Summary of Product Characteristics
last updated on the eMC:
18/09/2009
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 18/09/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - childrens posology expanded to:
Children
In the above indications children over 10 years of age may be given the lower adult doses described above. Children between 5 and 10 years may be given half the adult dose. Tablets are not suitable for administration to children aged between 2 and 5 years. An oral liquid preparation is recommended in this age group. Not for use in children under 2 years of age (see section 4.3).
Section 4.3 - section expanded to:
Avomine should not be used in patients with
Hypersensitivity to promethazine or any of the excipients
Hypersensitivity to other phenothiazines
Coma or CNS depression of any cause
Avomine should not be used in children less than two years of age because of the potential for fatal respiratory depression.
Avomine should not be administered to patients who have been taking monoamine oxidase inhibitors within the previous 14 days.
Section 4.4 - expanded to:
Avomine may thicken or dry lung secretions and impair expectoration, it should therefore be used with caution in patients with asthma, bronchitis or bronchiectesis.
Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy or hepatic and renal insufficiency.
Caution should be exercised in patients with bladder, neck or pyloro-duodenal obstruction.
Promethazine may mask the warnings signs of ototoxicity caused by ototoxic drugs e.g salicylates.
Promethazine may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through suppression of vomiting.
The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
Avomine should not be used for longer than seven days without seeking medical advice.
Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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Updated on 28/08/2009 and displayed until 18/09/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.9 Overdose has been expanded and udpated
Replace the references to induction of vomiting and gastric lavage with a statement regarding the use of activatd charcoal if the patient presents within one hour of ingestion and to mention the use of procyclidine injection. Also to add tachycardia to the list of possible effects of overdose
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Updated on 26/09/2008 and displayed until 28/08/2009
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to MA holder contact details
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| Date of revision of text on the SPC: 01-Mar-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update MA holder address to:
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
United Kingdom
Section 6.5 - addition of 60 tablets securitainer pack size
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Updated on 29/09/2006 and displayed until 26/09/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 01/01/0001 and displayed until 29/09/2006
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 01/01/0001
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