TIMLATAN Eye Drops Solution 50+5
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-06-2024
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Active ingredient:
LATANOPROST TIMOLOL MALEATE
Available from:
Przedsiebiorstwo Farmaceutyczne Jelfa S.A.
Dosage:
50+5
Pharmaceutical form:
Eye Drops Solution
Authorization date:
2011-08-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Timlatan 50 micrograms/ml + 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol.
One drop contains approximately 1.5 micrograms latanoprost and 150 micrograms timolol.
Excipients with known effect: benzalkonium chloride 0.2 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
The solution is a clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are
insufficiently responsive to topical beta-blockers or prostaglandin analogues.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dosage for adults (including the elderly):
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in
the affected eye(s) daily.
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may
result in a decrease in systemic side effects and an increase in local activity.
Administration:
Contact lenses should be removed before instillation of the eye drops and may be reinserted
after 15 minutes (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Use in children and adolescents:
Safety and effectiveness in children and adolescents has not been established.
4.3 CONTRAINDICATIONS
Latanoprost/timolol is contraindicated in patients with:
-
Hypersensitivity to one or both active substances
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