Tertensif kombi

Package leaflet: Information for the patient

Tertensif Kombi, 5 mg + 1.25 mg, film-coated tablets
Perindoprilum argininum + Indapamidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Tertensif Kombi is a combination medicine containing two active substances: perindopril and indapamide. It is an antihypertensive medicine used to treat high blood pressure (hypertension) in adults.
Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These medicines work by relaxing blood vessels, making it easier for the heart to pump blood.
Indapamide is a diuretic medicine. Diuretics increase the amount of urine produced by the kidneys. Indapamide differs from other diuretics in that it only slightly increases urine output.
Both active substances lower blood pressure and work together to help normalize the patient's blood pressure.

2. Important information before using Tertensif Kombi

When not to use Tertensif Kombi:

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

Warnings and precautions
Before starting Tertensif Kombi, discuss with your doctor or
pharmacist:

• if the patient has aortic valve stenosis (narrowing of the main blood vessel carrying blood from the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
• if the patient has heart failure or any other heart conditions;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient experiences worsening vision or eye pain. These may be symptoms of fluid accumulation in the choroid layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks of taking Tertensif Kombi. Untreated, these symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulphonamides, the risk of these disorders is higher.
• 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 the patient has liver disease;
• if the patient has a collagen disease (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 the parathyroid glands);
• 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 (spironolactone, triamterene), or potassium supplements – these should be avoided during treatment with Tertensif Kombi (see "Tertensif Kombi with other medicines");
• if the patient is elderly;
• if the patient previously experienced light-sensitive allergic reactions;
• if the patient develops a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, causing difficulty in swallowing or breathing (angioedema) – swelling may occur at any time during treatment. If such symptoms occur, treatment must be stopped immediately and medical advice sought without delay;
• 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 – for example, 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 Tertensif Kombi".

• if the patient is of Black race – in such cases, there may be 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 membranes;
• if the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs known as mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment);
• 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 drugs known as gliptins (used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Tertensif Kombi, cases of angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, the patient must stop taking Tertensif Kombi and contact a doctor immediately. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. The use of Tertensif Kombi is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child (see "Pregnancy and breastfeeding").
When taking Tertensif Kombi, also inform your doctor or medical staff:

• if the patient is to undergo anaesthesia and/or surgery;
• if the patient has recently experienced diarrhoea or vomiting, or is 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 an iodine-containing contrast agent (a substance allowing organs such as the kidney or stomach to be seen on X-ray) is to be performed;
• if vision disturbances or eye pain occur in one or both eyes during treatment with Tertensif Kombi. These may be symptoms of glaucoma or increased pressure in one or both eyes. The use of Tertensif Kombi should be stopped and medical advice sought.

Athletes should be aware that Tertensif Kombi contains an active substance (indapamide)
that may lead to a positive result in anti-doping tests.
Children and adolescents
Tertensif Kombi must not be used in children and adolescents.
Tertensif Kombi with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Avoid using 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 to prevent clots, trimethoprim, and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• 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 Tertensif Kombi. Your doctor may recommend a dose adjustment and/or additional precautions. Inform your doctor if the patient is taking any of the following medicines, as special caution 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 Tertensif Kombi" 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 doses of 12.5 mg to 50 mg per day;
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group known as 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 Tertensif Kombi" and "Warnings and precautions".
• anaesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, erythromycin administered 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 to prevent organ transplant rejection (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 cognitive symptoms 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 (used to treat gastrointestinal disorders);
• digoxin or other cardiac 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. sena);
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance contained 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);
• trimethoprim (used to treat infections);
• vasodilating medicines, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

Tertensif Kombi with food and drink
It is recommended to take Tertensif Kombi before a meal.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. Usually, your doctor will advise stopping Tertensif Kombi before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Tertensif Kombi is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child.
Breastfeeding
The use of Tertensif Kombi is not recommended if the patient is breastfeeding.
Inform your doctor immediately if you are breastfeeding or plan to breastfeed.
Contact your doctor without delay.
Driving and operating machinery
Tertensif Kombi usually does not affect the ability to drive or operate machinery. However, some patients may experience dizziness or fatigue related to low blood pressure.
In such cases, the ability to drive or operate machinery may be impaired.
Tertensif Kombi contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Tertensif Kombi contains sodium
Tertensif Kombi contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tertensif Kombi

