Package leaflet: Information for the patient

NAPROXEN HASCO
250 mg, suppositories
Naproxenum
Please read the entire 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, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What is Naproxen Hasco and what is it used for
Important information before using Naproxen Hasco
How to use Naproxen Hasco
Possible side effects
How to store Naproxen Hasco
Contents of the package and other information

1. What is Naproxen Hasco and what is it used for

Naproxen Hasco contains the active substance naproxen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory and analgesic properties.
Indications for Naproxen Hasco:
Rheumatic diseases

Rheumatoid arthritis
Juvenile rheumatoid arthritis
Ankylosing spondylitis
Acute gout attack
Acute musculoskeletal pain
Sprains
Post-traumatic injuries
Low back pain
Herniated intervertebral disc
Tendinitis
Bursitis
Fibromyalgia
Other types of pain (e.g. menstrual pain, headache).

2. Important information before using Naproxen Hasco

When not to use Naproxen Hasco

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
if the patient is allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs),

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in patients who, during treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, have previously experienced allergic reactions such as rhinitis, urticaria, or bronchial asthma,
in patients with severe hepatic insufficiency, severe renal insufficiency, or severe cardiac insufficiency,
in patients with active or a history of 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 bleeding disorders.

Warnings and precautions
Before starting treatment with Naproxen Hasco, discuss it with your doctor, pharmacist, or
nurse.

Treatment should be initiated at the lowest effective dose and for the shortest duration necessary to relieve symptoms, as this reduces the risk of adverse effects. Patients undergoing long-term treatment with NSAIDs should have regular medical check-ups to monitor for possible 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. Do not use higher doses or longer treatment durations than recommended. If you have heart problems, have had a stroke, or are at risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss treatment with your doctor or pharmacist.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be life-threatening and may occur without warning symptoms or in patients who have previously experienced such warning signs.
If gastrointestinal bleeding or ulceration occurs, naproxen should be discontinued. Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial phase of treatment.
Concomitant administration of naproxen with other nonsteroidal anti-inflammatory drugs is not recommended due to increased risk of serious adverse effects.
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, particularly in patients with previous coagulation disorders or those taking anticoagulant medications.
Caution is advised when using naproxen in patients with bronchial asthma or allergic conditions, as the drug 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 with NSAIDs. The highest risk of these severe reactions occurs early in therapy, most often within the first month of treatment. Treatment should be discontinued at the first signs of skin rash, mucosal lesions, other signs of hypersensitivity, or DRESS syndrome.
Due to its anti-inflammatory and antipyretic effects, naproxen may mask symptoms of other diseases, thereby complicating diagnosis.

Patients with heart failure
Naproxen should be administered cautiously, using the lowest effective dose, in patients with heart failure (as it may exacerbate peripheral edema).
Patients with impaired renal and/or hepatic function
Naproxen should be administered cautiously, using the lowest effective dose, in patients with impaired liver or kidney function.
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In alcoholic liver disease and other forms of cirrhosis, plasma naproxen concentrations are 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 drug is not recommended for patients with creatinine clearance below 20 ml/min.
Elderly patients
Naproxen should be administered cautiously, using the lowest effective dose, in elderly patients due to increased risk of gastrointestinal complications.

Naproxen Hasco and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Before starting treatment with this medicine, talk to your doctor 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.
Nonsteroidal anti-inflammatory drugs may enhance the effect of anticoagulants such as warfarin.
Naproxen may inhibit the diuretic effect of furosemide.
Naproxen reduces lithium excretion, increasing serum lithium concentrations.
Probenecid increases plasma naproxen concentrations.
Naproxen reduces methotrexate excretion, increasing its toxicity.
Concurrent use of naproxen with cardiac glycosides may reduce their renal excretion, leading to increased serum concentrations.
Naproxen may reduce the antihypertensive effect of propranolol and other beta-blockers, and may increase the risk of renal impairment associated with use of 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 concurrently.
Caution is advised when using corticosteroids concomitantly with naproxen due to increased risk of gastrointestinal bleeding.
Nonsteroidal 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.

