Diclofenac sodium 25mg gastro-resistant tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Diclofenac sodium

Dostupno od:

DE Pharmaceuticals

ATC koda:

M01AB05

INN (International ime):

Diclofenac sodium

Doziranje:

25mg

Farmaceutski oblik:

Gastro-resistant tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 10010100

Uputa o lijeku

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 only.
Do not pass it on to others. It may harm them, even
if their signs of illness 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.
IN THIS LEAFLET
1. What DICLOFENAC SODIUM 25MG is and what
it is used for
2. What you need to know before you take
DICLOFENAC SODIUM 25MG
3. How to take DICLOFENAC SODIUM 25MG
4. Possible side effects
5. How to store DICLOFENAC SODIUM 25MG
6. Contents of the pack and other information
1. WHAT DICLOFENAC SODIUM IS AND WHAT IT
IS USED FOR
Diclofenac
sodium,
the
active
ingredient
in
DICLOFENAC SODIUM 25MG, is one of a group
of medicines called non-steroidal anti-inflammatory
drugs
(NSAIDs).
NSAIDs
reduce
pain
and
inflammation.
DICLOFENAC SODIUM 25MG tablets relieve pain,
reduce swelling and ease inflammation in conditions
affecting the joints, muscles and tendons including:
• Rheumatoid
arthritis,
osteoarthritis,
acute
gout
(painful inflammation of the joints especially in the
feet and hands), ankylosing spondylitis (form of
spinal arthritis).
• Backache, sprains and strains, soft tissue sports
injuries, frozen shoulder, dislocations and fractures
• Conditions
affecting
the
tendons
for
example,
tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation
associated with dental and minor surgery.
In children aged 1-12 years DICLOFENAC SODIUM
25 mg tablets are used to treat juvenile chronic
arthritis.
In children aged 9 years and above DICLOFENAC
SODIUM 25 mg tablets are used for short term
treatment of fever related to infections of the ear,
nose or throat, and for relief of acute post-operative
pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE DI

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diclofenac Sodium 25 mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric-coated tablet contains Diclofenac Sodium 25 mg.
Each tablet contains 30.00 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant Tablets.
The tablets are 6.60 to 7.00 mm in diameter, round, pale yellow,
enteric coated tablets,
plain on both the sides.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_Adults and Elderly: _
Relief of all grades of pain and inflammation in a wide range of
conditions, including:
i.
arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, acute gout,
ii.
acute musculo-skeletal disorders such as periarthritis (for example
frozen
shoulder), tendinitis, tenosynovitis, bursitis,
iii.
other painful conditions resulting from trauma, including fracture,
low back
pain, sprains, strains, dislocations, orthopaedic, dental and other
minor
surgery.
_Children (aged 1-12 years): _Juvenile chronic arthritis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4
Special
warnings and precautions for use).
For oral administration
75-150mg daily in two or three divided doses.
The recommended maximum daily dose of diclofenac is 150mg.
SPECIAL POPULATIONS
ELDERLY
Although the pharmacokinetics of diclofenac are not impaired to any
clinically
relevant extent in elderly patients, nonsteroidal anti-inflammatory
drugs
should be used with particular caution in such patients who generally
are more
prone to adverse reactions. In particular it is recommended that the
lowest
effective dosage be used in frail elderly patients or those with a low
body
weight (see also precautions) and the patient should be monitored for
GI
bleeding during NSAID therapy.
RENAL IMPAIRMENT
Diclofenac is contraindicated in patients with severe renal imp