Rosemont Pharmaceuticals Limited

Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE

Telephone: +44 (0)113 244 1400
Fax: +44 (0)113 246 0738
WWW: http://www.rosemontpharma.com
Customer Care direct line: +44 (0)800 919 312

Out of Hours Telephone: +44 (0)7836 557 879
Out of Hours contact: pharmacovigilance@rosemontpharma.com

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Summary of Product Characteristics last updated on the eMC: 13/01/2012

SPC	Aciclovir 400mg/5ml Oral 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 13/01/2012 and displayed until Current

Reasons for adding or updating:
Change to section 4.1 - Therapeutic indications Change to section 5.2 - Pharmacokinetic Properties Change to section 10 date of revision of the text
Date of revision of text on the SPC: 07-Dec-2011
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
4.1 Therapeutic indications The following text in red has been added: Aciclovir Suspension is indicated for the following:- 1. The treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children). 5.2 Pharmacokinetic properties Reference to ‘young infants’ has been removed from the following sentence: In neonates (0 to 3 months of age) treated with doses of 10mg/Kg administered by infusion over a one-hour period every 8 hours the C^ss max was found to be 61.2 microMol (13.8 micrograms/ml) and C^ssmin to be 10.1 microMol (2.3 micrograms/ml) The following text has been added: A separate group of neonates treated with 15mg/Kg every 8 hours showed approximate dose proportional increases, with Cmax of 83.5 micromolar (18.8 microgram/ml) and Cmin of 14.1 micromolar (3.2 microgram/ml). 10 DATE OF REVISION OF THE TEXT 07.12.11

Updated on 11/01/2010 and displayed until 13/01/2012

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use Change to section 4.8 - Undesirable Effects Change to section 10 date of revision of the text
Date of revision of text on the SPC: 03-Nov-2009
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
In section 4.4 (special warnings and precautions for use) advice in renal impairment and elderly patients has been added. In section 4.8 (undesirable effects) a comment regarding frequency categories and incidence has been added. Anaphylaxis has been changed to 'rarely' anaphylaxis. The heading for nervous system disorders has been updated to read 'psychiatric and' nervous system disorders. Headache and dizziness have both been added as common effects. Very rare effects of agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy and coma have been added. A heading for respiratory, thoracic and mediastinal disorders has been added, with dyspnoea as a rare effect. The GI symptoms listed have been updated to read commonly reported. Under skin and subcutaneous tissue disorders, pruritis, rashes (including photosensitivity) have been added as common. Uncommon effects have been updated to include urticaria. Occasional reports of hair loss has been added. Angioedema has been added as a rare event. Under renal and urinary disorders, renal pain has been added. In section 10 (date of revision of the text) the date had been updated to 03-Nov-2009.