Diclac 50 mg Gastro-resistant Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diclofenac sodium

Available from:

Rowex Ltd

ATC code:

M01AB; M01AB05

INN (International Name):

Diclofenac sodium

Dosage:

50 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

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 50MG GASTRO-RESISTANT TABLETS
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 fractures, low back pain, sprains,
strains, dislocations, orthopaedic
or dental surgery
•
pain and swelling after surgery
•
painful menstrual periods
•
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 type of
allergic reaction. .
-
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.
-
you suffer from severe kidney or liver disease
-
you suffer from severe heart failure
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT

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 50 mg Gastro-resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains diclofenac sodium 50 mg.
Excipients: Each tablet contains lactose monohydrate 30mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablets.
Yellow-brown, round film-coated gastro-resistant tablets.
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, spondylarthritis
and psoriatic arthropathy.

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.

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).
As a general recommendation, the dose should be individually adjusted
and the lowest effective dose given for the shortest
possible duration.
Route of Administration:
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be divided or chewed.
ADULTS:
DICLAC 50 mg: 75-150mg daily in two or three divided doses. The
recommended maximum daily dose is 150 mg. This may be
administered using a combination of dosage forms, e.g. tablets and
suppositories