Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Timolol; Latanoprost
Alapis S.A.
S01ED; S01ED51
Timolol; Latanoprost
50 mcg+5 milligram(s)/millilitre
Eye drops, solution
Product subject to prescription which may not be renewed (A)
Beta blocking agents1); timolol, combinations
Authorised
2011-05-27
Health Products Regulatory Authority 14 October 2019 CRN009DFZ Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lataneau Plus 50 microgram/ml + 5 mg/ml Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains latanoprost 50 micrograms and timolol maleate 6.83 mg equivalent to 5 mg timolol. It contains 0.412 mg/ml of benzalkonium chloride solution 50%. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution The solution is a clear colourless liquid. pH 5.5 -6.5. Osmolality 260-320 mOsm/kg. 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. 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. Health Products Regulatory Authority 14 October 2019 CRN009DFZ Page 2 of 9 4.3 CONTRAINDICATIONS Lataneu Plus is contraindicated in patients with: - Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease. - Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock. - Hypersensitivity to the active substances or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _SYSTEMIC EFFECTS _ Like ot Read the complete document