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AFLUON Nasal Spray Ū Astelin (Azelastine)
a name="COMPOSITION">COMPOSITION AND PRESENTATION
Astelin, Azelastine (INN) HCl, 0,01 gr., hypromellose, disodium edetate, anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride and purified water, q.s.
Astelin, Azelastine .A nasal spray, available in bottles of 20 ml. with a metered-dose spray pump.
ACTIVITY
Astelin, Azelastine, a phthalazinone derivative of novel structure, is classified as a potent long acting anti-allergic compound.
INDICATIONS
Astelin, Azelastine: The treatment of symptoms of both seasonal allergic rhinitis and acute exacerbations of perennial allergic rhinitis.
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CONTRAINDICATIONS
Astelin, Azelastine : Proven allergy against azelastine hydrochloride.
PRECAUTIONS
Astelin, Azelastine: None reported.
WARNING
Astelin, Azelastine: Use during pregnancy and lactation: Due to the nasal route of administration and the low dose administered, minimal systemic exposure can be expected. However as with all medicines caution should be exercised with use during pregnancy and lactation.
Use in the elderly: There have been no specific studies in the elderly.
Effects on ability to drive: None reported.
POSOLOGY
Astelin, Azelastine:
- Adults and children over 6 years of age: one application (0,14 ml.) in each nostril twice daily (0,56 mg. of azelastine hydrochloride).
- Elderly: There have been no specific studies in the elderly.
INSTRUCTIONS FOR CORRECT USE AND HANDLING OF THE MEDICATION
1. Remove the protective cap.
2. Before first using, press the pump several times (3-4 times) until an even spray emerges.
3. Spray once into each nostril keeping head upright.
4. Wipe and replace the protective cap.
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INTERACTIONS
Astelin, Azelastine: No specific interactions have been studied.
OVERDOSE
Astelin, Azelastine: The results of animal studies show that toxic doses can produce Central Nervous System symptoms, e.g. excitation, tremor, convulsions. Should these occur in humans, symptomatic and supportive treatment should be instigated. Gastric lavage is recommended if the overdose is recent. With the nasal route of administration overdosage reactions are not anticipated.
ADVERSE EFFECTS
Astelin, Azelastine: In rare cases (0,7%), irritation of the inflamed nasal mucosa may occur, with symptoms such as stinging, itching and sneezing. A substance-specific bitter taste may be experienced after administration (often due to incorrect method of application, namely tilting the head too far backwards during administration) which, in some cases, may lead to nausea. In isolated cases epistaxis may be experienced.
If you notice any other adverse reaction not mentioned above, consult your doctor or pharmacist.
PRECAUTIONS FOR STORAGE
Astelin, Azelastine: Do not store below 8°C. Do not refrigerate.
EXPIRY
Astelin, Azelastine must not be used after the expiry date indicated on the box.
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