NOTICE 
 ANSM - Last updated: 20/04/2012 
 Name of the medicinal product 
 ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution 
 Sodium Cromoglicate 
 framed 
 Read this leaflet carefully before you start using this medicine. It contains important information for your treatment. 
 ·           This medication can be used in self-medication, ie used without consultation or prescription from a doctor. 
 ·           If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor. 
 ·           This leaflet is designed to help you use this medicine. Keep there, you might need to reread it. 
 DO NOT LEAVE THIS MEDICINE FOR CHILDREN 
 Review summary 
 In this notice : 
 1. What is ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, solution for nasal spray and in which cases it is used? 
 2. What information should I know before using ALAIRGIX RHEINTHERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution ? 
 3. How to use ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution ? 
 4. What are the possible side effects? 
 5. How to store ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution ? 
 6. Additional information. 
 1. WHAT IS ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution AND IN WHAT CASES IS IT USED? 
 Pharmacotherapeutic group 
 Not applicable. 
 Therapeutic indications 
 This medicine is indicated in adults and children in the treatment of seasonal allergic rhinitis (hay fever) or non-seasonal (animal hair, mold, mites ...). 
 2. BEFORE YOU USE ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution? 
 List of information needed before taking the medication 
 Not applicable. 
 Cons-indications 
 Never use ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution: 
 If you are allergic to sodium cromoglicate (the active substance) or to any of the other ingredients of this medication (see section 6 "Additional information"). 
 IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHARMACIST OR YOUR DOCTOR. 
 Precautions for use; special warnings 
 Take special care with ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution: 
 ·           never leave it within the reach of children. 
 ·           do not exceed recommended dosage. 
 ·           in the absence of improvement as in the case of persisting symptoms, take a medical opinion. 
 IN CASE OF DOUBT, DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR PHARMACIST OR YOUR DOCTOR 
 Interaction with other medicines 
 Use of other medicines 
 If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist. 
 Interactions with food and beverages 
 Not applicable. 
 Interactions with Herbal Medicines or Alternative Therapies 
 Not applicable. 
 Use during pregnancy and lactation 
 Pregnancy and breast feeding 
 ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution can be used during pregnancy and lactation. 
 Ask your doctor or pharmacist for advice before taking any medicine. 
 Sport 
 Not applicable. 
 Effects on ability to drive or use machines 
 Not applicable. 
 List of excipients with known effect 
 Not applicable. 
 3. HOW TO USE ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, solution for nasal spray? 
 Instructions for proper use 
 Not applicable. 
 Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment 
 Dosage 
 Adults and children: 
 Before each take, blow your nose to clear the nostrils. 
 1 spray in each nostril 4 to 6 times a day, to be distributed at regular intervals. 
 Symptoms of seasonal or non-seasonal allergic rhinitis may recur if the treatment is not followed regularly, treatment should be continuously monitored throughout the duration of exposure to allergens. 
 If you have any new symptoms, or if you have any concerns about your condition, please ask your pharmacist or consult your doctor. 
 Method and route of administration 
 Nasal route. 
 1) Before use, remove the cap by pulling it upwards. 
 The sprayer is ready to use. 
 When first used, hold the bottle vertically and press the sprayer generally 1 or 2 times to prime the pump. 
 2) Before each catch, blow your nose. Then hold the bottle vertically, insert the nasal nozzle into one of the nostrils and plug the other with your finger. Briefly press the sprayer and inhale through the nose and exhale slowly through the mouth. 
 3) Repeat the same operation in the other nostril. 
 4) Wipe the nosepiece and replace the cap to prevent accidental spraying. 
 Frequency of Administration 
 The catch must be distributed at regular intervals. 
 Duration of treatment : 
 Treatment should be monitored continuously throughout the duration of exposure to allergens (responsible for allergy). 
 Indeed, symptoms of seasonal or non-seasonal allergic rhinitis may reappear when treatment is not followed regularly. 
 However, if exposure to allergens can be avoided, this is preferable to the use of any medication ( see "Health Advice / Education "). 
 Symptoms and Instructions for Overdose 
 If you used more ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution you should: 
 Immediately consult your doctor or pharmacist. 
 Instructions for omission of one or more doses 
 If you forget to use ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution: 
 Do not take a double dose to make up for the single dose you have forgotten to take, but simply continue with your treatment. 
 Risk of withdrawal syndrome 
 Not applicable. 
 4. WHAT ARE POSSIBLE SIDE EFFECTS? 
 Description of adverse reactions 
 Like all drugs, ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution is likely to have unwanted effects, although not everyone is subject to it. 
