MOTILIUM®

domperidone
DATASHEET
1. PRODUCT NAME
Motilium 10 mg film-coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 10 mg domperidone base.
Excipients with known effect:
Each film-coated tablet contains 54.2 mg of lactose monohydrate
For the full list of excipients, see 6.1 List of excipients.

3. PHARMACEUTICAL FORM
Film-coated tablets
MOTILIUM 10 mg tablets are white, circular, film-coated, biconvex tablets with m/10 imprinted
on one side and JANSSEN on the other.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Adults and adolescents weighing ≥ 35kg
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
MOTILIUM should be taken 15-30 minutes before meals and, if necessary, before retiring. If
taken after meals, absorption is somewhat delayed.

Adults and adolescents ≥ 12 years of age and weighing ≥ 35 kg

1 tablet three to four times daily.
The dose of MOTILIUM 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. If nausea and vomiting persists for longer than one week, patients
should consult their physician. For other indications, the initial duration of treatment is up to
four weeks. If treatment exceeds four weeks, patients should be re-evaluated and the need for

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 continued treatment re-assessed.
MOTILIUM tablets are unsuitable for use in adults and adolescents weighing less than 35 kg.

Infants and children < 12 years of age

MOTILIUM should not be used in children < 12 years of age.

Use in renal impairment

It is unlikely that the dose needs to be adjusted for single administration in patients with renal
insufficiency. However, since the elimination half-life of domperidone is prolonged in severe
renal impairment, on repeated administration the dosing frequency of MOTILIUM should be
reduced to once or twice daily depending on the severity of the impairment (see section 4.4
Special warnings and precautions for use). Generally, patients on prolonged therapy
should be reviewed regularly.

Hepatic impairment
MOTILIUM is contraindicated for patients with moderate or severe hepatic impairment (see
section 4.3 Contraindications).

4.3 Contraindications
MOTILIUM is contraindicated in the following situations:
• Known hypersensitivity to domperidone or any of the excipients
• Prolactin-releasing pituitary tumour (prolactinoma)
• Use in children under 2 years of age. See also section 4.2 Dose and method of
administration and section 4.4 Special warnings and precautions for use.
• Co-administration with potent CYP3A4 inhibitors has been shown to increase
domperidone concentrations to the point where QT interval prolongation may occur.
Examples of potent CYP3A4 inhibitors include some azole antifungals (eg,
intraconazole, voriconazole, posaconzazole), some macrolide antibiotics (eg,
clarithromycin, telithromycin), and some protease inhibitors (ritonavir, saquinavir,
telaprevir).
• Co-administration with medicines that prolong the QTc interval.
• MOTILIUM should not be used whenever stimulation of gastrointestinal motility might
be dangerous such as in the presence of gastrointestinal haemorrhage, mechanical
obstruction, or perforation.
• In patients with moderate or severe hepatic impairment (see section 5.2
Pharmacokinetic properties).

4.4 Special warnings and precautions for use

Cardiovascular effects
MOTILIUM should be used with caution in older patients or those with current or history of
cardiac disease. An increase in the risk of serious ventricular arrhythmias and sudden cardiac
death has been reported in epidemiology studies (see section 4.8 Undesirable Effects).
Those studies suggest this increased risk may be higher in patients older than 60 years or at
total daily doses of more than 30mg. Therefore, MOTILIUM should be used with caution in
older patients. MOTILIUM should be used at the lowest effective dose in adults. Treatment
with domperidone should be stopped if signs or symptoms occur that may be associated
with cardiac arrhythmia, and the patient should consult their physician.
Use of MOTILIUM and other drugs which prolong QTc intervals requires that caution be
exercised in patients who have existing prolongation of cardiac conduction intervals,
particularly QTc, patients with significant electrolyte disturbances (hypokalaemia,

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 hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac
diseases such as congestive heart failure. Electrolyte disturbances (hypokalaemia,
hyperkalaemia, hypomagnesaemia) and bradycardia are known to be conditions increasing
the proarrhythmic risk. Other risk factors for sudden cardiac arrest include a family history of
coronary artery disease, high blood pressure, high blood cholesterol, obesity, diabetes,
smoking and excessive alcohol consumption. It is desirable to optimise electrolyte levels
prior to starting domperidone.

