Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT
Xalatan 0.005% w/v eye drops solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml eye drops solution contains 0.005 g latanoprost.
One drop contains approximately 1.5 micrograms latanoprost.
Excipient:
Benzalkonium chloride 0.02% w/v is included as a preservative.
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 elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
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. Optimal effect is obtained if Xalatan is administered in the evening.
The dosage of Xalatan should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart
Paediatric population:
Xalatan eye drops may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
4.3 Contraindications
Known hypersensitivity to any component in Xalatan.
4.4 Special warnings and precautions for use
Xalatan may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a perma
