1. WHAT PROPAIN IS AND WHAT ARE ITS PROPERTIES

Naproxen, the active ingredient of Propain, is a Non-Steroidal-Anti-Inflammatory Drug (NSAID), which belongs to the group of propionic acid.

The NSAIDs are medicines which are used to relieve the symptoms caused from arthritis (rheumatic pain), such as inflammation, oedema (swelling), stiffness and arthritic pain.  NSAIDs act by inhibiting the production of prostaglandins.

These medicines do not cure arthritis but they only help during their consumption.

Indications:

Treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout, acute musculoskeletal disorders and dysmenorrhoea. 

 

2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE PROPAIN

Be particularly careful with Propain.

Inform your doctor:

• if you are allergic to naproxen, to other NSAIDs or to any of the excipients of the product.
• if you are pregnant or you intend to become pregnant or if you are breast-feeding.
• if you have a history of stomach ulcer (especially accompanied with haemorrhage or perforation).
• if you suffer from hypertension or heart failure.

Contra-Indications:

Propain is contra-indicated in patients hypersensitive to Naproxen or Naproxen Sodium formulations, patients with a history of gastrointestinal bleeding or perforation related to previous NSAIDs therapy, active or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding) and severe heart failure. Propain should not be given to patients in whom Aspirin or other NSAIDs induce the syndrome of asthma, rhinitis or urticaria.

Interactions:

A number of medicines interact with Νaproxen and should not be given concomitantly.

However, a few of them can be used concomitantly under special precautions.  In this case your doctor can change the posology or take other precautions if needed.  If you are about to take Propain it is important to inform your doctor or pharmacist if are taking any other medicines and particularly any of the following:

Corticosteroids, anti-coagulants (warfarin), sulphonylureas, anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs), frusemide, propranolol, b-blockers, probenecid, methotrexate, carciac glycosides, cyclosporine, mifepristone, quinolone, angiotensin enzyme inhibitors.

Administration of antacids or cholestyramine, as well as food, can delay the absorption of naproxen.

Treatment with naproxen should be temporarily discontinued 48 hours before adrenal function tests because it may interfere with some of these tests.

Special warnings:

The use of Propain with concomitant NSAIDs including cyclooxygenase-2-selective inhibitors should be avoided.  Undesirable effects may be minimized by using the minimum effective dose for the shortest duration necessary to control symptoms.  Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.

Elderly: the elderly have an increased frequency of adverse reactions to NSAIDs especially GI bleeding and perforation which may be fatal.

Gastrointestinal effects: Gl bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without symptoms or a previous history of serious Gl events. The risk is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. Patients with a history of Gl toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially Gl bleeding) particularly in the initial stages of treatment.  Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (warfarin), aspirin, selective serotonin reuptake inhibitors or anti-platelet agents such as Aspirin. When Gl bleeding or ulceration occurs in patients receiving Propain, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as this condition may exacerbate.

Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.

Cardiovascular effects: Medicines such as Propain may be associated with a small increase of the risk for cardiac attack («myocardial infarction») or cerebrovascular episode. This is more possible to happen when taking high doses and during long-term treatment. Do not exceed the recommended dose or duration of treatment. If you have cardiac problems, history of cerebrovascular episode or if you believe that you have an increased risk for such situations (for example if you have high pressure, diabetes, high cholesterol or if you are a smoker) you should discuss your therapy with your doctor or pharmacist. Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Dermatological effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (mostly within the first month).  Propain should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Use in patients with impaired renal function: Naproxen should be used with great caution in patients with impaired renal function and the monitoring of serum creatinine and/or creatinine clearance is advised in these patients. Certain patients, specifically those whose renal blood flow is compromised, some elderly patients as well as patients using diuretics should have renal function assessed before and during Propain therapy. A reduction in daily dosage should be considered.

Use in patients with impaired liver function: It is prudent to use the lowest effective dose.

Haematological effects: Patients who have coagulation disorders or are receiving drug therapy that interferes with haemostasis should be carefully observed.

Anaphylactic (anaphylactoid) reactions: Hypersensitivity reactions, sometimes fatal, may occur in susceptible individuals.

Steroids: If steroid dosage is reduced or eliminated during therapy, the steroid dosage should be reduced slowly and the patients must be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

Ocular effects: In rare cases, adverse ocular disorders (i.e. papillitis, retrobulbar optic neuritis and papilloedema), have been reported in users of NSAIDs including Naproxen.  Accordingly, patients who develop visual disturbances during the treatment should have an ophthalmological examination.