Drug interaction potential

The main metabolic pathway of domperidone is through CYP3A4. In vitro and human data
show that the concomitant use of drugs that significantly inhibit this enzyme may result in
increased plasma levels of domperidone. Co-administration of domperidone with potent
CYP3A4 inhibitors which have been shown to cause QT interval prolongation is
contraindicated (see section 4.3 Contraindications).
Caution should be exercised when domperidone is co-administered with potent CYP3A4
inhibitors which have not been shown to cause QT interval prolongation such as indinavir and
patients should be monitored closely for signs or symptoms of adverse reactions (see section
4.8 Undesirable Effects).
Caution should be exercised when domperidone is co-administered with drugs which have
been shown to cause QT interval prolongation and patients should be monitored closely for
signs or symptoms of cardiovascular adverse reactions (see section 4.8 Undesirable
Effects). Examples include:
• anti arrhythmics class IA (e.g., disopyramide, quinidine)
• anti arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
• certain antipsychotics (e.g., haloperidol, pimozide, sertindole)
• certain antidepressants (e.g., citalopram, escitalopram)
• certain antibiotics (e.g., levofloxacin, moxifloxacin)
• certain antifungal agents (e.g., pentamidine)
• certain antimalarial agents (e.g., halofantrine)
• certain azole antifungals, (e.g., itraconazole, ketoconazole, voriconazole)
• certain calcium antagonists, (e.g., diltiazem, verapamil)
• certain gastro intestinal drugs (e.g., dolasetron)
• certain HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir,
nelfinavir, ritonavir, saquinavir)
• certain drugs used in cancer (e.g., toremifene, vandetanib)
• certain macrolide antibiotics (e.g., clarithromycin, erythromycin)
• certain other drugs (e.g., aprepitant, bepridil, methadone, nefazodone, telithromycin)
Antacids or antisecretory agents should not be taken simultaneously with MOTILIUM, as they
lower the oral bioavailability of domperidone (see section 4.5 Interactions with other
medicines and other forms of interactions). When used concomitantly, MOTILIUM should
be taken before meals and antacids or antisecretory agents after meals.

Intolerance to lactose
The film-coated tablets contain lactose and may be unsuitable for patients with lactose
intolerance, galactosemia or glucose/galactose malabsorption.

Prolactin levels

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 MOTILIUM produces an increase in plasma prolactin. The raised level persists with chronic
administration but falls to normal on discontinuing the medicine. During chronic oral
administration of 30 mg daily for two weeks the plasma prolactin level measured 90 minutes
after medicine intake remained fairly constant at 25 ng/mL in males (normal value was
5 ng/mL) whilst in females the level of 117 ng/mL after the first dose decreased to 56 ng/mL
after 14 doses (pretreatment normal value was 9 ng/mL).
Tissue culture experiments indicate that approximately one-third of human breast cancers are
prolactin-dependent in vitro, a factor of potential importance if the administration of
domperidone is contemplated in a patient with a past history of breast cancer. Although
disturbances such as galactorrhoea, amenorrhoea, gynaecomastia and impotence have been
reported with other prolactin-elevating medicines, the clinical significance of elevated serum
prolactin levels is unknown. An increase in mammary neoplasms has been found in rodents
after chronic administration of domperidone and other prolactin-stimulating medicines.
Neither clinical studies nor epidemiological studies conducted to date have shown an
association between chronic administration of these medicines and mammary tumorigenesis.
Domperidone does not affect plasma growth hormone or aldosterone levels.

Renal impairment
Since the elimination half-life of domperidone is prolonged in severe renal impairment, the
dosing frequency of MOTILIUM should to be reduced to once or twice daily depending on the
severity of the impairment. The dose may also need to be reduced. Such patients with severe
renal impairment should be reviewed regularly (see sections 5.2 Pharmacokinetic
properties and 4.2 Dose and method of administration).

