Tertensif Bi-kombi

Package Leaflet: Information for the Patient

Tertensif Bi-Kombi, 10 mg + 2.5 mg, Film-Coated Tablets

Perindopril Arginine + Indapamide

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine 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 Tertensif Bi-Kombi and what is it used for
• 2. Important information before taking Tertensif Bi-Kombi
• 3. How to take Tertensif Bi-Kombi
• 4. Possible side effects
• 5. How to store Tertensif Bi-Kombi
• 6. Contents of the pack and other information

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

Tertensif Bi-Kombi is a combination medicine that contains two active substances: perindopril and indapamide. It is used to treat high blood pressure (hypertension). Tertensif Bi-Kombi is prescribed to patients who are already taking 10 mg of perindopril and 2,5 mg of indapamide in separate tablets, and these patients can take one tablet of Tertensif Bi-Kombi instead, which contains both components.
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 urine production.
Both active substances lower blood pressure and work together to normalize the patient's blood pressure.

2. Important information before taking Tertensif Bi-Kombi

When not to take Tertensif Bi-Kombi:

• if you are 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 you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rash while taking an ACE inhibitor, or if you have experienced such symptoms in any other circumstances (a condition called angioedema);
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine that contains aliskiren;
• if you have severe liver disease or a condition called hepatic encephalopathy (a disease that damages the brain);
• if you have kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• if you are undergoing dialysis or blood filtration by other methods. Depending on the device used, Tertensif Bi-Kombi may not be suitable for you.
• if you have low potassium levels in your blood;
• if you have untreated or uncontrolled heart failure (severe water retention in the body, difficulty breathing);
• if you are pregnant more than 3 months (it is also recommended to avoid taking Tertensif Bi-Kombi in early pregnancy - see "Pregnancy and breastfeeding");
• if you have taken or are 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 Bi-Kombi with other medicines").

Warnings and precautions

Before taking Tertensif Bi-Kombi, discuss with your doctor or pharmacist:

• if you have 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 narrowing of the renal artery (narrowing of the blood vessel supplying blood to the kidney);
• if you have heart failure or any other heart disease;
• if you have kidney disease or are undergoing dialysis;
• if you experience 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 can occur within hours or weeks of taking Tertensif Bi-Kombi. Untreated symptoms can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you are at greater risk of developing these disorders.
• if you have muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if you have an excessive level of a hormone called aldosterone in your blood (primary aldosteronism);
• if you have liver disease;
• if you have collagenosis (a skin disease), such as systemic lupus erythematosus or scleroderma;
• if you have atherosclerosis (hardening of the arteries);
• if you have hyperparathyroidism (overactive parathyroid gland);
• if you have gout;
• if you have diabetes;
• if you are on a low-salt diet or using salt substitutes that contain potassium;
• if you are taking lithium or potassium-sparing diuretics (such as spironolactone, triamterene), or potassium supplements - you should avoid taking these medicines while taking Tertensif Bi-Kombi (see "Tertensif Bi-Kombi with other medicines");
• if you are elderly;
• if you have had allergic reactions to light;
• if you have had a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema) - swelling can occur at any time during treatment. If such symptoms occur, treatment should be discontinued and medical attention should be sought immediately;
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, 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 (such as potassium) in your blood. See also the subsection "When not to take Tertensif Bi-Kombi".
• if you are 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 you are undergoing dialysis using high-flux membranes;
• if you are 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 rejection of transplanted organs and to 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
Angioedema (a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, and difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Tertensif Bi-Kombi. This reaction can occur at any time during treatment. If such symptoms occur, Tertensif Bi-Kombi should be discontinued and medical attention should be sought immediately. See also section 4.
You must tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Do not take Tertensif Bi-Kombi if you are pregnant more than 3 months, as it can cause serious harm to your baby (see "Pregnancy and breastfeeding").
When taking Tertensif Bi-Kombi, you should also inform your doctor or healthcare professional:

• if you are to be given anesthesia and/or surgery;
• if you have recently had diarrhea or vomiting, or if you are dehydrated;
• if you are to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if you are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if you are 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 you experience vision loss or pain in one or both eyes while taking Tertensif Bi-Kombi. These may be symptoms of glaucoma or increased pressure in the eye. You should stop taking Tertensif Bi-Kombi and consult your doctor.

