Voltaren D

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Diclofenac 46.5mg (as free acid = 50mg diclofenac sodium);  

Disponible des:

Novartis New Zealand Ltd

Designació comuna internacional (DCI):

Diclofenac 46.5 mg (as free acid = 50mg diclofenac sodium)

Dosis:

50 mg

formulario farmacéutico:

Dispersible tablet

Composición:

Active: Diclofenac 46.5mg (as free acid = 50mg diclofenac sodium)   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hydrogenated castor oil Microcrystalline cellulose Purified talc Sodium starch glycolate

Unidades en paquete:

Blister pack, Physican's sample, 5 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Novartis Grimsby Limited

indicaciones terapéuticas:

Latest Regulatory Activity

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, Physican's sample - 5 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC - 20 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC - 20 tablets - 24 months from date of manufacture stored at or below 25°C

Data d'autorització:

1992-09-22

Informació per a l'usuari

__________________________________________________________________________________________________
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

Fitxa tècnica

NEW ZEALAND DATA SHEET
Page 1 of 14
1
PRODUCT NAME
VOLTAREN®
D 50 mg Dispersible tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 46.5 mg of diclofenac free acid,
which is equivalent to 50 mg of
diclofenac sodium.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Dispersible tablets.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short‐term treatment of the following acute conditions:

Post‐operative inflammation and pain, e.g. following dental or
orthopaedic surgery.

Painful post‐traumatic inflammatory states, e.g. due to sprains.

Flare‐up of osteoarthritis.

Acute attacks of gout.

Non‐articular rheumatism.

Painful syndromes of the vertebral column.

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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Voltaren D 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 2 to 3 Voltaren D dispersible
tablets. In milder cases, 2 Voltaren
D dispersible tablets daily are usually sufficient. The total daily
dose should generally be divided into
2 to 3 separate doses.
In primary dysmenorrhoea, the daily dose should be individually
adjusted and is generally 1 to 3
Voltaren D dispersible tablets. A dose of 1 to 2 tablets should be
given initially and, if necessary,
increased over the course of