Hepatic Impairment
MOTILIUM is contraindicated for patients with moderate or severe hepatic impairment (see
section 4.3 Contraindications). Dose adjustment is not required for patients with mild hepatic
impairment (see section 5.2 Pharmacokinetic properties).

Infants
MOTILIUM tablets are unsuitable for use in children <12 years of age (see section 4.2 Dose
and method of administration).

4.5 Interactions with other medicines and other forms of interactions

Concomitant administration of anticholinergic drugs may antagonise the anti-dyspeptic effect
of MOTILIUM.
If administered prior to atropine, domperidone reduces the relaxant effect of atropine upon the
lower oesophageal sphincter, but has no reversing effect if atropine is administered first. The
main metabolic pathway of domperidone is through the cytochrome P450 isoenzyme CYP3A4.
In vitro and human data show that the concomitant use of drugs that significantly inhibit this
enzyme may result in increased plasma levels of domperidone.
When domperidone was co-administered with potent CYP3A4 inhibitors which have been
shown to cause QT interval prolongation, clinically relevant changes in QT intervals were
observed. Therefore, co-administration of domperidone with certain drugs is contraindicated
(see section 4.3 Contraindications).
Caution should be exercised when domperidone is co-administered with potent CYP3A4
inhibitors which have not been shown to cause QT interval prolongation or drugs which have
been shown to cause QT interval prolongation (see section 4.4 Special warnings and
precautions for use).
Theoretically, since MOTILIUM has gastro-kinetic effects, it could influence the absorption of
concomitantly orally administered drugs, particularly those with sustained-release or enteric-
coated formulations. However, in patients already stabilised on digoxin or paracetamol,
concomitant administration of domperidone did not influence the blood levels of these drugs.

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 Domperidone has been used with:
• neuroleptics, without potentiation of their activity,
• dopaminergic agonists (bromocriptine, L-dopa) for suppression of unwanted peripheral
effects such as digestive disorders, nausea and vomiting, without affecting their central
activity.

4.6 Fertility, pregnancy & lactation

Pregnancy
There are limited post-marketing data on the use of domperidone in pregnant women. A study
in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for
humans is unknown. Therefore, MOTILIUM should only be used during pregnancy when
justified by the anticipated therapeutic benefit.

Lactation
The amount of domperidone that could be ingested by an infant through breast milk is low.
The maximal relative infant dose (%) is estimated to be about 0.1% of the maternal weight-
adjusted dosage. It is not known whether this is harmful to the newborn. Therefore breast-
feeding is not recommended for women who are taking MOTILIUM.

4.7 Effects on Ability to Drive and Use Machines

Dizziness and somnolence have been observed following use of domperidone (see section
4.8 Undesirable Effects). Therefore, patients should be advised not to drive or use machinery
or engage in other activities requiring mental alertness and coordination until they have
established how MOTILIUM affects them.

4.8 Undesirable Effects

Clinical Trial Data
The safety of MOTILIUM was evaluated in 1221 patients with gastroparesis, dyspepsia,
gastro-oesophagoeal reflux disorder (GERD), or other related conditions in 45 clinical trials
included in the safety database. All patients were ≥ 15 years old and received at least one
dose of oral MOTILIUM (domperidone base). Slightly fewer than one-half (553/1221) of
patients were diabetic. The median total daily dose was 80 mg (range 10 to 160 mg), with
230 patients receiving a dose greater than 80 mg. Median duration of exposure was 56 days
(range 1 to 2248 days).

Table 1. Adverse - Reactions Reported by ≥ 1% of MOTILIUM-Treated Patients in 45 Clinical

Trials
System/Organ Class MOTILIUM (n=1221)
Adverse Reaction %
Psychiatric Disorders
Depression 2.5
Anxiety 1.6
Libido Decreased/Loss of Libido 1.5
Nervous System Disorders
Headache 5.6
Somnolence 2.5
Akathisia 1.0
Gastrointestinal Disorders
Diarrhoea 5.2
Skin and Subcutaneous Tissue Disorders
Rash 2.8

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 System/Organ Class MOTILIUM (n=1221)
Adverse Reaction %
Pruritus 1.7
Reproductive System and Breast Disorders
Breast Enlargement/Gynaecomastia 5.3
Breast Tenderness 4.4
Galactorrhoea 3.3
Amenorrhoea 2.9
Breast Pain 2.3
Menstruation Irregular 2.0
Lactation Disorder 1.6
General Disorders and Administration Site Conditions
Asthenia 1.9

ADRs that occurred in < 1% of Domperidone-treated patients in the 45 clinical trials (n=1221)
are listed below in Table 2.

