Domperidone 10mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Domperidone maleate

Доступна с:

Accord-UK Ltd

код АТС:

A03FA03

ИНН (Международная Имя):

Domperidone maleate

дозировка:

10mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04060000; GTIN: 5012617017239 5012617017246

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
Domperidone 10mg Tablets
(domperidone maleate)
This medicine is subject to additional monitoring. This will allow
quick identifi-
cation of new safety information. You can help by reporting any side
effects you
may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this
medicine because it
contains important information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Domperidone Tablets are and what they are used for
2. What you need to know before you take Domperidone Tablets
3. How to take Domperidone Tablets
4. Possible side effects
5. How to store Domperidone Tablets
6. Contents of the pack and other information
1. WHAT DOMPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR
Domperidone Tablets contain domperidone as the active ingredient,
which
belongs to a group of medicines called 'dopamine antagonists'.
Domperidone works by helping to move food faster through your food
pipe (oesopha-
gus), stomach
and gut. This is so that it does not stay in the same place for too
long. It also helps stop food flowing the wrong way back up your food
pipe.
This medicine is used to treat nausea (feeling sick) and vomiting
(being sick) in
adults and adolescents (12 years of age and older and weighing 35 kg
or more).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMPERIDONE TABLETS
Do not take Domperidone Tablets if you:
•
are allergic (hypersensitive) to domperidone or any of the other
ingredients in
the tablets
.
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your
lips,

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
▼
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See the end of section 4.8 for how to report side effects.
1.
NAME OF THE MEDICINAL PRODUCT
Domperidone 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Domperidone maleate equivalent to 10mg
domperidone base.
Excipient(s) with known effect
Each tablet contains 54.20mg of lactose monohydrate
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
Domperidone 10mg Tablet is presented as a white round biconvex tablet
with “Dm 10”
inscription on one side.
4
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Domperidone is indicated for the relief of the symptoms of nausea and
vomiting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Domeperidone should be used at the lowest effective dose for the
shortest duration necessary
to control nausea and vomiting.
It is recommended to take oral domperidone before meals. If taken
after meals, absorption
of the drug is somewhat delayed.
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.
Usually, the maximum treatment duration should not exceed one week
(See section 4.4).
_Adults and adolescents (over12 years and weighing 35kg or more): _
One 10 mg tablet up to three times per day with a maximum dose of 30
mg per day.
Hepatic Impairment
Domperidone is contraindicated in moderate or severe hepatic
impairment (see section 4.3).
Dose modification in mild hepatic impairment is however not needed
(see section 5.2).
Renal Impairment
Since the elimination half-life of domperidone is prolonged in severe
renal impairment, on
repeated administration, the dosing frequency of domperidone should be
reduced to once or
twice daily dependin