Summary of Product Characteristics
last updated on the eMC:
23/09/2008
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 23/09/2008 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 5.2 - Pharmacokinetic Properties
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 16-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2:
Replaced: uSE IN CHILDREN HAS NOT BEEN ESTABLISHED
with
Children:
Placebo-controlled trails, in which 334 patients were treated with buspirone for up to six weeks, have not shown buspirone at doses recommended for adult to be an effective treatment for generalised anxiety disorder in patients less than 18 years.
Plasma concentrations of buspirone and its active metabolite were higher in paediatric patients, compared to adults given equivalent doses. (See 5.2, Pharmacokinetic Properties.)
5.2:
Insertion of:
At steady state, the following doses of buspirone in children aged 6-12 years resulted in increases in Cmax (maximum concentration) and AUC (area under the curve), compared with adults, as shown in the table:
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Dosage
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Cmax
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AUC
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7.5 mg b.i.d
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2.9 – fold
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1.8 – fold
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15 mg b.i.d
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2.1 – fold
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1.5 – fold
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Across the dose range studied, the Cmax and AUC of 1-PP (the active metabolite of buspirone, 1-pyrimidinylpiperazine) in children were approximately double those of adults.
6.4 Special Precautions for Storage
store below
Do not store above 25°C
6.6 Instructions for Use/handling
none
No specific instructions.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
11.06.1987 / 11.06.9216.05.2008
10. DATE OF REVISION OF THE TEXT
March 200716.05.2008
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Updated on 30/03/2007 and displayed until 23/09/2008
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Reasons for adding or updating:
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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: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - addition of:
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine product.
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Updated on 28/07/2005 and displayed until 30/03/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 06/08/2002 and displayed until 28/07/2005
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 18/01/2002 and displayed until 06/08/2002
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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 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Updated on 27/07/2001 and displayed until 18/01/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 10/02/2000 and displayed until 27/07/2001
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Updated on 06/09/1999 and displayed until 10/02/2000
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