Naproxen Polfarmex

Package Leaflet: Information for the User

NAPROXEN POLFARMEX, 500 mg, tablets

Naproxen

Read the package 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Naproxen Polfarmex belongs to a group of non-steroidal anti-inflammatory drugs with analgesic and antipyretic properties.
Naproxen Polfarmex is indicated for use in:

• rheumatoid arthritis;
• juvenile rheumatoid arthritis;
• ankylosing spondylitis;
• acute musculoskeletal pain;
• acute attacks of gout;
• relief of moderate pain (in soft tissue injuries) and painful menstruation.

2. Important information before taking Naproxen Polfarmex

When not to take Naproxen Polfarmex:

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs: asthma, rhinitis, urticaria;
• if you have or have had stomach or duodenal ulcers, perforation or bleeding;
• if you have bleeding disorders;
• if you have severe heart, liver or kidney failure;
• if you are in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Naproxen Polfarmex, discuss it with your doctor or pharmacist.
Naproxen should be given with caution, using the smallest effective dose, to patients with heart failure (due to the possibility of increasing peripheral edema).
To detect potential side effects, patients taking non-steroidal anti-inflammatory drugs for a long time should undergo regular medical check-ups.
In people with a risk factor for cardiovascular complications - hypertension, hyperlipidemia, peripheral circulation disorders, diabetes, and smokers - naproxen should be used with extreme caution.
Taking naproxen carries the risk of developing ulcers, perforation or bleeding in the gastrointestinal tract. These side effects, which can be fatal, may be preceded by warning signs, but do not have to be. Naproxen treatment should be discontinued in case of gastrointestinal bleeding or ulcers. Patients who have had gastrointestinal diseases, especially the elderly, should be informed about the need to report any unusual gastrointestinal symptoms to their doctor, especially bleeding. This is especially important in the initial treatment period. In such patients, the use of the smallest dose of the drug is recommended.
Concomitant use of naproxen and other non-steroidal anti-inflammatory drugs (including selective COX-2 inhibitors) increases the risk of serious side effects characteristic of this group of drugs.
Concomitant use of naproxen with heparin or warfarin should be carried out under medical supervision.
Naproxen inhibits platelet aggregation and prolongs bleeding time. In patients taking anticoagulant drugs (e.g. dicumarol) or who have previously had coagulation disorders, the risk of bleeding increases.
Patient with liver failure should be given naproxen with caution, using the smallest effective dose. In patients with liver cirrhosis (alcoholic or other forms), the concentration of naproxen in the serum decreases, with a simultaneous increase in the amount of unbound naproxen.
In patients with asthma or other allergic diseases, naproxen increases the risk of bronchospasm.
Naproxen should be administered with caution to patients with impaired renal function. In these patients, periodic renal function tests should be performed: serum creatinine levels and/or creatinine clearance should be monitored. In patients with a creatinine clearance of less than 20 mL/minute, the drug is contraindicated.
Due to its anti-inflammatory and antipyretic effects, the use of the drug may mask the symptoms of another disease and make diagnosis difficult.
Due to the increased risk of side effects, long-term therapy with non-steroidal anti-inflammatory drugs is not recommended in elderly patients. They should take naproxen in the smallest effective dose. Elderly patients taking non-steroidal anti-inflammatory drugs for a long time should be regularly monitored.
Taking non-steroidal anti-inflammatory drugs carries the risk of serious gastrointestinal side effects. This risk is independent of the duration of non-steroidal anti-inflammatory drug use. Most side effects occur in the elderly and frail, who tolerate ulcers and bleeding in the stomach and intestines poorly. So far, studies have not shown that there is a group of people who are less likely to develop stomach ulcers or bleeding.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Naproxen Polfarmex. You should stop taking Naproxen Polfarmex and seek medical attention immediately if you experience any symptoms associated with these severe skin reactions, described in section 4. The greatest risk of these reactions occurs at the beginning of treatment with naproxen, most often in the first month of taking the drug. After the first symptoms of rash, oral mucosa damage, or other signs of hypersensitivity appear, you should stop taking the drug.
Hypersensitivity reactions may occur in people with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, as well as in people without hypersensitivity, in patients with angioedema, asthma, rhinitis, and nasal polyps. Hypersensitivity reactions can be fatal.
Non-steroidal anti-inflammatory drugs rarely cause eye diseases: optic neuritis, papilledema. The causal relationship of this mechanism is not known. In case of eye diseases, ophthalmological examinations are recommended.
During treatment with naproxen, the dose of steroids or their withdrawal should be gradual. Due to the possibility of side effects, such as adrenal insufficiency, worsening of arthritis symptoms, the patient should be under supervision.
Taking such drugs as Naproxen Polfarmex may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the drug. Do not use higher doses or longer treatment than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, increased cholesterol levels, smoking), consult your doctor or pharmacist.