 ·           Possibility of an allergic reaction to the cromoglicate or one of the components of the product. 
 ·           A brief nasal irritation with sneezing may occur at the start of treatment within minutes of spraying. These symptoms are usually transient. 
 ·           Rarely may a nose bleed occur. 
 If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist. 
 5. HOW TO STORE ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, solution for nasal spray? 
 Keep out of the reach and sight of children. 
 Expiration date 
 Do not use ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution after the expiry date stated on the carton. The expiry date refers to the last day of the month. 
 Storage conditions 
 No special storage conditions. 
 This medication is preserved 3 months after first opening. 
 If necessary, warnings against visible signs of deterioration 
 Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment. 
 6. ADDITIONAL INFORMATION 
 Full list of active substances and excipients 
 What contains ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution? 
 The active substance is : 
 Sodium Cromoglicate ............................................... .................................................. ..................... 2.00 g 
 For 100 ml of solution. 
 The other components are : 
 Disodium edetate, sorbitol, sodium hydroxide (for pH adjustment), water for injections. 
 Pharmaceutical form and content 
 What is ALAIRGIX ALLERGIC RHINITE SODIUM CROMOGLICATE 2%, nasal spray solution and contents of the pack? 
 This medication is in the form of a nasal spray solution in a 15 ml spray bottle. 
 Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different 
 Holder 
 French pharmaceutical cooperation 
 PLACE LUCIEN AUVERT 
 77020 MELUN cedex 
 exploiting 
 French pharmaceutical cooperation 
 PLACE LUCIEN AUVERT 
 77020 MELUN cedex 
 Maker 
 URSAPhARM ARZNEIMITTEL GMBH 
 STRASSE INDUSTRY 
 66129 SAARBRUCKEN 
 GERMANY 
 Names of the medicinal product in the Member States of the European Economic Area 
 Not applicable. 
 Date of approval of the notice 
 The last date on which this leaflet was approved is {date}. 
 AMM under exceptional circumstances 
 Not applicable. 
 Internet Information 
 Detailed information on this medicine is available on the Afssaps website (France). 
 Information for health professionals only 
 Not applicable. 
 Other 
 ADVICE / HEALTH EDUCATION 
 a) What is an allergy, what is an allergic reaction? 
 Allergy is an overreaction of our body to substances it considers harmful, allergens. Allergens are the factors and substances triggering allergy and associated disorders. 
 During repeated and intensive contacts of our body with the allergen, an allergic reaction is triggered. 
 The allergic reaction refers to all symptoms appearing a few minutes or hours after exposure to allergens. These allergens come from plants, animal hair, food, dust mites, molds or are substances of occupational origin. 
 This allergic reaction causes the release in the body of substances such as the histamine responsible for the disorders felt. 
|  As with any disease of an allergic nature, it is important to   to consult a doctor at least once.   IT SHALL DETERMINE IN PARTICULAR THE NEED FOR   AN ALLERGOLOGICAL BALANCE.  | 
 b) How to recognize allergic rhinitis, seasonal or non-seasonal allergic conjunctivitis? 
 Allergic rhinitis results in the following symptoms: nasal congestion, successive sneezing, colorless nasal discharge, nasal obstruction (stuffy nose), itching and tingling of the nose. It may be accompanied by irritations of both eyes (tearing, redness), throat and nose. 
 We distinguish : 
 Seasonal allergic rhinitis or hay fever: frequent, they occur every year in the same season, when pollen concentration increases in the air, and usually occur for the first time during adolescence. However, you may not be allergic to all pollens, but to one or more of them only. 
 Perennial allergic rhinitis occurs throughout the year and most often depends on domestic allergens such as dust mites, mold, and domestic animals. 
 c) Some practical tips 
 Removing the allergen (foreclosure) is the measure of choice to suppress or reduce the symptoms of allergy. 
 For household allergens: measures to reduce the presence of allergens are essential: 
 ·           The mattress should be completely surrounded by a plastic dust mite cover as well as the pillows. The bed base, unless it is in slats or metal, shall be surrounded by a plastic. All bedding should be washed twice a month at 60 ° C if possible. 
 ·           The room should be ventilated and cleaned regularly. 
 ·           On the floor, you will avoid bed runs and carpets. 
 ·           Avoid pets. 
 ·           During the pollen season it is possible to reduce the exposure to pollen: 
 ·           In your garden, diversify the plantations avoiding the most allergenic species (cypress, thuja, birch ...). 
 ·           Avoid mowing the lawn yourself during the pollen season. 
 ·           Garde preferably with glasses and a protective mask.