Anagraine Tablet Blister Pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

metoclopramide hydrochloride, Quantity: 5 mg; paracetamol, Quantity: 500 mg

可用日期:

Aspen Pharmacare Australia Pty Ltd

药物剂型:

Tablet, uncoated

组成:

Excipient Ingredients: sodium starch glycollate; magnesium stearate

给药途径:

Oral

每包单位数:

24 tablets, 2 tablets, 8 tablets

类:

Medicine Registered

处方类型:

(S4) Prescription Only Medicine, (S3) Pharmacist Only Medicine

疗效迹象:

For the symptomatic relief of headache, nausea and vomiting associated with migrane.

產品總結:

Visual Identification: White, round, flat, 12mm in diameter; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

授权状态:

Registered

授权日期:

1991-09-20

资料单张

________________________________________________________________________________
ANAGRAINE CMI – 050210
Page 1 of 3
ANAGRAINE
_ _
_Metoclopramide hydrochloride / Paracetamol _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Anagraine. It does
not contain all the available
information. It does not take the
place of talking to your pharmacist
or doctor.
All medicines have risks and
benefits
.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ANAGRAINE IS USED
FOR
Anagraine is used for the relief of
headache, nausea and vomiting
associated with migraine.
Anagraine contains the active
ingredients metoclopramide (as
metoclopramide hydrochloride
anhydrous) and paracetamol.
Metoclopramide helps control
nausea and vomiting caused by
migraine and other illnesses. It
works by blocking the action of a
chemical in the brain which causes
nausea and vomiting. It also acts in
the stomach and upper intestine to
increase muscle contractions.
Paracetamol is an analgesic. It
provides effective temporary relief
from pain.
There is no evidence that
Anagraine is addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE ANAGRAINE IF YOU
HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
metoclopramide
•
paracetamol
•
any of the ingredients listed at
the end of this leaflet.
Symptoms of an allergic reaction
may include asthma, wheezing,
shortness of breath, swelling of the
face, lips or tongue which may
cause difficulty in swallowing or
breathing, skin rash, itching or
hives.
DO NOT TAKE IT IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS:
•
bleeding from the stomach
and/or digestive tract
•
intestinal blockage
•
recent surgery on the stomach
and/or digestive tract
•
phaeochromocytoma (a rare
tumour of the adrenal gland).
DO NOT TAKE ANAGRAINE IF:
•
YOU ARE PREGNANT, OR INTEND TO
BECOME PREGNANT
It may af

产品特点

1
AUSTRALIAN PRODUCT INFORMATION ANAGRAINE (PARACETAMOL/METOCLOPRAMIDE HYDROCHLORIDE)
TABLETS
1
NAME OF THE MEDICINE
Metoclopramide hydrochloride and paracetamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ANAGRAINE tablet contains 5 mg metoclopramide and 500 mg
paracetamol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet, white, round, flat, 12 mm in diameter
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the symptomatic relief of headache, nausea and vomiting associated
with migraine.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ANAGRAINE should be taken at the first warning of a migraine attack.
If symptoms persist, further
doses may be taken at four-hourly intervals. Total dosage in any 24
hour period should not exceed
the quantity stated.
The dosage recommendations given below should be strictly adhered to
if side effects of the
dystonic type are to be avoided. It should be noted that a total daily
dosage of metoclopramide,
especially for adolescents and young adults, should not normally
exceed 0.5mg/kg body weight.
Adults: The recommended dose is one or two tablets initially, and then
one or two tablets every 4
hours (maximum dose of 6 tablets in 24 hours).
4.3
C
ONTRAINDICATIONS
Hypersensitivity to paracetamol or metoclopramide, phaeochromocytoma
and in cases wherever
stimulation of the gastrointestinal tract may be dangerous, eg. in the
presence of gastrointestinal
haemorrhage, mechanical obstruction or perforation.
Insufficient safety data exists to support the use of ANAGRAINE
(metoclopramide/paracetamol
combination) in pregnancy or during lactation (see Section 4.4 –
Special Precautions and Warnings
for Use).
Children under 18 years of age (see Section 4.4 – Special
Precautions and Warnings for Use).
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
2
IDENTIFIED PRECAUTIONS
Metoclopramide
Dystonic reactions occur in approximately 1% of patients given
metoclopramide. These occur more
frequently in children and young adults and may occur after a si