Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Indix Combi (Perindopril/Indapamide Teva)
10 mg + 2.5 mg, film-coated tablets
Perindoprili tosilas + Indapamidum
Indix Combi and Perindopril/Indapamide Teva are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

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

2. Important information before using Indix Combi

When not to use 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 during previous treatment with an ACE inhibitor the patient experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes, or if such symptoms occurred in the patient or a relative under any circumstances (a condition known as 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 liver disease affecting the brain);
if the patient has kidney disease causing reduced blood flow to the kidneys (renal artery stenosis);
if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Indix Combi may not be suitable;
if the patient has low potassium levels in the blood;
if the patient has untreated, uncontrolled heart failure (significant fluid retention, breathing difficulties);
after the 3rd month of pregnancy (it is also advisable to avoid using 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 certain types of chronic heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

Warnings and precautions
Before starting Indix Combi, discuss with your doctor or pharmacist:

if there is aortic valve stenosis (narrowing of the main blood vessel carrying blood from the heart), hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
if there is heart failure or any other heart disease;
if there is kidney disease or the patient is undergoing dialysis;
if the patient has muscle disorders, including pain, tenderness, weakness, or cramps;
if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
if there is liver disease;
if there is a collagen disease (skin disorder), such as systemic lupus erythematosus or scleroderma;
if there is atherosclerosis (hardening of the blood vessels);
if there is hyperparathyroidism (a disorder of the parathyroid glands);
if there is gout;
if there is diabetes;
if the patient is on a low-salt diet or using salt substitutes containing potassium;
if the patient is taking lithium, potassium-sparing diuretics (spironolactone, triamterene), or potassium supplements – these medicines should be avoided while taking Indix Combi (see section "Indix Combi with other medicines");
if the patient is elderly;
if the patient has previously experienced photosensitivity reactions;
if there are severe allergic reactions with swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing (angioedema). Such symptoms may occur at any time during treatment, and if they appear, the medicine should be stopped immediately and the doctor contacted without delay.
if the patient is taking any of the following medicines for high blood pressure:
- an angiotensin II receptor antagonist (AIIRA) (also known as 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 blood electrolyte levels (e.g. potassium). See also the section "When not to use Indix Combi".
if the patient is taking any of the following medicines, the risk of angioedema may increase:
racecadotril, a medicine used to treat diarrhoea,
medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus),
linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group called gliptins (used in diabetes treatment),
sacubitril (available in a combination medicine containing sacubitril and valsartan), used in the treatment of chronic heart failure.
- if the patient is of Black race, 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 blurred vision or eye pain. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure – they may occur from several hours to weeks after taking Indix Combi. If untreated, they may lead to permanent vision loss. The risk of such disorders is higher in patients allergic to penicillin or sulfonamides.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Indix Combi. It may occur at any time during treatment. If such symptoms occur, Indix Combi should be discontinued and the doctor contacted immediately. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of Indix Combi is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section "Pregnancy and breastfeeding").
When taking Indix Combi, you should also inform your doctor or medical staff:

if you are to undergo anaesthesia and/or surgery;
if you have recently had diarrhoea or vomiting, or if you are dehydrated;
if dialysis or LDL apheresis (removal of cholesterol from the blood using a special device) is planned;
if desensitisation treatment is planned to reduce allergic reactions to bee or wasp stings;
if an imaging test requiring iodine-containing contrast agents (substances allowing visualisation of organs such as the kidney or stomach in X-ray examinations) is to be performed;
if visual disturbances or eye pain in one or both eyes occur during treatment with Indix Combi. These may be symptoms of glaucoma or increased intraocular pressure. In such cases, treatment with Indix Combi should be stopped and medical advice sought.

Athletes should be informed that Indix Combi contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children and adolescents
Indix Combi must not be used in children and adolescents.
Indix Combi with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Avoid using Indix Combi with:

lithium (used to treat mania or depression);
aliskiren (used to treat high blood pressure) 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 in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
estramustine (used to treat cancer);
other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with Indix Combi. Your doctor may recommend a dose adjustment and/or additional precautions. Inform your doctor if you are taking any of the following medicines, as special precautions may be required:

other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also sections "When not to use Indix Combi" and "Warnings and precautions"), or diuretics (medicines that increase urine output by the kidneys);
potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at daily doses from 12.5 mg to 50 mg;
anaesthetics;
iodine-containing contrast agents;
antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, intravenous erythromycin);
methadone (used in addiction treatment);
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 to prevent organ rejection after transplantation (e.g. cyclosporine, tacrolimus);
halofantrine (used to treat certain types of malaria);
pentamidine (used to treat pneumonia);
gold salts administered by injection (used to treat rheumatoid arthritis);
vinpocetine (used to treat symptomatic cognitive disorders in elderly patients, 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);
cisapride, difemanil (medicines used to treat gastrointestinal disorders);
digoxin or other digitalis glycosides (used in heart diseases);
baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis);
medicines used to treat diabetes, such as insulin, metformin, or gliptins;
calcium, including calcium supplements;
stimulant laxatives (e.g. senna);
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (the substance found in many medicines used for pain relief, fever reduction, and prevention of blood clots));
intravenous amphotericin B (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);
vasodilating medicines, including nitrates;
medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);
medicines most commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of 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 use Indix Combi" and "Warnings and precautions".

