Metoclopramide Tablets 10mg

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

METOCLOPRAMIDE HYDROCHLORIDE

Доступна з:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

Код атс:

A03FA01

ІПН (Міжнародна Ім'я):

METOCLOPRAMIDE HYDROCHLORIDE 10.5 mg

Фармацевтична форма:

TABLET

Склад:

METOCLOPRAMIDE HYDROCHLORIDE 10.5 mg

Тип рецепту:

POM

Терапевтична области:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Статус Авторизація:

Authorised

Дата Авторизація:

2019-08-30

інформаційний буклет

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METOCLOPRAMIDE 10MG TABLETS
metoclopramide hydrochloride
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.
The name of your medicine is Metoclopramide 10mg Tablets but will be
referred to as ‘Metoclopramide
Tablets’ throughout this leaflet.
WHAT IS IN THIS
LEAFLET
1.
What Metoclopramide Tablets are and what they are used for
2.
What you need to know before you take Metoclopramide Tablets
3.
How to take Metoclopramide Tablets
4.
Possible side effects
5.
How to store Metoclopramide Tablets
6.
Contents of the pack and other information
1. WHAT
METOCLOPRAMIDE TABLETS
ARE AND
WHAT
THEY ARE USED
FOR
Metoclopramide Tablets are an antiemetic. They contain a medicine
called
"metoclopramide"
.
It works on
a part of your brain that prevents you from feeling sick (nausea) or
being sick (vomiting).
Adults
Metoclopramide Tablets are used in
adults:
•
to prevent delayed nausea and vomiting that may occur after
chemotherapy
•
to prevent nausea and vomiting caused by radiotherapy
•
to treat nausea and vomiting including nausea and vomiting which may
occur with a
migraine.
Metoclopramide can be taken with oral painkillers in case of migraine
to help painkillers work more
effectively.
Children and adolescents
Metoclopramide Tablets are used in children (aged 1-18 years) if other
treatment does not work or
cannot be used to prevent delayed nausea and vomiting that may occur
after
chemotherapy
.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOCLOPRAMIDE TABLETS
DO NOT TAKE THESE TABLETS

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metoclopramide 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains metoclopramide hydrochloride 10.50 mg equivalent
to 10mg of the
anhydrous substance.
Excipients with known effect: lactose and sodium.
Each tablet contains 80 mg lactose and 5 mg of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White, normal convex tablets, engraved with the company logo on one
side and scored on
the other, engraved with “A” above and “306” below the score.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metoclopramide is indicated in adults for:
Prevention of delayed chemotherapy induced nausea and vomiting (CINV).
Prevention of radiotherapy induced nausea and vomiting (RINV).
Symptomatic treatment of nausea and vomiting, including acute migraine
induced nausea
and vomiting. Metoclopramide can be used in combination with oral
analgesics to
improve the absorption of analgesics in acute migraine.
Metoclopramide is indicated in children (aged 1 to 18 years) for:
Prevention of delayed chemotherapy induced nausea and vomiting (CINV)
as a second line
option.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult
The recommended single dose is 10 mg, repeated up to three times
daily. The maximum
recommended daily dose is 30 mg or 0.5mg/kg body weight. The maximum
recommended
treatment duration is 5 days.
_ _
_ _
_ _
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_Special populations _
_Elderly_
In elderly patients a dose reduction should be considered, based on
renal and hepatic
function and overall frailty.
_Renal impairment_
In patients with end stage renal disease (Creatinine clearance ≤ 15
mL/min), the daily dose
should be reduced by 75%.
In patients with moderate to severe renal impairment (Creatinine
clearance 15-60 mL/min),
the dose should be reduced by 50% (see section 5.2).
_Hepatic impairment_
In patients with severe hepatic impairment, the dose should be reduced
by 50% (see section
5.2).
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