Diclofenac sodium 25mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Actavis UK Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

25mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

This section is continued overleaf
READ ALL OF THESE 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,
asks
your
doctor,
or
pharmacist, or nurse
•
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
•
The name of this medicine is Diclofenac Sodium 25 mg Gastro-
resistant Tablets but it will be referred to as Diclofenac Tablets
throughout this leaflet.
WHAT IS IN THIS LEAFLET
1. What Diclofenac Tablets are and what they are used for
2. What you need to know before you take Diclofenac Tablets
3. How to take Diclofenac Tablets
4. Possible side effects
5. How to store Diclofenac Tablets
6. Contents of the pack and other information
1. WHAT DICLOFENAC TABLETS ARE AND WHAT THEY ARE USED FOR
Diclofenac
tablṭets
contain
the
active
ingredient
Diclofenac
Sodium, which is part of a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). NSAIDs are used to reduce
pain and inflammation.
Diclofenac Tablets relieve pain, reduce swelling and ease inflammation
in conditions affecting the joints, muscles and tendons including:
-
rheumatoid
arthritis,
osteoarthritis,
acute
gout,
ankylosing
spondylitis
-
backache, sprains and strains, soft tissue sports injuries, frozen
shoulder, dislocations and fractures
-
tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation associated with
dental and minor surgery.
In children, Diclofenac Tablets are used to treat juvenile chronic
arthritis
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFENAC TABLETS
DO NOT TAKE DICLOFENAC TABLETS IF YOU:
•
are allergic to diclofenac sodium, aspirin, ibuprofen or any
other NSAID, or to any of the other ingredients of

Summary of Product characteristics

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