What is OPATANOL?
OPATANOL is a clear solution of eye drops containing the active ingredient olopatadine.
What is OPATANOL used for?
OPATANOL is indicated in the treatment of ocular symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hay fever), including itching, redness and swelling.
The medicine can only be obtained with a prescription.
How is OPATANOL used?
OPATANOL can be used in adults and children aged three and up. The dose is one drop in the eye or in the affected eyes twice a day eight hours apart. In the case of concomitant therapy with other ocular medicines, an interval of five to ten minutes should be allowed between one administration and another. Treatment can be extended up to four months, if considered necessary.
How does OPATANOL work?
The active substance in OPATANOL, olopatadine, is an antihistamine. Olopatadine works by blocking the receptors on which histamine, a substance present in the body that causes allergic symptoms, is usually fixed. Once the receptors are blocked, histamine fails to produce its effect and a decrease in allergy symptoms is observed.
What studies have been carried out on OPATANOL?
OPATANOL has been studied in 688 patients in four main studies, lasting between six and 14 weeks. Two of these studies involved children. OPATANOL was compared with sodium cromoglycate (another antiallergic drug), with levocabastine (another antihistamine) and, in two studies, with placebo (a dummy treatment). In all the studies the main measure of effectiveness was based on the degree of itching and redness of the eye. One of the placebo studies also focused on the analysis of these symptoms in relation to pollen counts.
What benefit has OPATANOL shown during the studies?
OPATANOL was as effective as sodium cromoglicate and levocabastine. OPATANOL was found to be more effective than placebo only when pollen counts were taken into account: in particular, the higher the concentration level of pollen in the air, the greater the difference between the effects of OPATANOL and those of placebo. With lower pollen counts, no difference was found between the two treatments.
What is the risk associated with OPATANOL?
The most common side effects with OPATANOL (seen in between 1 and 10 patients in 100) are headache, dysgeusia (taste disturbances), eye pain, eye irritation, abnormal sensations in the eye, nasal dryness and asthenia (weakness). For the full list of all side effects reported with OPATANOL, see the Package Leaflet.
OPATANOL should not be used in people who may be hypersensitive (allergic) to olopatadine or any of the other ingredients. OPATANOL contains benzalkonium chloride, which can make soft contact lenses opaque; therefore, people who wear soft contact lenses must pay special attention.
Why has OPATANOL been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that OPATANOL's benefits are greater than its risks for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis. The Committee recommended that it be given marketing authorization
for OPATANOL.
Other information on OPATANOL:
On May 17, 2002, the European Commission granted a marketing authorization valid for OPATANOL, valid throughout the European Union, to Alcon Laboratories (UK) Limited.
The marketing authorization was renewed on 17 May 2007.
The full EPAR for OPATANOL can be found here .
Last update of this summary: 08-2007
