Maxolon Tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metoclopramide hydrochloride monohydrate, Quantity: 10.537 mg (Equivalent: metoclopramide hydrochloride, Qty 10 mg)

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch; magnesium stearate; maize starch

Administration route:

Oral

Units in package:

25, 100

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 10 AUGUST 1994: Adults (20 years and over): As an adjunct to X-ray examination of the stomach and duodenum. To assist in intestinal intubation. To control nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties; uraemia; radiation sickness; malignant disease; postoperative vomiting; labour; infectious diseases. There is no clear benefit in motion sickness or other labyrinth disturbances. Intramuscular administration of Maxolon facilitates the absorption of a range of drugs including the absorption of aspirin in people with migraine. Maxolon has been found useful in the management of gastric retention after gastric surgery. Maxolon may be useful in the treatment of diabetic gastroparesis of mild to moderate severity. Once control of diabetes has been established by diet and/or insulin, Maxolon should be discontinued. Young Adults and Children: The use of Maxolon in patients under 20 years should be restricted to the following s

Product summary:

Visual Identification: round, biconvex, white tablets approx 7mm in diameter with a break bar on one side and "MAXOLON" debossed on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-14

Patient Information leaflet

MAXOLON
®
_Metoclopramide hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Maxolon.
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 has weighed
the risks of you taking Maxolon
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 MAXOLON IS USED
FOR
In adults over 20 years this medicine
is used to:
•
treat nausea and vomiting caused
by infectious diseases, migraine,
kidney disease, child birth, other
medications, cancer, or following
surgery, chemotherapy or
radiation treatment.
•
activate stomach contractions in
conditions where there is a need
to encourage normal passage of
food through the stomach and
intestines.
•
with X-rays to help diagnose
problems of the stomach and/or
intestines.
•
help with passing tubes into the
intestine.
In young adults and children over 1
year of age this medicine is used to:
•
treat severe vomiting of known
cause or following chemotherapy
or radiation treatment.
•
help with passing tubes into the
intestine.
This medicine 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
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU OR
YOUR CHILD.
Your doctor may have prescribed it
for another reason.
BEFORE TAKING MAXOLON
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MAXOLON IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
Metoclopramide
•
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 bod

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – MAXOLON
(METOCLOPRAMIDE HYDROCHLORIDE) TABLETS AND INJECTION
1
NAME OF THE MEDICINE
Metoclopramide hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets: Metoclopramide 10 mg (as hydrochloride).
Injection: Metoclopramide hydrochloride monohydrate 10 mg/2mL.
Maxolon tablets contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Tablets: round biconvex, white tablets approximately 7mm in diameter
with a break bar on one side
and "MAXOLON" debossed on the other.
Injection: A clear solution free from particulate matter
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Adults (20 years and over)_ _
As an adjunct to X-ray examination of the stomach and duodenum.
To assist in intestinal intubation.
To control nausea and vomiting associated with the following
conditions: intolerance to essential
drugs possessing emetic properties; uraemia; radiation sickness;
malignant disease; postoperative
vomiting; labour; infectious diseases. There is no clear benefit in
motion sickness or other labyrinth
disturbances.
Intramuscular administration of Maxolon facilitates the absorption of
a range of drugs including the
absorption of aspirin in people with migraine.
Maxolon has been found useful in the management of gastric retention
after gastric surgery.
Maxolon may be useful in the treatment of diabetic gastroparesis of
mild to moderate severity. Once
control of diabetes has been established by diet and/or insulin,
Maxolon should be discontinued.
Young adults and children over 1 year of age
The use of Maxolon in patients under 20 years should be restricted to
the following situations and
only used as second line therapy:
Severe intractable vomiting of known cause.
Vomiting associated with radiotherapy and intolerance to cytotoxic
drugs.
As an aid to gastrointestinal intubation.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Patients with normal renal and hepatic function
_ _The dosage recommendations given below should be str