Nausicalm

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Cyclizine hydrochloride 50mg

Beschikbaar vanaf:

AFT Pharmaceuticals Ltd

INN (Algemene Internationale Benaming):

Cyclizine hydrochloride 50 mg

Dosering:

50 mg

farmaceutische vorm:

Tablet

Samenstelling:

Active: Cyclizine hydrochloride 50mg Excipient: Acacia Lactose monohydrate Magnesium stearate Potato starch

Prescription-type:

Restricted

Geproduceerd door:

Srikem Laboratories Pvt Ltd

therapeutische indicaties:

Nausicalm is indicated for the prevention and treatment of nausea and vomiting including motion sickness, nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period and radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels. Nausicalm may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 6 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisatie datum:

2016-04-12

Productkenmerken

NEW ZEALAND DATA SHEET
NAUSICALM Tablets SPC v 1.0 January 2017
Page 1 of 7
1 PRODUCT NAME
NAUSICALM
Cyclizine hydrochloride 50 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg cyclizine hydrochloride
Excipient with known effect: Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White, circular, biconvex, uncoated tablets with a score line on one
side, plain on the
other.
The tablets can be divided into two halves.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NAUSICALM is indicated for the prevention and treatment of nausea and
vomiting
including
•
motion sickness.
•
nausea and vomiting caused by narcotic analgesics and by general
anaesthetics in
the post-operative period.
•
nausea and vomiting associated with radiotherapy, especially for
breast cancer
since cyclizine does not elevate prolactin levels.
NAUSICALM may be of value in relieving vomiting and attacks of vertigo
associated
with Meniere’s disease and other forms of vestibular disturbance.
4.2
DOSE AND METHOD OF ADMINISTRATION
Route of administration: Oral
Adults and children over 12 years: one tablet up to three times daily
Children 6 – 12 years: half a tablet up to three times daily
Children under 6 years: Not recommended
Use in the Elderly: There have been no specific studies of cyclizine
in the elderly.
Experience has indicated that normal adult dosage is appropriate.
NEW ZEALAND DATA SHEET
NAUSICALM Tablets SPC v 1.0 January 2017
Page 2 of 7
4.3
CONTRAINDICATIONS
NAUSICALM should not be given to individuals with known
hypersensitivity to
cyclizine or to any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Potential anticholinergic effects
As with other anticholinergic agents, cyclizine should be used with
caution and
appropriate monitoring in patients with glaucoma, obstructive disease
of the
gastrointestinal tract and in males with possible prostatic
hypertrophy.
Heart failure
Cyclizine should be used with caution in patients w