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Spectrum Thea Pharmaceuticals Limited
Telephone: (0)845 5211 290
Fax: +44(0)1625 619 959
Medical Information Direct Line: +44 (0)79 074 344 03
Medical Information e-mail: medical.enquiries@spectrum-thea.co.uk
Customer Care direct line: 0845 521 1290
Medical Information Fax: +44(0)1625 619 959

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: 19/03/2010
SPC Otrivine Antistin Eye Drops

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 19/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   12-Jun-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 7

Change from: Novartis Pharmceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR to Novartis Consumer Health UK Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

 

Section 8

Change from PL 00101/0602 to PL 00030/0440.
Updated on 16/07/2009 and displayed until 19/03/2010
Reasons for adding or updating:
  • 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:   12-Jun-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8    Addition of paragraph: Local allergic reactions (e.g. rash, oedema, pruritus) and eye irritation have also been reported post-marketing.

 

Section 10     Date of revision of the text changed from 16 October 2008 to 12 June 2009
Updated on 29/12/2008 and displayed until 16/07/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   16-Oct-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1: addition of strength of ingredients to name

 

 

Section 4.2: change to dosage recommendation for children. Previous recommendation for use in children aged 5 – 12 years deleted. Now not recommended in children under 12 years. Recommendation for elderly dosage remains the same but separated out from the child dosage.

 

Section 4.4: addition of  “Otrivine Antistin should be used with caution in elderly patients with severe cardiovascular disease, including arrhythmia, poorly controlled hypertension or diabetes”

Addition of  phaeochromocytoma to list of cautions.

Addition of use with caution in patients with conditions causing urinary retention such as prostatic hypertrophy and patients receiving other sympathomimetic drugs.

 

Section 4.5: Addition of warnings about combination with CNS depressants such as alcohol, hypnotics, opioid analgesics, anxiolytic sedatives and anti-psychotics; combination with anti-muscarinics such as atropine and some antidepressants. Use with caution in patients receiving digitalis, beta-adrenergic blockers, guanetidine, reserpine, methyldopa or anti-hypertensives. Warning re concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane as they may provoke or worsen ventricular arrhythmias.

 

Section 6.3: amendment of unopened shelf life from 5 years to 36 months

 

Section 10: Revision date changed to 16 October 2008 from March 2008

 
Updated on 20/06/2008 and displayed until 29/12/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  xylometazoline hydrochloride
  antazoline sulphate