Cataflam 50mg sugar-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DICLOFENAC POTASSIUM

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

M01AB05

INN (International Name):

DICLOFENAC POTASSIUM 50 mg

Pharmaceutical form:

COATED TABLET

Composition:

DICLOFENAC POTASSIUM 50 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2005-07-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CATAFLAM
®
25 mg sugar-coated tablets.
CATAFLAM
®
50 mg sugar-coated tablets.
DICLOFENAC POTASSIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
-
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 affects 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 Catatflam Tablets are and what they are used for
2
What you need to know before you take Cataflam Tablets
3
How to take Cataflam Tablets
4
Possible side effects
5
How to store Cataflam Tablets
6
Contents of the pack and other 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 sprains and
strains, soft tissue sports
injuries, frozen shoulder, dislocations, and fractures, and other
forms of soft-tissue
rheumatism.
•
Conditions affecting the tendons for example tendonitis, tenosynovitis
bursitis.
•
Painful inflammatory conditions in gynaecology, including painful
menstrual periods.
•
Infections of the ear, nose, or throat.
They are also used to treat pain and inflammation associated with
orthopaedic, dental and
other minor surgery.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CATAFLAM TABLETS
Tell your doctor if you recentl

Summary of Product characteristics

Novartis Pharma Services Inc
Malta
CATAFLAM
®
(DICLOFENAC POTASSIUM)
25 mg and 50 mg Sugar-coated tablets
SUMMARY OF PRODUCT CHARACTERISTICS
Novartis
Page 2
Cataflam® 25mg & 50mg Coated Tablets
1
TRADE NAME(S)
CATAFLAM 25 mg sugar-coated tablets.
CATAFLAM
50 mg sugar-coated tablets.
2 DESCRIPTION AND COMPOSITION
The active substance 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 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
DOSAGE AND ADMINISTRATION
DOSAGE
As a general recommendation, the dose should be individually adjusted.
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).
GENERAL TARGET POPULATION: ADULTS
Novartis
Page 3
Cataflam® 25mg & 50mg Coated Tablets
The recommended initial daily dose is 100 to 150 mg. In milder cases,
75 to 100 mg daily
is usually sufficient.
The total daily dose should generally be divided in 2 to 3 doses.
In primary dysmenorrhoea, the daily dose should be individually
adjusted and is generally
50 to 150