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Winthrop Pharmaceuticals UK Ltd
One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 554 831
E-mail: UK-medicalinformation@sanofi-aventis.com
Medical Information Direct Line: +44 (0)1483 554 101
Medical Information Fax: +44 (0)1483 554 831

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Summary of Product Characteristics last updated on the eMC: 19/04/2011
SPC Domperidone 1mg/ml Suspension

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 19/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3 Preclinical Safety Data

In in vitro experiments on isolated cells transfected with HERG and on isolated guinea

pig myocytes, exposure ratios were about 10 ranged between 5 and 30-fold,

based on IC50 values inhibiting currents through IKr ion channels in

comparison to the free plasma concentrations in humans after administration

of the maximum daily dose of 20mg (q.i.d.). Exposure margins for

prolongation of action potential duration in in vitro experiments on isolated

cardiac tissues exceeded the free plasma concentrations in humans at

maximum daily dose (20mg q.i.d) by 17-fold. However, safety margins in
experiments on isolated cardiac tissues  in vitro pro-arrhythmic models (isolated

Langendorff perfused heart) and in in vivo models (dog, guinea pig, rabbits

sensitised for torsades de pointes) exceeded the free plasma concentrations in

humans at maximum daily dose (20mg q.i.d.) by more than 5017-fold. In the

presence of inhibition of the metabolism via CYP3A4 free plasma

concentrations of domperidone can rise up to 10-fold.
Updated on 15/06/2009 and displayed until 19/04/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   29-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4        Special warnings and precautions for use

Deletion of previous sub-section titled “Use with ketoconazole”, to be replaced with:

Use with Potent CYP3A4 Inhibitors:
Co-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QTc interval should be avoided (see
section 4.5 Interaction with other medicinal products and other forms of
interaction).


4.5 Interaction with other medicinal products and other forms of interaction

Deletion of:

A pharmacokinetic study has demonstrated that the AUC and the peak plasma concentration of domperidone is increased by a factor 3 when oral ketoconazole is administered concomitantly (at steady state). A slight QT prolonging effect (mean less than 10msec) of this combination was detected, which was greater than the one seen with ketoconazole alone. A QT prolonging effect could not be detected when domperidone was given alone in patients with no co-morbidity, even at high oral doses (up to 160mg/day).

The results of this interaction study should be taken into account when prescribing domperidone concomitantly with strong CYP3A4 inhibitors: for example: ketoconazole, ritonavir and erythromycin (see also section 5.2).

Replaced with:

Separate in vivo pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of domperidone's CYP3 A4 mediated first pass metabolism by these drugs.
With the combination of oral domperidone 10mg four times daily and
ketoconazole 200mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2 to 17.5 msec. With the combination of domperidone 10mg four times daily and oral erythromycin 500mg three times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6 to 14.3 msec. Both the Cmax and AUC of domperidone at steady state were increased approximately three-fold in each of these interaction studies. In these studies domperidone monotherapy at 10mg given orally four times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while ketoconazole monotherapy (200mg twice daily) led to increases in QTc of 3.8 and 4.9 msec, respectively, over the observation period.

4.8 Undesirable effects

Addition of the following undesirable effects

Immune System Disorder:
Very rare: anaphylactic reactions including anaphylactic shock, angioneurotic oedema

Psychiatric System Disorder: Very rare; agitation, nervousness

Nervous system disorders:
Very rare; convulsions, somnolence, headache

Skin and subcutaneous tissue disorders:
Very rare; pruritus, rash

Cardiac disorders:
Very rare; ventricular arrhythmias,
Frequency not known: QTc prolongation

Investigations:
Very rare; liver function test abnormal

Under sub-heading of “Extrapyramidal side effects”, the following has been added:

Other central nervous system-related effects of convulsion, agitation and somnolence also are very rare and primarily reported in infants and children.

4.9 Overdose
(red denotes additonal text in this section)
Symptoms
Overdose has been reported primarily in infants and children. Symptoms of overdosage may include drowsiness,agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions., especially in children.

Updated on 09/01/2009 and displayed until 15/06/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change of product licence name
Date of revision of text on the SPC:   10-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - update to Cardiovascular warnings
Section 4.9 - updated in line with Company Core Safety Data
Section 6.1 - excipient change from BP to EP (was dispersible cellulose)
The name of this product has now changed from Motilium 1mg/ml Suspension to Domperidone 1mg/ml Suspension
Updated on 24/09/2008 and displayed until 09/01/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   09-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Completely updated version of SmPC reflecting changes to sections 4.4, 4.5 and 5.3 as well as change in MAH.
Updated on 17/09/2004 and displayed until 24/09/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 12/09/2003 and displayed until 17/09/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 06/06/2003 and displayed until 12/09/2003
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Updated on 26/09/2002 and displayed until 06/06/2003
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  domperidone