Stirlescent 250mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naproxen

Available from:

Stirling Anglian Pharmaceuticals Ltd

ATC code:

M01AE02

INN (International Name):

Naproxen

Dosage:

250mg

Pharmaceutical form:

Effervescent tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5060384790244

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 perforation in y

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 dissolved