Table 2. Adverse Drug Reactions Reported by <1% of MOTILIUM -Treated Patients

in 45 Clinical Trials
System/Organ Class MOTILIUM (n=1221)
Adverse Reaction %
Immune System Disorders
Hypersensitivity 0.2
Skin and Subcutaneous Tissue Disorders
Urticaria 0.7
Reproductive System and Breast Disorders
Breast Discharge 0.8
Breast Swelling 0.5

The following adverse reaction has been reported with over-the-counter use: dry mouth.

Postmarketing
In addition to the adverse effects reported during clinical studies and listed above, the following
adverse drug reactions have been reported. In each table, the frequencies are provided
according to the following convention:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥ 1/ 1,000 and < 1/100
Rare ≥1/10,000 and < 1/1,000
Very rare <1/10,000, including isolated reports.

In Table 3, ADRs are presented by frequency category based on spontaneous reporting rates,
when known.
Table 3. Adverse Drug Reactions Identified During Postmarketing Experience with
MOTILIUM by Frequency Category Estimated from Spontaneous Reporting Rates
Immune System Disorders
Very rare Anaphylactic Reaction (including Anaphylactic Shock)
Psychiatric Disorders
Very rare Agitation, Nervousness
Nervous System Disorders
Very rare Dizziness, Extrapyramidal Disorder, Convulsion
Cardiac Disorders

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 Very rare Sudden Cardiac Death*, Serious Ventricular Arrhythmias*
Skin and Subcutaneous Tissue Disorders
Very rare Angioedema, Urticaria
Renal and Urinary Disorders
Very rare Urinary Retention
Reproductive System and Breast Disorders
Rare Gynaecomastia, Amenorrhoea
Investigations
Very rare Liver Function Test Abnormal, Blood Prolactin Increased
* Based on epidemiology data (see below)

Very rare case reports of QTc prolongation, ventricular arrhythmia, and sudden death have
occurred with domperidone use. Although most reported cases have occurred in patients
receiving the intravenous form of domperidone, or in patients with other risk factors, an
association with oral domperidone cannot be completely ruled out. Therefore, domperidone
should be used with caution in patients with other risk factors for QTc prolongation including
hypokalaemia, severe hypomagnesaemia, structural heart disease, the concomitant
administration of QTc prolonging medicines, or an underlying genetic predisposition.
Extrapyramidal disorder occurs primarily in neonates and infants. Other central nervous system-
related effects of convulsion and agitation also are reported primarily in infants and children.
An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been
reported in some epidemiology studies. The risk may be higher in patients older than 60 years
or at total daily doses of more than 30mg. Domperidone should be used at the lowest effective
dose in adults. Due to the limitations of these data, the exact frequency of these adverse
reactions could not be defined.

Paediatric population
In postmarketing experience, there were no differences in the safety profile of adults and
children., with the exception of extrapyramidal disorder which occurred primarily in neonates
and infants (up to one year of age), and other central nervous system-related effects of
convulsion and agitation which were reported primarily in infants and children. See also section
4.2 Dose and method of administration and section 4.4 Special warnings and precautions
for use.

4.9 Overdose
Symptoms and signs
Overdose has been reported primarily in infants and children. Symptoms of overdosage may
include agitation, altered consciousness, convulsion, disorientation, somnolence and
extrapyramidal reactions.

Treatment
There is no specific antidote to domperidone. Anticholinergics, anti-Parkinsonian agents may
be helpful in controlling the extrapyramidal reactions. Close observation and supportive
therapy is recommended.
For advice on the management of overdose please contact the National Poisons Centre on
0800 POISON (0800 764766).