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will usually advise stopping Indix Combi before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Indix Combi is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.
Breastfeeding
Indix Combi is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you intend to breastfeed, especially if the baby is a newborn or was born prematurely.
Contact your doctor immediately.
Driving and operating machinery
Indix Combi usually does not affect attention, but some patients may experience dizziness or fatigue due to low blood pressure. If such symptoms occur, the ability to drive or operate machinery may be impaired.
Indix Combi contains monohydrate lactose
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Indix Combi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Indix Combi

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one tablet per day. The tablet should preferably be taken in the morning, before a meal. Swallow the tablet with a glass of water.
Taking more Indix Combi than recommended
If you take more tablets than recommended, contact your doctor immediately or go to the nearest hospital emergency department. The most common symptom of overdose is low blood pressure. If significantly low blood pressure occurs (with symptoms such as nausea, vomiting, cramps, dizziness, drowsiness, confusion, changes in urine output), lying down with legs raised may help.
Missing a dose of Indix Combi
It is important to take the medicine every day, as regular use is most effective. However, if you miss a dose of Indix Combi, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
Stopping treatment with Indix Combi
Treatment for high blood pressure usually lasts a lifetime, so you should consult your doctor before stopping this medicine.
If you have any further questions about 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 will experience them.
If the patient experiences any of the following symptoms (which may be severe), the medicine must be discontinued and medical advice must be sought immediately:

Severe dizziness or fainting due to low blood pressure (common – may occur in less than 1 in 10 patients);
Bronchospasm (feeling of tightness in the chest, 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 breathing (angioedema, see section 2 “Warnings and precautions”) (uncommon – may occur in less than 1 in 100 patients);
Severe skin reactions, including erythema multiforme (skin rash, which often begins with red, itchy spots on the face, hands or legs), intense skin rash, urticaria, redness of the entire skin, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions (very rare – may occur in less than 1 in 10,000 patients);
Cardiovascular disorders (heart rhythm disturbances, angina pectoris (chest pain radiating to the jaw and back following physical exertion), myocardial infarction) (very rare – may occur in less than 1 in 10,000 patients);
Weakness of the arms or legs, or speech disturbances, which may be signs of stroke (very rare – may occur in less than 1 in 10,000 patients);
Pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition (very rare – may occur in less than 1 in 10,000 patients);
Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare – may occur in less than 1 in 10,000 patients);
Life-threatening heart rhythm disturbances (frequency unknown);
Brain disorder caused by liver disease (hepatic encephalopathy) (frequency unknown);
Muscle weakness, cramps, tenderness or pain, particularly if the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Adverse reactions listed in decreasing order of frequency are:

Common: (may occur in less than 1 in 10 patients) low blood potassium levels, skin reactions in patients predisposed to allergic and asthmatic reactions, headache, central dizziness, labyrinthine dizziness, tingling and pricking sensations, visual disturbances, tinnitus (perception of ringing or other sounds in the ears), cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhoea, 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 (small red spots on the skin), blister formation, kidney function disorders, impotence (inability to achieve or maintain erection), excessive sweating, increased eosinophil count (a type of white blood cell), changes in laboratory test results: high blood potassium levels (transient and resolving after discontinuation of treatment), low blood sodium levels (which may lead to dehydration and low blood pressure), drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heartbeat), hypoglycaemia (very low blood sugar levels) in diabetic patients, vasculitis, dryness of the oral mucosa, photosensitivity reactions (increased skin sensitivity to sunlight), joint pain, muscle pain, chest pain, malaise, peripheral oedema, fever, increased blood urea levels, increased blood creatinine levels, falls.
Rare: (may occur in less than 1 in 1,000 patients) dark urine, nausea or vomiting, muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). Sudden redness of the face and neck, worsening of psoriasis, changes in laboratory test results: low blood chloride levels, low blood magnesium levels, increased liver enzyme activity, high serum bilirubin levels, reduced urine output or absence of urine, acute kidney failure, fatigue.
Very rare: (may occur in less than 1 in 10,000 patients) confusion, eosinophilic pneumonia (a rare type of lung inflammation), rhinitis (nasal congestion or discharge), allergic reaction in the small intestine (intestinal angioedema), severe kidney function disorders, blood parameter changes such as decreased white blood cell and red blood cell counts, decreased haemoglobin concentration, decreased platelet count, high blood calcium levels, liver function disorders.
Frequency not known: (cannot be estimated from available data) abnormal heart function detected in ECG examination, changes in laboratory test results: high blood uric acid levels and high blood glucose levels, worsening of vision and eye pain due to high intraocular pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive accumulation of fluid between choroid and sclera – or acute angle-closure glaucoma), myopia, blurred vision, visual disturbances, cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon). If the patient has systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.

Disorders of the blood, kidneys, liver or pancreas, as well as changes in laboratory test results (blood tests), may occur. The doctor may recommend blood tests to monitor the patient's health.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Indix Combi

Keep this medicine out of 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 stated month.
There are no special temperature storage requirements. Store the container tightly closed to protect from moisture.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Indix Combi contains

The active substances in this medicine are: perindopril tert-butylamine salt and indapamide. Each coated tablet contains 10 mg of perindopril tert-butylamine salt (equivalent to 6.816 mg of perindopril) and 2.5 mg of indapamide.
Other components of the tablet: monohydrate lactose, corn starch, sodium hydrogen carbonate, pregelatinized corn starch, 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 packaging
White, round, biconvex coated tablets with a diameter of approximately 10 mm, smooth on both sides.
Tablets are available in polypropylene containers with polyethylene caps, packed in cardboard boxes. Packaging size: 30 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Latvia, country of export:
Teva Pharma B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer:
Teva Gyógyszergyár Zrt.
Pallagi út 13
H-4042 Debrecen
Hungary
Pharmachemie B.V.
Swensweg 5, Haarlem
2031 GA, The 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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation Number in Latvia, country of export: 17-0018
Parallel Import Licence Number: 230/25