Summary of Product Characteristics
last updated on the eMC:
06/10/2010
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 06/10/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 4.3 - Contraindications
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| Date of revision of text on the SPC: 07-Sep-2010 |
| Legal Category: P |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In Section 4.3 (contraindications), updated according to QRD - hypersensitivity to active ingredients and excipients.
In Section 4.4 (special warnings and special precautions for use), the warning - only for ocular use added.
In section 4.5 (interaction with other medicinal products and other forms of interaction), the following sentence has been added - 'If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.'
In Section 4.6 (pregnancy and lactation) Deatils on use of teras naturale during pregnancy and lactation and the conclusion that tears naturale single dose can be used - are added.
In Section 4.7 (effects on ability to drive and use machines), warnings relating to - driving and use of machines after instilling tears naturale single dose - are added.
In Section 4.8 (undesirable effects), summary of the safety profile and tabulated list of adverse reactions are added.
In Section 4.9 (overdose), the following text is added - 'No case of overdose has been reported. An overdose of Tears Naturale Single Dose can easily be washed out of the eye with lukewarm tap water.'
In Section 10 (date of revision of the text), the date of revision is updated.
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Updated on 23/06/2008 and displayed until 06/10/2010
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: P |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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