Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
DIBROMPROPAMIDINE ISETIONATE
Sanofi-Aventis Ireland Limited T/A SANOFI
S01AX; S01AX14
DIBROMPROPAMIDINE ISETIONATE
0.15 percent weight/weight
Eye ointment
Product not subject to medical prescription
Other antiinfectives; dibrompropamidine
Marketed
1983-04-01
_I_ TURN OVER PACKAGE LEAFLET: INFORMATION FOR THE USER BROLENE® 0.15% W/W EYE OINTMENT dibrompropamidine isethionate IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 FOR HELP 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 OR PHARMACIST 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 or pharmacist. 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 IN THIS LEAFLET: 1. What Brolene Eye Ointment is and what it is used for 2. What you need to know before you use Brolene Eye Ointment 3. How to use Brolene Eye Ointment 4. Possible side effects 5. How to store Brolene Eye Ointment 6. Contents of the pack and other information 1. WHAT BROLENE EYE OINTMENT IS AND WHAT IT IS USED FOR Brolene Eye Ointment contains a medicine called dibrompropamidine isetionate. This belongs to a group of medicines called disinfectants and antifungals. It works by stopping the growth of bacteria, allowing your body to fight off the infection. It is used for minor infections of the eye or eyelid. Signs include sore, red or inflamed eyes, stickiness or a crust on the eyelids. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BROLENE EYE OINTMENT DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR OR PHARMACIST IF: You are allergic (hypersensitive) to dibrom- propamidine isetionate or any of the other ingredients of Brolene Eye Ointment (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid You wear contact lenses. You should not wear contact lenses while using this ointment Do not use Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brolene 0.15 % w/w Eye Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dibrompropamidine Isetionate 0.15 % w/w. Excipients: contains Wool fat 9.7% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye ointment. A pale yellow, smooth, sterile ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anti-infective for use in local infections of the superficial structures of the eye due to microorganisms sensitive to its action. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For ocular use. Adults, elderly persons, and children: Cleanse the affected area and apply the ointment topically to the eyelid or conjunctival sac once or twice daily, for not more than 2 days. 4.3 CONTRAINDICATIONS Hypersensitivity to any component of the preparation. Use of contact lenses. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If there is no significant improvement within 2 days medical advice should be sought. There is always the possibility, although rare, of a sensitisation reaction resulting from the use of Brolene preparations. In such an event treatment should be discontinued immediately. Should erythema or other evidence of increased inflammation occur application should cease immediately and medical opinion should be sought. If problems of visual acuity occur or its symptoms are detected, the doctor should be consulted immediately. Brolene Ointment contains wool fat, which may cause local skin reactions (e.g. contact dermatitis). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None stated. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Prečítajte si celý dokument