Diclac 75 mg Prolonged-release Tablet

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:

75 milligram(s)

Pharmaceutical form:

Prolonged-release 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:

1999-05-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLAC 75MG PROLONGED RELEASE 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 75 mg is a prolonged release tablet.
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.
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 to any other NSAID, or to
any of the other ingredients of Diclac. (They 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.
-
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
-
you have established heart disease and/or cerebrovascular disease e.g.
if you have had

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 75 mg Prolonged-release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg diclofenac sodium.
Each tablet also contains 41.75mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Round, flat, two - layered pink and white coloured, prolonged release
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, ankylosing spondylitis,
osteoarthritis and spondylarthritis, psoriatic arthropathy, painful
syndromes of the vertebral column,
non-articular rheumatis
(ii) acute musculo-skeletal disorders such as periarthritis (for
example frozen shoulder), tendonitis,
tenosynovitis, bursitis;
(iii) other painful conditions resulting from trauma, including
fracture, low back pain, sprains, strains,
dislocations, orthopaedic, dental and other minor surgery;
(iv) post-traumatic and post operative pain, inflammation and swelling
e.g. following dental or orthopaedic
surgery;
(v) painful and/or inflammatory conditions in gynaecology, e.g.
primary dysmenorrhea or adnexitis and
menorrhagia
(vi) acute gout.
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 special precautions for
use).
Route of Administration:
Oral.
The tablets should be swallowed whole with liquid, preferably with
meals and must not be divided or chewed.
Recommended Dosage Schedule:
ADULTS: the recommended initial daily dose is 100 to 150mg,
administered as 1 tablet of diclofenac prolonged-released 100mg
or 2 tablets of diclofenac prolonged-released 75mg. This may be
administered using a combination of dosage forms, e.g.
tablets and suppositories.
The recommended maximum daily dose is 150mg.
Healt