Diclofenac sodium 25mg gastro-resistant tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Diclofenac sodium

Verfügbar ab:

Mawdsley-Brooks & Company Ltd

ATC-Code:

M01AB05

INN (Internationale Bezeichnung):

Diclofenac sodium

Dosierung:

25mg

Darreichungsform:

Gastro-resistant tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 10010100

Gebrauchsinformation

This section is continued overleaf
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. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT DICLOFENAC TABLETS CONTAIN:
•
The active ingredient is diclofenac sodium 25 mg
•
The
other
ingredients
are
Lactose
Monohydrate,
Povidone
(K30),
Maize
starch,
Sodiu

Fachinformation

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