Noliprel Forte

Leaflet accompanying the packaging: patient information

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

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

Noliprel Forte 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 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 Forte

When not to take Noliprel Forte:

• if the patient is allergic to perindopril or other ACE inhibitors, indapamide or other sulfonamides, or 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, Noliprel Forte may not be suitable for the patient.
• if the patient has low potassium levels in the blood;
• if the patient has untreated, uncontrolled heart failure (severe water retention, breathing difficulties);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Noliprel Forte 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, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Noliprel Forte and other medicines").

Warnings and precautions

Before starting to take Noliprel 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 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 Noliprel 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 (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 (spironolactone, triamterene), or potassium supplements - they should avoid taking these medicines while taking Noliprel Forte (see "Noliprel 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 facial, lip, mouth, tongue, or throat swelling, 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 Noliprel Forte and consult their 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 - 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 (e.g., potassium) in the blood.

See also the subsection "When not to take Noliprel 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 increases 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, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema

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

The patient should tell their doctor about pregnancy, suspected pregnancy, or planning pregnancy. It is not recommended to take Noliprel Forte during early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus (see "Pregnancy and breastfeeding").

When taking Noliprel Forte, the patient should also inform their doctor or medical staff:

• if they are to be anesthetized and/or undergo surgery;
• if they have recently had diarrhea or vomiting, or are dehydrated;
• if they are to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if they are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if they are to undergo a test that requires 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);
• if they experience vision loss or eye pain while taking Noliprel Forte. These may be symptoms of glaucoma or increased pressure in one or both eyes. The patient should stop taking Noliprel Forte and consult their doctor.

Athletes should be aware that Noliprel Forte contains the active substance indapamide, which may cause a positive doping test result.

Children and adolescents

Noliprel Forte should not be used in children and adolescents.

Noliprel Forte and 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 Noliprel 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 clot formation, 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 the treatment with Noliprel Forte. The doctor may recommend changing the dose and/or taking other precautions. The patient should tell their doctor about taking any of the following medicines, as special caution 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 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 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 "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take Noliprel Forte" and "Warnings and precautions";
• anesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, erythromycin 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 injected (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 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 antipyretic, as well as to prevent blood clot formation);
• amphotericin B injected (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 Forte with food and drink

Noliprel 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

The patient should inform their doctor about pregnancy, suspected pregnancy, or planning pregnancy. The doctor will usually recommend stopping Noliprel Forte before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend a different medicine instead of Noliprel Forte. It is not recommended to take Noliprel Forte during early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus.

Breastfeeding

Noliprel Forte should not be taken if the patient is breastfeeding.

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

The patient should contact their doctor immediately.

Driving and using machines

Noliprel Forte 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.

Noliprel Forte contains lactose monohydrate

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

Noliprel Forte contains sodium

Noliprel 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 Forte

This medicine should always be taken as directed 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 Noliprel Forte

In case of overdose, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. The most common symptom of overdose is low blood pressure.

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

Missing a dose of Noliprel Forte

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

If a dose of Noliprel Forte is missed, the next dose should be taken at the usual time.

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

Stopping treatment with Noliprel Forte

Treatment of high blood pressure is long-term, so before stopping treatment with this medicine, the patient should consult 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 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 this medicine and contact 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 "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 the appearance of red, itchy patches on the face, arms, or legs) or severe skin rash, urticaria, 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, heart attack; very rare - may occur in less than 1 in 10,000 patients);
• weakness or numbness 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);
• 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 temperature, 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 disorders, 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, feeling of fatigue.
• uncommon (may occur in less than 1 in 100 patients): mood swings, depression, sleep disorders, urticaria, 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, which may be temporary 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 levels) in patients with diabetes, vasculitis (inflammation of blood vessels), dryness of the mucous membranes of the mouth, hypersensitivity reactions 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): worsening 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, 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 occur in less than 1 in 10,000 patients): disorientation, eosinophilic pneumonia (a rare type of pneumonia), inflammation of the nasal mucous membranes (nasal congestion or runny nose), severe kidney disease, changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, elevated calcium levels in the blood, liver function disorders.
• frequency not known (cannot be estimated from available data): abnormal heart function detected in an ECG, changes in laboratory test results: elevated uric acid levels and elevated blood sugar levels, myopia, blurred vision, vision disorders, worsening of 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 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 such symptoms occur, the patient should contact 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

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 Forte

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" (abbreviation used to describe the expiry date). The expiry date refers to the last day of the specified month.

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 Noliprel Forte contains

• The active substances of Noliprel Forte are perindopril and indapamide. One film-coated tablet contains 5 mg of perindopril arginine (which corresponds 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 Noliprel Forte looks like and contents of the pack

Noliprel Forte 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, 60, and 90.

Marketing authorization holder:

ANPHARM Pharmaceutical Company S.A.

ul. Annopol 6 B

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

EGIS Pharmaceuticals Private Limited Company

Mátyás király u. 65

9900 Körmend - Hungary

ANPHARM Pharmaceutical Company S.A.

ul. Annopol 6 B

03-236 Warsaw

To obtain detailed information, the patient should contact the representative of the marketing authorization holder:

Servier Polska Sp. z o.o.

Phone: (22) 594-90-00

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

Belgium

COVERSYL PLUS 5 mg/1.25 mg

Czech Republic

Prestarium Neo Combi 5 mg/1.25 mg

France

PRETERVAL 5 mg/1.25 mg

Hungary

Coverex-AS Komb

Italy

PRELECTAL 5 mg/1.25 mg

Latvia

PRESTARIUM COMBI ARGININE 5 mg/1.25 mg film-coated tablets

Luxembourg

COVERSYL PLUS 5 mg/1.25 mg

Malta

Coversyl Plus 5 mg/1.25 mg

Poland

NOLIPREL FORTE

Romania

PREXAREL 5 mg/1.25 mg

Slovakia

Prestarium combi A

Slovenia

BIOPREXANIL COMBI 5 mg/1.25 mg film-coated tablets

Date of last revision of the leaflet: 05/2022