Motifene 75mg modified-release capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diclofenac sodium

Available from:

Glenwood GmbH

ATC code:

M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

75mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5015494137564

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOTIFENE
® 75 MG CAPSULES
DICLOFENAC SODIUM
_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, please ask your doctor or
pharmacist. _

_This medicine has been prescribed for you_
_only. Do not give it to anyone else. 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. _
WHAT IS IN THIS LEAFLET:
1.
What Motifene is and what it is used for
2.
What you need to know before you take Motifene
3.
How to take Motifene
4.
Possible side effects
5.
How to store Motifene
6.
Contents of the pack and other information
1. WHAT MOTIFENE IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active ingredient in Motifene, is one of a
group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain
and inflammation. Some
of the pellets inside the Motifene capsule shell release diclofenac
quickly to give a rapid effect
(gastro-resistant pellets). The remainder of the pellets dissolve more
slowly to produce a longer
lasting effect (prolonged release pellets).
Motifene can be used for the treatment of pain and inflammation due
to:

Acute attacks of gout

Acute musculo-skeletal disorders (for example frozen shoulder,
inflamed tendons)

Dental or other minor surgery

Joint disorders (such as ankylosing spondylitis, osteoarthritis,
rheumatoid arthritis)

Traumatic conditions (including sprains, strains, dislocations,
fractures)

Low back pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOTIFENE
DO NOT TAKE MOTIFENE:

if you have had an allergic reaction to any of the ingredients in
Motifene (see ‘What Motifene
contains’ below in section 6)

if you have had an allergic r

Summary of Product characteristics

OBJECT 1
MOTIFENE 75MG
Summary of Product Characteristics Updated 10-Jan-2018 | Daiichi
Sankyo UK Limited
1. Name of the medicinal product
Motifene 75 mg Capsules
2. Qualitative and quantitative composition
Each capsule contains 75 mg diclofenac sodium (25 mg as
gastro-resistant pellets and 50 mg as prolonged
release pellets).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
Size 2 hard gelatin capsule with a light blue opaque cap and
colourless transparent body, containing white
to cream-coloured pellets. The capsules are printed “D75M” in
white.
4. Clinical particulars
4.1 Therapeutic indications
Motifene is indicated for the treatment of rheumatoid arthritis;
osteoarthrosis; low back pain; 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.
4.2 Posology and method of administration
Posology
For oral administration.
The capsules should be swallowed whole with a liberal quantity of
liquid.
To be taken preferably with or after food.
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).
_Adults:_
One capsule daily. Dose may be increased to two capsules daily if
necessary. The first dose should be
taken in the morning with breakfast and the second if required 8-12
hours later.
_Paediatric population:_
The safety and efficacy of Motifene in children and adolescents below
18 years have not yet been
established.
_Older People (age 65 years or over):_
Older people are at increased risk of the serious consequences of
adverse reactions. If an NSAID is
considered necessary, the lowest effective dose should be used and for
the shortest possible duration. The
patient should be monitored regularl