Travoprost Eye Drops 2.5ml


Travoprost Eye Drops 2.5ml

Travoprost eye drops, the generic version of Travatan , is one of a group of medicines called prostaglandin analogues. Travoprost eye solution works by reducing the pressure in the eye. Travoprost eye drops may be used on its own or with other drops e.g.
beta-blockers, which also reduce pressure.
Travoprost is used to reduce high pressure in the eye in adults, adolescents and children from 2
months old onward. This high eye pressure can lead to an illness called glaucoma.

Common side effects

Travoprost drops may increase the length, thickness, colour and/or number of your eyelashes.
Changes in the eyelids including unusual hair growth or in the tissues around the eye have also
been observed.

 


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Travoprost Eye Drops 2.5ml

Travoprost eye solution is used to decrease elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma

Travoprost Eye Drops 2.5ml

Travoprost eye drops, the generic version of Travatan , is one of a group of medicines called prostaglandin analogues. Travoprost eye solution works by reducing the pressure in the eye. Travoprost eye drops may be used on its own or with other drops e.g.
beta-blockers, which also reduce pressure.
Travoprost is used to reduce high pressure in the eye in adults, adolescents and children from 2
months old onward. This high eye pressure can lead to an illness called glaucoma.

Common side effects

Travoprost drops may increase the length, thickness, colour and/or number of your eyelashes.
Changes in the eyelids including unusual hair growth or in the tissues around the eye have also
been observed.

 

How To Use

One drop in the affected eye or eyes, once a day in the evening.

Patient information leaflet  click here

Warning / Side Effects

Use in adults, including elderly population

The dose is one drop of Bondulc in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5).

If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.

When substituting another ophthalmic antiglaucoma medicinal product with Bondulc, the other medicinal product should be discontinued and Travoprost should be started the following day.

Hepatic and renal impairment

Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min). No dosage adjustment is necessary in these patients (see section 5.2).

Paediatric population

Bondulc can be used in paediatric patients from 2 months to < 18 years at the same posology as in adults. However, data in the age group 2 months to < 3 years (9 patients) is limited (see section 5.1).

The safety and efficacy of Bondulc in children below the age of 2 months have not been established. No data are available.

Method of administration

For ocular use

For patients who wear contact lenses, please refer to section 4.4.

The patient should remove the protective overwrap immediately prior to initial use. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Eye colour change

Travoprost 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.

Periorbital and eye lid changes

In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of Travoprost 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.

Travoprost 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.

Travoprost 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 Travoprost 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. Travoprost should therefore be used with caution in patients with active intraocular inflammation.

Aphakic patients

Macular oedema has been reported during treatment with prostaglandin F2a analogues.

Caution is recommended when using Travoprost 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.

Iritis/uveitis

In patients with known predisposing risk factors for iritis/uveitis, Travoprost should be used with caution.

Contact with the skin

Skin contact with Bondulc 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

Excipients

Bondulc contains the preservative benzalkonium chloride, which may cause irritation. Avoid contact with soft contact lenses.

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

Bondulc contains Macrogol glycerol hydroxy stearate 40 which may cause skin reactions.

Paediatric population

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.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6 Fertility, pregnancy and lactation

Women of child-bearing potential/contraception

Travoprost must not be used in women of child bearing age/potential unless adequate contraceptive measures are in place (see section 5.3).

Pregnancy

Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-born child. Travoprost should not be used during pregnancy unless clearly necessary.

Breastfeeding

It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of travoprost by breast-feeding mothers is not recommended.

Fertility

There are no data on the effects of travoprost on human fertility. Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.

4.7 Effects on ability to drive and use machines

Bundulc 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.

4.8 Undesirable effects

Summary of the safety profile

In clinical trials with travoprost, the most common adverse reactions were ocular hyperaemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.

Ingredients

Each 1 ml of solution contains 40 micrograms of Travoprost

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