Cataflam 50mg Coated Tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

DICLOFENAC POTASSIUM

Saadav alates:

NM Pharma Limited 3/4, Cantrija Complex Triq it-Targa, il-Maghtab Naxxar NXR 6613 , Malta

ATC kood:

M01AB05

INN (Rahvusvaheline Nimetus):

DICLOFENAC POTASSIUM 50 mg

Ravimvorm:

TABLET

Koostis:

DICLOFENAC POTASSIUM 50 mg

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Toote kokkuvõte:

Licence number in the source country: Ireland - PA0896/004/001

Volitamisolek:

Authorised

Loa andmise kuupäev:

2018-11-15

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
CATAFLAM® 50 MG COATED TABLETS
(diclofenac potassium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 onto
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.
•
This medicine will be referred to as Cataflam in this leaflet.
WHAT IS IN THIS LEAFLET?
1. What Cataflam is and what it is used for
2. What you need to know before you take Cataflam
3. How to take Cataflam
4. Possible side effects
5. How to store Cataflam
6. Contents of the pack and other information
1. WHAT CATAFLAM IS AND WHAT IT IS USED FOR
Diclofenac potassium, the active ingredient in Cataflam is one of a
group of medicines called “non-
steroidal anti-inflammatory drugs” (NSAIDs). NSAIDs reduce pain and
inflammation. They have no effect
on the causes of inflammation.
Cataflam is used to treat a number of painful conditions including:
•
joint, muscle or tendon pain
•
attacks of gout
•
pain and swelling caused after surgery
•
sprains, strains and other injuries
•
gynaecology problems such as period pain
•
painful ear, nose or throat infections
•
migraine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CATAFLAM
DO NOT TAKE CATAFLAM IF:
•
you think you may be allergic to diclofenac potassium or to any of the
other ingredients of Cataflam
(listed in Section 6). Signs of a hypersensitivity reaction include
swelling of the face and mouth
(angioedema), breathing problems, chest pain, runny nose, skin rash or
any other allergic type
reaction
•
you have now, or have ever had, a stomach (gastric) or duodenal
(peptic) ulcer, or bleeding in the
gut (digestive tract). This can inc

Toote omadused

Health Products Regulatory Authority
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cataflam 50mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg diclofenac potassium.
Each tablet also contains 67mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet (Tablet).
Circular, biconvex, reddish brown sugar coated tablets approximately
8.8mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of all grades of pain and inflammation in the
following acute conditions:
•
Post-traumatic pain, inflammation and swelling, e.g. due to sprains.
•
Acute musculo-skeletal disorders such as periarthritis (for example
frozen shoulder), tendonitis,
tenosynovitis, bursitis.
•
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 and
associated menorrhagia.
•
Migraine attacks.
•
Acute gout
•
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
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4). The tablets should be swallowed whole with
liquid, preferably before meals, and must not be
divided or chewed.
ADULTS
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 mg. A dose of 50 to 100
mg should be given initially