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Alcon Laboratories (U.K) Limited

Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Herts, HP2 7UD , UK
Telephone: +44 (0) 1442 341 234
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: 06/11/2009
SPC Betoptic 0.5% Eye Drops Solution

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 06/11/2009 and displayed until Current
Reasons for adding or updating:
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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:   31-Oct-2007
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 2 - 'Excipients: Benzalkonium Chloride 0.01% w/v' has been added

Section 4.3 - 'Hypersensitivity to the active substance or to any of the excipients' has been added

Section 4.4 - Sections on diabetes mellitus, thyrotoxicosis, major surgey, pulmonary, myasthenia and ocular have been added

Section 4.5 - Reference to orally administered beta-adrenergic blocking agents has been added and refernce to other products such as catecholamine-depleting drugs such as reserpine. Information on waiting time between supplementary eye preparations added

Section 4.6 - Section on lactation added

Section 4.7 - Reference to temporary impaired vision added

Section 4.8 - Whole section amended to Medra coding

Section 4.9 - 'Treatment of a suspected overdose or accidental ingestion is symptomatic and supportive' added

Section 5.1 -  Betaxolol, a cardioselective (beta-1-adrenergic) receptor blocking -agent, does not have significant membrane-stabilizing (local anesthetic) and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic blocking agents reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function 

Betaxolol has no significant effect on pulmonary function as measured by Forced Expiratory Volume in one second (FEV1,), Forced Vital capacity (FVC), FEV1 / FVC and no evidence of

cardiovascular beta-adrenergic-blockade during exercise was observed.

When instilled in the eye, Betaxolol has the action of reducing elevated as well as normal intraocular pressure (IOP), whether or not accompanied by glaucoma. Ophthalmic Betaxolol has little or no effect on the constriction of the pupil and minimal effect on pulmonary and cardiovascular parameters.Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss Betaxolol has the action of reducing elevated as well as normal intraocular pressure, and the mechanism of ocular hypotensive action appears to be a reduction of aqueous humour production as demonstrated by tonography and aqueous fluorophotometry has been added

Section 5.2 - Information on plasma concentrations has been added

Section 5.3 - Information on post-implantation loss added

Section 9 - Date of first authorisation and last renewal amended

Section 10 - Date of revision changed to October 2007

Updated on 23/08/2006 and displayed until 06/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2004
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 -  Text added:
  Ocular Effects

                        Common: discomfort

                        Uncommon:  tearing

                        Rare:  decreased corneal sensitivity, erythema, itching, corneal punctate staining, keratitis, aniscoria and photophobia

 

                        Systemic reactions following topical administration of betaxolol have been rarely reported. 

Updated on 06/06/2003 and displayed until 23/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Betaxolol Hydrochloride

Versions

 
06/11/2009 to Current
23/08/2006 to 06/11/2009
06/06/2003 to 23/08/2006
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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