It is recommended to discontinue naproxen 48 hours before assessment of adrenal cortex function,
due to the possibility of interfering with test results.
Naproxen Hasco with food and drink
Naproxen Hasco can be taken independently of meals.
Pregnancy, breastfeeding, and effects on fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Naproxen Hasco if you are in the last three 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 bleed in both the mother and the child and may delay or prolong labor. During the first 6 months of pregnancy, the medicine should not be used unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From the 20th week of pregnancy, Naproxen Hasco may cause kidney dysfunction in the unborn child if used for more than a few days—this may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the fetal heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Naproxen passes into human milk; therefore, it should not be used during breastfeeding.
Fertility
Use of naproxen may adversely affect fertility in women and is not recommended in women attempting to conceive.
Driving and operating machinery
In some patients, the medicine may cause drowsiness, dizziness, insomnia, or depression.
Consult your doctor regarding the suitability of using naproxen while driving or operating machinery.

3. How to use Naproxen Hasco

This medicine should always be used according to the recommendations of your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Rectal administration.
Use in children
Children over 5 years of age

Juvenile rheumatoid arthritis: the recommended dose is 10 mg/kg body weight twice daily (every 12 hours). This medicine is not recommended for any other indication in children under 16 years of age.

Adults

Rheumatoid arthritis and ankylosing spondylitis: 250 mg to 500 mg twice daily (morning and evening)
Acute gouty arthritis: initial dose of 750 mg, followed by 250 mg every 8 hours
Short-term relief of pain: initial dose of 500 mg, then 250 mg every 6 to 8 hours
Acute musculoskeletal pain: initial dose of 500 mg, then 250 mg every 6 to 8 hours. The maximum daily dose is 1250 mg.

Elderly patients
The lowest effective dose should be used, as the risk of adverse effects is higher than in younger individuals.
Use of a higher than recommended dose of Naproxen Hasco
If a higher than recommended dose is taken, consult your doctor or pharmacist.
Dosing not in accordance with the instructions in this patient leaflet may lead to symptoms
of overdose such as gastrointestinal disturbances, headache and dizziness,
and blood abnormalities.
Missed dose of Naproxen Hasco
Do not take a double dose to make up for a missed dose.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur, discontinue use of
Naproxen Hasco and contact a doctor immediately:
Frequency unknown (frequency cannot be estimated from the available data):

widespread rash, high fever, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2;
characteristic skin allergic 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 skin swelling, blisters (urticaria), itching.

Common (affects up to 1 in 10 patients taking the medicine):

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

Uncommon (affects up to 1 in 100 patients taking the medicine):

diarrhoea, constipation, vomiting, rash, urticaria, itching, lethargy, insomnia, somnolence.

Rare (affects up to 1 in 1000 patients taking the medicine):

gastrointestinal bleeding, tarry stools, vomiting blood, angioedema, impaired kidney function.

Very rare (affects up to 1 in 10,000 patients taking 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 and photosensitivity (including cases resembling porphyria cutanea tarda), bullous skin detachment;
glomerulonephritis, interstitial nephritis, nephrotic syndrome, haematuria, proteinuria, elevated blood potassium levels (hyperkalaemia), increased serum creatinine levels, renal papillary necrosis, renal failure;
convulsions, disturbances in concentration, meningitis;
dyspnoea, oedema, palpitations, congestive heart failure, arterial hypertension;
decreased platelet count (thrombocytopenia), decreased white blood cell count (granulocytopenia, agranulocytosis, eosinophilia, leukopenia), vasculitis, anaemia (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 (severe hypersensitivity reactions presenting e.g. as fever, oedema, malaise, muscle pain, muscle weakness);
abnormal liver function test results.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, inform a doctor, pharmacist or nurse.
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:
Aleje Jerozolimskie 181C, 02 - 222 Warsaw
tel.: + 48 22 49 21 301, fax: +48 22 49 21 309
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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 the medicine.

5. How to store Naproxen Hasco

Store below 25°C, in the original packaging.
Keep the medicine out of the 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.
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 packaging and other information

What Naproxen Hasco contains

The active substance is naproxen. Each suppository contains 250 mg of naproxen.
The other component (excipient) is: hard fat (Witepsol).

What Naproxen Hasco looks like and contents of the packaging
White, milky-white, matte suppositories in torpedo shape with smooth surface. The packaging contains 10 suppositories.
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]
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