Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml Eye Drops, Solution
Country: United Kingdom
Language: English
Source: myHealthbox
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
Latanoprost, Timolol
Available from:
Tubilux Pharma
ATC code:
S01ED51
INN (International Name):
Latanoprost, Timolol
Dosage:
50 micrograms/ml + 5 mg/ml
Pharmaceutical form:
Eye drops
Administration route:
Eye solution use
Units in package:
1 × 2.5 ml, 3 × 2.5 ml, 6 × 2.5 ml bottle
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Tubilux Pharma
Therapeutic group:
Ophthalmological-betablocking agents - timolol, combinations
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.
Authorization status:
Authorised
Authorization date:
2014-01-13
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Latanoprost+Timolol 50 micrograms/ml + 5 mg/ml Eye Drops, Solution.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains latanoprost 50 micrograms and timolol
maleate 6.8 mg
equivalent to 5 mg timolol.
Excipient: Benzalkonium chloride 0.20 mg/ml.
For a 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 older people):
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.
_ _
Method of administration:
Contact lenses should be removed before instillation of the eye
drops and may be
reinserted after 15 minutes.
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.
If more than one topical ophthalmic drug is being used, the drugs
should be
administered at least five minutes apart.
_ _
_Paediatric population: _
Safety and effectiveness in children and adolescents has
not been established. No data
are available.
4.3 CONTRAINDICATIONS
Latanoprost+Timolol is contraindicated in patients with:
•
Hypersensitivity to the active substances or to any of the
excipients listed in
section 6.1.
•
Reactive airway disease including
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