DIFENE 100 Milligram Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DICLOFENAC SODIUM

Available from:

Astellas Pharma Co. Ltd

ATC code:

M01AB05

INN (International Name):

DICLOFENAC SODIUM

Dosage:

100 Milligram

Pharmaceutical form:

Suppositories

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances

Authorization status:

Authorised

Authorization date:

2006-06-13

Patient Information leaflet

51734239
1.
2.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT 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. 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, talk to your doctor or
pharmacist. This includes any possible side ef-
fects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Difene is and what it is used for
2. What you need to know before you use Difene
3. How to use Difene
4. Possible side effects
5. How to store Difene
6. Contents of the pack and other information
1. WHAT DIFENE IS AND WHAT IT IS USED FOR
Difene contains diclofenac sodium as the active in-
gredient, which is a non-steroidal anti-inflammatory
drug (NSAID).
This means that it is a painkilling medicine which
reduces inflammation and swelling, but it does not
contain any steroid medicine.
Difene
suppositories
are
used
rectally
in
the
symptomatic management of rheumatoid arthritis
including juvenile chronic arthritis, osteoarthritis,
ankylosing spondylitis, psoriatic arthropathy, low
back
pain
and
acute
musculoskeletal
disorders
including
peri-arthritis,
tendonitis,
tenosynovitis,
bursitis, sprains, strains, dislocations and in acute
gout.
It can also be used to treat pain and inflammation
after orthopaedic, dental or other minor surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIFENE SUPPOSITORIES
DO NOT TAKE DIFENE IF YOU:
•
are allergic (hypersensitive) to diclofenac or any
of the other ingredients of this medicine (listed in
section 6).
•
have ever had an allergic reaction (difficulty in
breathing, skin rash and runny nose) to aspirin
(acetylsalicylic acid) or any other NSAID such as
ibuprofen.
•
have
had
any
gastrointestinal
problems
after
taking any other NSAID, e.g. vomiting blood or
passing black, tarry stools.
•
ha

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Difene 100mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains diclofenac sodium 100mg.
Each suppository contains 100mg of diclofenac sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
White torpedo-shaped rectal suppositories consisting of a waxy base weighing approximately 2 g.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Difene can be used in the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis,
osteoarthritis, ankylosing spondylitis, psoriatic arthropathy, low back pain and acute musculoskeletal disorders
including peri-arthritis, tendinitis, tenosynovitis, bursitis, sprains, strains, dislocations and in acute gout.
It can also be of use in the management of post operative pain and inflammation in orthopaedic, dental and other minor
surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For rectal use only.
Adults: The usual dosage is 100 mg inserted into the rectum in the evening.
Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The
lowest dose compatible with adequate safe clinical control should be employed (see section 4.4, Special warnings and
precautions for use).
Children: Use in children or adolescents is not recommended.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control
symptoms. See also section 4.4, Special warnings and precautions for use.
Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Active gastric or i