OCUFEN Eye drops, solution Ref.[8116] Active ingredients: Flurbiprofen

Wound healing may be delayed with the use of Ocufen.

There have been reports that Ocufen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery.

Patients with a history of herpes simplex keratitis should be monitored closely.

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in some surgical patients treated with Ocufen.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Ocufen should not be given unless clearly necessary.

If Ocufen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose

the foetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, Ocufen is contraindicated during the third trimester of pregnancy.

Breast-feeding

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

It is unknown whether flurbiprofen/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ocufen therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Transient blurred vision can result after instillation. If this occurs, the patient should wait until the vision clears before driving or using machinery.

The following adverse reactions were reported during the use of Ocufen in clinical studies.

Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000) adverse reactions are presented according to MedDRA System organ class

Eye disorders

Very common: Eye irritation, eye pain, Hyphema*

Additionally, the following adverse reactions have been identified during post marketing experience.

Eye disorders

Not known: eye haemorrhage*, mydriasis (prolonged mydriasis), ocular hyperaemia.

^* see section 4.4 for further information.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.

Not applicable.