Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
AZELASTINE HYDROCHLORIDE
Brown & Burk UK Ltd
S01GX07
AZELASTINE HYDROCHLORIDE
0.5 Mg/Ml
Eye Drops Solution
Product subject to prescription which may be renewed (B)
Other antiallergics
Authorised
2013-03-22
420 mm Area for Pharma code Area for Pharma code If possible, you should use Azelastine hydrochloride Eye drops regularly until your symptoms have disappeared. If you interrupt the use of Azelastine hydrochloride Eye drops your symptoms are likely to return. Remember: ! Do not take Azelastine hydrochloride Eye drops for more than 6 weeks ! Azelastine hydrochloride Eye drops should only be applied to the eyes. OPENING YOUR AZELASTIN HYDROCHLORIDE EYE DROPS FOR THE FIRST TIME: These eye drops come in a bottle with a screw cap with shrink wrap around the cap extending upto shoulder of the container. You must not use the bottle if the tamper-proof shrink wrap is broken before you first use it. The inside of the screw cap contains a spike. The screw cap is fitted to the bottle in such a way that there is no contact between the spike and the top of the bottle, In order to open the bottle it is necessary to remove the tamper-proof shrink wrap and tighten the screw cap further, so that the edge of the screw cap and the bottle edge are totally aligned. At this point the screw cap spike will pierce the top of the bottle which will open the bottle. Once the bottle has been opened in this way, unscrew the screw cap fully to remove it from the bottle and apply the eye drops. PUTTING IN YOUR AZELASTINE HYDROCHLORIDE EYE DROPS To help you put in your eye drops correctly, you may find it useful to sit in front of a mirror so you can see what you are doing for the first few times. 1. Wash your hands. 2. Gently wipe around your eyes with a tissues to remove any moisture (Diagram 1). 3. Unscrew the top of the bottle and check that the dropper is clean. 4. Gently pull your lower eye lid down (Diagram 2). 5. Carefully place the drop inside the middle of your Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azelastine Hydrochloride 0.5mg/ml Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop (30µl) contains 0.015 mg azelastine hydrochloride Excipients: 1 ml contains 0.125 mg benzalkonium chloride Liquid sorbitol crystallising 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 Azelastine hydrochloride 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other ophthalmic solutions, Azelastine hydrochloride Eye drops is not recommended for use whilst wearing contact lenses. Contact lenses should be removed prior to appli Baca dokumen lengkapnya