Stirlescent 250 mg Effervescent Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NAPROXEN

Available from:

Stirling Anglian Pharmaceuticals Ltd Hillington Park Innovation Centre, 1 Ainslie Road, Hillington Park, Glasgow G52 4RU, United

ATC code:

M01AE02

INN (International Name):

NAPROXEN

Pharmaceutical form:

EFFERVESCENT TABLET

Composition:

NAPROXEN 250 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2015-12-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STIRLESCENT 250 MG EFFERVESCENT TABLETS
Naproxen
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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. Do not pass it on to
others. It may harm them even if their
symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Stirlescent 250 mg Effervescent Tablets is and what it is used
for
2.
What you need to know before you take Stirlescent 250 mg Effervescent
Tablets
3.
How to take Stirlescent 250 mg Effervescent Tablets
4.
Possible side effects
5.
How to store Stirlescent 250 mg Effervescent Tablets
6.
Contents of the pack and other information
1.
WHAT STIRLESCENT 250 MG EFFERVESCENT TABLETS IS AND WHAT IT IS USED
FOR
Stirlescent 250 mg Effervescent Tablets contains the drug naproxen.
This is a ‘Non Steroidal Anti
Inflammatory Drug’ or NSAID.
Stirlescent 250 mg Effervescent Tablets can lessen pain and
inflammation (swelling, redness and heat)
and is used to treat adults for:
•
Pain in your muscles, joints and tendons, like strains, gout,
arthritis and ankylosing spondylitis.
•
Period pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STIRLESCENT 250 MG EFFERVESCENT
TABLETS DO
NOT TAKE STIRLESCENT 250 MG EFFERVESCENT TABLETS
•
If you are allergic to naproxen or any of the other ingredients of
this medicine (listed in section 6).
•
If you are allergic to aspirin, other NSAIDs or any other pain relief
medicines (such as ibuprofen or
diclofenac).
•
If you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or have
had two or more episodes of peptic ulcers, stomach bleeding or
perforation.
•
If you have previously experienced bleeding or perforat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Stirlescent 250 mg Effervescent Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg Naproxen.
Excipients with known effect
Each effervescent tablet contains:
-
0.52 mg benzyl alcohol
-
342.01 mg sodium
-
0.097 mg sorbitol (E420)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stirlescent is used in the treatment of rheumatoid arthritis,
osteoarthritis, ankylosing spondylitis, acute
musculoskeletal disorders, dysmenorrhoea and acute gout in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use of the lowest effective dose for the shortest duration necessary
to control symptoms is recommended, in
order to minimise undesirable effects (see section 4.4).
Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
Start at 250 mg, twice daily. Adjust to 500 mg to 1000 mg daily in two
divided doses.
Acute gout
Start at 750 mg, followed by 250 mg every 8 hours.
Acute musculoskeletal disorders and dysmenorrhoea
Start at 500 mg, followed by 250 mg every 6 to 8 hours.
Paediatric population
Stirlescent should not be used in the paediatric population because
the correct dose cannot be
administered using this formulation.
Elderly
Reduced elimination in the elderly (see section 4.4). Increased risk
of serious consequences of adverse
reactions. If NSAID use is considered necessary, the lowest effective
dose should be used for the shortest
possible duration. Monitor regularly for GI bleeding during treatment.
Review treatment at regular intervals
and discontinue if no benefit is seen, or if intolerance occurs.
Renal/hepatic impairment
Consider a lower dose in patients with renal or hepatic impairment.
Contraindicated in patients with baseline
creatinine clearance less than 30 ml/minute due to potential
accumulation of naproxen metabolites (see
section 4.3).
Method of administration
Oral.
Doses of 1 to 2 tablets must be diss