Noliprel

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Noliprel

2.5 mg + 0.625 mg, coated tablets

Perindopril arginine + Indapamide

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Noliprel and what is it used for

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

2. Important information before taking Noliprel

When not to take Noliprel:

• 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 ever had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rash when taking an ACE inhibitor; or if you have had 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 containing aliskiren;

with high blood pressure;

• if you have severe liver disease or a condition called hepatic encephalopathy (a disease that damages the brain);
• if you have severe 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, Noliprel may not be suitable for you.
• if you have low potassium levels in your blood;
• if you have untreated, uncontrolled heart failure (severe water retention in the body, difficulty breathing);
• if you are pregnant over 3 months (it is also recommended to avoid taking Noliprel in early pregnancy - see "Pregnancy");
• 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 "Noliprel and other medicines").

Warnings and precautions

Before taking Noliprel, you should discuss it 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 renal artery stenosis (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 may occur within a few hours or weeks of taking Noliprel. 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 (a disorder of parathyroid function);
• 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 medicines (spironolactone, triamterene), or potassium supplements - you should avoid taking these medicines while taking Noliprel (see "Noliprel and 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, you should stop taking Noliprel and consult your doctor 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 diabetic kidney disease;

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 section "When not to take Noliprel".
• 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, 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, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If such symptoms occur, you should stop taking Noliprel and contact your doctor immediately. See also section 4.
You should tell your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Usually, your doctor will advise you to stop taking Noliprel before becoming pregnant or as soon as you find out you are pregnant, and will prescribe another medicine instead of Noliprel. It is not recommended to take Noliprel in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby (see "Pregnancy and breastfeeding").
When taking Noliprel, you should also inform your doctor or medical staff:

• if you are to be anesthetized and/or undergo 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 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 you experience vision loss or pain in one or both eyes while taking Noliprel. These may be symptoms of glaucoma or increased pressure in one or both eyes. You should stop taking Noliprel and consult your doctor.

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

Children and adolescents

Noliprel should not be used in children and adolescents.

Noliprel and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should avoid taking Noliprel 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 disease;
• 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. Your doctor may recommend changing the dose and/or taking other precautions. You should tell your doctor if you are 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 the sections "When not to take Noliprel" and "Warnings and precautions"), or diuretics (medicines that increase urine excretion);
• 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 rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See the section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the sections "When not to take Noliprel" and "Warnings and precautions".
• anesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, erythromycin given by injection);
• methadone (used to treat addiction);
• procainamide (used to treat heart rhythm disorders);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, astemizole);
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• immunosuppressive medicines used to treat autoimmune diseases or 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 antipyretic, 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 (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 with food and drink

It is recommended to take Noliprel before a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Usually, your doctor will advise you to stop taking Noliprel before becoming pregnant or as soon as you find out you are pregnant, and will prescribe another medicine instead of Noliprel. It is not recommended to take Noliprel in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

Noliprel should not be taken if you are breastfeeding.
You should immediately tell your doctor if you are breastfeeding or plan to breastfeed.
You should contact your doctor immediately.

Driving and using machines

Noliprel usually does not affect the ability to drive and 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 contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

Noliprel contains sodium

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

3. How to take Noliprel

This medicine should always be taken as directed by your doctor or pharmacist.
If you are unsure, you should consult your doctor or pharmacist.
The recommended dose is one tablet per day. Your doctor may decide to increase the dose to 2 tablets per day or modify the dosing regimen if you have kidney problems.
The tablet should be taken preferably in the morning, before a meal. The tablet should be swallowed with a glass of water.
The score line on the tablet is not intended for breaking the tablet.

Taking a higher dose of Noliprel than recommended

If you have taken too many tablets, you should immediately contact your doctor or go to the emergency department of the nearest hospital. The most common symptom of overdose is low blood pressure.
If you experience significantly low blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine excretion), you can help by lying down with your legs raised.

