Diclac 100mg Suppositories
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-12-2022
Summary of Product characteristics
(SPC)
07-12-2022
Active ingredient:
Diclofenac sodium
Available from:
Rowex Ltd
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:
Marketed
Authorization date:
1992-03-05
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLAC 100 MG SUPPOSITORIES
DICLOFENAC SODIUM
WHAT IS IN THIS LEAFLET
1.
What Diclac is and what it is used for
2.
What you need to know before you take Diclac
3.
How to take Diclac
4.
Possible side effects
5.
How to store Diclac
6.
Contents of the pack and other information
1
WHAT DICLAC IS AND WHAT IT IS USED FOR
Diclac belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs), which
are used to treat pain and inflammation.
Diclac relieves symptoms of inflammation, such as swelling and pain
and also reduces fever. It has no
effect on the cause of inflammation or fever. Diclac can be used to
treat the following conditions:
•
inflammatory conditions such as rheumatoid arthritis, osteoarthritis
•
acute musculoskeletal disorders such as frozen shoulder or tendinitis
•
other painful conditions such as low back pain, sprains, strains,
dislocations, orthopaedic or dental
surgery
•
pain and swelling after surgery
•
painful menstrual periods
•
migraine
•
attacks of gout
•
painful ear, nose and throat infections.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLAC
SOME PEOPLE MUST NOT USE DICLAC. TALK TO YOUR DOCTOR IF:
-
-
you think you may be allergic to diclofenac sodium, aspirin, ibuprofen
or any other NSAID or to any
of the other ingredients of Diclac. (These are listed at the end of
the leaflet) 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. If you think you
may be allergic, ask your doctor for advice.
-
you have now, or have ever had, a stomach (gastric) or duodenal
(peptic) ulcer, or bleeding in the
gut (digestive tract). This can include blood in vomit, bleeding when
emptying bowels, fresh blood
in stools or black tarry stools. This may have been when you used an
NSAID before.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
07 December 2022
CRN00D6H1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclac 100mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 100mg of diclofenac sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
White to cream coloured torpedo shaped suppositories, odourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of all grades of pain and inflammation in a wide range of
conditions.
Treatment of:
Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, juvenile rheumatoid arthritis,
ankylosing spondylitis, osteoarthritis and spondylarthritis, psoriatic
arthropathy, painful syndromes of the vertebral
column, non-articular rheumatism.
Acute attacks of gout.
Post-traumatic and 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.
Acute musculo-skeletal disorders such as periarthritis (for example
frozen shoulder), tendonitis, tenosynovitis,
bursitis.
Migraine attacks.
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 Special warnings and precautions for use).
The suppositories should be inserted well into the rectum. It is
recommended to use the suppository after passing stools.
Not to be taken by mouth as for rectal use only.
ADULTS:
The recommended initial daily dosage is 100 to 150 mg. In milder
cases, as well as for long-term therapy, 75 to 100
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