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FDC International Ltd
Unit 6 Fulcrum1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE
Telephone: +44 (0)1489 565222
Fax: +44 (0)1489 565222
WWW: http://www.fdcindia.com
Medical Information e-mail: fdcil@btconnect.com

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: 23/11/2010
SPC Hypromellose Eye Drops BP

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 23/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   14-Jun-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
$0       4.3           Contra-indications$0$0$0$0                                Hypersensitivity to any component of the preparation$0$0$0$0$04.4           Special warnings and specialprecautions for use$0$0 $0$0May causetransient stinging or temporary blurred vision. If irritation persists orworsens, or headache, eye pain, vision changes or continued redness occur,patients should discontinue use and consult a physician or pharmacist (seesection 4.8).$0$0 $0$0In order tohelp preserve sterility the dropper should not be allowed to touch the eyelidsor any other surface.  (Labelwarning:  do not touch the eyelid withthe dropper).   The product containsbenzalkonium chloride and should not be used if soft contact lenses are beingworn.$0$0  4.7           Effects on ability to drive anduse machines$0$0$0$0 $0$0May cause transient blurring of vision oninstillation. Do not drive or operate hazardous machinery unless vision isclear.$0$0$0$0$0 4.8           Undesirable effects$0$0$0$0 $0$0May cause transient mild stinging ortemporarily blurred vision.$0$0 $0$0
Updated on 20/01/2010 and displayed until 23/11/2010
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

 
  hypromellose