Azelastin pos
Poland
Table of Contents
Patient Information Leaflet
Azelastin POS, 1 mg/ml, nasal spray, solution
Azelastine hydrochloride
Read this entire leaflet carefully before using the medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days, or if you feel worse, consult your doctor.
Table of Contents
- What Azelastin POS is and what it is used for
- Important information before using Azelastin POS
- How to use Azelastin POS
- Possible side effects
- How to store Azelastin POS
- Contents of the pack and other information
1. What Azelastin POS is and what it is used for
The active substance in Azelastin POS is azelastine, which belongs to a group of medicines called antihistamines. Antihistamines block the action of histamine, a substance produced by the body during an allergic reaction.
Azelastin POS is used for symptomatic treatment of hay fever (seasonal allergic rhinitis).
It is intended for use in adults and children aged 6 years and older.
2. Information before using Azelastin POS
When not to use Azelastin POS:
If the patient is allergic to azelastine or to any of the other ingredients of this medicine
(listed in section 6).
Azelastin POS must not be used in children below 6 years of age. The rules for use are the same
for adolescents as for adults (see also section 3, "Use in children and adolescents").
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Warnings and precautions
Before starting to use Azelastin POS, discuss this with a doctor or pharmacist if:
- the patient is unsure whether their symptoms are caused by allergy.
Azelastin POS is not suitable for the treatment of colds or flu.
Azelastin POS and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
There are no data available on the effect of other medicines on the action of Azelastin POS.
Azelastin POS with food, drink and alcohol
Interaction with food and drink is not known.
As a general rule, alcohol consumption should be avoided during treatment.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Pregnancy
Although it does not appear that azelastine has harmful effects on the unborn child, use of this medicine is not recommended during the first trimester of pregnancy.
Breastfeeding
Due to lack of data, Azelastin POS should not be used during breastfeeding.
Driving and operating machinery
In very rare cases, the patient may experience fatigue, tiredness, exhaustion, dizziness or weakness related to disease symptoms or use of Azelastin POS. In such cases, driving vehicles or operating machinery should be avoided. It should be remembered that alcohol consumption or taking other medicines may intensify these effects.
3. How to use Azelastin POS
This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
The recommended dose is one spray of Azelastin POS nasal aerosol into each nostril, twice daily (morning and evening). This corresponds to a daily dose of 0.56 mg of azelastine hydrochloride.
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Instructions for use:
Azelastin POS is intended for nasal use only.
- Blow your nose before using Azelastin POS.
- Remove the protective cap.
- Prime the pump by pressing it until the aerosol is released (usually 1–2 times).
- Keep your head upright, without tilting it backward.
- Insert the nozzle into one nostril and press the pump once, while gently inhaling through the nose.
- Repeat the procedure for the other nostril.
- Wipe the nozzle clean and replace the protective cap.
Azelastin POS should be used by only one individual.
Duration of use:
Azelastin POS should be used until symptoms subside. However, it should not be used continuously for longer than 6 months.
If symptoms worsen or no significant improvement is observed within 3 days of using Azelastin POS, consult a doctor or pharmacist.
Use in children and adolescents
The use of Azelastin POS is not recommended in children under 6 years of age due to lack of data on safety and efficacy.
Use of a higher than recommended dose of Azelastin POS
Azelastin POS is administered as a nasal spray. Since each spray contains a small dose of azelastine, the occurrence of adverse effects is unlikely, even if a higher than recommended dose is used.
In case of accidental ingestion of a large amount of Azelastin POS (e.g. a child swallowing the contents of one bottle), contact a doctor immediately.
There are no human data on overdose; however, animal studies have shown that the following adverse effects may occur: restlessness, marked persistent fatigue or drowsiness, stimulation, or exhaustion and fatigue.
Missed dose of Azelastin POS
No special action is required. Continue treatment with the next dose at the usual time. Do not use a double dose to make up for a missed dose.
Stopping Azelastin POS
Azelastin POS should be used regularly until symptoms subside. If treatment with Azelastin POS is stopped, typical allergy symptoms may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
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Assessment of adverse effects is usually based on the following frequency of occurrence:
Common adverse effects (may occur in fewer than 1 in 10 people):
an unpleasant taste in the mouth after administration (often associated with incorrect spraying technique, namely tilting the head backward during aerosol administration), which in rare cases may lead to nausea
Uncommon adverse effects (may occur in fewer than 1 in 100 people):
nasal discomfort due to inflammation of the nasal mucosa (burning, itching), sneezing, nosebleeds
Rare adverse effects (may occur in fewer than 1 in 1,000 people):
nausea
Very rare adverse effects (may occur in fewer than 1 in 10,000 people):
feeling of fatigue (tiredness, exhaustion), dizziness or weakness (may also occur related to the patient's condition), hypersensitivity reactions, rash, itching, urticaria.
If any adverse effects occur, discontinue use of Azelastin POS and contact your doctor immediately. The listed adverse effects usually resolve quickly. If a bitter taste in the mouth occurs after using Azelastin POS, it can be neutralized by drinking a non-alcoholic beverage (e.g. juice, milk).
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather further information on the safety of the medicine.
5. How to store Azelastin POS
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP.
The expiry date refers to the last day of the stated month.
Do not store in a refrigerator or freeze. Do not store at temperatures above 25°C.
Shelf life after first opening: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
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6. Contents of the pack and other information
What Azelastin POS contains
The active substance is azelastine hydrochloride. One pump spray (one dose) delivers 0.14 ml of solution containing 0.14 mg of azelastine hydrochloride.
The other ingredients are: hypromellose, disodium edetate, anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride, purified water.
What Azelastin POS looks like and contents of the pack
Azelastin POS is a clear, colourless nasal aerosol supplied in a multidose container (made of high-density polyethylene) with a metering pump spray, packaged in a cardboard box.
One pack contains one 10 ml plastic container with a metering pump spray.
Marketing Authorisation Holder:
URSAPHARM Poland Sp. z o.o.,
Wybrzeże Gdyńskie 27,
01-531 Warsaw
Tel.: 022 732 07 90
Fax: 022 732 07 99
www.ursapharm.pl
e-mail: [email protected]
Manufacturer:
URSAPHARM Arzneimittel GmbH
Industriestrasse 35
66129 Saarbrücken
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Azelastin POS Nasenspray 1 mg/ml
Belgium/Luxembourg: Pollival 1 mg/ml solution for nasal spray
Germany: Pollival 1 mg/ml Nasenspray, Lösung
Netherlands: Pollispray 1 mg/ml neusspray, oplossing
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