APO-DOMPERIDONE domperidone (as maleate) 10 mg tablets blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

domperidone maleate, Quantity: 12.72 mg (Equivalent: domperidone, Qty 10 mg)

Доступна с:

Arrotex Pharmaceuticals Pty Ltd

ИНН (Международная Имя):

domperidone maleate

Фармацевтическая форма:

Tablet, uncoated

состав:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; povidone; sodium lauryl sulfate; lactose monohydrate; maize starch

Администрация маршрут:

Oral

Штук в упаковке:

100, 30, 25

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

APO-DOMPERIDONE 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 APO-DOMPERIDONE).,? Intractable nausea and vomiting from any cause.

Обзор продуктов:

Visual Identification: White round, biconvex uncoated tablet with the inscription 'Dm 10' on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизация:

Licence status A

Дата Авторизация:

2016-05-30

тонкая брошюра

APO-Domperidone Tablets
1
APO-DOMPERIDONE
_Domperidone maleate _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about domperidone. 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 domperidone
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 YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE
USED FOR
Domperidone is used to treat nausea,
vomiting, and discomfort caused by a
slow-moving stomach (known as
gastroparesis). Symptoms include not
being able to finish a meal, a feeling
of being bloated after a meal, a loss
of appetite, feeling sick, vomiting, or
belching without relief.
_HOW IT WORKS _
Domperidone belongs to a group of
medicines called antiemetics and
prokinetics. It works by blocking the
action of a chemical messenger in the
brain which causes the feeling of
nausea and vomiting. It also works to
increase 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 it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
Domperidone should not be used in
children under the age of 18 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
domperidone
•
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,
throat or other parts of the body
•
rash, itching or hives on the s

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION
APO- DOMPERIDONE (DOMPERIDONE MALEATE) TABLET
1
NAME OF THE MEDICINE
Domperidone maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains domperidone maleate, as the active ingredient.
Each tablet contains 10 mg domperidone (as maleate), as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate (see section 4.4 Special warnings and precautions
for use)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White round, biconvex uncoated tablet with the inscription ‘Dm 10’
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Domperidone 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 domperidone).
•
Intractable nausea and vomiting from any cause.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO- Domperidone tablets are intended for oral administration.
DOSAGE
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).
Domperidone 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.
2
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
treat