Summary of Product Characteristics
last updated on the eMC:
27/01/2012
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 27/01/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 25-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5 Interactions with other Medicaments and other forms of Interaction
Econazole is a known inhibitor of CYP3A4/2C9. Although not studied, based on the chemical similarity of econazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists.Due to the limited systemic availability after vaginal application (see Section 5.2. Pharmacokinetic Properties), clinically relevant interactions are unlikely to occur but have been reported with oral anticoagulants. In patients on taking oral anticoagulants, such as warfarin and or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored more frequently.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole.
Section 4.9 Overdose
This product is intended for vaginal use. Overdose with econazole nitrate has not been reported to date. Adverse events associated with overdose or misuse of Gyno-Pevaryl are expected to be consistent with adverse drug reactions already listed in Section 4.8. (Undesirable effects).
In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically
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Updated on 29/03/2011 and displayed until 27/01/2012
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Reasons for adding or updating:
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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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: 23-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.3 Contraindications
Hypersensitivity to any imidazole preparation, (or other vaginal antifungal products ) or to any ingredients of Gyno- Pevaryl 1 vaginal pessary.
4.4 Special warnings and precautions
Addition of :
This preparation is not for oral use.
Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation. (moved from section 4.5).Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive. Gyno-Pevaryl 1 vaginal pessary should not be used in conjunction with other internal or external treatment of the genitalia.
4.5. Interaction with other Medicaments and other forms of Interactions
Addition of:the anticoagulant effect should be considered monitored more frequently.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole.
4.6-Preganancy and Lactationa Addition of:Lactation: Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Pevaryl 1 vaginal pessary if the patient is breast-feeding.
4.8 Undesirable effects : Addition of table
4.9 Overdose Updated statement
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Updated on 08/05/2009 and displayed until 29/03/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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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: 28-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 3 – pharmaceutical form
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Removal of ‘with a fat like odour’ change from bullet shape to torpedo shaped
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Change to section 10 – Date of revision of the text
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Changed to 28th April 09
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Updated on 02/09/2008 and displayed until 08/05/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 22-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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7. Marketing Authorisation Holder
Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
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Updated on 22/07/2008 and displayed until 02/09/2008
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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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-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.4 – Special Precautions for Storage
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Increase in storage temperature , changed from 25 deg C to 30 deg C
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Change to section 10 – Date of revision of the text
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15th July 2008
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Updated on 30/09/2004 and displayed until 22/07/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 21/08/2001 and displayed until 30/09/2004
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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