Tertensif Kombi

Leaflet accompanying the packaging: patient information

Tertensif Kombi, 5 mg + 1.25 mg, film-coated tablets

Perindopril arginine + Indapamide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tertensif Kombi and what is it used for

Tertensif Kombi is a combination medicine that contains two active substances: perindopril and indapamide. It is an antihypertensive medicine used to treat high blood pressure in adults.

Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). These medicines work by widening the blood vessels, making it easier for the heart to pump blood.

Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. Indapamide differs from other diuretics in that it only slightly increases the amount of urine produced.

Both active substances lower blood pressure and work together to normalize the patient's blood pressure.

2. Important information before taking Tertensif Kombi

When not to take Tertensif Kombi:

• if the patient is allergic to perindopril or other ACE inhibitors, to indapamide or other sulfonamides, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash while taking an ACE inhibitor in the past, 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 severe 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, Tertensif Kombi may not be suitable for the patient.
• if the patient has low potassium levels in the blood;
• if the patient has untreated or uncontrolled heart failure (severe fluid retention in the body, difficulty breathing);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Tertensif Kombi in early pregnancy - see "Pregnancy and breastfeeding");
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Tertensif Kombi with other medicines").

Warnings and precautions

Before taking Tertensif Kombi, the patient should discuss the following 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 experiences vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur within a few hours or weeks of taking Tertensif Kombi. Untreated symptoms may lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, there is a greater risk of these disorders.
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if the patient has an excessive 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 arteries);
• 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 uses salt substitutes containing potassium;
• if the patient is taking lithium or potassium-sparing medicines (such as spironolactone, triamterene), or potassium supplements - the patient should avoid taking these medicines while taking Tertensif Kombi (see "Tertensif Kombi with other medicines");
• if the patient is elderly;
• if the patient has had allergic reactions to light;
• if the patient experiences a severe allergic reaction with facial, lip, mouth, tongue, or throat swelling, which may cause difficulty swallowing or breathing (angioedema) - swelling may occur at any time during treatment. If such symptoms occur, the patient should stop taking Tertensif Kombi and consult their doctor immediately;
• if the patient is taking any of the following medicines used to treat 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 electrolyte levels (such as potassium) in the blood.

See also the section "When not to take Tertensif Kombi".

• if the patient is black - in this case, there may be a greater risk of angioedema and the medicine may be less effective in lowering blood pressure than in patients of other races;
• if the patient is undergoing dialysis using high-flux membranes;
• if the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent organ rejection and treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Tertensif Kombi, angioedema (a severe allergic reaction with facial, lip, tongue, or throat swelling, and difficulty swallowing or breathing) has been reported. This reaction may occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Tertensif Kombi and consult their doctor immediately. See also section 4.

The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Tertensif Kombi before pregnancy or as soon as the patient finds out they are pregnant, and will recommend a different medicine instead of Tertensif Kombi. It is not recommended to take Tertensif Kombi in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby (see "Pregnancy and breastfeeding").

When taking Tertensif Kombi, 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 the patient is to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if the patient is to undergo a test that requires the use of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray);
• if the patient experiences vision loss or eye pain while taking Tertensif Kombi. These may be symptoms of glaucoma or increased pressure in the eye. The patient should stop taking Tertensif Kombi and consult their doctor.

Athletes should be aware that Tertensif Kombi contains an active substance (indapamide) that may cause a positive result in a doping test.

Children and adolescents

Tertensif Kombi should not be used in children and adolescents.

Tertensif Kombi with 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 Tertensif Kombi with:

• lithium (used to treat mania or depression);
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney problems;
• potassium-sparing diuretics (e.g., triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent clot formation, trimethoprim, and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• estrMustine (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 Tertensif Kombi. The doctor may recommend a change in dose and/or take other precautions. The patient should tell their doctor about taking any of the following medicines, as special precautions may be necessary:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also the sections "When not to take Tertensif Kombi" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• medicines used to treat diarrhea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See the section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the sections "When not to take Tertensif Kombi" and "Warnings and precautions".
• 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 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);
• vinpocetine (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);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used to treat heart disease);
• baclofen (used to treat muscle stiffness that occurs in diseases such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• laxatives with a stimulant 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 fever reducer, as well as to prevent blood clot formation);
• 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);
• trimethoprim (used to treat infections);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline).

Tertensif Kombi with food and drink

Tertensif Kombi should be taken before a meal.

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

The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Tertensif Kombi before pregnancy or as soon as the patient finds out they are pregnant, and will recommend a different medicine instead of Tertensif Kombi. It is not recommended to take Tertensif Kombi in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

Tertensif Kombi should not be taken if the patient is breastfeeding.

The patient should tell their doctor immediately if they are breastfeeding or plan to breastfeed.

The patient should consult their doctor immediately.

Driving and using machines

Tertensif Kombi usually does not affect the ability to drive or use machines, however, some patients may experience dizziness or fatigue related to low blood pressure.

In such cases, the ability to drive or use machines may be impaired.

Tertensif Kombi contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Tertensif Kombi contains sodium

Tertensif Kombi contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tertensif Kombi

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.

In case of doubts, the patient should consult their doctor or pharmacist.

The recommended dose is one tablet per day. The doctor may recommend a different dose if the patient has kidney problems.

The tablet should be taken in the morning, before a meal. The tablet should be swallowed with a glass of water.

Overdose of Tertensif Kombi

If the patient has taken too many tablets, they should consult their doctor or go to the emergency department of the nearest hospital immediately. The most common symptom of overdose is low blood pressure.

If the patient experiences severely low blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine output), they may be helped by lying down with their legs raised.

Missed dose of Tertensif Kombi

It is important to take the medicine every day, as regular treatment is most effective.

