Taflotan eye drops tube/dropper 0.0015% 0.3 ml №30

Indications

To reduce elevated intraocular pressure in patients with open-angle glaucoma and ophthalmic hypertension as monotherapy in patients:

- which shows eye drops that do not contain a preservative;

- with insufficient response to first-line drugs;

- do not carry first-line drugs or have contraindications to these drugs.

As an additional therapy to beta-blockers.

Tafluprost is designed for patients over 18 years old.

Dosage and administration

The recommended dose - 1 drop of eye drops Taflotan^® in the conjunctival sac of the affected eye (s) 1 time / day, in the evening.

The drug in the specified dose should be instilled strictly 1 time / day, because more frequent use may reduce the effect of IOP reduction.

For single use only. The contents of one tube-dropper is enough for instillation in both eyes. The remaining drug should be discarded immediately after use.

Have elderly patients dose adjustment is not required.

Safety and efficacy of tafluprost children and adolescents under the age of 18 not installed, data on the application is not available.

Efficacy and safety of tafluprost patients with impaired liver and / or kidney function not studied, so if necessary, use of the drug in this category of patients requires caution.

Mode of application

To reduce the risk of darkening of the eyelid skin, patients should remove excess solution from the skin.

As with the application of other eye drops, nasolacrimal occlusion is recommended - a soft closing of the eyelids after the instillation of the drug. This may reduce the systemic absorption of drugs administered through the eyes.

When using several local ophthalmic drugs, the intervals between their use should be at least 5 minutes.

Adverse effects

In clinical studies, over 1400 patients were treated with tafluprost with a preservative - either as monotherapy or as an additional drug for treatment with Timolol 0.5%. The most frequently detected treatment-related side effect was eye flushing. It was observed in approximately 13% of patients who participated in clinical studies of tafluprost in Europe and the USA. In most cases, hyperemia was moderate and resulted in cessation of treatment on average in 0.4%. patients. In a 3-month phase III study, in the USA, when comparing the composition of tafluprost 0.0015% without preservative, with timolol, also without preservative, eye hyperemia was observed in 4.1% (13/320) of patients receiving tafluprost.

The following side effects associated with treatment were reported during clinical trials of tafluprost in Europe and the USA after their maximum expansion for 24 months.

Special senses: often (from> 1/100 to <1/10) - itchy eyes, eye irritation, eye pain, conjunctiva / eye hyperemia, eyelash changes (increase in length, thickness and number of eyelashes), dry eye syndrome, foreign body sensation in the eyes, change in eyelash color, eyelid erythema, superficial punctate keratitis, photophobia, increased tearing, blurred vision, reduced visual acuity, and increased pigmentation of the iris; infrequently (from> 1/1000 to <1/100) - eyelid pigmentation, eyelid edema, asthenopia, conjunctival edema, appearance of discharge from the eyes, blepharitis, anterior chamber inflammation, eye anterior discomfort, conjunctival pigmentation, conjunctival follicles, allergic conjunctivitis and atypical sensation in the eye.

Nervous system: often (from> 1/100 to <1/10) - a headache.

Dermatological: infrequently (from> 1/1000 to <1/100) - eyelid hypertrichosis.

Contraindications

- hypersensitivity to the drug.

Use during pregnancy and lactation

Data on the use of tafluprost in pregnant women is not enough. Tafluprost may have an adverse pharmacological effect on the course of pregnancy and / or on the fetus / newborn baby. In this regard, Taflotan^® should not be used during pregnancy, unless there are no other treatment options.

Women of childbearing age should not appoint taflotan^®if they do not use adequate contraception.

It is not known whether tafluprost or its metabolites are excreted in human breast milk. Taflotan^® should not be used during breastfeeding.

AT experimental studies The toxic effects of tafluprost on the reproductive system have been demonstrated in animals. In a study on rats, it was found that after topical administration, tafluprost is excreted in breast milk. Fertility of female and male rats, mating ability and fertility remained unchanged with the introduction of tafluprost up to 100 mcg / kg / day IV.

Special notes

Prior to treatment, patients should be warned about the possibility of excessive growth of eyelashes, darkening of the eyelid skin and enhancing the iris pigmentation. Some of these changes may be permanent, and this can lead to differences in the appearance of the eyes if only one eye has been treated.

The change in pigmentation of the iris occurs slowly, and may remain imperceptible for several months. The change in eye color is observed mainly in patients with iris of mixed colors, for example, if the eyes are brown-blue, gray-brown, yellow-brown or green-brown. Treatment of only one eye can lead to persistent heterochromia.

There is no experience of using tafluprost in cases of neovascular, angle-closure, narrow-angle or congenital glaucoma. There is only limited experience in treating patients with aphakia, pigmentary or pseudoexfoliative glaucoma with tafluprost.

It is recommended to use caution when treating patients with aphakia, artifakia, a damaged posterior lens capsule or implanting the lens into the anterior chamber of the eye, as well as patients with established risk factors for developing cystic macular edema or iritis / uveitis.

There is no experience with the drug in patients with severe asthma. In this regard, patients in this group should be treated with caution.

Influence on ability to drive motor transport and control mechanisms

Tafluprost does not affect the ability to drive vehicles and work with mechanisms. As with the use of any other ophthalmologic agents, a short-term blurring of vision may occur after the installation of the drug. In this case, the patient must wait until the vision is fully restored and only after that to drive a car or work with mechanical equipment.

Overdosage

Overdose cases have not been reported. After instillation of the drug in the eye overdose is unlikely.

Treatment: in case of overdose, symptomatic therapy is carried out.

Drug interaction

No cross-interaction with other drugs in the treatment of humans is expected, since the concentration of tafluprost in the systemic circulation after the instillation of the drug in the eye is extremely low, therefore no special studies have been conducted to study the specific interaction of tafluprost with other drugs.

In clinical studies, tafluprost was used simultaneously with timolol, and no symptoms of cross-interaction were noted.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 2 ° to 8 ° C.

After opening the package with a tube-droppers stored at a temperature not higher than 25 ° C. Store tube dropper in the package.

After a single use, the dropper tube should be discarded along with the remaining residue.