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Propulsives, ATC code: A03F A 03

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 Mechanism of Actions
Domperidone is a dopamine antagonist with antiemetic properties. Domperidone does not
readily cross the blood-brain barrier. It seldom causes extrapyramidal side effects, but does
cause a rise in prolactin levels. Its antiemetic effect may be due to a combination of peripheral
(gastrokinetic) effects and antagonism of central dopamine receptors in the chemoreceptor
trigger zone which lies in the area postrema and is regarded as being outside the blood-brain
barrier.
It also antagonises the behavioural effects of dopamine much more effectively when
administered intracerebrally than when given systemically. These findings, together with the
low concentrations found in the brain, indicate a predominantly peripheral effect of
domperidone on dopamine receptors.
Studies in humans have shown intravenous and oral domperidone to increase lower
oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying.
Domperidone has no effect on gastric secretion.

Effect on QT/QTc Interval and Cardiac Electrophysiology

In accordance with ICH—E14 guidelines, a thorough QT study was performed in healthy
subjects. This study included a placebo, active comparator and positive control and was
conducted using recommended therapeutic doses (10 or 20 mg administered 4 times a day).
This study found a maximal difference of QTc between domperidone and placebo in LS-means
in the change from baseline was 3.4 msec for 20 mg domperidone administered 4 times a day
on Day 4, and the 2-sided 90% CI (1.0 - 5.9 msec) did not exceed 10 msec. The QT
prolongation observed in this study when domperidone was administered according to the
recommended dosing is not clinically relevant.
This lack of clinical relevance is corroborated by pharmacokinetics and QTc interval data from
two older studies which involved a 5-day treatment of 20 mg and 40 mg domperidone
administered 4 times a day. ECGs were recorded prior to the study, on Day 5 at 1 hour
(approximately at tmax) after the morning dose, and 3 days later. In both studies, no difference
between QTc after active treatment and placebo was observed. It was therefore concluded
that concentrations of domperidone after 80 and 160 mg daily had no clinically significant effect
on QTc in healthy subjects.

Clinical Studies
Infants and children ≤ 12 years of age
A multicenter, double-blind, randomized, placebo-controlled, parallel-group, prospective study
was conducted to evaluate the safety and efficacy of domperidone in 292 children with acute
gastroenteritis aged 6 months to 12 years (median age 7 years). In addition to oral rehydration
treatment (ORT), randomized subjects received domperidone oral suspension at 0.25 mg/kg
(up to a maximum of 30 mg domperidone/day), or placebo, 3 times a day, for up to 7 days.
This study did not achieve the primary objective, which was to demonstrate that domperidone
suspension plus ORT is more effective than placebo plus ORT at reducing the percentage of
subjects with no vomiting episodes during the first 48 hours after the first treatment
administration. See also section 4.2 Dose and method of administration and section 4.4
Special warnings and precautions for use.

5.2 Pharmacokinetic properties

Absorption
In fasting subjects, domperidone is rapidly absorbed following oral administration with peak
plasma concentrations occurring at approximately 30 to 60 minutes.
The low oral bioavailability (approximately 15%) is due to extensive first pass metabolism in
the gut wall and liver. Although the bioavailability of domperidone is enhanced in normal

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 subjects when taken after a meal, patients with gastro-intestinal complaints should take
domperidone 15 to 30 minutes before a meal. Oral bioavailability of domperidone base is
decreased by prior concomitant administration of cimetidine and sodium bicarbonate (see
section 4.5 Interactions with other medicines and other forms of interactions). The time
of peak absorption is slightly delayed and the AUC somewhat increased when the oral
medicine is taken after a meal.

Distribution
Oral domperidone does not appear to accumulate or induce its own metabolism; a peak
plasma level after 90 minutes of 21 ng/mL after two weeks oral administration of 30 mg per
day was almost the same as that of 18 ng/mL after the first dose. Domperidone is 91 to 93%
bound to plasma proteins. Distribution studies with radiolabelled drug in animals have shown
wide tissue distribution, but low brain concentration. Small amount of drug cross the placenta
in rats.

