with very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• jaundice (yellowing of the skin and eyes), which may be a symptom of liver inflammation (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• liver disease that damages the brain (hepatic encephalopathy) (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high fever, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects, presented in order of decreasing frequency, are:

• Common: (may occur in less than 1 in 10 patients) low potassium levels in the blood, skin reactions in people prone to allergic and asthmatic reactions, headache, dizziness of central origin, dizziness of labyrinthine origin, tingling and numbness, vision disturbances, tinnitus (feeling of hearing sounds), cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of fatigue,

(uncommon - may occur in less than 1 in 100 patients) mood changes, sleep disturbances, depression, urticaria, purpura (red spots on the skin), blistering, kidney function disorders, impotence (inability to achieve or maintain an erection), excessive sweating, high levels of potassium in the blood, which may be temporary and resolve after stopping treatment, low levels of sodium in the blood, which may cause dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (fast heart rate), hypoglycemia (very low blood sugar levels) in patients with diabetes, kidney inflammation, dryness of the mucous membranes of the mouth, hypersensitivity reactions to light, joint pain, muscle pain, chest pain, general malaise, peripheral edema, fever, increased levels of urea in the blood, increased levels of creatinine in the blood, falls.

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests). The doctor may recommend blood tests to monitor the patient's health.

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Indix Combi

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special storage temperature recommendations. The container should be kept tightly closed to protect it from moisture.
Medicines should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Indix Combi contains

• The active substances of the medicine are perindopril tosilate and indapamide. Each film-coated tablet contains 10 mg of perindopril tosilate (which corresponds to 6.816 mg of perindopril) and 2.5 mg of indapamide.
• Other ingredients of the tablet: lactose monohydrate, cornstarch, sodium bicarbonate, pregelatinized cornstarch, povidone K 30, magnesium stearate, coating: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc.

What Indix Combi looks like and contents of the pack

White, round, biconvex film-coated tablets with a diameter of about 10 mm, smooth on both sides.
The tablets are available in polypropylene containers with polyethylene caps, in cardboard boxes. Pack size: 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer:

Teva Gyógyszergyár Zrt.
Pallagi út 13
H-4042 Debrecen
Hungary
Pharmachemie B.V.
Swensweg 5, Haarlem
2031 GA, Netherlands
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków, Poland

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Latvia, the country of export: 17-0018

Parallel import authorization number: 230/25

Date of leaflet approval: 01.07.2025

[Information about the trademark]