Voltaren

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Diclofenac sodium 25mg;  ;  

Disponibil de la:

Novartis New Zealand Ltd

INN (nume internaţional):

Diclofenac sodium 25 mg

Dozare:

25 mg

Forma farmaceutică:

Enteric coated tablet

Compoziție:

Active: Diclofenac sodium 25mg     Excipient: Ammonia solution Colloidal silicon dioxide Hypromellose   Silicone antifoam emulsion (Enteric-coat)   Pigment Suspension White   Pigment Suspension White (Colour-coat) Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Methacrylic acid copolymer Microcrystalline cellulose Polyethylene glycol hydrogenated castor oil   Povidone Purified talc     Purified water     Sodium starch glycolate

Unități în pachet:

Blister pack, (not marketed), 100 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Novartis Grimsby Limited

Indicații terapeutice:

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 postoperative pain, inflammation, and swelling, e.g. following dental or orthopaedic surgery; painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis; 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.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Aluminium foil - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 50 tablets - 36 months from date of manufacture stored at or below 30°C

Data de autorizare:

1979-08-30

Prospect

__________________________________________________________________________________________________
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

Caracteristicilor produsului

NEW ZEALAND DATA SHEET
Page 1 of 15
1
PRODUCT NAME
VOLTAREN®
50 mg Enteric coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg Tablet: Each enteric coated tablet contains 50 mg of diclofenac
sodium.
List of excipients with known effect: lactose monohydrate
For the full list of excipients, see section 6.1
This product is not able to deliver all approved dose regimens.
3 PHARMACEUTICAL FORM
Enteric coated tablets.
50 mg Tablets: Light brown, round, slightly biconvex, enteric coated
tablets with bevelled edges.
Imprints: ‘GT’ on one side and ‘CG’ on the other side.
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.

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
This product is not able to deliver all approved dose regimens.
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
GENERAL POPULATION
NEW ZEALAND DATA SHEET
Page 2 of 15
The recommended initial daily dose is 100 to 150