Metabolism
Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and
N-dealkylation. In vitro metabolism experiments with diagnostic inhibitors revealed that
CYP3A4 is a major form of cytochrome P-450 involved in the N-dealkylation of domperidone,
whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone aromatic hydroxylation
(see section 4.5 Interactions with other medicines and other forms of interactions).

Elimination
Urinary and faecal excretion amounts to 31 and 66%, respectively, of the oral dose. The
proportion of the medicine excreted unchanged is small (10% of faecal excretion and
approximately 1% of urinary excretion). The plasma half-life after a single oral dose is 7-9
hours in healthy subjects but is prolonged in patients with severe renal insufficiency.

Special Populations
Hepatic Impairment
In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the
AUC and Cmax of domperidone is 2.9- and 1.5-fold higher, respectively, than in healthy
subjects. The unbound fraction is increased by 25%, and the terminal elimination half-life is
prolonged from 15 to 23 hours. Subjects with mild hepatic impairment have a somewhat lower
systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein
binding or terminal half-life. Subjects with severe hepatic impairment were not studied (see
section 4.3 Contraindications).

Renal impairment
In studies with severe renal insufficiency (serum creatinine > 6 mg/100 mL, i.e., > 0.6 mmol/L)
the half-life of domperidone is increased from 7.4 to 20.8 hours, but plasma drug levels are
lower than in subjects with normal renal function. Very little unchanged drug (approximately
1%) is excreted via the kidneys (see section 4.4 Special warnings and precautions use).

5.3 Preclinical safety data

Carcinogenicity, Mutagenicity, Teratogenicity
MOTILIUM was administered to mice for 18 months and rats for 24 months in carcinogenicity
studies. No dose-related effects were observed except for an increased incidence of malignant
mammary tumours at 25 times the maximum human dose in female mice and rats and an
increased incidence of pituitary tumours at 25 times the human dose in male rats.
No evidence for mutagenic potential was seen in dominant lethal studies in male and female
mice, micronucleus tests in female mice and female rats, a study of chromosomal aberrations

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 in human lymphocytes, a sex-linked recessive lethal test on Drosophila melanogaster, and in
the Ames metabolic activation test with Salmonella typhimurium. Minor teratogenic effects
were seen in one study where MOTILIUM was administered to rats orally at approximately 125
times the maximum human dose level. These findings were not confirmed by another study
where the medicine was administered orally to rats at dosage levels as high as 400 times than
that given to man.
Embryotoxicity without maternal toxicity was encountered when MOTILIUM was administered
intravenously to rats (> 6 times the maximum human dose level) and orally to mice (44 times
the maximum human dose level). Concurrent embryotoxicity and maternal toxicity were
inconsistently found at oral dose levels approximately 6 times the maximum human level in
rabbits and in rats and approximately 24 times the maximum human dose level.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Maize starch
Microcrystalline cellulose
Pregelatinized potato starch
Povidone
Magnesium stearate
Hydrogenated cottonseed oil
Sodium lauryl sulfate
Hypromellose.

6.2 Incompatibilities
Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions for Storage

Stored at or below 30°C. Protect from light. Store at room temperature.

6.5 Nature and contents of container

Blister packs of 100 tablets.

6.6 Special precautions for disposal

No special requirements.

7. MEDICINE SCHEDULE
Prescription Medicine.

8. SPONSOR
JNTL Consumer Health (New Zealand) Limited
Auckland, NEW ZEALAND
Australia: 1800 029 979
New Zealand: 0800 446 147
Overseas: +61 2 8260 8366

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 9. DATE OF FIRST APPROVAL
28 June 1984

10. DATE OF REVISION OF THE TEXT

7 August 2023

Summary table of changes

Section changes Summary of new information
4.1 - Limit domperidone use to adults and adolescents aged 12 years or more and
weighing 35kg or more
4.2 - Delete dosing reference to ‘children (<12 years) and weighing 35kg or more’
and in patients weighing <35 kgs.
4.3, 4.8 & 5.1 - Add cross reference to section 4.2 & 4.4.
4.4, 4.8 - Delete references to use in children
9 Sponsor change
8 Contact details updated

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