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Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Herts, HP2 7UD , UK
Telephone: 0871 376 7402
Fax: +44 (0) 1442 341 280
Medical Information Direct Line: +44 (0) 1442 341 192
Medical Information e-mail: ukmedical@alconlabs.com
Summary of Product Characteristics last updated on medicines.ie: 13/06/2011
SPC Maxitrol Ointment

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


In Section 2, Qualitative and quantitative composition, ‘(E218) and (E216)’ are added against the ingredients methyl parahydroxybenzoate and propyl parahydroxybenzoate respectively.

 

In section 4.6, Pregnancy and lactation, the section header is amended to read ‘Fertility, pregnancy and lactation’

 

In Section 6.1, List of excipients, petrolatum is replaced with white soft paraffin.

 

In Section 6.3, Shelf-life, the unopened shelf life is updated to 4 years.

 

In Section 10, Date of revision of the text, the revision date is updated.
Updated on 17/02/2011 and displayed until 13/06/2011
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   24-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


In Section 6.4, ‘Do not store above 25 C. Keep away from direct sunlight. Do not refrigerate. Keep the container tightly closed’ is replaced with ‘Do not store above 25°C. Do not refrigerate or freeze. Store in the original package (to protect from light). Keep the container tightly closed. ’
Updated on 13/08/2010 and displayed until 17/02/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 1 - Name of the product changed to 'Maxitrol 0.1% w/w, 6000IU/g, 3500 IU/g eye ointment'.

Section 2 - 'Also contains : Methyl parahydroxybenzoate 0.05% w/w, Propyl parahydroxybenzoate 0.01% w/w, Liquid lanolin 3.0% w/w' is added.

Section 4.3 - 'Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding' is removed.

Section 4.4 - This section has been updated to include the warning ' For ophthalmic use only. Not for inejection or ingestion'. Information relating to - Sensitivity to topically aplied aminoglycosides, nephrotoxic and neurotoxic reactions, reduction of resistance to bacterial and fungal infections - has been added. Warning regarding contact lens wear during treatment has also been added.

Section 4.5 - Information related to - concomitant use of more than one ophthalmic product and drugs that have neurotoxic, ototoxic or nephrotoxic effects - has been added.

Section 4.6 - Advise on use during laction - No information on the ingredients being excreted in human milk, but it still poses a risk and a decision is to be made whether to discontinue breastfeeding or discontinue/abstain from the therapy - is added.

Section 4.7 - Advise - If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery - is added.

Section 4.8 - Section updated to MEDRA coding.

Section 4.9 - 'A topical ophthalmic overdose of Maxitrol eye ointment may be flushed from the eye(s) with lukewarm water' and signs and symptoms of overdosage are added.

Section 5.1 - Pharmacodynamic properties are updated under the following groups - mechanism of action, mechanism of resistance, breakpoints and susceptability.

Section 5.3 - Priclinical safety data is added under the following groups - mutagenecity and carcinogenecity, teratogenecity and local tolerance and systemic effects.

Section 6.3 - 'after opning 28 days' is replaced with 'Discard 4 weeks after first opening'.

Section 6.5 - '3.5 g metal tube with applicator nozzle and screw cap' changed to 'Epoxy-phenolic lines aluminium tube with polyethylene nozzle and screw cap. The tube contains 3.5g of eye ointment'

Section 6.6 - 'Any unused product or waste material should be disposed of in accordance with local requirements.' is added.

Section 9 - Date of last renewal updated.

Section 10 - Date of revision updated.
Updated on 20/06/2003 and displayed until 13/08/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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