Arthrosin 500 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naproxen

Available from:

Ashbourne Pharmaceuticals Ltd

ATC code:

M01AE02

INN (International Name):

Naproxen

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

CHILDREN
Do not give this medicine to children under 5 years old.
OTHER MEDICINES AND ARTHROSIN EC TABLETS
Tell your doctor or pharmacist if you are taking, or have
recently taken, or might take any other medicines, even
medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any
of
the
following
medicines,
as
they
may
affect
how
this
medicine works:

Aspirin or other NSAIDs for pain and swelling or
Probenecid to treat gout

Methotrexate to treat cancer

Medicines to prevent blood clots such as aspirin/
acetylsalicylic acid, warfarin

Medicines for high blood pressure or heart failure

Diuretics (water tablets) like furosemide

Medicines to suppress the immune system such as
Tacrolimus or steroid hormones

Medicines called Sulphonamides or Quinolone antibiotics
to treat bacterial infections

Zidovudine to treat viral infections

Digoxin to treat heart failure

Lithium for mental health problems

Medicines called Selective Serotonin Re-uptake Inhibitors
(SSRIs) for depression

Phenytoin for epilepsy

Medicines to increase urine production

Mifepristone for abortion

Bisphosphonates

Colestyramine.
If you go into hospital or have treatment for other conditions,
tell the doctor that you are taking Arthrosin EC Gastro-resistant
tablets.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
PREGNANCY
Do not take this medicine if you are in the last three months of
your pregnancy. Avoid these tablets if you are in first six
months of your pregnancy.
BREAST-FEEDING
If you are breast-feeding unless your doctor has advised you to
take them.
FERTILITY
Arthrosin EC may make it more difficult to become pregnant.
DRIVING AND USING MACHINES
Arthrosin EC Gastro-resistant tablets may cause dizziness,
drowsiness, tiredness, problems with your vision, depressed
or
difficulty
sleeping.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nycopren 500 mg
Naproxen 500 mg Gastro-resistant Tablets
Arthrosin EC 500
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Naproxen BP 500 mg
Excipients(s) with known effect
Each tablet contains 36.000 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablets for oral administration.
White oblong tablets with a break line engraved on one side with
approximately 16
mm diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
Naproxen is used in the treatment of rheumatoid arthritis,
osteoarthrosis (degenerative
arthritis), ankylosing spondylitis, acute gout and acute inflammatory
musculoskeletal
disorders.
Children
Naproxen is effective in the treatment of juvenile rheumatoid
arthritis in children over
5 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult dosage:
a)
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: 500 mg
to 1 g per day
taken in 2 doses at 12 hour intervals .
b)
In severe night-time pain and/or morning stiffness, in patients being
switched to
Naproxen from a high dose of another NSAID, or in osteoarthrosis where
pain is
the predominant symptom:
Loading dose of 750 mg – 1 g per day during the acute phase.
c)
Acute gout:
Initial dose of 750 mg at once then 250 mg every 6- 8 hours until the
attack has
passed.
d)
Acute inflammatory musculoskeletal disorders:
500 mg initially, followed by 250 mg 6- 8 hour in intervals as needed.
Maximum
daily dose is 1250 mg.
Paediatric population
For juvenile rheumatoid arthritis:
A dose of 10 mg per kg body weight daily in two divided doses taken in
children over
5 years of age with juvenile rheumatoid arthritis.
Naproxen is not recommended for use in any other indication in
children under 16
years of age.
Use in the elderly:
The elderly are at increased risk of the serious consequences of
adverse reactions. If
an NSAID is considered necessary, the lowest effective dose should be
used and fo