Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Xylometazoline hydrochloride; ANTAZOLINE SULFATE
Laboratoires Thea
S01GA; S01GA53
Xylometazoline hydrochloride; ANTAZOLINE SULFATE
0.05 %w/v + 0.5 percent weight/volume
Eye drops, solution
Product not subject to medical prescription
Sympathomimetics used as decongestants; xylometazoline, combinations
Marketed
1983-04-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OTRIVINE-ANTISTIN ® EYE DROPS, XYLOMETAZOLINE 0.05% W/V & ANTAZOLINE 0.5% W/V READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 2 days. WHAT IS IN THIS LEAFLET 1. What Otrivine-Antistin is and what it is used for 2. What you need to know before you use Otrivine-Antistin 3. How to use Otrivine-Antistin 4. Possible side effects 5. How to store Otrivine-Antistin 6. Contents of the pack and other information 1. WHAT OTRIVINE-ANTISTIN IS AND WHAT IT IS USED FOR Otrivine-Antistin contains two active ingredients. Xylometazoline hydrochloride is a decongestant and antazoline sulphate is an anti-allergic agent. Otrivine-Antistin helps to make your eyes feel more comfortable by relieving the redness and itching caused by allergies such as hay fever, or house dust allergy. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE-ANTISTIN DO NOT USE OTRIVINE-ANTISTIN: - if you are allergic to xylometazoline hydrochloride or antazoline sulphate or any of the other ingredients of this medicine (listed in section 6) - if you have a condition called narrow angle glaucoma - if you wear contact lenses of any type - if you are taking, or in the last 14 days have taken, one of a group of anti-depressant drugs called monoamineoxidase inhibitors. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Otrivine-Antistin: - if you have high blood pressure, a heart condition (e.g. long QT syndrome), a thyroid problem or diabetes - if you are pregna Lire le document complet
Health Products Regulatory Authority 23 July 2021 CRN00CDJ0 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Otrivine-Antistin Eye Drops 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Xylometazoline hydrochloride 0.05 % w/v Antazoline sulphate 0.5 % w/v Excipients with known effect: Benzalkonium chloride (0.1 mg/ml), boric acid (30 mg/ml). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops solution (Eye Drops). Clear, colourless aqueous eye drops solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of conjunctival hyperaemia and oedema associated with conjunctivitis of allergic origin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ 1 or 2 drops instilled 2 - 3 times a day. _Paediatric population_ _Children aged 12 years and over_: 1 drop instilled 2 to 3 times a day. No specific studies are available in this patient group. Due to possible systemic effects, Otrivine-Antistin is not recommended for use in children younger than 12 years of age (_see also section 4.4_). _Elderly_ 1 drop instilled 2 to 3 times a day. Method of administration For local administration to the eye. The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures as this may contaminate the solution. If more than one medication needs to be instilled into the eye, an interval of 5 minutes between application of the different medicinal products must be allowed. 4.3 CONTRAINDICATIONS o Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 o Presence of narrow angle glaucoma o Use with contact lenses o Use in patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment Health Products Regulatory Authority 23 July 2021 CRN00CDJ0 Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Like other topically applied ophthalmic drugs, Otrivine-Antis Lire le document complet