Antinaus

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Prochlorperazine maleate 5mg; Prochlorperazine maleate 5mg

Beschikbaar vanaf:

Viatris Limited

INN (Algemene Internationale Benaming):

Prochlorperazine maleate 5 mg

Dosering:

5 mg

farmaceutische vorm:

Tablet

Samenstelling:

Active: Prochlorperazine maleate 5mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Povidone Active: Prochlorperazine maleate 5mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Povidone

Eenheden in pakket:

Blister pack, 100s, 100 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Trifarma SpA

therapeutische indicaties:

ANTINAUS is used in vertigo due to Meniere's syndrome, labyrinthitis and other causes, and for nausea and vomiting from whatever cause. It may also be used for migraine, schizophrenia (particularly in the chronic stage), acute mania and as an adjunct to the short term management of anxiety.

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, - 500 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Autorisatie datum:

1975-05-15

Bijsluiter

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ANTINAUS
_PROCHLORPERAZINE MALEATE TABLETS 5 MG _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Antinaus.
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 or pharmacist
has weighed the risks of you taking
Antinaus 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 ANTINAUS IS
USED FOR
Antinaus is used for the treatment of
nausea associated with migraine.
Antinaus contains the active
ingredient prochlorperazine
maleate_._ It belongs to a group of
medicines called phenothiazines.
Antinaus works by acting on specific
receptors in the brain.
This medicine is available in packs
of 10 tablets over the counter at a
pharmacy.
ASK YOUR PHARMACIST IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN RECOMMENDED
FOR YOU.
BEFORE YOU TAKE
ANTINAUS
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE ANTINAUS IF YOU HAVE
AN ALLERGY TO:

any medicine containing
prochlorperazine or
phenothiazines

any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
You should not take Antinaus if you
have any of the following medical
conditions:

shock

disease of the blood with a
low number of blood cells
(bone marrow depression)
DO NOT GIVE THIS MEDICINE TO A
CHILD.
DO NOT TAKE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged,
return it to your pharmacist for
disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TAKING THIS MEDICINE,
TALK TO YOUR PHARMACIST OR DOCTOR.
_BE

Productkenmerken

Page 1 of 9
NEW ZEALAND DATA SHEET
ANTINAUS
1. PRODUCT NAME
ANTINAUS 5 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ANTINAUS tablet contains 5 mg of prochlorperazine maleate.
ANTINAUS contains lactose. For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
White biconvex tablets, 9/32” (7.1mm) diameter, imprinted PM/5 on
one side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
ANTINAUS is used in vertigo due to Meniere’s syndrome,
labyrinthitis and other causes, and for
nausea and vomiting from whatever cause. It may also be used for
migraine, schizophrenia
(particularly in the chronic stage), acute mania and as an adjunct to
the short term management of
anxiety.
For
the
treatment
of
nausea
associated
with
migraine.
(This
indication
only
is
classified
Pharmacist Only).
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_NAUSEA AND VOMITING_
ADULTS
Prevention of nausea and vomiting: 5 or 10 mg two or three times
daily.
Treatment of nausea and vomiting: 20 mg immediately followed, if
necessary, by 10 mg two hours
later.
CHILDREN
Prevention
and
treatment
of
nausea
and
vomiting:
if
it
is
considered
unavoidable
to
use
prochlorperazine for a child, the dosage is 0.25 mg/kg bodyweight, two
or three times a day.
_VERTIGO AND MENIERE’S DISEASE_
ADULTS
Page 2 of 9
5 mg three times a day, increasing if necessary to a total of 30 mg
daily. After several weeks
dosage may be reduced gradually to 5-10 mg daily.
_ADJUNCT IN THE SHORT-TERM MANAGEMENT OF ANXIETY_
ADULTS
10-20 mg daily in divided doses initially but this may be increased if
necessary to a maximum of
40 mg daily in divided doses.
_SCHIZOPHRENIA AND OTHER PSYCHOTIC DISORDERS_
ADULTS
Usual effective daily oral dosage is in the order of 75-100 mg daily.
Patients vary widely in
response. The following schedule is suggested:
Initially 12.5 mg twice daily for 7 days, the daily amount being
subsequently increased by 12.5 mg
at four to seven day intervals until a satisfactory response