If the patient misses a dose of Tertensif Kombi, they should take the next dose at the usual time.

The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Tertensif Kombi

Treatment of high blood pressure is long-term, so the patient should consult their doctor before stopping treatment with this medicine.

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, Tertensif Kombi can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Tertensif Kombi and consult 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);
• facial, lip, mouth, tongue, or throat swelling, difficulty swallowing (angioedema, see the section "Warnings and precautions" in section 2); uncommon - may occur in less than 1 in 100 patients;
• severe skin reactions, including erythema multiforme (a skin rash often starting with red, itchy patches on the face, arms, or legs) or severe skin rash, urticaria, redness of the skin, severe 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 and very poor general condition (very rare - may occur in less than 1 in 10,000 patients);
• jaundice (yellowing of the skin or 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);
• brain disease caused by liver disease (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, grouped by frequency of occurrence, may include:

• common (may occur in less than 1 in 10 patients): low potassium levels in the blood, skin reactions in patients prone to allergic and asthmatic reactions, headache, dizziness of central origin, dizziness of labyrinthine origin, tingling, visual disturbances, tinnitus (feeling of hearing sounds), cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disorders, indigestion or digestive disorders, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, fatigue.
• uncommon (may occur in less than 1 in 100 patients): mood changes, depression, sleep disorders, urticaria, purpura (red spots on the skin), blistering, liver or kidney disease, impotence (inability to achieve or maintain an erection), increased sweating, elevated potassium levels in the blood, transient after stopping treatment, low sodium levels in the blood, which may cause dehydration and low blood pressure, drowsiness, fainting, palpitations (feeling of heart beating), tachycardia (fast heart rate), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dryness of the mucous membranes, hypersensitivity to light, joint pain, muscle pain, chest pain, malaise, peripheral edema, fever, elevated urea levels in the blood, elevated creatinine levels in the blood, falls.
• rare (may occur in less than 1 in 1,000 patients): exacerbation of psoriasis, changes in laboratory test results: low chloride levels in the blood, low magnesium levels in the blood, elevated liver enzyme activity, elevated bilirubin levels in serum; fatigue, sudden redness of the face and neck, decreased or absent urine output. Dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).
• very rare (may occur in less than 1 in 10,000 patients): disorientation, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (nasal congestion or runny nose), severe kidney disease, changes in blood parameters, such as decreased white blood cell count, decreased red blood cell count, decreased platelet count, elevated calcium levels in the blood; liver function disorders.
• frequency not known (cannot be estimated from available data): abnormal heart function detectable on an electrocardiogram (ECG), changes in laboratory test results: elevated uric acid levels and elevated blood sugar levels, myopia, blurred vision, visual disturbances, eye pain due to high pressure (possible symptoms of choroidal effusion or acute angle-closure glaucoma), cyanosis, numbness, and pain in the fingers or toes (Raynaud's phenomenon). If the patient has systemic lupus erythematosus (a type of collagenosis), the symptoms of the disease may worsen.

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.

If the patient experiences any of these symptoms, they should consult their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their 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, 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 the medicine.

5. How to store Tertensif Kombi

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP" (used to describe the expiry date). The expiry date refers to the last day of the month stated.

The word "Lot" on the packaging means the batch number of the medicine.

Store the container tightly closed to protect from moisture.

Medicines should not be disposed of via 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 packaging and other information

What Tertensif Kombi contains

• The active substances of Tertensif Kombi are perindopril and indapamide. One film-coated tablet contains 5 mg of perindopril arginine (equivalent to 3.395 mg of perindopril) and 1.25 mg of indapamide.
• Other ingredients of the tablet core: lactose monohydrate, magnesium stearate, maltodextrin, colloidal silica anhydrous, sodium carboxymethylcellulose (type A); ingredients of the film coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Tertensif Kombi looks like and contents of the pack

Tertensif Kombi is a white, oval, film-coated tablet. One film-coated tablet contains 5 mg of perindopril arginine and 1.25 mg of indapamide.

The tablets are available in packs of 30 and 90.

Marketing authorization holder:

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturer:

Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France; Servier Ireland Industries Ltd, Gorey Road, Arklow - Co. Wicklow, Ireland; ANPHARM Przedsiebiorstwo Farmaceutyczne S.A., ul. Annopol 6 B, 03-236 Warsaw, Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria

BI_PRETERAX-ARGININ

Belgium

Preterax 5 mg/1,25 mg

Cyprus

Preterax 5 mg/1,25 mg

Denmark

COVERSYL COMP NOVUM

Estonia

NOLIPREL FORTE ARGININE

Finland

COVERSYL COMP NOVUM

France

BIPRETERAX 5 mg/1,25 mg

Germany

BI PRETERAX N 5 mg / 1,25 mg Filmtabletten

Greece

PRETERAX 5 mg/1,25 mg

Ireland

COVERSYL ARGININE PLUS 5mg/1.25mg Film-coated tablets

Italy

PRETERAX 5 mg/1,25 mg

Latvia

NOLIPREL FORTE ARGININE

Lithuania

Noliprel forte 5 mg/1,25 mg tablets

Luxembourg

Preterax 5 mg/1,25 mg

Netherlands

Coversyl Plus arg 5 mg/1,25 mg

Poland

TERTENSIF KOMBI

Portugal

PRETERAX 5 mg/1,25 mg

Romania

NOLIPREL ARG FORTE 5 mg/ 1,25 mg

Slovakia

NOLIPREL FORTE A

Slovenia

BIONOLIPREL 5mg/1.25mg film-coated tablets

United Kingdom

Coversyl Arginine Plus 5 mg/1.25 mg (Northern Ireland)

Date of last revision of the leaflet: 05/2022