Diclofenac potassium 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac potassium

Available from:

Accord-UK Ltd

ATC code:

M01AB05

INN (International Name):

Diclofenac potassium

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5012617016225

Patient Information leaflet

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[e-mail]
R.Paul
07.09.2022
04.10.2022
R.Paul
170 x 320
8pts
Specifar S.A.
07.09.2022
DICLOFENAC POTASSIUM 25MG & 50MG 28 (4X7) TABLETS PIL FOR BLISTERS -
UK
Black
Profile
BBBB5584
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Version 7
12.02.2020
Cartons and label leaflets only
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German GTIN 14
(incorporating PZN):
BBBB5584
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DICLOFENAC POTASSIUM 25MG & 50MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
•
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
_Continued over page_
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 belongs to a group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce
pain and inflammation in the following conditions:
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diclofenac Potassium 25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of diclofenac potassium
Also contains:
Lecithin Soya E322.
0.075 mmol (2.92mg) potassium per 25mg tablet.
0.37mg sodium per 25mg tablet.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablets
Pink, circular, coated, biconvex tablets, diameter 6mm
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
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
It is recommended that the tablets be taken with fluid, preferably
with or after
food.
ADULTS
The recommended daily dose is 100-150mg in two or three divided doses.
For
milder cases, 75-100mg daily in two or three divided doses is usually
sufficient.
In migraine an initial dose of 50mg 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 50mg may be taken. If needed, further
doses of
50mg may be taken at intervals of 4-6 hours, not exceeding a total
dose of
200mg per day.
SPECIAL POPULATIONS
PAEDIATRIC POPULATION
For children over 14 years of age, the recommended daily dose is
75-100mg in
two or three divided doses. Diclofenac Potassium Tablets are not
recommended for children under 14 years of age.
The use of Diclofenac Potassium tablets in migr