Naproxen Polfarmex and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take.
Concomitant use of naproxen with antacids or cholestyramine may delay its absorption. Food intake does not significantly affect the absorption of naproxen.
Naproxen may inhibit the diuretic effect of furosemide and the excretion of lithium (decrease in renal clearance of lithium ions), leading to an increase in lithium levels in the serum.
Naproxen may enhance the effect of anticoagulant drugs (e.g. warfarin).
Probenecid increases the concentration of naproxen in the serum and prolongs its half-life.
Concomitant use of naproxen with digitalis glycosides may inhibit the renal excretion of glycosides, leading to an increase in their serum levels.
Naproxen decreases the tubular excretion of methotrexate, which may lead to an increase in its toxicity.
It weakens the hypotensive effect of propranolol and other beta-adrenergic receptor blockers.
Naproxen increases the risk of renal dysfunction associated with the use of ACE inhibitors.
Acetylsalicylic acid may increase the renal clearance of naproxen and decrease its serum concentration.
Concomitant use of naproxen with cyclosporine may increase the serum concentration of cyclosporine, which may lead to neurotoxic effects.
Naproxen enhances the effect of hydantoin, sulfonamides, and oral anticoagulants by displacing their binding to proteins.
Concomitant use of naproxen with corticosteroids increases the risk of gastrointestinal disorders: gastrointestinal bleeding.
Naproxen, like other non-steroidal anti-inflammatory drugs, weakens the effect of mifepristone. Only after 8 to 12 days from the last dose of mifepristone can naproxen treatment be started.
Taking naproxen at the same time as fluoroquinolones increases the risk of seizures.
Taking naproxen within 48 hours before an adrenal function test may lead to false results of 17-ketosteroid and 5-hydroxyindoleacetic acid measurements in urine.
Concomitant use of naproxen with antiplatelet agents and non-selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The drug may be used during pregnancy only if absolutely necessary in the first and second trimester.
The use of naproxen is contraindicated during the third trimester of pregnancy.
Naproxen passes into breast milk, so it should not be used in breastfeeding women.
Naproxen Polfarmex may make it harder to get pregnant. If you plan to get pregnant or have problems getting pregnant, tell your doctor.

Driving and using machines

While taking Naproxen Polfarmex, be careful. Some patients may experience: drowsiness, dizziness, insomnia, depression.

Naproxen Polfarmex contains yellow quinoline (E 104)

This medicine contains yellow quinoline, which may cause allergic reactions.

3. How to take Naproxen Polfarmex

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The dose of the medicine must be adjusted to the patient's clinical response.

Adults:

Rheumatoid arthritis, ankylosing spondylitis
The recommended initial dose is usually 750 mg to 1000 mg per day, given in a single dose (loading dose), and then 250 mg to 500 mg every 12 hours. In acute conditions, the dose can be increased (for a short period, under close medical supervision) from 750 mg to 1000 mg per day, in divided doses.
Acute attack of gout
Initially 750 mg, then 250 mg every 8 hours until the pain subsides.
Painful menstruation, soft tissue injuries
Initial dose 500 mg, then 250 mg every 6 to 8 hours as needed.
Maximum daily dose - 1250 mg.

Children:

Juvenile rheumatoid arthritis (children over 5 years old with a body weight over 20 kg)
The recommended daily dose is 10 mg/kg body weight in 2 divided doses in the morning and evening.
Naproxen is not recommended for use in children under 16 years of age for indications other than juvenile rheumatoid arthritis.
The medicine should be taken with food or milk.
Taking the medicine in the smallest effective dose and for the shortest duration necessary to relieve symptoms reduces the risk of side effects.

