Voltaren

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Diclofenac sodium 50mg;  

Tilgjengelig fra:

Novartis New Zealand Ltd

INN (International Name):

Diclofenac sodium 50 mg

Dosering :

50 mg

Legemiddelform:

Suppository

Sammensetning:

Active: Diclofenac sodium 50mg   Excipient: Hard fat

Enheter i pakken:

Blister pack, 10 suppositories

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Unique Chemicals (A Division of JB Chemicals & Pharmaceuticals Ltd)

Indikasjoner:

· 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.

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, - 10 suppositories - 36 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

1980-05-21

Informasjon til brukeren

__________________________________________________________________________________________________
VOLTAREN

Page
1
of
5
VOLTAREN
 SUPPOSITORIES
_12.5MG, 25MG, 50MG AND 100MG SUPPOSITORIES _
_DICLOFENAC SODIUM _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Voltaren
Suppositories
.
It does not contain all the available information
.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking it
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VOLTAREN IS USED FOR
Voltaren relieves pain and reduces inflammation (swelling and redness)
that may occur in the following:

different types of arthritis including rheumatoid arthritis and
osteoarthritis

other painful conditions where swelling is a problem such as back
pain, rheumatism, muscle strains, sprains and tendonitis
(eg. tennis elbow)

menstrual cramps (period pain)

migraine attacks
Voltaren belongs to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). These medicines can
relieve the symptoms of pain and inflammation but they will not cure
your condition.
Your doctor may prescribe Voltaren for another purpose.
Ask your doctor if you have any questions about why it has been
prescribed for you.
Voltaren is only available with a doctor's prescription. It is not
addictive.
BEFORE YOU TAKE VOLTAREN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VOLTAREN IF YOU HAVE AN ALLERGY TO:

diclofenac (the active ingredient in Voltaren) or any of the other
ingredients listed at the end of this leaflet

other medicines containing diclofenac (eg.Voltaren Emulgel)

aspirin/ acetylsalicylic acid

any other NSAID medicine
Many medicines used to treat headache, period pain and other aches and
pains contain aspirin or NSAID medicines. If you are
not sure i

Preparatomtale

NEW ZEALAND DATA SHEET
Page 1 of 15
1
PRODUCT NAME
VOLTAREN®
12.5 mg Suppositories
VOLTAREN® 25 mg Suppositories
VOLTAREN® 50 mg Suppositories
VOLTAREN® 100 mg Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg suppositories
Each suppository contains 12.5 mg of diclofenac sodium.
25 mg suppositories
Each suppository contains 25 mg of diclofenac sodium.
50 mg suppositories
Each suppository contains 50 mg of diclofenac sodium.
100 mg suppositories
Each suppository contains 100 mg of diclofenac sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suppositories.
Suppository strength
Approx. weight (mg)
Approx. length (cm)
12.5 mg
900
2.5
25 mg
1000
2.5
50 mg
2000
3
100 mg
2140
3
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC 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.
•
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.
NEW ZEALAND DATA SHEET
Page 2 of 15
•
Migraine attacks.
•
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
DOSE AND METHOD OF ADMINISTRATION
Voltaren should only be prescribed when the benefits are considered to
outweigh the potential risks.
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest possible duration should be used. Adverse effects may be
minimized by using the lowest
effective dose for the shortest duration necessary to control symptoms
(see section 4.4).
Dosage