Diclofenac potassium 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac potassium

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac potassium

Dosage:

50mg

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLOFENAC POTASSIUM 50MG TABLETS
DICLOFENAC POTASSIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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.
WHAT IS IN THIS LEAFLET:
1.
What Diclofenac potassium tablets are and what they are used for
2.
What you need to know before you take Diclofenac potassium tablets
3.
How to take Diclofenac potassium tablets
4.
Possible side effects
5.
How to store Diclofenac potassium tablets
6.
Contents of the pack and other information
1. WHAT DICLOFENAC POTASSIUM TABLETS ARE AND WHAT THEY ARE USED FOR
Diclofenac potassium tablets belong to a group of medicines called
non-steroidal anti-inflammatory drugs
(NSAIDs), which are used to reduce pain and inflammation in the
following conditions:

Sprains, strains and other injuries

Pain and inflammation following surgery

Gout

Other painful conditions affecting the joints and muscles such as
backache, rheumatoid arthritis,
osteoarthritis, ankylosing spondylytis and pyrophosphate arthropathy.
The tablets can also be used to relieve the symptoms associated with
migraine attacks in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLOFENAC POTASSIUM TABLETS
DO NOT TAKE DICLOFENAC POTASSIUM TABLETS IF YOU:

are allergic (hypersensitive) to diclofenac potassium or any of the
other ingredients in the tablet (see
section 6)

have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in
your stomach, or have had two
or more episodes of peptic ulcers, stomach bleeding or perforation

have previously had a reaction (ASTHMA, HIVES or a COLD) caused by an
allergy to salicylate

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diclofenac Potassium 50 mg Tablets
Adacium Rapid 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of diclofenac potassium
Also contains Lecithin Soya E322.
This medicine contains 0.150 mmol (5.85mg) potassium per 50mg tablet.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets
Reddish brown, circular, coated, biconvex tablets, diameter 9 mm
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
Osteoarthrosis
Low back pain
Migraine attacks
Acute musculo-skeletal disorders and trauma such as periarthritis
(especially frozen
shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and
dislocations; relief of
pain in fractures
Ankylosing spondylitis
Acute gout
Control of pain and inflammation in orthopaedic, dental and other
minor surgery
Pyrophosphate arthropathy and associated disorders
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
The recommended daily dose is 100 – 150 mg in two or three divided
doses.
For milder cases, 75 – 100 mg daily in two or three divided doses is
usually
sufficient.
In migraine an initial dose of 50 mg should be taken at the first
signs of an
impending attack. In cases where relief 2 hours after the first dose
is not
sufficient, a further dose of 50 mg may be taken. If needed, further
doses of 50
mg may be taken at intervals of 4 – 6 hours, not exceeding a total
dose of 200
mg per day.
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 in frail elderly patients or those with a low body
weight (also
see precautions) and for the shortest possible duration. The patient
should be
monitored regularly for GI bleeding during NSAID therapy.
_Paediatric population _
For children over 14 years of age, the recommended daily dose is 75
– 100 mg
in two or three divided doses.
Diclofenac Pota