Noliprel forte

Package leaflet: Information for the patient

Noliprel Forte, 5 mg + 1.25 mg, film-coated tablets
Perindoprilum argininum + Indapamidum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

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

2. Important information before using Noliprel Forte

When not to use Noliprel Forte:

• 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 such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes while taking an ACE inhibitor, or if such symptoms occurred in the patient or a blood relative under any circumstances (a condition known as 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 brain disorder caused by liver damage);
• if the patient has severe kidney disease causing reduced blood flow to the kidneys (renal artery stenosis);
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Noliprel Forte may not be suitable;
• if the patient has low levels of potassium 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 Forte in early pregnancy – see "Pregnancy");
• if the patient is currently taking or has recently taken a combination medicine containing sacubitril and valsartan, used to treat heart failure, because this increases the risk of angioedema (rapid swelling of tissues under the skin, particularly in the throat) (see "Warnings and precautions" and "Noliprel Forte with other medicines").

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

• if the patient has aortic valve stenosis (narrowing of the main blood vessel carrying blood from the heart), hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
• if the patient has heart failure or any other heart conditions;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient experiences worsening vision or eye pain. These may be signs of fluid accumulation in the choroid layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours or weeks of taking Noliprel Forte. If left untreated, these symptoms may lead to permanent vision loss. The risk is higher if the patient previously had an allergy to penicillin or sulfonamides.
• if the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps;
• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• if the patient has liver disease;
• if the patient has a collagen vascular 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 the parathyroid glands);
• 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 should be avoided while taking Noliprel Forte (see "Noliprel Forte 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, stop treatment immediately and contact a doctor without delay;
• if the patient is taking any of the following medicines for 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 problems 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 Forte".

• if the patient is of Black African origin – in such cases, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other ethnicities;
• 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 diarrhoea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group known as mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group known as gliptins (used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Noliprel Forte. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Noliprel Forte 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. Noliprel Forte 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 Forte, also inform your doctor or medical staff:

• if the patient is to undergo anaesthesia and/or surgery;
• if the patient has recently had 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 is planned to reduce allergic reactions to bee or wasp stings;
• if an imaging test requiring iodine-containing contrast agents (substances used to visualise organs such as the kidney or stomach in X-ray examinations) is to be performed;
• if vision disturbances or eye pain occur in one or both eyes during treatment with Noliprel Forte. These may be signs of glaucoma or increased pressure in one or both eyes. Stop taking Noliprel Forte and consult a doctor immediately.

Athletes should be aware that Noliprel Forte contains an active substance (indapamide)
that may lead to a positive result in anti-doping tests.
Children and adolescents
Noliprel Forte must not be used in children and adolescents.
Noliprel Forte with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Avoid using Noliprel Forte with:

• lithium (used to treat mania or depression);
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney problems;
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in the body (such as heparin, a blood thinner used to prevent 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 (ACE) inhibitors and angiotensin II receptor antagonists.

Other medicines may affect treatment with Noliprel Forte. Your doctor may recommend a dose adjustment and/or additional precautions. Inform your doctor if you are taking any of the following medicines, as special caution may be required:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also sections "When not to use Noliprel Forte" and "Warnings and precautions"), or diuretics (medicines that increase urine output 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 organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group known as 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 Forte" and "Warnings and precautions".
• anaesthetics;
• iodine-containing contrast agents;
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, intravenous erythromycin);
• methadone (used in addiction treatment);
• 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 conditions, 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);
• injectable gold salts (used to treat rheumatoid arthritis);
• vincamine (used to treat cognitive symptoms in elderly patients, including memory loss);
• bepridil (used to treat angina);
• 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 in heart conditions);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• medicines used to treat diabetes, such as insulin, metformin, or gliptins;
• calcium, including calcium supplements;
• stimulant laxatives (e.g. senna);
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance found 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, or schizophrenia (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• tetracosactide (used to treat Crohn's disease);
• trimethoprim (used to treat infections);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

Noliprel Forte with food and drink
It is recommended to take Noliprel Forte 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. Your doctor will usually advise stopping Noliprel Forte before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Noliprel Forte 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 Forte 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 Forte usually does not affect the ability to drive or operate machinery. However, some patients may experience dizziness or fatigue due to low blood pressure.
In such cases, the ability to drive or operate machinery may be impaired.
Noliprel Forte contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.
Noliprel Forte contains sodium
Noliprel Forte contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Noliprel Forte

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet once daily. Your doctor may recommend a different dosage if you have
kidney function impairment.
The tablet should preferably be taken in the morning, before a meal. Swallow the tablet with a glass of water.