What to do if you take more Naproxen Polfarmex than you should

Overdose symptoms: drowsiness, vomiting, heartburn, nausea, abdominal pain, kidney function disorders. If you experience any of these symptoms, contact your doctor immediately.
In case of naproxen overdose, the stomach should be emptied, and then appropriate supportive treatment should be applied. Rapid administration of a sufficient amount of activated carbon reduces the amount of absorbed drug.
In case of kidney failure, hemodialysis may be necessary.

What to do if you forget to take Naproxen Polfarmex

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Naproxen Polfarmex can cause side effects, although not everybody gets them.
Common side effects(in 1 to 10 people in 100):

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

Uncommon side effects(in 1 to 10 people in 1,000):

• lethargy, insomnia, drowsiness;
• constipation, diarrhea, vomiting;
• dizziness;
• rash, itching, urticaria.

Rare side effects(in 1 to 10 people in 10,000):

• esophagitis, oral mucosa ulceration, gastrointestinal ulcers with or without complications of bleeding or perforation, gastrointestinal bleeding, vomiting blood, black stools, acute pancreatitis;
• angioedema;
• hepatitis (including fatal cases), jaundice;
• thrombocytopenia, granulocytopenia with agranulocytosis, leukopenia, eosinophilia, aplastic and hemolytic anemia;
• vasculitis;
• renal function disorders;
• peripheral edema, especially in patients with hypertension or renal failure, fever (including chills and febrile conditions).

Very rare side effects(in less than 1 person in 10,000):

• aseptic meningitis, cognitive disorders, seizures;
• pancreatitis, colitis, aphthous stomatitis, oral mucosa ulceration, gastrointestinal ulcers;
• hearing impairment, tinnitus, hearing disorders;
• alopecia (usually reversible), photosensitivity, porphyria, erythema multiforme, bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema nodosum, lupus erythematosus, hypersensitivity reactions to light, including porphyria cutanea tarda (pseudoporphyria) or blistering skin separation, purpura, petechiae, excessive sweating, exfoliative dermatitis;
• interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure, hematuria;
• anaphylaxis/anaphylactoid reactions, including fatal shock;
• psychiatric disorders, depression, sleep disorders, inability to concentrate;
• edema, increased thirst, malaise;
• vision disorders, corneal clouding, optic neuritis, papilledema;
• congestive heart failure, hypertension, pulmonary edema, palpitations;
• dyspnea, asthma, eosinophilic pneumonia;
• induction of labor;
• closure of the ductus arteriosus;
• in women - fertility disorders;
• increased creatinine levels, abnormal liver function test results, hyperkalemia.

Frequency not known:frequency cannot be estimated from the available data

• widespread rash, high fever, elevated 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). See also section 2;
• characteristic skin allergic reaction, called fixed drug eruption, which usually recurs in the same place (places) as a result of re-administration of the drug and may take the form of round or oval red patches and skin swelling, blisters (urticaria), itching.

Non-steroidal anti-inflammatory drugs have been reported to cause seizures, concentration disorders, meningitis.
The following side effects may also occur: glomerulonephritis, hyperkalemia, increased serum creatinine levels.
During treatment with naproxen, mild peripheral edema, fever, muscle pain, muscle weakness, malaise may occur.
Non-steroidal anti-inflammatory drugs have been reported to cause edema, dyspnea.
Taking such drugs as Naproxen Polfarmex may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
The following side effects may also occur during treatment with naproxen: asthma, eosinophilic pneumonia, pulmonary edema.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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
Tel.: +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 the medicine.

5. How to store Naproxen Polfarmex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister or container after EXP. The expiry date refers to the last day of that month.
Store in a temperature below 25°C.
Store in the original package to protect from light.
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 Naproxen Polfarmex contains

• The active substance is naproxen. One tablet contains 500 mg of naproxen.
• The other ingredients are: cornstarch, povidone, magnesium stearate, yellow quinoline (E 104).

What Naproxen Polfarmex looks like and contents of the pack

Naproxen Polfarmex, 500 mg - the pack contains 20 or 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the leaflet: