EMEXLON metoclopramide hydrochloride 10 mg film coated tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metoclopramide hydrochloride, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

metoclopramide hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; stearic acid; macrogol 6000; pregelatinised maize starch; hypromellose; titanium dioxide; colloidal anhydrous silica; maize starch; microcrystalline cellulose

Administration route:

Oral

Units in package:

500, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

In 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. Metoclopramide hydrochloride has been found useful in the management of gastric retention after gastric surgery. Metoclopramide hydrochloride 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, metoclopramide hydrochloride should be discontinued.,Young Adults: The use of metoclopramide hydrochloride in patients under 20 years should be restricted to the following situations: Severe intractable vomiting of known cause. Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. As an aid to gastrointestinal intubation

Product summary:

Visual Identification: White to off-white, circular, biconvex film-coated tablets with breakline on both sides.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-05-04

Patient Information leaflet

Emexlon
Page 1 of 7
EMEXLON
_metoclopramide hydrochloride (as monohydrate) _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Emexlon. 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 Emexlon
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 EMEXLON 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.
•
to 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.
•
to help with passing tubes into the intestine.
In young adults between 15 to 20 years 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 YOU TAKE EMEXLON
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE EMEXLON IF YOU HAVE AN ALLERGY TO:
•
any medicine containing Metoclopramide hydrochloride (as monohydrate)
•
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
Emexlon
Page 2 of 7
•
shortness of breath

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION
–
EMEXLON
(METOCLOPRAMIDE
HYDROCHLORIDE (AS MONOHYDRATE)) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Metoclopramide hydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Emexlon film coated tablets come in two strengths and contain either 5
mg or 10 mg of
Metoclopramide hydrochloride (as monohydrate).
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Emexlon film coated tablets containing metoclopramide hydrochloride
(as monohydrate) 10 mg are
white to off-white, circular, biconvex film-coated tablets with
breakline on both sides.
Emexlon film coated tablets containing metoclopramide hydrochloride
(as monohydrate) 5 mg are
white to off-white, circular, biconvex film-coated tablets plain on
both sides.
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.
Metoclopramide hydrochloride (as monohydrate) has been found useful in
the management of gastric
retention after gastric surgery.
Metoclopramide
hydrochloride
(as
monohydrate)
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, metoclopramide hydrochloride (as monohydrate) should
be discontinued.
2
_Young Adults and Children over 1 year of age: _ The use of
metoclopramide hydrochloride (as
monohydrate) 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 a