Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Azelastine hydrochloride
Mylan IRE Healthcare Limited
S01GX; S01GX07
Azelastine hydrochloride
0.5 milligram(s)/millilitre
Eye drops, solution
Product subject to prescription which may be renewed (B)
Other antiallergics; azelastine
Not marketed
1998-08-28
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPTILAST 0.5 MG/ML EYE DROPS, SOLUTION Azelastine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ) Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet Optilast 0.5 mg/ml Eye Drops, Solution is called Optilast. WHAT IS IN THIS LEAFLET 1. What Optilast is and what it is used for 2. What you need to know before you use Optilast 3. How to use Optilast 4. Possible side effects 5. How to store Optilast 6. Contents of the pack and other information. 1. WHAT OPTILAST IS AND WHAT IT IS USED FOR Optilast contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye. Optilast can be used to treat and prevent eye disorders which you get with hayfever (seasonal allergic conjunctivitis) in adults and children aged 4 years and above. Optilast can be used for eye disorders caused by an allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children aged 12 years and above. You must talk to a doctor if you do not feel better or if you feel worse after 2 days. OPTILAST IS NOT SUITABLE FOR TREATING EYE INFECTIONS. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTILAST DO NOT USE OPTILAST: if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicin Read the complete document
Health Products Regulatory Authority 30 November 2020 CRN00C208 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Optilast, 0.5 mg/ml Eye Drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride. Excipient with known effect: 1 ml contains 0.125 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older. Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary, to four times daily. If allergen exposure is anticipated Optilast eye drops should be administered prophylactically, prior to the exposure. Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary, to four times daily. As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks. Patientsshould be advised to contact their doctor if symptoms worsen or do not approve after 48 hours. Health Products Regulatory Authority 30 November 2020 CRN00C208 Page 2 of 4 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Optilast eye drops is not intended for treatment of eye infections. Optilast eye drops contains the preservative benzalkonium chloride which may cause eye irritation. Contact with sof Read the complete document