Diclofenac sodium 50mg gastro-resistant tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Medreich Plc

ATC code:

M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

50mg

Pharmaceutical form:

Gastro-resistant tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5060292741710 5060242741722

Patient Information leaflet

Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation
of the inside of the mouth or lips, taste changes, lower gut disorders
(including inflammation of the colon or worsening of ulcerative
colitis
or Ischaemic colitis or Crohn’s disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension
(high
blood pressure), inflammation of blood vessels (vasculitis),
inflammation
of the lung (pneumonitis), heart disorders, including congestive heart
failure or heart attack, blood disorders (including anaemia).
Effects on the liver or kidneys: Kidney or severe liver disorders
including liver failure, presence of blood or protein in the urine.
Effects on skin or hair: Serious skin rashes including Stevens-Johnson
syndrome and Lyell’s syndrome and other skin rashes which may be
made worse by exposure to sunlight.
Hair loss.
OTHER SIDE EFFECTS THAT HAVE ALSO BEEN REPORTED INCLUDE:
Inflammation
of
the
pancreas,
impotence.
Facial
swelling,
inflammation of the lining of the brain (meningitis), stroke, throat
disorders, confusion, hallucinations, malaise (general feeling of
discomfort), inflammation of the nerves of the eye.
REPORTING OF SIDE EFFECTS:
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly
via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side-effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE DICLOFENAC TABLETS
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date which is stated on the
outer packaging. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diclofenac Sodium 50 mg Gastro-resistant Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated tablet contains Diclofenac Sodium 50 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gastro-resistant tablets.
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:_ Not recommended.
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
ADULTS:
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 impairment
(see
section 4.3). No specific studies have been carried out in patients
with renal
impairment, therefore, no specific dose adjustment recommendations can
be
made. Caution is advis