Difene 100mg Suppositories

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Glenwood GmbH

ATC code:

M01AB; M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

100 milligram(s)

Pharmaceutical form:

Suppository

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Acetic acid derivatives and related substances; diclofenac

Authorization status:

Not marketed

Authorization date:

1990-08-28

Patient Information leaflet

Page 1 of 8
Package Leaflet – Difene 100 mg Suppositories – Glenwood GmbH
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFENE 100 MG SUPPOSITORIES
(DICLOFENAC SODIUM)
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. 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 effects
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 ingredient, 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

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2023
CRN00D67H
Page 1 of 9
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 intestinal ulcer, bleeding or perforation.
- History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy. Active, or history