Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lodoxamide trometamol
Alcon Eye Care UK Ltd
S01GX05
Lodoxamide trometamol
1mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11040200; GTIN: 5015664023420
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALOMIDE ® ALLERGY EYE DROPS, SOLUTION LODOXAMIDE READ ALL OF THIS LEAFLET CAREFULLY because it contains important information for you. THIS MEDICINE IS AVAILABLE WITHOUT A PRESCRIPTION. However, you still need to use ALOMIDE Allergy Eye Drops 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 AFTER 2 DAYS. • IF ANY OF THE SIDE EFFECTS GET SERIOUS, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. WHAT ALOMIDE ALLERGY EYE DROPS IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE ALOMIDE ALLERGY EYE DROPS 3. HOW TO USE ALOMIDE ALLERGY EYE DROPS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ALOMIDE ALLERGY EYE DROPS 6. FURTHER INFORMATION 1. WHAT ALOMIDE ® ALLERGY EYE DROPS IS AND WHAT IT IS USED FOR ALOMIDE ALLERGY EYE DROPS belongs to a group of medicines called anti-allergics. IT IS USED FOR THE RELIEF AND TREATMENT of the eye symptoms of allergic conjunctivitis. These symptoms include red, itchy, puffy and watery eyes. 2. BEFORE YOU USE ALOMIDE® ALLERGY EYE DROPS DO NOT USE ALOMIDE ALLERGY EYE DROPS… • If you are ALLERGIC to lodoxamide or any of the other ingredients listed in section 6. • In CHILDREN BELOW 4 YEARS of age. If any of these apply, ask your doctor for advice. TAKE SPECIAL CARE... THIS MEDICINE IS AVAILABLE WITHOUT A PRESCRIPTION. However, you still need to use ALOMIDE Allergy Eye Drops carefully to get the best results from it. • Only use ALOMIDE Allergy Eye Drops in your eye(s). • You may experience eye discomfort, such as burning or stinging, at the beginning of treatment with ALOMIDE Allergy Eye Drops. These symptoms should wear off, however if they persist, ask your doctor for advice. • ONLY USE THIS MEDICINE if you are sure that you have allergic conjunctivitis. You can be sure that you are sufferi Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alomide Allergy 0.1% Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.1% w/v lodoxamide (as 0.178% w/v lodoxamide trometamol) For excipients, see section 6.1 3 PHARMACEUTICAL FORM Eye Drops, Solution A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALOMIDE is indicated in the treatment of the ocular signs and symptoms of allergic conjunctivitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children (4 years and above): one or two drops in each eye four times a day at regular intervals. ALOMIDE therapy is dependent upon its administration at regular intervals, as directed. ALOMIDE therapy should not be used for more than 4 weeks without seeking medical advice. Improvements in signs and symptoms in response to ALOMIDE therapy (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, conjunctival redness, limbal reaction, epithelial disease, ptosis) are usually evident within a few days, but longer treatment for up to four weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. Instillation of eye drops in allergic conjunctivitis may cause discomfort initially and that this will decline with improvement of the disease (see 4.8 Undesirable Effects). Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. Children less than 4 years: The safety and effectiveness of ALOMIDE in children below the age of four years have not been established. Elderly: There are no special precautions to be followed in prescribing ALOMIDE for the elderly. If required, corticosteroids may be used concomitantly with ALOMIDE. 4.3 CONTRAINDICATIONS ALOMIDE is con Прочетете целия документ