Package leaflet: Information for the patient

NAPROXEN 250 HASCO
250 mg, tablets
Naproxenum
NAPROXEN 500 HASCO
500 mg, tablets
Naproxenum
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is N 250 H or N 500 H and what is it used for
Important information before taking N 250 H or N 500 H
How to take N 250 H or N 500 H
Possible side effects
How to store N 250 H or N 500 H
Contents of the pack and other information

1. What is N 250 H or N 500 H and what is it used for

The medicine contains the active substance – naproxen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), and has anti-inflammatory, analgesic and antipyretic properties.
Indications for use include:

rheumatoid arthritis;
juvenile rheumatoid arthritis;
osteoarthritis;
ankylosing spondylitis;
acute gout attack;
acute musculoskeletal pain;
moderate pain of various origins, including menstrual pain, headache, toothache, postoperative pain;
febrile conditions.

2. Important information before using the medicine N 250 H or N 500 H

H
When not to use the medicine N 250 H or N 500 H

if the patient is allergic to naproxen or any of the other components of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs);
in patients who previously experienced allergic reactions such as rhinitis, urticaria or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs;
in patients with severe hepatic insufficiency, severe renal insufficiency or severe heart failure;
in patients with active or past peptic ulcer disease of the stomach and/or duodenum, perforation or gastrointestinal bleeding, including those occurring after use of NSAIDs;
during the third trimester of pregnancy;
in patients with haemorrhagic diathesis.

Warnings and precautions

The medicine should be used at the lowest effective dose and for the shortest duration necessary to relieve symptoms, in order to minimize the risk of adverse effects. Patients undergoing long-term treatment with NSAIDs should have regular medical check-ups to detect any potential side effects.
Use of medicines such as naproxen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with prolonged use of high doses of the medicine. Doses higher than recommended or longer treatment duration should not be used.
In case of cardiac disorders, history of stroke, or suspected risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), treatment should be discussed with a physician or pharmacist.
There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and may occur without warning symptoms or in patients with prior history of such events. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued. Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their physician of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period.
Concomitant administration of naproxen and other non-steroidal anti-inflammatory drugs is not recommended due to increased risk of serious adverse effects typical of this group of medicines.
Naproxen belongs to a group of medicines (NSAIDs) which may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.
Naproxen inhibits platelet aggregation and prolongs bleeding time, especially in patients with previous coagulation disorders or those taking anticoagulant medicines.
Caution should be exercised when using naproxen in patients with bronchial asthma or allergic disorders, as the medicine may provoke bronchospasm.
Severe skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), have been reported in association with NSAIDs. The highest risk of these severe reactions occurs at the beginning of treatment, mostly within the first month of use. Treatment should be discontinued at the first signs of skin rash, mucosal lesions, other hypersensitivity symptoms or DRESS syndrome.
Due to its anti-inflammatory and antipyretic effects, naproxen may mask symptoms of other diseases, making diagnosis more difficult.

Patients with heart failure
Naproxen should be administered with caution, using the lowest effective dose, in patients with cardiac insufficiency (as it may exacerbate peripheral edema).
Patients with impaired renal and/or liver function
Naproxen should be administered with caution, using the lowest effective dose, in patients with impaired liver or kidney function.
In alcoholic liver disease and other forms of cirrhosis, plasma naproxen concentration is reduced, with a simultaneous increase in unbound naproxen.
In patients with impaired renal function, serum creatinine levels and/or creatinine clearance should be monitored periodically. The medicine is not recommended for patients with creatinine clearance below 20 ml/min.
Elderly patients
Naproxen should be administered with caution, using the lowest effective dose, in elderly patients due to increased risk of gastrointestinal complications.
Consult a physician even if the above warnings refer to conditions occurring in the past.

N 250 H or N 500 H and other medicines
Inform your physician or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use.

Before starting this medicine, talk to your physician or pharmacist if you are taking any of the following medicines:
Acetylsalicylic acid used for prevention of blood clots.
Concurrent administration of antacids or cholestyramine with naproxen may delay its absorption.
Non-steroidal anti-inflammatory drugs may enhance the effect of anticoagulants, e.g. warfarin.
Naproxen may inhibit the diuretic effect of furosemide.
Naproxen inhibits lithium excretion, increasing serum lithium concentration.
Probenecid increases naproxen plasma concentration.
Naproxen inhibits methotrexate excretion, increasing its toxicity.
Concurrent use of naproxen and cardiac glycosides may reduce renal excretion of the latter, leading to increased serum concentration.
Naproxen may reduce the antihypertensive effect of propranolol and other beta-blockers, and increase the risk of impaired renal function associated with acetylcholinesterase inhibitors.
Caution is advised when administering naproxen concomitantly with cyclosporine due to increased risk of nephrotoxicity.
Naproxen enhances the effects of hydantoin, oral anticoagulants and sulfonamides when used concomitantly.
Caution is advised when using corticosteroids concomitantly with naproxen due to increased risk of gastrointestinal bleeding.
Non-steroidal anti-inflammatory drugs reduce the efficacy of mifepristone. Administration of naproxen may be started 8 to 12 days after the last dose of mifepristone.
Concurrent use of naproxen with fluoroquinolones increases the risk of seizures.
Naproxen administration should be withheld 48 hours before assessment of adrenal cortex function, due to potential interference with urinary 17-ketosteroid and 5-hydroxyindoleacetic acid measurements.