Athletes should be aware that Tertensif Bi-Kombi contains the active substance indapamide, which may cause a positive doping test result.

Children and Adolescents

Tertensif Bi-Kombi should not be used in children and adolescents.

Tertensif Bi-Kombi with Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.
Do not take Tertensif Bi-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 (such as triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in your body (such as heparin, a medicine used to thin the blood to prevent blood clots, trimethoprim, and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• estr Mustine (used to treat cancer);
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect your treatment with Tertensif Bi-Kombi. Your doctor may recommend a dose change and/or take other precautions. You should tell your doctor if you are taking any of the following medicines, as special care may be needed:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also subsections "When not to take Tertensif Bi-Kombi" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing diuretics used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• medicines used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take Tertensif Bi-Kombi" and "Warnings and precautions".
• anesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (such as 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 (such as mizolastine, terfenadine, astemizole);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• immunosuppressants used to treat autoimmune diseases or to prevent rejection of transplanted organs (such as 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);
• medicines used to treat heart rhythm disorders (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• cyzapride, difemanil (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used to treat heart diseases);
• 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 stimulating effect (such as senna);
• non-steroidal anti-inflammatory medicines (such as ibuprofen) or high doses of salicylates (such as acetylsalicylic acid (a substance found in many medicines, used as a pain reliever and to reduce fever, as well as to prevent blood clots));
• amphotericin B given by injection (used to treat severe fungal infections);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (such as 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 (such as ephedrine, noradrenaline, or adrenaline).

Tertensif Bi-Kombi with Food and Drink

Tertensif Bi-Kombi should be taken before a meal.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

Normally, your doctor will advise you to stop taking Tertensif Bi-Kombi before you become pregnant or as soon as you know you are pregnant, and will prescribe a different medicine instead of Tertensif Bi-Kombi.
Tertensif Bi-Kombi should not be taken during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it can cause serious harm to your baby.

Breastfeeding

Tertensif Bi-Kombi should not be taken by breastfeeding mothers, and your doctor may choose a different treatment if you intend to breastfeed, especially if your baby is a newborn or was born prematurely.
You should contact your doctor immediately.

Driving and Using Machines

Tertensif Bi-Kombi does not normally affect alertness, but some patients may experience dizziness or weakness related to low blood pressure. In such cases, the ability to drive or operate machinery may be impaired.

Tertensif Bi-Kombi Contains Lactose (a Type of Sugar)

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

Tertensif Bi-Kombi Contains Sodium

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

3. How to Take Tertensif Bi-Kombi

This medicine should always be taken exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet per day. The tablet should be taken preferably in the morning, before a meal. The tablet should be swallowed with a glass of water.

Overdose of Tertensif Bi-Kombi

If you have taken too many tablets, you should 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 severe low blood pressure (with nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine production), lying down with your legs raised may help.

Missed Dose of Tertensif Bi-Kombi

It is important to take your medicine every day, as regular treatment is most effective.
If you miss a dose of Tertensif Bi-Kombi, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

Stopping Treatment with Tertensif Bi-Kombi

Treatment of high blood pressure is usually long-term, so before stopping treatment with this medicine, you should discuss it with your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Tertensif Bi-Kombi can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Tertensif Bi-Kombi and contact your doctor immediately:

• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath; uncommon - may affect up to 1 in 100 people);
• swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing (angioedema, see "Warnings and precautions" in section 2); uncommon - may affect up to 1 in 100 people;
• severe skin reactions, including erythema multiforme (a skin rash that often starts with red, itchy patches on the face, arms, or legs), severe skin rash, hives, redness of the skin, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare - may affect up to 1 in 10,000 people);
• cardiovascular disorders (heart rhythm disorders, angina pectoris, heart attack; very rare - may affect up to 1 in 10,000 people);
• weakness or numbness of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may affect up to 1 in 10,000 people);
• pancreatitis, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• jaundice (yellowing of the skin and eyes), which can be a symptom of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• life-threatening heart rhythm disorders (frequency not known);
• liver disease caused by liver disease (hepatic encephalopathy; frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects are listed below by frequency:

• common (may affect up to 1 in 10 people): 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, feeling of tingling and numbness, vision disturbances, tinnitus (feeling of hearing sounds), cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of tiredness.
• uncommon (may affect up to 1 in 100 people): mood changes, depression, sleep disturbances, hives, purpura (red spots on the skin), blistering, kidney disease, impotence (inability to achieve or maintain an erection), increased sweating, elevated potassium levels in the blood, changes in laboratory test results: transient elevated potassium levels in the blood, low sodium levels in the blood, which can cause dehydration and low blood pressure, drowsiness, fainting, palpitations (feeling of heartbeat), tachycardia (rapid heart rate), hypoglycemia (very low blood sugar levels) 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 affect up to 1 in 1,000 people): 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 production, acute kidney failure. 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 affect up to 1 in 10,000 people): 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 the available data): abnormal heart rhythm detected on an electrocardiogram (ECG), changes in laboratory test results: elevated uric acid levels and elevated blood sugar levels, myopia, blurred vision, vision disturbances, worsening vision, or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), 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), your disease symptoms may worsen.
  There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests). Your doctor may recommend blood tests to monitor your health.
  If you experience any of these symptoms, you should contact your doctor as soon as possible.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 this medicine.

5. How to Store Tertensif Bi-Kombi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP" (the expiry date is the last day of the month shown). The packaging is labeled with the batch number.
Store in the original packaging, tightly closed, to protect from moisture.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Tertensif Bi-Kombi Contains

• The active substances of Tertensif Bi-Kombi are perindopril arginine and indapamide. One film-coated tablet contains 10 mg of perindopril arginine (which corresponds to 6.79 mg of perindopril) and 2.5 mg of indapamide.
• The other ingredients of the tablet are: core - lactose monohydrate, magnesium stearate, maltodextrin, silica colloidal anhydrous, sodium carboxymethylcellulose (type A); coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Tertensif Bi-Kombi Looks Like and Contents of the Pack

Tertensif Bi-Kombi is a white, round, film-coated tablet with a diameter of 8 mm and a radius of curvature of 11 mm. One film-coated tablet contains 10 mg of perindopril arginine and 2.5 mg of indapamide.
Pack sizes: 30, 90, 100 tablets.

Marketing Authorization Holder

ANPHARM Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw

Manufacturer

Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
Servier (Ireland) Industries Ltd
Gorey Road
Arklow – Co. Wicklow
Ireland
ANPHARM Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Belgium
COVERSYL PLUS 10 mg /2,5 mg
Bulgaria
TERTENSIF COMBI 10 mg /2.5 mg
France
Perindopril arginine/Indapamide Servier 10mg/2,5mg film-coated tablet
Hungary
Coverex-AS Komb Forte
Italy
TERAXANS (10/2,5)
Latvia
Perindopril arginine /Indapamide Servier 10 mg/2,5 mg
Luxembourg
COVERSYL PLUS 10 mg /2,5 mg
Poland
TERTENSIF BI-KOMBI
Romania
NORIPLEX 10 mg /2,5 mg
Slovak Republic
PRESTARIUM FORTE COMBI A
Slovenia
TertensifKomb 10 mg/2,5 mg film-coated tablets
To obtain detailed information, you should contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o.
Phone: (22) 594-90-00

Date of Last Revision of the Leaflet: 05/2022