METOCLOPRAMIDE HYDROCHLORIDE

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

METOCLOPRAMIDE HYDROCHLORIDE

متاح من:

Accord Healthcare Limited

ATC رمز:

A03FA01

INN (الاسم الدولي):

METOCLOPRAMIDE HYDROCHLORIDE

جرعة:

10 Milligram

الشكل الصيدلاني:

Tablets

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

metoclopramide

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-03-11

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
METOCLOPRAMIDE HYDROCHLORIDE 10 MG 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.
WHAT IS IN THIS LEAFLET
1.
What Metoclopramide Hydrochloride tablets is and what it is used for
2.
What you need to know before you take Metoclopramide Hydrochloride
tablets
3.
How to take Metoclopramide Hydrochloride tablets
4.
Possible side effects
5.
How to store Metoclopramide Hydrochloride tablets
6.
Contents of the pack and other information
1.
WHAT METOCLOPRAMIDE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR
Metoclopramide Hydrochlride is an antiemetic. It contains a medicine
called “metoclopramide”. It
works on a part of your brain that prevents you from feeling sick
(nausea) or being sick (vomiting).
Adult population:
Metoclopramide Hydrochloride is 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.
Paediatric population
Metoclopramide Hydrochloride is indicated 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 HYDROCHLORIDE
TABLETS
DO NOT TAKE METOCLOPRAMIDE HYDROCHLORIDE TABLETS:
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خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoclopramide hydrochloride 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
Metoclopramide Hydrochloride equivalent to 10 mg anhydrous
Metoclopramide Hydrochloride
Excipients:
101.24 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, biconvex tablets with the inscription
‘BD’ on one side and a scoreline on the other side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adult population
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.
Paediatric population
Metoclopramide is indicated in children (aged 1-18 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 population
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.
Prevention of delayed chemotherapy induced nausea and vomiting (CINV)
(paediatric patients aged 1-18 years)
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to
three times daily by oral route. The maximum
dose in 24 hours is 0.5 mg/kg body weight.
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