Voltaren SR

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Diclofenac sodium 100mg;  ;  

Предлага се от:

Novartis New Zealand Ltd

INN (Международно Name):

Diclofenac sodium 100 mg

дозиране:

100 mg

Лекарствена форма:

Modified release tablet

Композиция:

Active: Diclofenac sodium 100mg     Excipient: Cetyl alcohol Colloidal silicon dioxide Hypromellose Iron oxide red Magnesium stearate Opacode black S-1-17823 Polysorbate 80 Povidone Purified talc Sucrose Titanium dioxide

Броя в опаковка:

Blister pack, 30 tablets

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

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

Терапевтични показания:

· Treatment of inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism.

Каталог на резюме:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 60 months from date of manufacture, no storage statement needed

Дата Оторизация:

1983-09-29

Листовка

__________________________________________________________________________________________________
VOLTAREN

Page
1
of
6
VOLTAREN

50MG TABLETS (DICLOFENAC SODIUM)
75MG SR TABLETS (DICLOFENAC SODIUM)
50MG DISPERSIBLE TABLETS (DICLOFENAC FREE ACID)
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Voltaren
.
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)
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

Данни за продукта

NEW ZEALAND DATA SHEET
Page 1 of 14
1
PRODUCT NAME
VOLTAREN®
SR 75 mg Modified release tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet contains 75 mg of diclofenac sodium.
For the full list of excipients, see section 6.1
This product is not able to deliver all approved dose regimens.
3 PHARMACEUTICAL FORM
Modified release tablets.
Pale pink, triangular, prolonged‐release, film‐coated tablet
containing 75mg diclofenac sodium.
Dimensions: height: 8.5mm, width: 9.00mm. Branding: CG on one side and
ID on the other side in
black ink.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of:

Inflammatory
and
degenerative
forms
of
rheumatism:
rheumatoid
arthritis,
ankylosing
spondylitis, osteoarthritis and spondylarthritis, painful syndromes of
the vertebral column, non‐
articular rheumatism.

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.
4.2
DOSE AND METHOD OF ADMINISTRATION
This product is not able to deliver all approved dose regimens.
Voltaren SR 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
GENERAL POPULATION
The recommended initial daily dose is 100 to 150 mg, in 1 or 2 divided
doses.
In milder cases, as well as for long‐term therapy, 75 to 100 mg
daily is usually sufficient.
Where the symptoms are most pronounced during the night or in the
morning, Voltaren SR 75 mg
should preferably be taken in the evening.
SPECIAL POPULATIONS
_PAEDIATRIC POPULATION _
Because of their dosage strength, Voltaren SR tablets 75 mg are not
suitable for children and
adolescents.