Azelastine Nasal Spray 1 mg / 1 ml

Transcription

1 Package Leaflet: Information for the User Allergodil 0,1% nasal spray, solution Active substance: Azelastine hydrochloride Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use 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. - 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. In this leaflet: 1. What is and what it is used for 2. Before you use 3. How to use 4. Possible side effects 5. How to store 6. Further information 1. WHAT IS AZELASTINE NASAL SPRAY AND WHAT IS IT USED FOR is an anti-allergic agent / antihistaminic agent. is used for the symptomatic treatment of hay fever (seasonal allergic rhinitis) and non-seasonal (perennial) allergic rhinitis. 2. BEFORE YOU USE AZELASTINE NASAL SPRAY Do not use if you are allergic (hypersensitive) to Azelastine hydrochloride or any of the ingredients of Azelastine Nasal Spray. Take special care with in the following cases: Children Do not use in children under 6 years of age. The elderly There are no special precautions for use in the elderly. Using with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. So far, no interactions with other medicines have been reported. Using with food and drink Page 1 Version of January, 2008

2 So far, no interactions with food and drink have been reported. However, as a general rule, persons taking medication should refrain from the consumption of alcoholic beverages. Pregnancy and breast-feeding Although doses far in excess of the therapeutic dose range tested in laboratory animals failed to generate any evidence of an embryotoxic effect of this medicinal product, current medical concepts discourage use of in the first trimester of pregnancy. should not be used by nursing mothers, because there is insufficient evidence of the safety of this medicinal product during the breast-feeding period. Driving and using machines In isolated cases, fatigue, weariness, exhaustion, dizziness or weakness that may also be caused by the disease itself, may occur when using. In these cases, the ability to drive and use machines may be impaired. Special attention should be paid to the fact that alcohol may enhance this effect. 3. HOW TO USE AZELASTINE NASAL SPRAY Always use exactly as described in this package leaflet. You should check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed, spray once into each nostril twice daily (mornings and evenings; equivalent to a daily dose of 0.56 mg Azelastine hydrochloride / day). Use with your head held upright. (Follow the instructions below the figures). 1. Remove protective cap. 2. Only when using your spray 3. Spray one puff into for the very first time, pump several each nostril with your times until an even spray appears. head held upright. 4. Replace the protective cap. may be used until symptoms clear up, but treatment should not be continued for more than 6 consecutive months. Please, speak to your doctor or pharmacist if you have the impression that the effect of Azelastine Nasal Spray is either too strong or too weak. Page 2 Version of January, 2008

3 If you use more than you should is locally used in the nose. Even in case of extreme local overdose, no intoxication symptoms should be expected due to the low content of active substance. However, in case of unintentional ingestion of larger portions (for instance: of the contents of a bottle by a child) medical advice must be obtained. There is no experience after administration of toxic (very large, poisonous) doses of Azelastine hydrochloride in humans. In the case of extremely high overdosage or intoxication (poisoning), disturbances of the central nervous system (such as restlessness, excitement or pronounced long-lasting tiredness and sleepiness) are to be expected on the basis of results of animal experiments. Therefore, treatment of these disorders must be symptomatic. If you forget to use If you forget once to use, no special measures need to be taken. Continue treatment using the planned dosage at the usual time. If required, you also may use Azelastine Nasal Spray in between two regular applications. If you stop using If somehow possible, treatment with should be continued on a regular basis until your symptoms clear up. If you stop using, you must be aware that the typical symptoms of your disease may reappear very soon. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, can cause side effects, although not everybody gets them. Evaluation of the side effects is based on the following frequency information: Very common: More than 1 of 10 treated patients Uncommon: Less than 1 of 100, but more than 1 of 1000 treated patients Very rare: Less than 1 of 10,000 treated patients, including isolated cases Common: Less than 1 of 10, but more than 1 of 100 treated patients Rare: Less than 1 of 1000, but more than 1 of 10,000 treated patients Immune system disorders Very rare: Hypersensitivity reactions Nervous system disorders Common: Improper administration (with head reclined back; see Instructions for Use) may produce a bitter taste which may lead to nausea occasionally. Very rare: Dizziness Respiratory tract disorders Uncommon: Irritations of the inflamed nasal mucosa can occur on spraying (e.g. stinging, itching), sneezing and nosebleeds. Page 3 Version of January, 2008

4 Gastrointestinal tract disorders Rare: Nausea General disorders Very rare: Fatigue (weariness, exhaustion), dizziness or weakness that may also be caused by the disease itself. Haut Very rare: Rash, itching, nettle fever. Countermeasures Usually, the side effects mentioned above are of transient nature. Therefore, it will not be necessary to take any special countermeasures. If you experience a bitter taste in your mouth after use of, you may want to drink a non-alcoholic beverage (such as juice or milk) to counteract that taste. 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 AZELASTINE NASAL SPRAY Keep medicaments out of the reach and sight of children. Do not use after the expiry date which is stated on the label and the carton. Storage conditions Do not store below +8 C (e. g. not in the refrigerator). You must not use if you notice the following: Should have been stored by mistake for a prolonged period below a temperature of +8 C (for instance in the refrigerator), the active substance of will start to crystallize out to a certain extent. If you hold the bottle against the light, these crystals ("flocculation") become visible. Do not use such a solution. However, if you store the solution for several hours at room temperature, these crystals will completely disappear. Now, you can continue to use this clear solution again (no flocculation is visible anymore). Information concerning in-use shelf-life After first opening of the bottle, should not be used for longer than half a year. 6. FURTHER INFORMATION What contains The active substance is Azelastine hydrochloride. 1 spray puff (0.14 ml) contains 0.14 mg of Azelastine hydrochloride. The other ingredients are: Sodium edetate, Hypromellose (HPMC), Sodium monohydrogenphosphate dodecahydrate, Citric acid, Sodium chloride, purified water. What looks like and contents of the pack is a solution. is supplied in the original sales pack containing 10 ml of solution. Page 4 Version of January, 2008

5 Marketing Authorization Holder and Manufacturer MEDA Pharma GmbH & Co. KG Benzstrasse Bad Homburg (Germany) Phone: (06172) Fax: (06172) info@medapharma.de is a medicinal product not subject to medical prescription. An allergy is the body's overreaction to normally harmless substances. For instance, an allergy can be triggered by contact with pollen, house dust mites or with cat hair or dog hair. To get relief of your allergy symptoms, you have bought containing the active substance Azelastine hydrochloride in your pharmacy. This active ingredient has a blocking effect on histamine and other inflammatory substances which are released to a much higher extent in case of allergy. Among other things, inhibits excessive nasal secretion, reduces the tormenting urge to sneeze and soothes swollen nasal mucous membranes. acts directly upon the nasal mucous membranes and therefore gives fast and effective relief of allergic discomfort in the nose despite the low dosage of its active substance. contains no preservatives. Page 5 Version of January, 2008