Avomine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Promethazine teoclate 25mg

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Promethazine teoclate 25 mg

Dosage:

25 mg

Pharmaceutical form:

Tablet

Composition:

Active: Promethazine teoclate 25mg Excipient: Dextrin Lactose monohydrate Magnesium stearate Purified talc Starch

Units in package:

Blister pack, 10 tablets

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Sanofi Chimie

Therapeutic indications:

Prevention and treatment of travel sickness.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 10 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1969-12-31

Patient Information leaflet

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_Page 1 _
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AVOMINE

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_PROMETHAZINE THEOCLATE 25 MG TABLETS 10 TABLET PACK _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about AVOMINE tablets.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist who have
more detailed information.
All medicines have risks and benefits.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE AS
YOU MAY WANT TO READ IT AGAIN.
WHAT AVOMINE IS USED
FOR
AVOMINE belongs to a group of
medicines called phenothiazines.
AVOMINE is used to prevent or treat
motion sickness.
DO NOT GIVE AVOMINE TO CHILDREN 9
YEARS OF AGE OR UNDER.
BEFORE YOU TAKE
AVOMINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AVOMINE IF YOU HAVE
AN ALLERGY TO AVOMINE OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THE LEAFLET.
DO NOT TAKE AVOMINE IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING
DO NOT TAKE AVOMINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
If you use this medicine after the
expiry date has passed, it may not work
as well.
DO NOT GIVE AVOMINE TO CHILDREN 9
YEARS OF AGE OR UNDER.
DO NOT GIVE AVOMINE TO CHILDREN OR
ADOLESCENTS WITH SIGNS OR SYMPTOMS
OF REYE’S SYNDROME.
Symptoms include feeling sick,
vomiting, tiredness, lack of energy, and
indifference.
_TELL YOUR PHARMACIST OR _
_DOCTOR IF: _
•
you are pregnant or intend to
become pregnant
•
you are breast feeding or plan to
breast feed
•
you are allergic to any other
medicines, foods, dyes or
preservatives
TELL YOUR PHARMACIST OR DOCTOR IF YOU
HAVE OR HAVE HAD ANY MEDICAL
CONDITIONS, ESPECIALLY THE FOLLOWING
:
•
asthma, bronchitis or a persistent
cough
•
epilepsy, seizures or fits
•
liver or kidney disease
•
fast or irregular heart beat
•
stomach problems
•
difficulty passing urine
•
glaucoma, a condition in which
there is usually a build up of fluid
in the eye
•
severe heart disease, caused by
poor blood flow in the blood
ves

Summary of Product characteristics

New Zealand Data Sheet
Avomine - Promethazine theoclate
Avomine-ccsiv2-dsv6-5oct18
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_Page 1 _
NEW ZEALAND DATA SHEET
1
AVOMINE 25 MG TABLETS
Avomine Tablets 25 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Promethazine theoclate
Avomine tablets contain 25 mg of promethazine theoclate.
Excipients with known effect: lactose monohydrate and wheat starch.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablets, 25 mg (white, scored).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of motion sickness.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS - TRAVEL SICKNESS
_PREVENTION _
Long journeys: 1 tablet each night at bedtime commencing on the night
before travelling.
Short journeys: 1 tablet to be taken 1 to 2 hours before the journey
commences.
New Zealand Data Sheet
Avomine - Promethazine theoclate
Avomine-ccsiv2-dsv6-5oct18
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_Page 2 _
_TREATMENT _
1 tablet followed by a second tablet the same evening and a third
tablet on the following
evening. Prompt treatment is important. Additional tablets may safely
be taken as a
preventive or when they appear to be needed but it will seldom be
necessary to give more
than 4 tablets in 24 hours or to repeat a dose in less than 8 hours.
4.3
CONTRAINDICATIONS
Avomine should not be used in patients who are in a coma or suffering
from CNS depression
of any cause. It must not be given to patients hypersensitive to
promethazine, phenothiazines
or to any of the excipients listed in section 6.1. Avomine should be
avoided in patients who
have been taking monoamine oxidase inhibitors within the previous 14
days.
Use in children: Avomine should not be used in children less than ten
years of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avomine may cause mild and temporary confusion or disorientation in
certain individuals.
Avomine may thicken or dry lung secretions and impair expectoration,
it should therefore be
used with caution in patients with asthma, bronchitis or
bronchiectesis. Use with care in
patients with severe coronary