Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
DEXTRAN, HYPROMELLOSE
Alcon Farmaceutika d.o.o Avenija Dubrovnik 16, 10160, Zagreb, Croatia
S01XA20
DEXTRAN 70 1 mg/ml HYPROMELLOSE 3 mg/ml
EYE DROPS, SOLUTION
DEXTRAN 70 1 mg/ml HYPROMELLOSE 3 mg/ml
OTC
OPHTHALMOLOGICALS
Authorised
2005-09-07
1/4 BASIC PATIENT LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. Nevertheless you still need to use TEARS NATURALE II 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 see a doctor if your symptoms worsen or do not improve after a number of days. _ CONTENTS OF THIS LEAFLET 1. What TEARS NATURALE II is and what it is used for. 2. What you should know before you use TEARS NATURALE II. 3. How to use TEARS NATURALE II. 4. Possible undesirable effects. 5. How to store TEARS NATURALE II. 6. Further information. TEARS NATURALE II, eye drops, solution - The active substances are dextran 70 1.0 mg/ml and hypromellose 3.0 mg/ml. - The other ingredients are sodium chloride, potassium chloride, borax, polyquaternium-1 solution, concentrated hydrochloric acid and/or sodium hydroxide and purified water to 1 ml. MARKETING AUTHORISATION HOLDER Alcon Farmaceutika d.o.o. Avenija Dubrovnik 16, 10160 Zagreb, Croatia MANUFACTURER SA Alcon-Couvreur NV Rijksweg 14 2870 Puurs BELGIUM Alcon Laboratories Belgium Lichterveld 3 2870 Puurs-Sint-Amands Belgium Siegfried El Masnou, S.A. Camil Fabra 58 08320 El Masnou/Barcelona Spain 2/4 MARKETING AUTHORISATION NUMBER MA1271/00101 1. WHAT TEARS NATURALE II IS AND WHAT IT IS USED FOR TEARS NATURALE II eye drops, solution, is packed in a 5, 10 and 15 ml droptainer. TEARS NATURALE II is used against dryness of the eye. TEARS NATURALE II is indicated for dry eyes, inadequate functioning of the lacrimal glands and instability of the lacrimal film. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEARS NATURALE II DO NOT USE TEARS NATURALE II - if you are allergic to dextran 70, hypromellose or any of the other ingredients of Tears Naturale II. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH TEARS NATURALE II - If you experience headache, eye pain, changes in vision, irritation of the e Aqra d-dokument sħiħ
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TEARS NATURALE II, eye drops, solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dextran 70 1,0 mg/ml – Hypromellose 3,0 mg/ml. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ▪ Dry eyes syndrome ▪ Deficient tear secretion ▪ Instability of the lacrimal film 4.2 POSOLOGY AND METHOD OF ADMINISTRATION After cap is removed, if tamper evident snap collar is loose, remove before using product. Instill 1 or 2 drops in each eye as necessary. 4.3 CONTRAINDICATIONS Hypersensitivity to dextran 70, hypromellose or to any of the excipients of this preparation. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Patients should discontinue administration in case of persistent irritation and consult a physician. If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists, they are to discontinue use and consult their doctor. TEARS NATURALE II is a sterile product. For topical use in the eye only. Page 2 of 6 Following measures are, after application of the eye drops, useful to reduce systemic resorption: - Keep the eyelid closed for 2 minutes. - Close the lacrimal duct with the finger for 2 minutes. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Interactions of TEARS NATURALE II with other medicinal products have not been specifically evaluated. Based on the composition of this product, no clinically relevant interactions have been described. In case of concomitant therapy with other topical ocular products, an interval of at least 5 minutes should be allowed between successive applications. Eye ointments should be administered last. 4.6 FERTILITY, PREGNANCY AND LACTATION Fertility There is no adequate data regarding the impact of Dextran 70 / Hypromellose Eye Drops on fertility. All of the components are pharmacologically inert compounds or generally Aqra d-dokument sħiħ