GOLD CROSS SLEEPWELL doxylamine succinate 25mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxylamine succinate, Quantity: 25 mg

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (International Name):

doxylamine succinate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: purified talc; microcrystalline cellulose; croscarmellose sodium; povidone; calcium hydrogen phosphate dihydrate; magnesium stearate; pregelatinised maize starch

Administration route:

Oral

Units in package:

12 tablets, 20 tablets, 10 tablets

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

Temporary relief of sleeplessness.

Product summary:

Visual Identification: White concave tablets with break bar on one side.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-05-11

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – GOLD CROSS SLEEPWELL
(DOXYLAMINE SUCCINATE) TABLETS
1
NAME OF THE MEDICINE
Doxylamine succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Gold Cross SleepWell tablet contains doxylamine succinate 25 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White concave tablet with break bar on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Gold Cross SleepWell is indicated for the temporary relief of
sleeplessness.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults and children over 12 years: 1 or 2 tablets with water 20
minutes before retiring. Do not
exceed the recommended dose.
4.3
C
ONTRAINDICATIONS
Epilepsy, narrow angle glaucoma and known hypersensitivity to
doxylamine succinate or to any
other ingredients in the product.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
Caution should be exercised with medical conditions such as prostatic
enlargement, urinary
retention, glaucoma, pyloroduodenal obstruction and cardiovascular
disorders.
USE IN THE ELDERLY
No data available.
PAEDIATRIC USE
Not recommended for use in children under 12 years of age except on
medical advice.
EFFECTS ON LABORATORY TESTS
Antihistamines should be discontinued approximately 48 hours prior to
any skin tests since
these drugs may suppress positive reactions to dermal reactivity
indicators.
2
4.5
I
NTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS
Doxylamine succinate may enhance the sedative effect of other CNS
depressants such as opioid
analgesics, neuroleptics, alcohol, hypnotics and psychotherapeutic
drugs.
MAOIs may enhance doxylamine succinate’s antimuscarinic effects.
An additive antimuscarinic action may be experienced with other
antimuscarinic drugs such as
atropine and tricyclic antidepressants.
4.6
F
ERTILITY
, PREGNANCY AND LACTATION
EFFECTS ON FERTILITY
No data available.
USE IN PREGNANCY – PREGNANCY CATEGORY A
In the first trimester of pregnancy, Gold Cross SleepWell should be
used only when th