Noliprel Bi-forte

Leaflet accompanying the packaging: patient information

Noliprel Bi-Forte, 10 mg + 2.5 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Noliprel Bi-Forte and what is it used for

Noliprel Bi-Forte is a combination medicine that contains two active substances: perindopril and indapamide. It is an antihypertensive medicine used to treat high blood pressure (hypertension). Noliprel Bi-Forte is prescribed to patients who are already taking 10 mg of perindopril and 2,5 mg of indapamide in separate tablets, these patients can receive one tablet of Noliprel Bi-Forte 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 excreted by the kidneys. Indapamide differs from other diuretics in that it only slightly increases the amount of urine excreted.
Both active substances lower blood pressure and work together to normalize the patient's blood pressure.

2. Important information before taking Noliprel Bi-Forte

When not to take Noliprel Bi-Forte:

• if the patient is allergic to perindopril or other ACE inhibitors, to indapamide or other sulfonamides, or to any of the other components of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rash while taking an ACE inhibitor, 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 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, Noliprel Bi-Forte 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 after the third month (it is also recommended to avoid taking Noliprel Bi-Forte 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 "Noliprel Bi-Forte and other medicines").

Warnings and precautions

Before starting to take Noliprel Bi-Forte, the patient should discuss it with their doctor or pharmacist:

• if the patient has a narrowing of the aortic valve (narrowing of the main blood vessel that carries blood from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle), or narrowing of the renal artery (narrowing of the blood vessel that supplies blood to 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 disturbances 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 Noliprel Bi-Forte. Untreated symptoms can 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 abnormally high 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 (overactive parathyroid gland);
• if the patient has gout;
• if the patient has diabetes;
• if the patient is on a low-salt diet or uses salt substitutes that contain potassium;
• if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), or potassium supplements - it is recommended to avoid taking these medicines while taking Noliprel Bi-Forte (see "Noliprel Bi-Forte and other medicines");
• if the patient is elderly;
• if the patient has had allergic reactions to light;
• if the patient has 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, the patient should stop taking the medicine and consult a doctor immediately;
• if the patient is 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 the patient has kidney problems related to diabetes;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Noliprel Bi-Forte".
• 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 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
Patient's taking ACE inhibitors, including Noliprel Bi-Forte, have reported angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Noliprel Bi-Forte and consult a doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Noliprel Bi-Forte in early pregnancy and it should not be taken after the third month of pregnancy, as it may cause serious harm to the fetus (see "Pregnancy and breastfeeding").
When taking Noliprel Bi-Forte, the patient should also inform their doctor or medical staff:

• if the patient is to be anesthetized and/or undergo surgery;
• if the patient has recently had diarrhea or vomiting, or has been dehydrated;
• if dialysis or LDL apheresis (removal of cholesterol from the blood using a special device) is to be performed;
• if desensitization treatment is to be performed to reduce allergic reactions to bee or wasp stings;
• if a test requiring the administration of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray) is to be performed;
• if vision disturbances or eye pain occur during treatment with Noliprel Bi-Forte. These may be symptoms of glaucoma or increased pressure in the eye. The patient should stop taking Noliprel Bi-Forte and consult a doctor.

Athletes should be aware that Noliprel Bi-Forte contains an active substance (indapamide) that may cause a positive result in a doping test.

Children and adolescents

Noliprel Bi-Forte should not be used in children and adolescents.

Noliprel Bi-Forte and other medicines

The patient should inform 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 Noliprel Bi-Forte 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 blood clots, trimethoprim, and cotrimoxazole, 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.

Taking other medicines may affect treatment with Noliprel Bi-Forte. The doctor may recommend a dose change and/or take other precautions. The patient should inform 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 (AIIRA) or aliskiren (see also subsections "When not to take Noliprel Bi-Forte" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine excreted 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 commonly 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 the "Warnings and precautions" section.
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take Noliprel Bi-Forte" and "Warnings and precautions".
• anesthetics;
• contrast agents containing iodine;
• 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 after organ transplantation to prevent rejection (e.g., cyclosporine, tacrolimus);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold salts given by injection (used to treat rheumatoid arthritis);
• vincamine (used to treat cognitive disorders in the elderly, including memory loss);
• bepridil (used to treat angina pectoris);
• 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 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 (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 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 (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).

Noliprel Bi-Forte with food and drink

Noliprel Bi-Forte 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 child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Usually, the doctor will recommend stopping Noliprel Bi-Forte before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend another medicine instead of Noliprel Bi-Forte.
Noliprel Bi-Forte should not be taken in early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to the fetus.

Breastfeeding

Noliprel Bi-Forte should not be taken by breastfeeding mothers, and the doctor may choose another treatment for the patient if they intend to breastfeed, especially if the baby is a newborn or was born prematurely.
The patient should consult their doctor immediately.

