Domperidone (Pharmacy Health)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Domperidone maleate 12.72mg equivalent to domperidone 10 mg

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

Dosage:

10 mg

Pharmaceutical form:

Tablet

Composition:

Active: Domperidone maleate 12.72mg equivalent to domperidone 10 mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified water Sodium laurilsulfate

Prescription type:

Prescription

Therapeutic indications:

Treatment of acute symptoms of nausea and vomiting.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 25 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2017-08-17

Patient Information leaflet

Domperidone (Pharmacy Health) 10 mg tablets
Consumer Medicine Information
NZ - V2 February 2018
1
DOMPERIDONE (PHARMACY HEALTH)
Domperidone (as maleate) 10 mg
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Domperidone. It does not
contain all the available
information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Domperidone the benefits this
medicine is expected to have
for you.
If you have any concerns about
taking Domperidone ask your
doctor or
pharmacist.
Keep this leaflet with your
medicine. You may need to
read it again.
WHAT DOMPERIDONE
IS USED FOR
Domperidone is used to treat
the following conditions in
adults:
•
nausea and vomiting
•
discomfort caused by a slow
moving stomach known as
gastroparesis. Symptoms
include not being able to
finish a meal, a feeling of
being “too full” or bloated
after a meal, a loss of
appetite, feeling sick and
maybe vomiting, or belching
without relief.
Domperidone is an antiemetic
and a prokinetic medicine. It
works by blocking the action of
a chemical messenger in the
brain which causes the feeling
of nausea and vomiting, as well
as increasing the movement or
contractions of the stomach
and intestines, allowing food to
move more easily through the
stomach.
There is insufficient evidence to
support use of Domperidone in
children reflux disease.
Domperidone may not be
suitable for chemotherapy or
radiotherapy induced nausea
and vomiting or vomiting after
an operation.
Your doctor may have
prescribed Domperidone for
another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE
DOMPERIDONE
WHEN YOU MUST NOT TAKE
IT
Do not take Domperidone if:
•
you have an allergy to
domperidone, or any of the
ingredients. See Product
Description at the end of
this leaflet for a list of
ingredients.
•
you have a tumour of the
pituitary gland called
prolact

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 13
DOMPERIDONE (PHARMACY HEALTH)
1.
PRODUCT NAME
Domperidone (Pharmacy Health)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
domperidone maleate Ph. Eur (equivalent to 10 mg of domperidone)
Excipient(s) with known effect
For the full list of excipients, see section 6.1. Contains: Lactose.
3.
PHARMACEUTICAL FORM
Oral – tablet, uncoated
Presentation
Domperidone (Pharmacy Health) are: White round, biconvex, uncoated
tablet with inscription
“Dm 10’ on one side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Adults and children aged 12 years and over (weighing ≥ 35 kg)
Symptomatic treatment of the dyspeptic symptom complex that may be
associated with
delayed gastric emptying such as epigastric sense of fullness,
abdominal distension or
swelling, or epigastric pain or discomfort.
Treatment of acute symptoms of nausea and vomiting.
There is insufficient evidence to support the use of domperidone in
childhood gastro‐
oesophageal reflux disease. Domperidone may not be suitable for
chemotherapy‐ or
radiotherapy‐induced nausea and vomiting or post‐operative nausea
and vomiting
.
4.2
Dose and method of administration
General
Domperidone (Pharmacy Health) should be taken 15‐30 minutes before
meals and, if
necessary, before going to bed at night. If taken after meals,
absorption is somewhat delayed.
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 13
DOMPERIDONE (PHARMACY HEALTH)
Adults and children aged 12 years and older (weighing ≥ 35 kg)
1 tablet three to four times daily. The dose of domperidone should be
the lowest effective
dose for the individual situation (typically 30 mg/day). The dose may
be increased, if necessary,
to a maximum daily oral dose of 40 mg (1 tablet four times daily).
Usually, the maximum treatment duration should not exceed one week for
the treatment of
acute nausea and vomiting. For other indications, the initial duration
of treatment is up to four
weeks.
If treatment exceed