Noliprel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Noliprel
2.5 mg + 0.625 mg, film-coated tablets
Perindoprilum argininum + Indapamidum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Noliprel is a combination medicine containing two active substances: perindopril and indapamide.
It is an antihypertensive medicine used in the treatment of high blood pressure (hypertension) in adults.
Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). These medicines work by relaxing blood vessels, which helps the heart pump blood more easily.
Indapamide is a diuretic medicine. Diuretics increase the amount of urine produced by the kidneys. Indapamide differs from other diuretics in that it only slightly increases urine output.
Both active substances lower blood pressure and work together to help normalize the patient's blood pressure.

2. Important information before using Noliprel

When not to use 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 previously experienced symptoms during treatment with an ACE inhibitor such as wheezing, facial or tongue swelling, severe itching, or intense skin rash, or if such symptoms occurred in the patient or a blood relative under any other circumstances (a condition called angioedema);
• if the patient has diabetes or kidney function disorders 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 damaging the brain);
• if the patient has severe kidney disease causing reduced blood supply to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the equipment 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, breathing difficulties);
• if the patient is more than 3 months pregnant (it is also advisable to avoid using Noliprel in early pregnancy - see "Pregnancy");
• if the patient has taken or is currently taking a medicine containing sacubitril and valsartan, used in the treatment of heart failure, because the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Noliprel with other medicines").

Warnings and precautions
Before starting treatment with Noliprel, discuss this with your doctor or pharmacist:

• if the patient has aortic valve stenosis (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a heart muscle disease), 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 diseases or is undergoing dialysis;
• if the patient experiences worsening vision or eye pain. These may be symptoms of fluid accumulation in the choroid layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks after taking Noliprel. Untreated symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, the risk of these disorders is higher;
• if the patient has muscle disorders, including pain, tenderness, weakness, or muscle cramps;
• if the patient has abnormally increased levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• if the patient has liver diseases;
• 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 gland 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 – these medicines should be avoided while taking Noliprel (see "Noliprel with other medicines");
• if the patient is elderly;
• if the patient has previously experienced photosensitivity reactions;
• if the patient develops a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, causing difficulty in swallowing or breathing (angioedema) – swelling may occur at any time during treatment. If such symptoms occur, treatment must be stopped immediately and medical advice sought without delay;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders related to diabetes;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use Noliprel".
• if the patient is of Black race – in such cases, 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 the patient is undergoing dialysis with high-flux membranes;
• if the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs called mTOR inhibitors (used to prevent rejection of transplanted organs and in cancer treatment);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used in the treatment of chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of drugs called gliptins (used in the treatment of diabetes).

Angioedema
In patients treated with ACE inhibitors, including Noliprel, cases of angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty in swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, the patient must stop taking Noliprel immediately and contact a doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Use of Noliprel is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child (see "Pregnancy and breastfeeding").

When taking Noliprel, you should also inform your doctor or medical staff:

• if the patient is to undergo anaesthesia and/or surgery;
• if the patient has recently experienced diarrhoea or vomiting, or is dehydrated;
• if dialysis or LDL apheresis (removal of cholesterol from the blood using a special device) is planned;
• if desensitisation treatment to reduce allergic reactions to bee or wasp stings is planned;
• if a diagnostic test requiring iodine-containing contrast agents (substances allowing visualisation of organs such as the kidney or stomach in X-ray examinations) is to be performed;
• if visual disturbances or pain in one or both eyes occur during treatment with Noliprel. These may be symptoms of glaucoma or increased pressure in one or both eyes. Treatment with Noliprel should be stopped and medical advice sought.

Athletes should be aware that Noliprel contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children and adolescents
Noliprel must not be used in children and adolescents.
Noliprel with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Avoid using 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 function disorders;
• 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 co-trimoxazole, 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: angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with Noliprel. The doctor may recommend a dose adjustment and/or additional precautions. Inform 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 (AIIRAs) or aliskiren (see also sections "When not to use Noliprel" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs called mTOR inhibitors). See section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use Noliprel" and "Warnings and precautions".
• anaesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, erythromycin administered 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 organ rejection after transplantation (e.g. cyclosporine, tacrolimus);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold salts administered by injection (used to treat rheumatoid arthritis);
• vincamine (used to treat symptomatic cognitive disorders in elderly patients, 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, difenamil (used to treat gastrointestinal disorders);
• digoxin or other cardiac glycosides (used in heart diseases);
• baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• stimulant laxatives (e.g. sena);
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance contained in many medicines used for pain relief, fever reduction, and prevention of blood clots));
• intravenous amphotericin B (used to treat severe fungal infections);
• medicines used to treat psychiatric 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);
• vasodilating medicines, 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 meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Usually, the doctor will recommend stopping Noliprel before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Noliprel is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child.
Breastfeeding
Noliprel is not recommended during breastfeeding.
Inform your doctor immediately if you are breastfeeding or plan to breastfeed. Contact your doctor without delay.
Driving and using machines
Noliprel usually does not affect the ability to drive or operate machinery. However, some patients may experience dizziness or fatigue related to low blood pressure.
In such cases, the ability to drive or operate machinery may be impaired.
Noliprel contains lactose monohydrate
If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Noliprel contains sodium
Noliprel contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Noliprel

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose is one tablet once daily. Your doctor may decide to increase the dose to
2 tablets daily or adjust the dosage if you have impaired kidney function.
The tablet should preferably be taken in the morning, before a meal. Swallow the tablet with a glass of water.
The break line on the tablet is not intended for dividing the tablet.