N 250 H or N 500 H with food and drink
Food intake does not significantly affect the extent of naproxen absorption.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a physician or pharmacist before using this medicine.
Pregnancy
Do not take N 250 H or N 500 H if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labor. The medicine should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a physician. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, N 250 H or N 500 H may cause kidney dysfunction in the unborn child if used for longer than a few days – this may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the physician may recommend additional monitoring.
Breastfeeding
Naproxen passes into human milk; therefore, it should not be used during breastfeeding.
Fertility
Naproxen may impair fertility. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her physician.
Driving and operating machinery
In some patients, the medicine may cause drowsiness, dizziness, insomnia or depression. Consult your physician regarding the use of naproxen while driving or operating machinery.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Naproxen 250 Hasco or Naproxen 500 Hasco
This medicine should always be used according to the physician's instructions. In case of doubt, consult your physician or pharmacist.
The medicine is taken orally.
Dosage in adults
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis:
250 mg to 500 mg twice daily (every 12 hours).
During acute phases of the disease, the dose may be increased to 750 mg or 1000 mg:

in patients experiencing severe night pain or stiffness;
in patients in whom naproxen has replaced other NSAIDs previously used at high doses;
in osteoarthritis with severe pain.

Acute gout attack:
Single dose of 750 mg, followed by 250 mg every 8 hours until pain subsides.
Acute musculoskeletal pain, menstrual pain, pain of various origins, fever:
Initial dose of 500 mg, followed by 250 mg every 6 to 8 hours.
Maximum daily dose: 1250 mg.
Use in children
Dosage in children over 5 years of age
Juvenile rheumatoid arthritis:
Recommended dose is 10 mg/kg body weight twice daily (every 12 hours).
The medicine is not recommended for any other indication in children under 16 years of age.
Use of higher than recommended dose of N 250 H or N 500 H
Heartburn, dyspepsia, nausea, vomiting may occur.
If a higher than recommended dose is taken, seek immediate advice from a physician or pharmacist.
Management in case of overdose
Symptomatic treatment should be applied; if necessary, gastric emptying should be induced and a physician should be notified immediately.
Missed dose of N 250 H or N 500 H
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur, stop using
Naproxen 250 Hasco or Naproxen 500 Hasco and contact a doctor immediately:
Frequency unknown (frequency cannot be estimated from available data):

extensive rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2;
characteristic allergic skin reaction called fixed drug eruption, which usually recurs in the same location(s) upon re-administration of the drug and may present as round or oval red patches and swelling of the skin, blisters (urticaria), itching.

Common (in no more than 1 in 10 patients using the medicine):

indigestion, heartburn, nausea, abdominal pain, dizziness, headache, feeling of emptiness in the head.

Uncommon (in no more than 1 in 100 patients using the medicine):

diarrhoea, constipation, vomiting, rash, urticaria, pruritus, fatigue, insomnia, somnolence.

Rare (in no more than 1 in 1000 patients using the medicine):

gastrointestinal bleeding, melaena, haematemesis, angioedema, impaired kidney function.

Very rare (in no more than 1 in 10,000 patients using the medicine):

oral mucosal ulcers, oesophagitis, acute pancreatitis, colitis, gastric and intestinal ulcers;
hepatitis (including fatal cases), jaundice;
alopecia, erythema multiforme, exfoliative dermatitis: Stevens-Johnson syndrome, lichen planus, epidermal necrolysis, photosensitivity (including cases resembling porphyria cutanea tarda), bullous epidermal detachment;
glomerulonephritis, interstitial nephritis, nephrotic syndrome, haematuria, proteinuria, hyperkalaemia, elevated serum creatinine levels, renal papillary necrosis, renal failure;
convulsions, concentration disturbances, meningitis;
dyspnoea, oedema, palpitations, congestive heart failure, arterial hypertension.

Use of medicines such as naproxen may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke.

thrombocytopenia, granulocytopenia including agranulocytosis, eosinophilia, leukopenia, vasculitis, aplastic and haemolytic anaemia;
eosinophilic pneumonia, asthma, pulmonary oedema;
tinnitus, hearing disturbances;
visual disturbances, corneal opacity, intraocular optic neuritis, extraocular optic neuritis, optic disc oedema;
anaphylactoid reactions (fever, mild peripheral oedema, malaise, myalgia, muscle weakness);
elevated creatinine levels, abnormal liver function tests, hyperkalaemia.

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Naproxen 250 Hasco or Naproxen 500 Hasco
Keep in the original packaging, below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Naproxen 250 Hasco or Naproxen 500 Hasco contains

The active substance is naproxen. Each tablet contains 250 or 500 mg of naproxen.
The other ingredients are: povidone (K-90), sodium croscarmellose, magnesium stearate.

What Naproxen 250 Hasco or Naproxen 500 Hasco looks like and contents of the pack
N 250 H
White, round, biconvex, smooth tablets.
Pack contains 10, 30, 50 or 100 tablets.
N 500 H
White, oval, biconvex, smooth tablets.
Pack contains 15, 30 or 45 tablets.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]