Diclo 75mg prolonged release tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Diclofenac sodium

Saatavilla:

Pinewood Laboratories Ltd

ATC-koodi:

M01AB; M01AB05

INN (Kansainvälinen yleisnimi):

Diclofenac sodium

Annos:

75 milligram(s)

Lääkemuoto:

Prolonged-release tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Acetic acid derivatives and related substances; diclofenac

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

1999-05-27

Pakkausseloste

PATIENT INFORMATION LEAFLET
DICLO 75 MG PROLONGED RELEASE TABLETS
DICLOFENAC SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
This medicine has been prescribed for you only. 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. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Diclo tablets are and what they are used for
2.
What you need to know before you take Diclo tablets
3.
How to take Diclo tablets
4.
Possible side effects
5.
How to store Diclo tablets
6.
Contents of the pack and other information
1.
WHAT DICLO TABLETS ARE AND WHAT THEY ARE USED FOR
Diclo tablets contain the active ingredient diclofenac sodium which is
a non-steroidal anti-
inflammatory drug (NSAID). It is used for the treatment of severe pain
and inflammation of the
following conditions:
•
osteoarthritis, rheumatoid arthritis, ankylosing spondylitis
(characterised by painful and stiff joints),
spondylarthritis, psoriatic arthropathy, painful syndrome of the
vertebral column, non-articular
rheumatism
•
acute gout
•
frozen shoulder, back pain, tendonitis, bursitis (inflammation of the
joints, commonly the knees and
elbows)
•
bone fractures, sprains, strains, dislocations, dental or other minor
surgery
•
painful menstruation (period pain).
These tablets are prolonged-release which means they are designed to
deliver a dose of a medication
over an extended period.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLO TABLETS
DO NOT TAKE DICLO TABLETS IF YOU:
•
are allergic to diclofenac sodium or any of the other ingredients of
this medicine (
_listed in section 6 _
_and end of Section 2_
)
•
are allergic to aspirin or any other NSAIDs (e.g. ibuprofen), seen as
a red skin rash, wheezing,
as

Valmisteyhteenveto

Health Products Regulatory Authority
02 December 2022
CRN00D6GP
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclo 75mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of Diclofenac Sodium in a prolonged release
formulation.
Excipients: each tablet contains lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Round, flat, two-layered pink and white coloured, prolonged release
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, ankylosing spondylitis, osteoarthritis and
spondylarthritis, psoriatic arthropathy, painful syndrome of the
vertebral column, non-articular rheumatism
- Acute musculo-skeletal disorders such as periarthritis (for example
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).
For oral administration. The tablets should be swallowed whole with
liquid, preferably with meals and must not be divided or
chewed.
Adults: The recommended initial daily dose is one or two tablets
daily.
The recommended maximum dose is 150mg.
In milder cases, as well as for long-term therapy, 75mg is usually
sufficient.
Where the symptoms are most pronounced during the night or in the
morning, Diclo 75mg prolonged release tablets should
preferably be taken in the evening.
_Elderly (patients aged 65 or above): _Although the pharmacokineti