Noliprel

Leaflet accompanying the packaging: patient information

Noliprel, 2.5 mg + 0.625 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please 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 pack 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 a 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;
• 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 using a method other than hemofiltration or ultrafiltration. 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 or uncontrolled heart failure (severe fluid retention, difficulty breathing);
• if you are pregnant more than 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, discuss with your doctor or pharmacist:

• if you have 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 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 more likely to experience these disorders.
• if you have muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if you have an abnormally high 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 containing 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 seek medical attention immediately;
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in your blood.

See also the subsection "When not to take Noliprel".

• if you are black - in this case, there may be a higher 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 seek medical attention immediately. See also section 4.
You should tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Noliprel is not recommended during early pregnancy and must 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 are dehydrated;
• if you are to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if you are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings;
• if you are to undergo a test that requires the use of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray);
• if you experience vision loss or pain in one or both eyes while taking Noliprel. These may be symptoms of glaucoma or increased pressure in the eye. You should stop taking Noliprel and seek medical attention.

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

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 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 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);
• estrustine (used to treat cancer);
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect your treatment with Noliprel. Your doctor may recommend a change in dose and/or take 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 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 rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take 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 to prevent rejection of transplanted organs (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);
• vinkamine (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 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

Noliprel should be taken before a meal.

Pregnancy and breastfeeding

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

Pregnancy

You should tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will normally advise you to stop taking Noliprel before you become pregnant or as soon as you find out you are pregnant, and will prescribe a different medicine instead of Noliprel. Noliprel is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

Noliprel is not recommended if you are breastfeeding.
You should tell your doctor immediately 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 or use machines, however, some patients may experience dizziness or fatigue associated with low blood pressure.
In such cases, the ability to drive or use machines may be impaired.

Noliprel contains lactose monohydrate

If you have been told that you have an intolerance to some sugars, 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 essentially "sodium-free".

3. How to take Noliprel

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If you are unsure, ask your doctor or pharmacist.
The recommended dose is one tablet once a day. Your doctor may decide to increase the dose to 2 tablets a 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 to break the tablet.

Taking a higher dose of Noliprel than recommended

If you have taken too many tablets, contact your doctor or go to the emergency department of your nearest hospital immediately. The most common symptom of overdose is low blood pressure.
If you experience severe low blood pressure (with nausea, vomiting, cramps, dizziness, drowsiness, disorientation, and changes in urine excretion), placing yourself in a reclined position with your legs elevated may help.

Missing a dose of Noliprel

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

Stopping treatment with Noliprel

Treatment of high blood pressure is long-term, so before stopping treatment with this medicine, contact your doctor.
If you have any further questions about taking this medicine, ask 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, stop taking Noliprel and contact your doctor immediately:

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

Side effects, grouped by frequency of occurrence, may include:

• common (may affect up to 1 in 10 people): low potassium levels in the blood, skin reactions in patients prone to allergic and asthmatic reactions, headache, dizziness of central origin, dizziness of labyrinthine origin, tingling, visual disturbances, 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, fatigue.
• uncommon (may affect up to 1 in 100 people): mood changes, 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: elevated 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) in diabetic patients, vasculitis (inflammation of blood vessels), dryness of the mucous membranes of the mouth, hypersensitivity reactions to light, joint pain, muscle pain, chest pain, poor general condition, peripheral edema, fever, elevated urea levels in the blood, elevated creatinine levels in the blood, falls.
• rare (may affect up to 1 in 1,000 people): exacerbation of psoriasis, changes in laboratory test results: low chloride levels in the blood, low magnesium levels in the blood, elevated liver enzyme activity, elevated bilirubin levels in serum; fatigue, sudden flushing of the face and neck, decreased or absent urine excretion, acute kidney failure. Dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).
• very rare (may affect up to 1 in 10,000 people): disorientation, eosinophilic pneumonia (a rare type of pneumonia); 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, decreased red blood cell count, 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 on an electrocardiogram, changes in laboratory test results: elevated uric acid levels and elevated blood sugar levels, myopia, blurred vision, visual disturbances, worsening vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you have systemic lupus erythematosus (a type of collagenosis), your symptoms may worsen.

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests). Your doctor may recommend blood tests to monitor your health.
If you experience any of these symptoms, you should contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
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 to gather more information on the safety of this medicine.

5. How to store Noliprel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP" (the expiry date stated on the packaging). The expiry date refers to the last day of the month stated.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Noliprel contains

• The active substances of Noliprel are perindopril and indapamide. One film-coated tablet contains 2.5 mg of perindopril arginine (equivalent 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 film coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

What Noliprel looks like and contents of the pack

Noliprel is a white, elongated 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.
Tablets are available in packs of 30, 60, and 90.

Marketing authorization holder:

Servier Laboratories
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer:

Servier Industrial Laboratories
905 route de Saran
45520 Gidy
France
Servier Ireland Industries Ltd
Gorey Road
Arklow – Co. Wicklow
Ireland
ANPHARM Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw
To obtain detailed information, contact the representative of the marketing authorization holder:
Servier Poland Ltd.
Phone: (22) 594-90-00

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 film-coated tablets
Lithuania
NOLIPREL 2,5 mg/0,625 mg tablets
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
Slovak Republic
NOLIPREL A
Slovenia
BIONOLIPREL 2.5mg/0.625mg film-coated tablets

Date of last revision of the leaflet: 05/2022