Maxolon 10 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metoclopramide hydrochloride

Available from:

Amdipharm Limited

ATC code:

A03FA; A03FA01

INN (International Name):

Metoclopramide hydrochloride

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Propulsives; metoclopramide

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MAXOLON
® 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, pharmacist or
nurse.
- 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, pharmacist or
nurse.
-This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Maxolon Tablets are and what they are used for
2. What you need to know before you take Maxolon Tablets
3. How to take Maxolon Tablets
4. Possible side effects
5. How to store Maxolon Tablets
6. Contents of the pack and other information
1. WHAT MAXOLON TABLETS ARE AND WHAT THEY ARE USED FOR
Maxolon Tablets are 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
Maxolon 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.
Paediatric population
Maxolon Tablets are indicated in children (aged 15-18 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 MAXOLON TABLETS
DO NOT TAKE MAXOLON TABLETS:
- if you are allergic to metoclopramide hydrochloride or any of the
other ingredients of this medicine (listed
in section 6)
- if you have bleeding, obstruction or a tear in your stomach o

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2022
CRN00CZYN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maxolon 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains metoclopramide hydrochloride equivalent to 10 mg
of the anhydrous substance.
Excipient(s) with known effect
Lactose: contains 125.00 mg of lactose (as monohydrate) per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to ivory-white circular double convex tablet with a single break
bar on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULT POPULATION:
Maxolon 10 mg tablets are indicated in adults for:
- Prevention of delayedchemotherapyinduced nausea and vomiting (CINV)
- Prevention of radiotherapyinduced 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
Maxolon 10mg tablets are indicated in adolescents aged 15-18years and
weighing more than 60kg for:
- Prevention of delayedchemotherapyinduced nausea and vomiting (CINV)
as a second line option.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ALL INDICATIONS (ADULT POPULATION)
The recommended single dose is 10 mg, repeated up to three times
daily.
The maximum recommended dailydose is 30 mg or 0.5mg/kg bodyweight.
The maximum recommended treatment duration is 5 days.
PAEDIATRIC POPULATION
ADOLESCENTS AGED 15-18 YEARS AND WEIGHING > 60KG.
Prevention of delayedchemotherapyinduced nausea and vomiting (CINV)
Health Products Regulatory Authority
14 September 2022
CRN00CZYN
Page 2 of 8
The recommended dose is 0.1 to 0.15 mg/kg bodyweight, repeated up to
three times dailybyoral route. The maximum dose in
24 hours is 0.5 mg/kg bodyweight.
BODY WEIGHT DOSE FREQUENCY
ADOLESCENTS 15-18 YEARS OVER 60KG
10MG UP TO 3 TIMES DAILY
The maximum treatment duration is 5 days for p