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INDOCOLLYRE

Information leaflet

                                                    Irish Medicines Board




                                                         Part II
                                Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Indocollyre 0.1%, eye drops

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 When reconstituted each 5ml contains 5mg of Indometacin, as a 0.1% w/v solution.

 For excipients, see 6.1

 3 PHARMACEUTICAL FORM

 Eye drops, powder and solvent for solution. The appearance of the powder in the vial is white to cream-coloured. The
 solvent solution appears as a clear, colourless and viscous solution.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

        Prevention of per-operative miosis during cataract surgery.
        Prevention of inflammatory manifestations related to surgical operations for cataract and to anterior segment
        of the eye.

 4.2 Posology and method of adminstration

 Adults

 -     Prevention of per-operative miosis during cataract surgery, 1 drop every 30 minutes within 2 hours preceding
       the operation.
 -     Prevention of inflammatory manifestations related to cataract and to anterior segment of the eye surgery.
 -     1 drop 4 to 6 times a day before operation, 1 drop every 30 minutes within 2 hours preceding the operation,
       and 1 drop 4 times per day for one month.
 -     To administer treatment, gently pull down the lower lid of the eye and apply one drop of solution while
       looking upwards.

 Children
 Safety and efficacy of use in children has not been established.

 4.3 Contraindications

 This product is contra-indicated in the following situations:

        from the 6th month of pregnancy onwards (see: Pregnancy and Breast-feeding),
        allergy to indomethacin or to drugs with similar activity e.g. other non-steroidal anti-inflammatory drugs
        or aspirin, allergy to the preservative (thiomersal),
        previous asthma attacks caused by aspirin or other non-steroidal anti-inflammatory drugs.




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Date Issued 09/11/2005                                CRN 2016632                                         page number: 1
                                                    Irish Medicines Board




 In general, this product should not be taken:

        in combination with other NSAIDs including high doses of salicylates, oral anticoagulants, injectable heparin,
        lithium, high doses of methotrexate, ticlopidine, diflunisal (see section: Drug interactions and other
        forms of interaction),
        during the first 5 months of pregnancy (see: Pregnancy and Breast-feeding),
        during breast-feeding (see: Pregnancy and Breast-feeding).

 4.4 Special warnings and special precautions for use

 Warning

 -     Children: no specific studies have been conducted in children.

 Precautions of use

 -     If hypersensitivity is noted, stop the treatment.
 -     Prescribe appropriate treatment in cases presenting a risk of eye infection.
 -     A NSAID may retard corneal healing.
 -     A NSAID may increase bleeding of ocular tissues during surgery, notably in patients with a known tendency to
       bleed or those receiving other treatments liable to prolong bleeding.
 -     It is inadvisable to wear contact lenses during treatment with INDOCOLLYRE 0.1% (5 mg/5 ml).
 -     If at the same time the patient is receiving treatment with another eye-drop preparation containing a different
       active substance, administer the two solutions at least 15 minutes apart.
 -     Do not touch the eye with the tip of the bottle.

 4.5 Interaction with other medicinal products and other forms of interaction

 To avoid diluting the active ingredients, instill products at least 15 minutes apart. If necessary, indometacin
 administered by ocular route can be combined with eye-drops containing corticosteroids.

 Although only small amounts of NSAID pass into the systemic bloodstream after ocular instillation, drugs interactions
 are nevertheless possible. It is therefore advisable to take account of the interactions observed with NSAIDS
 administered by general route.

 Inadvisable combinations:

       other NSAIDS, including high doses of salicylates: increased risk of inducing GI tract ulcers and bleeding
 -
       through synergy.

       oral anticoagulants, parenteral heparin: increased risk of bleeding through inhibition of platelet function and
 -
       damage to gastro-duodenal mucosa by NSAIDs.
       If such a combination is unavoidable, close clinical and laboratory monitoring is required.

       lithium (described with other NSAIDs): lithium blood levels may increase to toxic levels; this effect is due to
 -
       decreased lithium excretion by the kidney.
        If necessary, monitor lithium blood levels closely and adjust the lithium dosage during combined treatment then
       after the NSAID is withdrawn.

       high doses of methotrexate, i.e. 15 mg/week or more: methotrexate haematological toxicity increases as its
 -
       renal clearance is decreased by anti-inflammatory drugs.

       diflunisal: fatal GI tract bleeding with increased plasma levels of indomethacin (competition for glucuronide
 -
       conjugating enzymes).

       ticlopidine: increased risk of GI tract ulcers and bleeding because of synergy. If such a combination is
 -




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Date Issued 09/11/2005                                CRN 2016632                                         page number: 2
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