Metoclopramide hydrochloride Oral Solution 5mg/5ml

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

METOCLOPRAMIDE HYDROCHLORIDE

Mevcut itibaren:

Syri Pharma Limited Floor 0 1 WML, 1 Windmill Lane Dublin 2, D02 F206, Ireland

ATC kodu:

A03FA01

INN (International Adı):

METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5ml

Farmasötik formu:

ORAL SOLUTION

Kompozisyon:

METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5ml

Reçete türü:

POM

Terapötik alanı:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2016-08-22

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE USER
METOCLOPRAMIDE HYDROCHLORIDE 5MG/5ML ORAL SOLUTION
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 the medicine is Metoclopramide hydrochloride 5mg/5ml Oral
Solution but it will
be referred to as Metoclopramide throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
WHAT METOCLOPRAMIDE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOCLOPRAMIDE
3.
HOW TO TAKE METOCLOPRAMIDE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE METOCLOPRAMIDE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT METOCLOPRAMIDE IS AND WHAT IT IS USED FOR
Metoclopramide is an antiemetic. It works on a part of your brain that
prevents you from
feeling sick (nausea) or being sick (vomiting).
Adult population:
Metoclopramide 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 is indicated in children (aged 1-18 years) if other
treatments do not work or
cannot be used to prevent delayed nausea and vomiting that may occur
after chemotherapy.
You must talk to a doctor if you do not feel better or if you feel
worse.
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2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE METOCLOPRAMIDE
DO NOT TAKE METOCLOPRAMIDE IF:

you are allergi

Ürün özellikleri

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Metoclopramide hydrochloride 5mg/5ml Oral Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of oral solution contains 5mg metoclopramide hydrochloride
(anhydrous).
_Excipients with known effect_
:
Each 5ml of oral solution contains 1.25mg sodium benzoate (E211).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral Solution
Clear, colourless solution with lemon flavour
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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_Dosing table _
AGE
BODY WEIGHT
DOSE
FREQUENCY
1-3 years
10-14 kg
1 mg
Up to 3 times daily
3-5 years
15-19 kg
2 mg
Up to 3 times daily
5-9 years
20-29 kg
2.5 mg
Up to 3 times daily
9-18 years
30-60 kg
5 mg
Up to 3 times daily
15-18 years
Over 60 kg
10 mg
Up to 3 times daily
The maximum treatment duration is 5 days for prevention of delayed
chemotherapy indu