Driving and using machines

Noliprel Bi-Forte does not normally affect alertness, however, some patients may experience dizziness or weakness related to low blood pressure. In such cases, the ability to drive or operate machines may be impaired.

Noliprel Bi-Forte contains lactose (a type of sugar)

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

Noliprel Bi-Forte contains sodium

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

3. How to take Noliprel Bi-Forte

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

Overdose of Noliprel Bi-Forte

In case of overdose, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital. The most common symptom of overdose is low blood pressure. If severe low blood pressure occurs (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine output), the patient may be helped by lying down with their legs raised.

Missed dose of Noliprel Bi-Forte

It is important to take the medicine every day, as regular treatment is most effective.
If a dose of Noliprel Bi-Forte is missed, the next dose should be taken at the usual time.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Noliprel Bi-Forte

Treatment of high blood pressure is usually long-term, so before stopping treatment with this medicine, the patient should discuss it with their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking the medicine 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 constriction 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 the subsection "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 that often starts with the appearance of red, itchy patches on the face, arms, or legs) or 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 occur in less than 1 in 10,000 patients);
• cardiovascular disorders (heart rhythm disorders, angina pectoris (chest pain radiating to the jaw and back, caused by physical exertion), heart attack; 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 can 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);
• liver 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, 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 fatigue.
• uncommon (may occur in less than 1 in 100 patients): mood swings, depression, sleep disorders, 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 after discontinuation of treatment, low sodium levels in the blood, which may cause dehydration and low blood pressure, drowsiness, fainting, palpitations (feeling of heartbeat), tachycardia (fast heart rate), hypoglycemia (very low blood sugar levels) in patients with diabetes, vasculitis (inflammation of blood vessels), dryness of the mucous membranes of the mouth, hypersensitivity to light, joint pain, muscle pain, chest pain, 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 flushing 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 the available data): abnormal heart function detectable on an electrocardiogram, 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 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 disorders, 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 such symptoms occur, the patient should consult their doctor as soon as possible.

  Reporting side effects

  If side effects occur, including those not listed in this leaflet, the patient should inform 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
  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 gather more information on the safety of the medicine.

  5. How to store Noliprel Bi-Forte

  The medicine should be stored out of sight and reach of children.
  The medicine should not be taken after the expiration date stated on the packaging after the abbreviation "EXP" (abbreviation used to describe the expiration date). The expiration date refers to the last day of the specified month. The word "Lot" on the packaging means the batch number of the medicine.
  The medicine should be stored in its original packaging, tightly closed, to protect it from moisture.
  There are no special storage instructions for the medicine.
  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 Noliprel Bi-Forte contains

  • The active substances of Noliprel Bi-Forte 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, colloidal silica anhydrous, sodium carboxymethylcellulose (type A); coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

  What Noliprel Bi-Forte looks like and contents of the pack

  Noliprel Bi-Forte 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, 60, 90, 100 tablets.

  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 Przedsiębiorstwo Farmaceutyczne S.A.
  ul. Annopol 6B
  03-236 Warsaw

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

  Belgium
  PRETERAX 10 mg /2,5 mg
  Bulgaria
  NOLIPREL Bi-FORTE
  Cyprus
  Preterax 10 mg/ 2,5 mg
  Czech Republic
  Prestarium Neo Combi 10 mg/2,5 mg
  Estonia
  NOLITERAX 10mg/2.5mg
  Finland
  COVERSYL COMP NOVUM 10 mg /2,5 mg
  France
  BIPRETERAX 10mg/2,5mg comprimé pelliculé
  Greece
  Preterax 10 mg/2,5 mg
  Ireland
  COVERSYL ARGININE PLUS 10/2.5 mg
  Italy
  NOLITERAX 10/2,5
  Latvia
  NOLITERAX 10mg/2.5mg apvalkotās tablets
  Lithuania
  NOLITERAX 10mg/2,5mg plėvele dengtos tabletės
  Luxembourg
  PRETERAX 10 mg /2,5 mg
  Malta
  COVERSYL PLUS 10 mg/2,5 mg
  Netherlands
  COVERSYL PLUS arg 10 mg /2,5 mg
  Poland
  NOLIPREL Bi-FORTE
  Portugal
  PRETERAX
  Romania
  NOLITERAX 10 mg /2,5 mg
  Slovakia
  NOLIPREL Bi-FORTE A
  Slovenia
  BIONOLIPREL 10mg/2,5mg filmsko obložene tablete
  To obtain detailed information, the patient should contact the representative of the marketing authorization holder:
  Servier Polska Sp. z o.o.
  Phone number: (22) 594-90-00

  Date of last revision of the leaflet: 05/2022