Missing a dose of Noliprel

It is important to take the medicine every day, as regular treatment is most effective.
If you miss a dose of Noliprel, you should take the next dose at the usual time.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Noliprel

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

4. Possible side effects

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

If you experience any of the following serious side effects, you should stop taking Noliprel and contact your doctor immediately:

• severe dizziness or fainting due to low blood pressure (often - 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 section "Warnings and precautions" in section 2); uncommon - may occur in less than 1 in 100 patients;
• severe skin reactions, including erythema multiforme (a skin rash often starting with 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), myocardial infarction; very rare - may occur in less than 1 in 10,000 patients);
• weakness or paralysis of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may occur in less than 1 in 10,000 patients);
• pancreatitis, which 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 you feel unwell or have 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 with a tendency 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 changes, depression, sleep disorders, hives, purpura (red spots on the skin), blistering, liver disease, kidney disease, impotence (inability to achieve or maintain an erection), increased sweating, increased eosinophil count (a type of white blood cell), changes in laboratory test results: high potassium levels in the blood that are temporary and disappear after stopping treatment, low sodium levels in the blood, which can cause dehydration and low blood pressure, drowsiness, fainting, palpitations (feeling of heartbeat), tachycardia (fast heart rate), hypoglycemia (very low blood sugar) 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, increased urea levels in the blood, increased 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, increased liver enzyme activity, high bilirubin levels in serum; fatigue, sudden flushing of the face and neck, decreased or absent urine excretion. 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), kidney disease, changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, high calcium levels in the blood; liver function disorders.
• frequency not known (cannot be estimated from available data): abnormal heart function detectable on an ECG, changes in laboratory test results: high uric acid levels and high blood sugar levels, myopia, blurred vision, vision disorders, eye pain due to high pressure (possible symptoms of 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 symptoms may worsen.
  There may be blood disorders, 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 tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Noliprel

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. The expiry date refers to the last day of the month.
Store the container tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 contains

• The active substances of Noliprel are: perindopril and indapamide. One coated tablet contains 2.5 mg of perindopril arginine (which corresponds to 1.6975 mg of perindopril) and 0.625 mg of indapamide.
• Other ingredients of the tablet core: lactose monohydrate, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethylcellulose (type A); ingredients of the tablet coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Noliprel looks like and contents of the packaging

Noliprel is a white, oval, coated tablet with a score line on both sides. One coated tablet contains 2.5 mg of perindopril arginine and 0.625 mg of indapamide.
The tablets are available in packs of 30.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, the country of export: LT/1/07/0667/004
Parallel import authorization number: 56/20

Translation of day of the week symbols on the immediate packaging:

• P. – Monday
• A. – Tuesday
• T. – Wednesday
• K. – Thursday Pn. – Friday Š. – Saturday
• S. – Sunday

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

Austria
PRETERAX-ARGININ
Belgium
PRETERAX 2,5 mg/0,625 mg
Cyprus
COVERSYL PLUS ARGININE 2.5 mg/0.625 mg
Estonia
NOLIPREL ARGININE
Finland
PRETERAX NOVUM
France
PRETERAX 2,5mg/0,625mg
Germany
PRETERAX N 2,5 mg/ 0,625 mg Filmtabletten
Greece
PRETERAX 2,5 mg/0,625 mg
Ireland
COVERSYL ARGININE PLUS 2.5mg/0.625mg
Italy
PRETERAX 2,5 mg/0,625 mg
Latvia
NOLIPREL ARGININE 2.5mg/0.625mg apvalkotās tabletes
Lithuania
NOLIPREL 2,5 mg/0,625 mg tabletès
Luxembourg
PRETERAX 2,5 mg/0,625 mg
Malta
PRETERAX ARGININE 2.5mg/0.625mg
Poland
NOLIPREL
Portugal
PRETERAX 2,5 mg/0,625 mg
Romania
NOLIPREL ARG 2,5 mg/ 0,625 mg
Slovak Republic
NOLIPREL A
Slovenia
BIONOLIPREL 2.5mg/0.625mg filmsko obložene tablete

Date of approval of the leaflet: 30.12.2024

[Information about the trademark]