Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
olopatadine hydrochloride, Quantity: 1.11 mg/mL (Equivalent: olopatadine, Qty 1 mg/mL)
Viatris Pty Ltd
Olopatadine hydrochloride
Eye Drops
Excipient Ingredients: sodium hydroxide; water for injections; dibasic sodium phosphate; benzalkonium chloride; sodium chloride; hydrochloric acid
Ophthalmic
5 mL
(S4) Prescription Only Medicine
For the treatment of the signs and symptoms of seasonal allergic conjunctivitis. Treatment may be maintained for up to 14 weeks, if considered necessary.
Visual Identification: Clear, colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-10-23
PALADOPT 0.1% 1 PALADOPT 0.1 % EYE DROPS _Olopatadine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE YOU START TO USE PALADOPT EYE DROPS. This leaflet has been written to answer some common questions about PALADOPT. It does not contain all of the available information and does not take the place of talking to your doctor or pharmacist. Before prescribing PALADOPT for you or your child, your doctor will have examined the eye and decided that PALADOPT is the right medicine. Your doctor may have prescribed PALADOPT for another reason. Ask your doctor if you have any questions about why PALADOPT has been prescribed for you or your child. PALADOPT is not addictive. The preservative in PALADOPT Eye Drops (benzalkonium chloride) may be deposited in soft contact lenses. You can put your soft contact lenses into your eyes 15 minutes after you have used PALADOPT Eye Drops. DO NOT GIVE PALADOPT TO A CHILD UNDER 3 YEARS. The safety and effectiveness of PALADOPT in children under 3 years have not been established. All medicines have risks and IF YOU ARE NOT SURE WHETHER benefits. In deciding to prescribe PALADOPT for you or your child, your doctor has weighed the potential risks and benefits of using this medicine. The information in this leaflet applies to PALADOPTL only. This information does not apply to similar products, even if they contain the same ingredients. IF YOU HAVE ANY CONCERNS ABOUT USING PALADOPT, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need it again. WHAT PALADOPT EYE DROPS IS USED FOR PALADOPT belongs to the group of medicines called antihistamines and also to the group of medicines called anti- allergics. PALADOPT is used to treat allergic conjunctivitis, which is inflammation of the eye due to pollens that cause an allergic response to give watery, itchy and/or red eyes. BEFORE YOU USE PALADOPT EYE DROPS _WHEN YOU MUST NOT USE IT_ DO NOT USE PALADOPT IF: You are allergic to olopatadine or to any other of the ingre Lesen Sie das vollständige Dokument
AUSTRALIAN PRODUCT INFORMATION PALADOPT _olopatadine eye drops _ 1 NAME OF THE MEDICINE Olopatadine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL of eye drops contains 1.11 mg of olopatadine hydrochloride (equivalent to 1 mg olopatadine) as the active ingredient. For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM The solution is clear and colourless.. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PALADOPT is indicated for the treatment of the signs and symptoms of seasonal allergic conjunctivitis. Treatment may be maintained for up to 14 weeks, if considered necessary. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended therapy is one to two drops of PALADOPT in the affected eye(s) twice daily for up to 14 weeks. PALADOPT is for individual patient use only. 4.3 CONTRAINDICATIONS Olopatadine eye drops are contraindicated in patients hypersensitive to olopatadine hydrochloride or any other component of the preparation (see section 6.1 List of Excipients). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not for injection or oral ingestion USE IN THE ELDERLY No data available. PAEDIATRIC USE Safety and effectiveness have not been established in children below 3 years of age. EFFECTS ON LABORATORY TESTS No data available. INSTRUCTION TO PATIENTS PALADOPT contains the preservative benzalkonium chloride, which may cause eye irritation and be deposited in or discolour soft (hydrophilic) contact lenses. Avoid contact with soft contact lenses. Patients who wear soft contact lenses should remove their lenses prior to instilling PALADOPT and should not reinsert their lenses until at least 15 minutes after instillation of the eye drops. PALADOPT – PRODUCT INFORMATION 2 To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. The bottle should be tightly closed when not in use. Each bottle of PALADOPT should be discarded after 28 days of opening. 4.5 INTERACTIONS WITH OTHER M Lesen Sie das vollständige Dokument