This product contains Lactose, therefore if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

Pregnancy:

As with other drugs Naproxen affects the human foetal cardiovascular system (closure of the ductus arteriosus). Minimal drug usage in pregnancy should be considered, and it should be used only if the possible benefit outweighs the potential risk to the mother and the foetus, especially in the first and third trimesters.

Consult your doctor or pharmacist before you take any medication.

Lactation:

The use of Propain should be avoided in patients who are breast-feeding.

Consult your doctor or pharmacist before you take any medication.

Ability to drive or operate machinery:

Some patients may experience drowsiness, dizziness, vertigo, insomnia or depression with the use of naproxen. If patients experience these or similar undesirable effects, they should exercise caution in carrying out activities that require alertness.

 

3. HOW YOU SHOULD TAKE PROPAIN

Follow your doctor’s instructions.

Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: 500mg to 1g taken in 2 doses at

12-hour intervals or alternatively, as a single administration. In the following cases a loading dose of 750mg or 1g per day for the acute phase is recommended:

-In patients reporting severe nighttime pain/or morning stiffness.

-In patients being switched to Propain from a high dose of another anti-rheumatic compound.

-In osteoarthritis where pain is the predominant symptom.

Acute gout: 750mg at once then 250mg every 8 hours until the attack has passed.

Acute musculoskeletal disorders and dysmenorrhoea: 500mg initially followed by 250mg at 6 – 8   hour intervals as needed, with a maximum daily dose after the first day of 1250mg.

Children (over 5 years): For juvenile rheumatoid arthritis: 10mg/kg/day taken in 2 doses at 12-hour intervals.

Elderly: It is prudent to use the lowest effective dose.

If you receive a dose larger than normal:

In case you take a dose larger than normal, stop taking the medicine and contact your doctor    immediately.

Symptoms: drowsiness, heartburn, indigestion, nausea or vomiting.  A few patients have experienced seizures, but it is not known whether these were Naproxen-related or not.

Treatment: The stomach may be emptied and usual supportive measures employed.  Administration of activated charcoal is useful.

Haemodialysis may be appropriate in patients with renal failure who received large doses of Naproxen.

If you forget to take Propain:

If you have to take your medicine continuously and you missed a dose, take the missed dose as soon as possible.  However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.  Do not double doses.  Consult your doctor in case you missed more than one dose.

 

4. POSSIBLE UNDESIRABLE EFFECTS

As with all medicines Propain can cause undesirable effects.

Gastrointestinal: the most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or Gl bleeding, sometimes fatal, particularly in the elderly, may occur.  Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis, Crohn’s disease and rarely gastritis, have been reported.

Cardiovascular: Medicines such as Propain may be associated with a small increase of the risk for cardiac attack («myocardial infarction») or cerebrovascular episode. Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Skin reactions: skin rashes, urticaria, angio-oedema, alopecia, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, photosensitivity reactions (including cases in which the skin resembles porphyria cutanea tarda, ‘pseudoporphyria’), epidermolysis bullosa.

Renal: Glomerular nephritis, interstitial nephritis, nephrotic syndrome, haematuria, renal papillary necrosis and renal failure.

CNS: Convulsions, headache, insomnia, inability to concentrate and cognitive dysfunction.

Haematological (rarely): Thrombocytopenia, granulocytopenia including agranulocytosis, aplastic anaemia and haemolytic anaemia.

Other: Tinnitus, hearing impairment, vertigo, mild peripheral oedema, anaphylactic reactions. Rarely, jaundice, fatal hepatitis, visual disturbances, eosinophilic pneumonitis, vasculitis, hyperkalaemia, aseptic meningitis and ulcerative stomatitis.

If you have undesirable effects that are not mentioned above, please inform your doctor.

 

5. STORAGE OF PROPAIN

Product expiry date:

Shown on the inner and outer packaging.  In case the expiry date has lapsed, do not use.

Special precautions for storage of the product:

Store below 25^oC, away from light and moisture and in a safe place away from the reach of children.

 

6. OTHER INFORMATION

Propain 500: This product is available in pack-sizes of 100 tablets.

Not all pack-sizes may be marketed.

For any information regarding this pharmaceutical product, contact the marketing license holder.

Date of last revision of leaflet:

November 2007.

Legal category:

This medicine is dispensed only by medical prescription.