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Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Telephone: +44 (0)1707 366 000
Fax: +44 (0)1707 338 297
WWW: http://www.rocheuk.com
Medical Information Direct Line: +44 (0)800 032 7298
Medical Information e-mail: roche@professionalinformation.co.uk
Customer Care direct line: +44 (0)800 731 5711
Medical Information Fax: +44 (0)1748 828801

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 24/01/2012
SPC Vesanoid 10mg soft capsules

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 24/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Underlined Text = new text
Struck through Text = deleted text

1        NAME OF THE MEDICINAL PRODUCT

VESANOID®Vesanoid 10 mg soft capsules

2        QUALITATIVE AND QUANTITATIVE COMPOSITION

For the a full list of excipients, see section 6.1

4.1       Therapeutic indications

VESANOID Vesanoid (tretinoin) is indicated for induction of remission in acute promyelocytic leukaemia (APL; FAB classification AML-M3).

4.4       Special warnings and precautions for use

Micro-dosed progesterone preparations (”(“minipill”) are an inadequate method of contraception during treatment with tretinoin (see section 4.6).

6.6       Special precautions for disposal and other handling

Use and handling: No special requirements.

Disposal: Any unused product or waste material should be disposed of in accordance with local requirements.

Use and handling: No special requirements.

10      DATE OF REVISION OF THE TEXT

24/10/08September 2011
Updated on 31/10/2008 and displayed until 24/01/2012
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   24-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Underlined text has been added, text with strike through deleted:

4.9       Overdose

No cases of acute overdosage with tretinoin have been reported.

 

In the eventcase of overdose with all-trans retinoic,accidental overdosage of tretinoin, reversible signs of hyper-vitaminosis A (headache, nausea, vomiting, mucocutaneous symptoms) can appear.

 

The recommended dose in acute promyelocytic leukaemia is one-quarter of the maximum tolerated dose in solid tumor patients and below the maximum tolerated dose in children.

 

There is no specific treatment in the case of an overdose, however it is important that the patient be treated in a special haematological unit.
Updated on 26/01/2007 and displayed until 31/10/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Active substance :

1 capsule contains 10  mg of tretinoin (all-trans retinoic acid) and

 

Excipients :

1 capsule contains 107.92  mg of soya-bean oil.

 

The capsule-shell contains between 0.96 – 1.46  mg of sorbitol (E420).

 

For the full list of excipients, see section 6.1

 

3.       PHARMACEUTICAL form

 

Capsule, soft

Bi-coloured orange-yellow / reddish-brown capsules marked “ROCHE” on one side.

 

4.2     Posology and method of administration

 

A total daily dose of 45  mg/m2 body surface divided in two equal doses is recommended for oral administration. This is approximately 8 capsules per adult dose.

 

Capsules should be swallowed together with water. Capsules should not be chewed. It is recommended to take the capsules with a meal or shortly thereafter.

 

4.6     Pregnancy and lactation

 

All the measures listed below should be considered in relationship to the severity of the disease and the urgency of the treatment.

                                         

Pregnancy: Vesanoid contains a retinoid similar to vitamin A. Therefore Vesanoid should not be used by women who are pregnant or likely to become pregnant. Tretinoin causes serious birth defects when administered during pregnancy. Its use is contraindicated in pregnant women and women who might become pregnant during the treatment with tretinoin and within one month after cessation of treatment, unless the benefit of tretinoin  treatment outweighs the risk of foetal abnormalities due to the severity of the patient’s condition and the urgency of treatment. Therefore Vesanoid must not be used by women who are pregnant or likely to become pregnant.

 

6.1       List of excipients

 

Capsule contents:

Yellow beeswax

Hydrogenated soya-bean oil

Partially hydrogenated soya-bean oil

Soya-bean oil.

 

Capsule shell:

Gelatin

Glycerol (E 422)

Karion 83: Sorbitol (E 420), Mannitol (E 421), Starch (maize)

Titanium dioxide (E 171)

Iron oxide yellow (E 172)

Iron oxide red (E 172)

 

6.4     Special precautions for storage

 

Bottles:

Store between 5°C and 30°C.Do not store above 30°C.

Keep the bottle tightly closed in order to protect from moisture.

Keep the bottle in the outer carton in order to protect from light.

 

Blister packs:

Store between 5°C and 30°C. Do not store above 30°C.

Keep the blisters in the outer carton in order to protect from light.

 
Updated on 20/03/2006 and displayed until 26/01/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 4.3 - Contra-indications
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/11/2004 and displayed until 20/03/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
  • Improved Electronic Presentation
Updated on 20/09/2004 and displayed until 11/11/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
Updated on 24/09/2003 and displayed until 20/09/2004
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
Updated on 22/09/2003 and displayed until 24/09/2003
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
Updated on 13/06/2002 and displayed until 22/09/2003
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 4.8 - Undesirable Effects
Updated on 17/08/2001 and displayed until 13/06/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 19/04/2000 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 19/04/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  tretinoin