Noliprel

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Noliprel

2.5 mg + 0.625 mg, film-coated tablets
Perindopril arginine + Indapamide

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

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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.
This is an antihypertensive medicine used to treat high blood pressure (hypertension) 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 the patient is 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 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 using a method other than hemodialysis. Depending on the device used, Noliprel 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 fluid retention in the body, difficulty breathing);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Noliprel 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 and other medicines").

Warnings and precautions

Before starting to take Noliprel, 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 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 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 may 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 - the patient should avoid taking these medicines while taking Noliprel (see "Noliprel and other medicines");
• if the patient is elderly;
• if the patient has had allergic reactions to light;
• if the patient experiences 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 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 - for example, valsartan, telmisartan, irbesartan, especially if the patient has diabetic nephropathy;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the subsection "When not to take Noliprel".
• 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 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
Patients treated with ACE inhibitors, including Noliprel, have reported angioedema (severe allergic reaction with facial, lip, tongue, or throat swelling 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 and contact their doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Noliprel before becoming pregnant or as soon as the patient finds out they are pregnant, and recommend another medicine instead of Noliprel. It is not recommended to take Noliprel in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may cause serious harm to the baby (see "Pregnancy and breastfeeding").
When taking Noliprel, the patient should also inform their doctor or medical staff:

• if the patient is to undergo anesthesia and/or surgery;
• if the patient has recently experienced diarrhea or vomiting, or is dehydrated;
• if the patient is to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if the patient is 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 the patient experiences vision loss or eye pain while taking Noliprel. These may be symptoms of glaucoma or increased pressure in the eye. The patient should stop taking Noliprel and consult their doctor.

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

Children and adolescents

Noliprel should not be taken by children and adolescents.

Noliprel 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 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 clotting);

Other medicines may affect the treatment with Noliprel. The doctor may recommend changing the dose and/or taking 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 ACE inhibitors and angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also subsections "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 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" 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);
• 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 (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 anti-inflammatory, as well as to prevent blood clotting);
• 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

Noliprel 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 baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Noliprel before becoming pregnant or as soon as the patient finds out they are pregnant, and recommend another medicine instead of Noliprel. It is not recommended to take Noliprel in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

Noliprel should not be taken if the patient is breastfeeding.
The patient should immediately inform their doctor if they are breastfeeding or plan to breastfeed.
The patient should contact their doctor immediately.

Driving and using machines

Noliprel usually does not affect the ability to drive or use machines, however, some patients may experience dizziness or drowsiness related to low blood pressure.
In such cases, the ability to drive or use machines may be impaired.

Noliprel contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their 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 the doctor or pharmacist.
If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose is one tablet per day. The doctor may decide to increase the dose to 2 tablets per day or modify the dosing regimen in case of 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 the patient has taken too many tablets, they 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 significantly low blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine excretion), they may be helped by lying down with their legs raised.

Missing a dose of Noliprel

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

Stopping Noliprel treatment

Treatment of high blood pressure is long-term, so before stopping Noliprel, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following side effects, which may be serious, they should stop taking Noliprel 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 constriction in the chest, wheezing, and shortness of breath; uncommon - may occur in less than 1 in 100 patients);
• facial, lip, mouth, tongue, or throat swelling, difficulty breathing (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, severe 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, myocardial infarction; 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 radiating to the back and severe malaise (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 hepatitis (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• brain 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): skin reactions in patients prone to allergic and asthmatic reactions, headache, dizziness of central origin, dizziness of labyrinthine origin, tingling, visual 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, fatigue.
• uncommon (may occur in less than 1 in 100 patients): mood changes, sleep disorders, urticaria, purpura (red spots on the skin), blistering, liver disease, impotence, increased sweating, increased eosinophil count (a type of white blood cell), changes in laboratory test results: high potassium levels in the blood that are reversible after stopping treatment, low sodium levels in the blood, 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, hypersensitivity 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: increased liver enzyme activity, high bilirubin levels in the blood; fatigue.
• 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 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: low potassium levels, high uric acid levels, and high blood sugar levels, myopia, blurred vision, visual disturbances, 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, 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.
After taking ACE inhibitors, there may be a concentration of urine (dark urine color), nausea, vomiting, muscle cramps, disorientation, and seizures, which may be caused by inappropriate secretion of antidiuretic hormone. 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 any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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
Reporting side effects helps to 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.
The medicine should not be taken after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
The container should be kept tightly closed to protect it from moisture.
Medicines should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. 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 film-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, silicon dioxide, 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 pack

Noliprel is a white, oval, film-coated tablet with a score line on both sides. One film-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, the patient 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.
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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian marketing authorization number, in the country of export: LT/1/07/0667/004

Parallel import authorization number: 88/17

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 medicinal product 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

Poland

NOLIPREL

Portugal

PRETERAX 2,5 mg/0,625 mg

Romania

NOLIPREL ARG 2,5 mg/ 0,625 mg

Slovakia

NOLIPREL A

Slovenia

BIONOLIPREL 2.5mg/0.625mg filmsko obložene tablete

Date of leaflet approval: 01.03.2022
[Information about the trademark]