MOTILIUM domperidone 10mg tablet

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

domperidone, Quantity: 10 mg

Prieinama:

Johnson & Johnson Pacific Pty Ltd

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: magnesium stearate; pregelatinised potato starch; povidone; sodium lauryl sulfate; maize starch; hypromellose; lactose monohydrate; hydrogenated cottonseed oil; microcrystalline cellulose

Vartojimo būdas:

Oral

Vienetai pakuotėje:

10mg tablets, 25, 100

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

For the short term treatment in adults of: 1. Symptoms associated with idiopathic or diabetic gastroparesis(once control of diabetes has been established by diet and/or insulin, attempt should be made to discontinue MOTILIUM) 2. Intractable nausea and vomiting from any cause.

Produkto santrauka:

Visual Identification: White to faintly cream-coloured, circular, biconvex, film coated, tablet, with the inscription "JANSSEN" on one side and M 10 on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

1992-05-13

Pakuotės lapelis

MOTILIUM
®
(200826) ACMI
1
MOTILIUM
® TABLETS
_Domperidone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MOTILIUM tablets.
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 MOTILIUM
against the benefits this medicine is
expected to have for you.
If you have any concerns about
taking MOTILIUM ask your doctor
or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT MOTILIUM IS
USED FOR
MOTILIUM is used to treat the
following conditions in adults:
•
nausea and vomiting
•
discomfort caused by a slow
moving stomach known as
gastroparesis. Symptoms include
not being able to finish a meal, a
feeling of being "too full" or
bloated after a meal, a loss of
appetite, feeling sick and maybe
vomiting, or belching without
relief.
MOTILIUM is an antiemetic and a
prokinetic medicine. It works by
blocking the action of a chemical
messenger in the brain which causes
the feeling of nausea and vomiting,
as well as increasing the movement
or contractions of the stomach and
intestines, allowing food to move
more easily through the stomach.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
MOTILIUM for another reason.
BEFORE YOU TAKE
MOTILIUM
_WHEN YOU MUST NOT TAKE IT _
Do not take MOTILIUM if:
•
you have an allergy to
MOTILIUM, or any of the
ingredients. See Product
Description at the end of this
leaflet for a list of ingredients.
•
you have a tumour of the pituitary
gland called prolactinoma.
•
you have or have had liver
disease
•
an increase in stomach or bowel
contractions, for example, if you
have had bleeding, a blockage or
puncture in your gastrointestinal
tract
•
you have problems with your
heart, including abnormal heart
beat
•
you are taking another medicine
containing the active ingredien

Prekės savybės

CCDS180124
1
MOTILIUM (210730) API
AUSTRALIAN PRODUCT INFORMATION
MOTILIUM
 (
DOMPERIDONE)
TABLETS
1. NAME OF THE MEDICINE
Domperidone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg domperidone.
Excipient(s) with known effect:
Contains sugars as lactose. Each tablet contain 54.2 mg of lactose
monohydrate. (see SECTION
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE)
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Film-coated tablets
MOTILIUM 10 mg tablets are white to faintly cream-coloured, circular,
biconvex film coated
tablets with the inscription “JANSSEN” on one side and “M 10”
on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MOTILIUM is indicated for the short-term treatment in adults of:
•
Symptoms
associated
with
idiopathic
or
diabetic
gastroparesis
(once
control
of
diabetes has been established by diet and/or insulin, an attempt
should be made to
discontinue MOTILIUM).
•
Intractable nausea and vomiting from any cause.
4.2 DOSE AND METHOD ADMINISTRATION
Long-term use and use with medicines that prolong the QT interval or
medicines that inhibit
CYP3A should be avoided. The lowest dose needed to alleviate symptoms
should be taken
for the shortest period of time (see SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE
- CARDIAC EFFECTS).
MOTILIUM should be taken 15-30 minutes before meals and, if necessary,
before retiring.
Patients should try to take each dose at the scheduled time. If a
scheduled dose is missed,
the missed dose should be omitted and the usual dosing schedule
resumed. The dose should
not be doubled to make up for a missed dose.
ADULTS (WEIGHING ≥ 35 KG)
10 mg three times daily. Domperidone should be initiated at the lowest
effective dose for the
individual situation, which may be adjusted upward with caution to
achieve the desired effect.
The expected benefit of an increased dose should outweigh the
potential risks. Usually, the
maximum treatment duration should not exceed one week for the