Taking more Noliprel than recommended
If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department.
The most common symptom of overdose is low blood pressure.
If significantly low blood pressure occurs (accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, or changes in urine output), lying down with your legs raised may help.

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

Stopping Noliprel treatment
Treatment of high blood pressure is long-term; therefore, you should consult your doctor before stopping this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following adverse reactions, which may be
serious, treatment with this medicine must be discontinued and medical advice should be sought immediately:

• severe dizziness or fainting due to low blood pressure (common – may occur in less than 1 in 10 patients);
• bronchospasm (feeling of tightness 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 section “Warnings and precautions” in section 2); uncommon – may occur in less than 1 in 100 patients;
• severe skin reactions, including erythema multiforme (skin rash often starting with red, itchy spots on the face, arms or legs), or severe skin rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (very rare – may occur in less than 1 in 10,000 patients);
• cardiovascular disorders (heart rhythm disturbances, 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 of the arms or legs, or speech disturbances, which may be signs of stroke (very rare – may occur in less than 1 in 10,000 patients);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe malaise (very rare – may occur in less than 1 in 10,000 patients);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disturbances (frequency unknown);
• brain disease caused by liver disease (hepatic encephalopathy; frequency unknown);
• muscle weakness, cramps, tenderness or pain, particularly if the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

Adverse reactions, grouped by decreasing frequency of occurrence, may include:

• Common (may occur in less than 1 in 10 patients): low blood potassium levels, skin reactions in patients with a tendency to allergic or asthmatic reactions, headache, central dizziness, labyrinthine dizziness, prickling and tingling sensations, visual disturbances, tinnitus (perception of ringing or other sounds in the ears), cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disturbances, diarrhoea, 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 disturbances, urticaria, purpura (small red spots on the skin), clusters of blisters, kidney disorders, impotence (inability to achieve or maintain an erection), excessive sweating, increased eosinophil count (a type of white blood cell), changes in laboratory test results: high blood potassium levels, which may resolve after stopping treatment, low blood sodium levels, which may lead to dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (fast heart rate), hypoglycaemia (very low blood sugar levels) in patients with diabetes, vasculitis (inflammation of blood vessels), dryness of the oral mucosa, photosensitivity reactions (increased skin sensitivity to sunlight), joint pain, muscle pain, chest pain, malaise, peripheral oedema, fever, increased blood urea levels, increased blood creatinine levels, falls.
• Rare (may occur in less than 1 in 1,000 patients): worsening of psoriasis, changes in laboratory test results: low blood chloride levels, low blood magnesium levels, increased liver enzyme activity, high serum bilirubin levels; fatigue, sudden flushing of the face and neck, reduced or absent urine output, acute kidney failure. Dark-coloured urine, nausea or vomiting, muscle cramps, confusion and seizures may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
• Very rare (may occur in less than 1 in 10,000 patients): disorientation, eosinophilic pneumonia (a rare type of lung inflammation); inflammation of the nasal mucosa (nasal congestion or rhinitis), severe kidney diseases, blood test abnormalities such as reduced white blood cell and red blood cell counts, reduced haemoglobin levels, reduced platelet count, high blood calcium levels; liver function disorders.
• Frequency not known (cannot be estimated from available data): abnormal heart function detected on ECG, changes in laboratory test results: high blood uric acid levels and high blood glucose levels, myopia, blurred vision, visual disturbances, worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma), cyanosis, numbness and pain in fingers or toes (Raynaud's phenomenon). If the patient has systemic lupus erythematosus (a type of collagenosis), symptoms of the disease may worsen.
  Blood, kidney, liver or pancreas disorders may occur, as well as changes in laboratory test results (blood tests). The doctor may recommend blood tests to monitor the patient's health.
  If any of these symptoms occur, medical advice should be sought as soon as possible.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Noliprel

Keep the medicine 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 stated month.
Store the container tightly closed to protect from moisture.
Medicines must 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 are: perindopril and indapamide. One coated tablet contains 2.5 mg of perindopril with arginine (equivalent to 1.6975 mg of perindopril) and 0.625 mg of indapamide.
• Other components of the tablet core: monohydrate lactose, magnesium stearate, maltodextrin, colloidal anhydrous silica, sodium carboxymethyl starch (type A); components of the 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 coated tablet with an embossed line on both sides. One coated tablet contains 2.5 mg of perindopril with arginine and 0.625 mg of indapamide.
Tablets are available in packs containing 30 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in Lithuania, country of export:
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France
Manufacturer:
ANPHARM Przedsiębiorstwo Farmaceutyczne 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:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in Lithuania, country of export: LT/1/07/0667/004
Parallel import licence number: 56/20
Translation of weekday symbols on the immediate packaging:
P. – Monday
A. – Tuesday
T. – Wednesday
K. – Thursday
Pn. – Friday
Š. – Saturday
S. – Sunday
This medicinal product is authorised for marketing 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 tabletės
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
Slovakia NOLIPREL A
Slovenia BIONOLIPREL 2.5mg/0.625mg filmsko obložene tablete