Indix Combi

Package Leaflet: Information for the Patient

Indix Combi, 10 mg + 2.5 mg, Film-Coated Tablets

Perindopril Tosilate + Indapamide

Read the Package Leaflet Carefully Before Taking the Medication, 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 medication 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 Package and Other Information

1. What is Indix Combi and What is it Used For

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

• after the third month of pregnancy (it is also recommended to avoid taking Indix Combi in early pregnancy - see section "Pregnancy and Breastfeeding");

Warnings and Precautions

Before starting Indix Combi, discuss the following with your doctor or pharmacist:

• angiotensin II receptor antagonist (AIIRA) (also known as a sartan - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood. See also section "When Not to Take Indix Combi".
• racecadotril, a medication used to treat diarrhea,
• medications used to prevent organ rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medications belonging to the class of medications called gliptins (used to treat diabetes),
• sacubitril (available in a combination medication containing sacubitril and valsartan), used to treat chronic heart failure.

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, discontinue Indix Combi and seek medical attention immediately. See also section 4.
Inform your doctor about pregnancy, suspected pregnancy, or planning to become pregnant. Normally, your doctor will advise you to stop taking Indix Combi before becoming pregnant or as soon as you know you are pregnant and will prescribe another medication instead of Indix Combi. It is not recommended to take Indix Combi in early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and Breastfeeding").
When taking Indix Combi, also inform your doctor or medical staff:

Athletes should be informed that Indix Combi contains an active substance (indapamide) that may cause a positive result in anti-doping tests.

Children and Adolescents

Indix Combi should not be used in children and adolescents.

Indix Combi and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Do not take 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 medications that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ rejection, and heparin, a medication used to thin the blood to prevent blood clots);

Taking other medications may affect treatment with Indix Combi. Your doctor may recommend a dose change and/or take other precautions. Inform your doctor about taking any of the following medications, as it may require special precautions:

• other medications used to treat high blood pressure, including ACE inhibitors and angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also sections "When Not to Take Indix Combi" and "Warnings and Precautions"), or diuretics (medications that increase urine excretion);
• potassium-sparing medications used to treat heart failure: eplerenone and spironolactone in daily doses of 12.5 mg to 50 mg;
• anesthetics;
• iodine-containing contrast agents;
• 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 medications 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);
• vincamine (used to treat cognitive disorders in the elderly, including memory loss);
• bepridil (used to treat angina pectoris);
• medications used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• cyzapride, difemanil (medications used to treat gastrointestinal disorders);
• digoxin or other digitalis glycosides (used to treat heart conditions);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• medications used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives with a stimulant effect (e.g., senna);
• nonsteroidal anti-inflammatory medications (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid, a substance found in many medications, 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);
• medications used to treat mental disorders, such as depression, anxiety, or schizophrenia (e.g., tricyclic antidepressants, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol);
• tetracosactide (used to treat Crohn's disease);
• vasodilators, including nitrates;
• medications used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);
• medications commonly used to treat diarrhea (racecadotril) or prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the class of medications called mTOR inhibitors). See section "Warnings and Precautions";
• a combination medication 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 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 medication.
Pregnancy
Normally, your doctor will advise you to stop taking Indix Combi before becoming pregnant or as soon as you know you are pregnant and will prescribe another medication instead of Indix Combi. It is not recommended to take Indix Combi in early pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period.
Breastfeeding
It is not recommended to take Indix Combi while breastfeeding, and your doctor may choose another treatment for you if you intend to breastfeed, especially if the baby is a newborn or was born prematurely.
Seek medical attention immediately.

Driving and Using Machines

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

Indix Combi Contains Lactose

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

Indix Combi Contains Sodium

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

3. How to Take Indix Combi

Take this medication always as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
The recommended dose is one tablet per day. The tablet should be taken preferably in the morning, before breakfast.
Swallow the tablet with a glass of water.

Overdose of Indix Combi

If you have taken too many tablets, contact your doctor or go to the emergency department of your nearest hospital immediately. The most common symptom of overdose is low blood pressure. If you experience significantly low blood pressure (with symptoms such as nausea, vomiting, cramps, dizziness, drowsiness, confusion, and changes in urine output), lying down with your legs raised may help.

Missing a Dose of Indix Combi

It is important to take your medication every day, as regular treatment is most effective. However, if you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Treatment with Indix Combi

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

4. Possible Side Effects

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

If You Experience Any of the Following Symptoms (Which Can Be Serious), Stop Taking Indix Combi and Seek Medical Attention Immediately:

• severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath) (uncommon - may occur in less than 1 in 100 patients);
• facial swelling, lip swelling, mouth swelling, tongue swelling, or throat swelling, difficulty breathing (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, hives, 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, heart attack) (very rare - may occur in less than 1 in 10,000 patients);
• muscle weakness or speech disorders, which can be symptoms of a stroke (very rare - may occur in less than 1 in 10,000 patients);
• pancreatitis, which can 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 can 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 you feel unwell or have a high temperature, which can 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 individuals 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 tiredness,
• Uncommon: (may occur in less than 1 in 100 patients) mood swings, sleep disturbances, depression, hives, purpura (red spots on the skin), blistering, kidney function disorders, impotence (inability to achieve or maintain an erection), increased sweating, high levels of eosinophils (a type of white blood cell), changes in laboratory test results: high potassium levels in the blood, which may be transient and resolve after treatment is stopped, low sodium levels in the blood, which may cause dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heart rate), hypoglycemia (very low blood sugar levels) in patients with diabetes, vasculitis (inflammation of blood vessels), dryness of the mucous membranes of the mouth, hypersensitivity to light, joint pain, muscle pain, chest pain, poor general condition, peripheral edema, fever, increased levels of urea in the blood, increased levels of creatinine in the blood, falls.

Rare: (may occur in less than 1 in 1,000 patients) dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone). Sudden reddening of the face and neck, worsening of psoriasis, changes in laboratory test results: low chloride levels in the blood, low magnesium levels in the blood, increased liver enzyme activity, high bilirubin levels in serum, decreased urine output or absence of urine output, acute kidney failure, fatigue.

• Very rare: (may occur in less than 1 in 10,000 patients) disorientation, eosinophilic pneumonia (a rare type of pneumonia), inflammation of the nasal mucous membrane (nasal congestion or discharge), allergic reaction in the small intestine (angioedema of the intestine), severe kidney function disorders, changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, high calcium levels in the blood, liver function disorders.
• Frequency not known: (cannot be estimated from available data) abnormal heart function detected on an electrocardiogram, changes in laboratory test results: high uric acid levels and high blood sugar levels, worsening of vision and eye pain due to high pressure in the eye (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute glaucoma), myopia, blurred vision, visual disturbance, cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you have systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.

Blood disorders, kidney disorders, liver disorders, or pancreas disorders, as well as changes in laboratory test results (blood tests), may occur. Your doctor may recommend blood tests to monitor your health.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. 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, PL-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 medication.

5. How to Store Indix Combi

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging and label after "EXP:". The expiry date refers to the last day of the month.
Keep the container tightly closed to protect from moisture.
This medication does not require any special storage conditions.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Indix Combi Contains

• The active substances of Indix Combi 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, cornstarch, povidone, magnesium stearate, polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E171), macrogol/PEG 3350, talc.

What Indix Combi Looks Like and Contents of the Package

White, round, biconvex film-coated tablets with a diameter of approximately 10 mm, smooth on both sides.
Tablets are available in polypropylene containers with polyethylene caps.
Package sizes: 30, 50, 60 (2x30), 90 (3x30), or 100 (2x50) tablets.
Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

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

Date of Last Revision of the Leaflet: November 2024