Taking more Noliprel Forte than prescribed
If you take too many tablets, contact your doctor immediately or go to the emergency department of the nearest hospital.
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 Forte
It is important to take the medicine every day, as regular use is most effective.
However, if you miss a dose of Noliprel Forte, take the next dose at your usual time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Noliprel Forte
Treatment of high blood pressure is long-term, so you must 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 stopped immediately and the doctor contacted without delay:

• 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 point 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 body, 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 very poor general condition (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 muscle pain, particularly when 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, 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 (sensation of hearing sounds), cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, 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 (red spots on the skin), clusters of blisters, kidney disorders, impotence (inability to achieve or maintain erection), excessive sweating, increased eosinophil count (a type of white blood cells), changes in laboratory test results: high blood potassium levels, which may resolve after discontinuation of treatment, low blood sodium levels, which may lead to dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid 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 redness of the face and neck, reduced or absent urine output, acute kidney failure. Dark urine, nausea or vomiting, muscle cramps, confusion and seizures. These 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): confusion, eosinophilic pneumonia (a rare type of lung inflammation), nasal mucosal inflammation (nasal congestion or rhinitis), severe kidney disorders, blood parameter changes such as decreased white and red blood cell counts, decreased haemoglobin concentration, decreased 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 sugar 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 and changes in laboratory test results (blood tests) may occur. The doctor may recommend blood tests to monitor the patient's health.
If any of these symptoms occur, contact a doctor as soon as possible.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Noliprel Forte

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP" (the abbreviation used to describe the expiry date). The expiry date refers to the last day
of the stated month. The word "Lot" on the packaging indicates the batch number of the medicine.
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 in use. This will help protect the environment.

6. Contents of the package and other information

What Noliprel Forte contains

• The active substances are: perindopril and indapamide. One coated tablet contains 5 mg of perindopril arginine (equivalent to 3.395 mg of perindopril) and 1.25 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, polyethylene glycol 6000, magnesium stearate, titanium dioxide (E 171).

What Noliprel Forte looks like and contents of the pack
Noliprel Forte is a white, elongated coated tablet. One coated tablet contains 5 mg of perindopril arginine and 1.25 mg of indapamide.
The tablets are available in packs containing 30, 60, and 90 tablets.
Marketing Authorisation Holder:
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6 B
03-236 Warsaw
Manufacturer:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
Servier Ireland Industries Ltd
Gorey Road
Arklow – Co. Wicklow
Ireland
EGIS Pharmaceuticals Private Limited Company
Mátyás király u. 65
9900 Körmend – Hungary
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6 B
03-236 Warsaw
For detailed information, please contact the representative of the marketing authorisation holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594-90-00
This medicinal product is authorised in the European Economic Area member states under the following names:
Belgium COVERSYL PLUS 5 mg/1.25 mg
Czech Republic Prestarium Neo Combi 5 mg/1.25 mg
France PRETERVAL 5 mg/1.25 mg
Hungary Coverex-AS Komb
Italy PRELECTAL 5 mg/1.25 mg
Latvia PRESTARIUM COMBI ARGININE 5 mg/1.25 mg apvalkotās tabletes
Luxembourg COVERSYL PLUS 5 mg/1.25 mg
Malta Coversyl Plus 5 mg/1.25 mg
Poland NOLIPREL FORTE
Romania PREXAREL 5 mg/1.25 mg
Slovak Republic Prestarium combi A
Slovenia BIOPREXANIL COMBI 5 mg/1.25 mg filmsko obložene tablete