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CATAFLAM® TABLETS 25 AND 50MG
(DICLOFENAC POTASSIUM)
PATIENT INFORMATION LEAFLET
WHAT YOU NEED TO KNOW ABOUT CATAFLAM TABLETS
Your doctor had decided that you need this medicine to help treat your condition.
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IT CONTAINS
IMPORTANT INFORMATION. Keep the leaflet in a safe place because you may need to read it
again.
If you have any other questions, or if there is something you don’t understand, please ask your
doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It may not be the
right medicine for them even if their symptoms seem to be the same as yours.
If any of the side effects affects you severely, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1
What Catatflam
Tablets are and what they are used for
2
Things to consier before you start to take Cataflam Tablets
3
How to take Cataflam Tablets
4
Possible side effects
5
How to store Cataflam Tablets
6
Further information
1 WHAT CATAFLAM TABLETS ARE AND WHAT THEY ARE USED FOR
Diclofenac potassium, the active ingredient in Cataflam Tablets, is one of a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and
inflammation by blocking synthesis of the molecules (prostaglandins).
Cataflam Tablets relieve pain, reduce swelling, reduce fever and ease inflammation in:
•
Painful syndromes of the vertebral column for example low back pain
•
Migraine
•
Conditions affecting the joints and muscles such as sprain
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
CATAFLAM
®
25 mg sugar-coated tablets.
CATAFLAM
®
50 mg sugar-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= diclofenac
potassium).
One sugar-coated tablet contains 25 mg or 50 mg of diclofenac potassium. In Cataflam the sodium
ion of diclofenac sodium (Voltaren
®
) has been replaced by a potassium ion.
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sugar-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment in the following acute conditions:
•
Post-traumatic pain, inflammation and swelling, e.g. due to sprains.
•
Post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery.
•
Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or
adnexitis.
•
Migraine attacks.
•
Painful syndromes of the vertebral column.
•
Non-articular rheumatism.
•
As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g.
pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease
should be treated with basic therapy, as appropriate. Fever alone is not an indication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
As a general recommendation, the dose should be individually adjusted and the lowest effective
dose given for the shortest possible duration.
The tablets should be swallowed whole with liquid, preferably before meals, and must not be
divided or chewed.
Undesira
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