VOLTAREN RAPID 12.5 diclofenac potassium 12.5 mg film coated tablet blister pack (reformulation)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

diclofenac potassium, Quantity: 12.5 mg

Available from:

Haleon Australia Pty Ltd

INN (International Name):

diclofenac potassium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; stearic acid; lactose monohydrate; colloidal anhydrous silica; titanium dioxide; povidone; microcrystalline cellulose; magnesium stearate; maize starch; hypromellose

Administration route:

Oral

Units in package:

10, 20

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

Temporary relief of painful conditions such as headache, dental pain, period pain, rheumatic and muscular pain, backache. Temporary relief of symptoms of colds and flu (including aches and pains, sore throat pain). Reduces fever.

Product summary:

Visual Identification: White, oblong (capsule shaped) film-caoted tablet; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-01-15

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
VOLTAREN RAPID 12.5 (DICLOFENAC POTASSIUM) TABLET
1
NAME OF THE MEDICINE
Diclofenac potassium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: diclofenac potassium 12.5mg/tablet.
Each Voltaren Rapid 12.5 tablet contains 1.5 mg of potassium.
Contains: Sugars as lactose monohydrate (200.7 mg per maximum
recommended daily dose)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White oblong (capsule-shaped) film-coated tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Relief of headache, dental pain, period pain, rheumatic and muscular
pain, backache.
•
Relief of symptoms of colds and flu, including aches and pains, sore
throat pain.
•
Reduction of fever
4.2
D
OSE AND METHOD OF ADMINISTRATION
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the
shortest duration should be used. Adverse effects may be minimised by
using the lowest effective
dose for the shortest duration necessary to control symptoms (see
Section 4.4 ‘Special warnings and
precautions for use’).
The tablets should be swallowed whole with water and must not be
divided or chewed. It is
preferable to take the tablets before meals ( see section 5.2
Pharmacokinetic Properties –
Absorption).
Voltaren Rapid 12.5 should not be used for more than a few days at a
time unless on medical advice,
in which case the patient should be reviewed regularly with regards to
efficacy, risk factors and
ongoing need for treatment.
2
ADULTS AND CHILDREN AGED 14 YEARS AND OVER:
The initial dosage is 25 mg. If needed, further doses of 12.5 to 25 mg
may be taken every 4 to 6
hours. No more than 75 mg should be taken in 24 hours. Do not exceed
the stated dose.
If the pain has not resolved after a few days, the patient should be
instructed to return for review by
the healthcare professional.
CHILDREN UNDER 14 YEARS OF AGE:
Voltaren Rapid 12.5 is not recommended for use in children under 14
years of age.
Pregnancy:
See Sectio