Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The long term effects on the melanocytes and any consequences thereof are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years. The change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e. blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish. After discontinuation of therapy, no further increase in brown iris pigment has been observed.
In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues.
TRAVATAN may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes. The mechanism of eyelash changes and their long term consequences are currently unknown.
TRAVATAN has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey. However, this effect was not observed during the clinical trials and is considered to be species specific.
There is no experience of TRAVATAN in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma. TRAVATAN should therefore be used with caution in patients with active intraocular inflammation.
Macular oedema has been reported during treatment with prostaglandin F2a analogues. Caution is recommended when using Travatan in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
In patients with known predisposing risk factors for iritis/uveitis, TRAVATAN should be used with caution.
Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.
Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin. Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately.
Patients must be instructed to remove contact lenses prior to application of TRAVATAN and wait 15 minutes after instillation of the dose before reinsertion.
TRAVATAN contains propylene glycol which may cause skin irritation. TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
Efficacy and safety data in the age group 2 months to <3 years (9 patients) is limited (see section 5.1). No data are available for children below the age of 2 months.
In children <3 years old that mainly suffer from PCG (primary congenital glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
No long-term safety data are available in the paediatric population.
No interaction studies have been performed.
TRAVATAN must not be used in women of child bearing age/potential unless adequate contraceptive measures are in place (see section 5.3).
Travoprost has harmful pharmacological effects on pregnancy and/or the fetus/new-born child. TRAVATAN should not be used during pregnancy unless clearly necessary.
It is unknown whether travoprost from the eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of TRAVATAN by breast-feeding mothers is not recommended.
There are no data on the effects of TRAVATAN on human fertility. Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.
TRAVATAN has no or negligible influence on the ability to drive and use machines, however as with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
In clinical trials with TRAVATAN, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.
The following adverse reactions are classified according to the following convention: 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), or not known (frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post-marketing data with TRAVATAN.
Uncommon: hypersensitivity, seasonal allergy
Not known: depression, anxiety, insomnia
Uncommon: headache
Rare: dizziness, visual field defect, dysgeusia
Very common: ocular hyperaemia
Common: iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation
Uncommon: corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes
Rare: iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, asthenopia, eyelash hyperpigmentation, eyelash thickening
Not known: macular oedema, lid sulcus deepened
Not known: vertigo, tinnitus
Uncommon: palpitations
Rare: heart rate irregular, heart rate decreased
Not known: chest pain, bradycardia, tachycardia, arrhythmia
Rare: blood pressure diastolic decreased, blood pressure systolic increased, hypotension, hypertension
Uncommon: cough, nasal congestion, throat irritation
Rare: dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness
Not known: asthma aggravated, epistaxis
Rare: peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth
Not known: diarrhoea, abdominal pain, nausea, vomiting
Uncommon: skin hyperpigmentation (periocular), skin discolouration, hair texture abnormal, hypertrichosis
Rare: dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis
Not known: pruritus, hair growth abnormal
Rare: musculoskeletal pain, arthralgia
Not known: dysuria, urinary incontinence
Rare: asthenia
Not known: prostatic specific antigen increased
In a 3 month phase 3 study and a 7 days pharmacokinetic study, involving 102 paediatric patients exposed to TRAVATAN, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients. The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1). The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%). In a similar 3 month study in adult patients, these events occurred at an incidence of 11.4% and 0.0%, respectively.
Additional adverse drug reactions reported in paediatric patients in the 3 month paediatric study (n=77) compared to a similar trial in adults (n=185) included erythema of eyelid, keratitis, lacrimation increased, and photophobia all reported as single events with an incidence of 1.3% versus 0.0% seen in adults.
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 the national reporting system listed in Appendix V.
None known.
Specific in vitro interaction studies were performed with TRAVATAN and medicinal products containing thiomersal. No evidence of precipitation was observed.
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