VOLTAREN SUPPOSITORY 50MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

10Units Units

Dikeluarkan oleh:

Delpharm Huningue S.A.S.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
VOLTAREN
® SUPPOSITORIES
Diclofenac Sodium (12.5 mg, 25 mg, 50 mg)
1
WHAT IS IN THIS LEAFLET
1.
WHAT VOLTAREN IS USED FOR
2.
HOW VOLTAREN WORKS
3.
BEFORE YOU USE VOLTAREN
4.
HOW TO USE VOLTAREN
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
VOLTAREN
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
WHAT VOLTAREN IS USED FOR
Voltaren belongs to a group of
medicines called “non-steroidal anti-
inflammatory drugs” (NSAIDs), which
are used to treat pain and inflammation
as listed below.
_Indicated for treatment of:_

Inflammatory and degenerative
forms of rheumatism: rheumatoid
arthritis (systemic inflammatory
disorder that affects joints), juvenile
rheumatoid arthritis, ankylosing
spondylitis (chronic inflammatory
disease of the skeleton),
osteoarthritis (degeneration joint
disease) and spondylarthritis
(inflammation of the joint), painful
syndromes of the vertebral column,
non-articular rheumatism
(musculoskeletal aches and pains
which do not arise from joints).

Acute attacks of gout.

Post-traumatic and post-operative
pain, inflammation and swelling.

Primary dysmenorrhea (period
pain).
HOW VOLTAREN WORKS
Voltaren relieves the symptoms of
inflammation, such as pain and
swelling, by blocking the synthesis of
the molecules (prostaglandins)
responsible for inflammation, pain and
fever. It has no
effect on the causes of
inflammation or fever.
BEFORE YOU USE VOLTAREN
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
-
_When you must not use it _

If you are allergic
(hypersensitive)
to diclofenac or to any of the other
ingredients of Voltaren listed at
the end of this leaflet.

If you have
ever had an allergic
reaction after taking medicines to
treat inflammation or pain (e.g.
acetylsalicylic acid/aspirin,
diclofenac or ibuprofen. Reactions
may include asthma, runny nose,
skin rash, swelling of

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
04-Aug-2021
Voltaren suppositories
VOLTAREN

Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid
derivative.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Suppositories
ACTIVE SUBSTANCE
The active substance is diclofenac sodium.
One suppository contains 12.5 mg, 25 mg, or 50 mg of diclofenac
sodium.
DESCRIPTION
White to yellowish torpedo shaped suppositories with smooth surface.
ACTIVE MOIETY
Diclofenac
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Hard fat.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of:

Inflammatory
and
degenerative
forms
of
rheumatism:
rheumatoid
arthritis,
juvenile
rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and
spondylarthritis, painful
syndromes of the vertebral column, non-articular rheumatism.

Acute attacks of gout.

Painful post-traumatic and post-operative inflammation and swelling.

Primary dysmenorrhoea.
DOSAGE AND ADMINISTRATION
DOSAGE
As a general recommendation, the dose should be individually adjusted.
Adverse effects may
be minimized by using the lowest effective dose for the shortest
duration necessary to control
symptoms (see section WARNINGS AND PRECAUTIONS)
Novartis
Page 3
Malaysia Package Leaflet
04-Aug-2021
Voltaren suppositories
GENERAL TARGET POPULATION: ADULTS
The recommended initial daily dose is 100 to 150 mg. In milder cases,
as well as for long-term
therapy, 75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 to 3 separate
doses. To suppress
nocturnal pain and morning stiffness, treatment with tablets during
the day can be supplemented
by the administration of a suppository at bedtime (up to a total
maximum daily dose of 150
mg).
In primary dysmenorrhea, the daily dose should be individually
adjusted and is generally 50 to
150 mg. A dose of 50 to 100 mg should be given initially and, if
necessary, increased over the
course of several menstrual cycles up to a maximum