Diclac Retard 100 mg Prolonged-release 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:

100 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:

1992-03-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLAC RETARD 100MG PROLONGED-RELEASE TABLETS
DICLOFENAC SODIUM
WHAT IS IN THIS LEAFLET
1.
What Diclac Retard is and what it is used for
2.
What you need to know before you take Diclac Retard
3.
How to take Diclac Retard
4.
Possible side effects
5.
How to store Diclac Retard
6.
Contents of the pack and other information
1
WHAT DICLAC RETARD IS AND WHAT IT IS USED FOR
Diclac Retard is a prolonged release tablet.
Diclac Retard belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs),
which are used to treat pain and inflammation.
Diclac Retard 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 Retard
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 RETARD
•
SOME PEOPLE MUST NOT USE DICLAC. TALK TO YOUR DOCTOR IF:-
-
you think you may be allergic to aspirin, diclofenac sodium, 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
-
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 esta

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 Retard 100 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 100mg of diclofenac sodium.
Excipients: Each tablet contains lactose monohydrate 98.1mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged Release Tablets
White, round and biconvex 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 , ankylosing spondylitis, osteoarthritis
and spondylarthritis, psoriatic arthropathy, painful syndromes of the
vertebral column, non- articular rheumatis

acute musculoskeletal disorders such as periarthritis (e.g. frozen
shoulder) tendonitis, tenosynovitis, bursitis

other painful conditions resulting from trauma, including fracture,
low back pain, sprains, strains, dislocations,
orthopaedic dental and other minor surgery.

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 menorrhagia

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).
Method of administration:
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 prolonged-release 100mg or 2 tablets of
prolonged-released 75mg. This may be administered using a combination
of dosage forms, e.g. tablets and suppositories.
The recommended maximum daily dose is 150 mg.
In milder ca