MOTIFINE CAPSULES

Država: Južnoafrička Republika

Jezik: engleski

Izvor: South African Health Products Regulatory Authority (SAHPRA)

Dostupno od:

Biotech Laboratories (Pty) Ltd

Doziranje:

See ingredients

Farmaceutski oblik:

CAPSULES

Sastav:

EACH CAPSULE CONTAINS DICLOFENAC SODIUM 75,0 mg

Status autorizacije:

Registered

Datum autorizacije:

2017-06-02

Uputa o lijeku

Biotech Laboratories (Pty) Ltd
hard capsules
Each capsule contains 75 mg diclofenac sodium
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
MOTIFINE 75 MG CAPSULES
DICLOFENAC SODIUM
SUGAR FREE.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU:
MOTIFINE is available without a doctor’s prescription, for you to
treat a mild illness. Nevertheless,
you still need to use MOTIFINE carefully to get the best results from
it.
•
Keep this leaflet. You may need to read it again.
•
Do not share MOTIFINE with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
3 days.
WHAT IS IN THIS LEAFLET:
1.
What MOTIFINE is and what it is used for
2.
What you need to know before you take MOTIFINE
3.
How to take MOTIFINE
4.
Possible side effects
5.
How to store MOTIFINE
6.
Contents of the pack and other information
1.
WHAT MOTIFINE IS AND WHAT IT IS USED FOR
MOTIFINE belongs to a group of medicines called nonsteroidal
anti-inflammatory drugs (NSAIDs).
NSAIDs relieves pain and inflammation. MOTIFINE is used for the
emergency treatment of acute
gout attacks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOTIFINE
DO NOT TAKE MOTIFINE:
•
If you are hypersensitive (allergic) to diclofenac or any of the other
ingredients of MOTIFINE
(listed in section 6).
•
If you are hypersensitive to other anti-inflammatory medication
including aspirin.
•
If you have severe liver or kidney impairment.
Biotech Laboratories (Pty) Ltd
hard capsules
Each capsule contains 75 mg diclofenac sodium
Page 2 of 9
•
If you are pregnant or breastfeeding your baby (see “Pregnancy and
breastfeeding”).
•
If you have heart failure (when the heart is incapable to supply
sufficient blood flow to meet the
body's needs), established ischaemic heart disease (reduced blood
supply to your heart) and/or
stroke and peripheral arterial disease (narrowing of the arteries
resulting in reduced blood flo

Svojstava lijeka

Biotech Laboratories (Pty) Ltd
hard capsules
Each capsule contains 75 mg diclofenac sodium
Page 1 of 13
PROFESSIONAL INFORMATION FOR MOTIFINE
SCHEDULING STATUS
S2
1.
NAME OF THE MEDICINE
MOTIFINE 75 MG CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 75 mg diclofenac sodium (25 mg as enteric coated
pellets and 50 mg as
sustained release pellets).
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, hard.
Hard gelatine capsules (size 2) with light blue opaque cap and
colourless transparent body marked
in white print “D75M”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MOTIFINE is indicated for the emergency treatment of acute gout
attacks.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use the lowest effective dose for the shortest possible duration of
treatment.
_Adults _
One capsule daily. Dose may be increased to two capsules daily, if
necessary, with a maximum
daily dose of 150 mg. The first dose should be taken in the morning
with breakfast and the second
if required 8 - 12 hours later. The maximum treatment period of 3 days
should not be exceeded.
_Children _
Not for use in children.
_Elderly _
Biotech Laboratories (Pty) Ltd
hard capsules
Each capsule contains 75 mg diclofenac sodium
Page 2 of 13
Elderly patients are at increased risk of the serious consequences of
adverse reactions. If
MOTIFINE is considered necessary, the lowest effective dose should be
used and for the shortest
possible duration. The patient should be monitored regularly for
gastrointestinal bleeding during
MOTIFINE therapy.
METHOD OF ADMINISTRATION
For oral administration.
The capsules should be swallowed whole with a liberal quantity of
liquid.
To be taken preferably with or after food.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to diclofenac sodium or to any of the excipients
listed in section 6.1.
•
Previous hypersensitivity reactions (e.g., asthma, urticaria,
angioedema or rhinitis) in response
to ibuprofen, aspirin or other nonsteroidal anti-inflamm