This medicine should always be taken as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The recommended dose is one tablet once daily. Your doctor may recommend a different dosage if you have
kidney function disorders.
The tablet should preferably be taken in the morning, before a meal. Swallow the tablet with a glass of water.
Taking more Tertensif Kombi than recommended
If too many tablets are taken, contact a 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 (accompanied by nausea, vomiting, cramps, dizziness, drowsiness,
disorientation, or changes in urine output by the kidneys), lying down with legs raised may help.
Missing a dose of Tertensif Kombi
It is important to take the medicine every day, as regular use is most effective.
However, if a dose of Tertensif Kombi is missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
Stopping Tertensif Kombi treatment
Treatment of high blood pressure is long-term; therefore, consult your doctor before stopping this medicine.
If you have any further doubts about using 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 adverse reactions, which may be serious, treatment with this medicine must be discontinued immediately and medical advice must be sought without delay:

• 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 “Warnings and precautions” in point 2); uncommon – may occur in less than 1 in 100 patients;
• severe skin reactions, including erythema multiforme (skin rash often starting with red, itchy spots on the face, arms or legs) or severe skin rash, urticaria, redness of the entire skin surface, intense 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, triggered by 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 and general malaise (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 liver inflammation (very rare – may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disturbances (frequency unknown);
• brain disease 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, grouped by decreasing frequency of occurrence, may include:

• Common (may occur in less than 1 in 10 patients): low blood potassium levels, skin reactions in patients with a tendency to allergic or asthmatic reactions, headache, central dizziness, labyrinthine dizziness, prickling and tingling sensations, visual disturbances, tinnitus (sensation of hearing sounds), cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, 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 swings, depression, sleep disturbances, urticaria, purpura (red spots on the skin), clusters of blisters, kidney disorders, impotence (inability to achieve or maintain an erection), excessive sweating, increased eosinophil count (a type of white blood cell), changes in laboratory test results: high blood potassium levels which resolve 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 heart rate), 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): exacerbation of psoriasis, changes in laboratory test results: low blood chloride levels, low blood magnesium levels, increased liver enzyme activity, high serum bilirubin levels; fatigue, sudden flushing of the face and neck, reduced or absent urine output, acute kidney failure. Dark-coloured urine, nausea or vomiting, muscle cramps, disorientation and seizures may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
• Very rare (may occur in less than 1 in 10,000 patients): disorientation, eosinophilic pneumonia (a rare type of lung inflammation), inflammation of the nasal mucosa (nasal congestion or rhinitis), severe kidney disorders, blood parameter changes such as decreased white and red blood cell counts, decreased haemoglobin levels, decreased platelet count, high blood calcium levels; liver function disorders.
• Frequency not known (cannot be estimated from available data): abnormal heart function detected on ECG, changes in laboratory test results: high blood uric acid levels and high blood sugar levels, myopia, blurred vision, visual disturbance, worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma), cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon). If the patient has systemic lupus erythematosus (a type of collagenosis), symptoms of the disease may worsen.

Blood, kidney, liver or pancreas disorders may occur, as well as changes in laboratory test results (blood tests). The doctor may recommend blood tests to monitor the patient's health.
If any of these symptoms occur, medical advice should be sought as soon as possible.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tertensif Kombi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
„EXP” (abbreviation used to describe the expiry date). The expiry date refers to the last day
of the stated month. The word „Lot” on the packaging indicates the batch number of the medicine.
Store the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Tertensif Kombi contains

• The active substances are: perindopril and indapamide. One coated tablet contains 5 mg of perindopril with arginine (equivalent to 3.395 mg of perindopril) and 1.25 mg of indapamide.
• Other ingredients of the tablet core: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethyl starch (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, elongated coated tablet. Each coated tablet contains 5 mg of perindopril with arginine and 1.25 mg of indapamide.
Tablets are available in packs containing 30 and 90 tablets.
Marketing Authorisation 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 Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6 B Street
03-236 Warsaw
For detailed information, please contact the representative of the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594-90-00
This medicinal product is authorised in the European Economic Area countries 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 tabletès
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
Slovak Republic NOLIPREL FORTE A
Slovenia BIONOLIPREL 5mg/1.25mg filmsko obložene tablete
United Kingdom Coversyl Arginine Plus 5 mg/1.25 mg
(Northern Ireland)