Read all of this leaflet carefully before you start using this medicine.

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Allergo-COMOD nasal spray 20 mg/ml Nasal spray, solution Active ingredient: sodium cromoglicate (Ph. Eur.) 1 spray of 0.14 ml of Allergo-COMOD nasal spray contains 2.8 mg of sodium cromoglicate (Ph. Eur.). Read all of this leaflet carefully before you start using this medicine. This medicinal product is available without a doctor s prescription. To ensure the best possible level of success with treatment, Allergo-COMOD nasal spray must be used in accordance with these instructions. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. You must contact a doctor if your symptoms worsen or do not improve after 5 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 Allergo-COMOD nasal spray is and what it is used for 2. Before you use Allergo-COMOD nasal spray 3. How to use Allergo-COMOD nasal spray 4. Possible side effects 5. How to store Allergo-COMOD nasal spray 6. Further information 1. WHAT ALLERGO-COMOD NASAL SPRAY IS AND WHAT IT IS USED FOR Allergo-COMOD nasal spray is an antiallergic agent. Allergo-COMOD nasal spray is used for perennial and seasonal allergic rhinitis. 2. BEFORE YOU USE ALLERGO-COMOD NASAL SPRAY Do not use Allergo-COMOD nasal spray - if you are allergic (hypersensitive) to sodium cromoglicate (Ph. Eur.) or any of the other ingredients.

2 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Currently, there are no known drug interactions of Allergo-COMOD nasal spray with other medicinal products. Pregnancy and breast-feeding Based on studies involving animals and experience gathered so far involving humans, there is no evidence to suggest that Allergo-COMOD nasal spray has any harmful effects on unborn babies. From a general considerational perspective, however, Allergo-COMOD nasal spray should only be used during pregnancy after careful evaluation of the risks and benefits by a doctor. Based on animal studies and the experiences made during the treatment of humans, there is no evidence for any teratogenic effect of Allergo-COMOD nasal spray. However, Allergo-COMOD nasal spray should generally only be used during pregnancy at the recommendation of a doctor. The active ingredient in Allergo-COMOD nasal spray is transferred in small quantities to the mother s milk. Therefore Allergo-COMOD nasal spray should only be used during the lactation period at the recommendation of a doctor. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines No special precautionary measures are required. 3. HOW TO USE ALLERGO-COMOD NASAL SPRAY Always use Allergo-COMOD nasal spray exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure in accordance with the instructions contained in this package leaflet. If you are not sure about anything, consult your doctor or pharmacist. Unless prescribed otherwise by your doctor, the normal dosing instructions are as follows: The usual dose for adults and children is: 1 spray of Allergo-COMOD nasal spray in each nostril up to 4 times per day. The daily dose can be increased if required, however a dose of 6 times 1 spray of Allergo- COMOD nasal spray into each nostril must not be exceeded. Following stabilisation of clinical symptoms, the dose can be gradually reduced. Even after the resolution of symptoms, you should continue using Allergo-COMOD nasal spray for as long as you are exposed to the substances that cause your allergy (e.g. house dust, mould spores, pollen, etc.). Please speak to your doctor or pharmacist if you feel that the effect of Allergo-COMOD nasal spray is too strong or too weak. Note: In some patients it may be useful to additionally administer decongestive nasal sprays or systemic antiallergic medicinal products in the beginning of the treatment. This should be discussed in each individual case with a doctor.

3 Type of application Allergo-COMOD nasal spray is intended only for local administration to the nose. Remove the protective cap (1) before first use. Hold the spray flask as shown and press the pump mechanism until a fine spray is emitted. Insert the nose adapter ("nozzle") (2) into each nostril and apply one spray into each nostril. In order to avoid solidification of the solution within the pump mechanism, the protective cap should be attached again after each usage. For hygienic reasons, please wipe the nose adapter after each usage, then attach the protective cap. If you use more Allergo-COMOD nasal spray than you should: There are no symptoms recorded of sodium cromoglicate (Ph. Eur.) toxicity. If you forgot to use Allergo-COMOD nasal spray Do not administer more than 1 spray in each nostril in case that you forgot the last administration. If you stop using Allergo-COMOD nasal spray The complaints associated with the allergic rhinitis may increase or reoccur in case that you stop the administration of Allergo-COMOD nasal spray. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Allergo-COMOD nasal spray can cause side-effects, although not everybody gets them. Possible side effects: General complaints at the side of administration: Inflammation of the nasal mucosa, nosebleeding, sneezing, headache, hypersensitivity reactions (itching, difficulty in breathing, spasm of bronchial muscles (bronchospasm), swelling of the skin / mucosal tissue (angio-oedema)). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE ALLERGO-COMOD NASAL SPRAY Keep out of the reach and sight of children. Do not use Allergo-COMOD nasal spray after the expiry date which is stated on the carton/label. The expiry date refers to the last day of that month. Storage conditions Do not store above 25 C.

4 Shelf life after opening: Allergo-COMOD nasal spray can be used for 8 weeks after first opening. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Allergo-COMOD nasal spray contains: - The active ingredient is: Sodium cromoglicate (Ph. Eur.) 1 spray of 0.14 ml of Allergo-COMOD nasal spray contains 2.8 mg of sodium cromoglicate (Ph.Eur.). - The other ingredients are: Disodium edetate (Ph. Eur.); sorbitol (Ph. Eur.); purified water. What Allergo-COMOD nasal spray looks like and contents of the pack Allergo-COMOD nasal spray is a clear, colourless to slightly yellowish solution, filled in a multiple dose container with gas-free pump-system. A package contains 1 bottle with 15 ml solution. Marketing Authorisation Holder and Manufacturer: Ursapharm Arzneimittel GmbH & Co. KG Industriestraße Saarbrücken Tel.: 06805/ Fax: 06805/ info@ursapharm.de

5 This leaflet was last approved in May Further dosage forms: Allergo-COMOD eye drops: 10 ml eye drops (preservative-free) Allergocrom nasal spray: 15 ml solution (preservative-free) Allergocrom eye drops: 10 ml eye drops Allergocrom combination pack containing 10 ml eye drops and 15 ml nasal spray, solution Allergo-COMOD nasal spray is a propellant-free nasal spray whose most important feature is that it contains no preservatives. In previous systems, the preservative agent helped to prevent microbial contamination during use. This problem has been overcome with Allergo-COMOD nasal spray by preventing contamination using a sophisticated pump construction.