Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
HYPROMELLOSE
Imbat Limited
S01XA20
HYPROMELLOSE
3.2 Mg/Ml
Eye Drops Solution
Product not subject to medical prescription
Other ophthalmologicals
Authorised
2014-07-04
Page 1 of 2 ARTELAC ® PRESERVATIVE FREE SINGLE DOSE UNIT (hypromellose) PATIENT INFORMATION LEAFLET The name of your medicine is Artelac Preservative Free Single Dose Unit and it is called Artelac Preservative Free in this leaflet. PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However you still need to use Artelac Preservative Free carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. _ _ IN THIS LEAFLET: 1. WHAT ARTELAC PRESERVATIVE FREE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARTELAC PRESERVATIVE FREE 3. HOW TO USE ARTELAC PRESERVATIVE FREE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ARTELAC PRESERVATIVE FREE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ARTELAC PRESERVATIVE FREE IS AND WHAT IT IS USED FOR Your drops contain the active ingredient hypromellose which acts as a lubricant to treat symptoms of dry eye. It is a soothing solution that is used as an artificial tear when the eyes are lacking in tears. Your eyes will normally produce just enough natural tears to allow them to move easily and comfortably. If your eyes do not produce enough tears they can become dry, red and painful. Your drops keep the surface of the eye lubricated (moist) when production of tears is less than normal, and has a refreshing, cooling actio Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Artelac Preservative Free Single Dose Unit 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 3.2mg hypromellose (0.32% w/v). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution in single dose container. (Eye Drops, Solution) _Product imported from France:_ Sterile solution for eye drops, presented in plastic single dose, single use units. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage Suitable for use in adults and children. Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication. Administration For ocular use only. Therapy of dry eye syndrome requires an individual dosage regime. 4.3 CONTRAINDICATIONS There are no known contra-indications except use in patients hypersensitive to the ingredients of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If irritation persists, discontinue use and consult a doctor. Ensure the dropper tip does not touch any surface including the eye surface. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/07/2014_ _CRN 2134509_ _page number: 1_ 4.6 FERTILITY, PREGNANCY AND LACTATION Artelac Preservative Free Single Dose Unit can be used in pregnancy and lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Artelac Preservative Free Single Dose Unit o Soma hati kamili