Otrason 50 micrograms/dose Nasal Spray, Fluticasone Propionate Suspension
What Otrason Is And What Otrason Used For
Otrason is a cortisone preparation that counteracts inflammation and allergies even in very small doses. Otrason is used for runny nose and nasal congestion caused by allergies to, e.g., pollen (so-called hay fever), animals, or dust. Otrason can also be used for runny nose, nasal congestion, and sneezing without an allergic cause (so-called vasomotor runny nose ), but not for common cold, runny nose. The full effect comes only after a few days of regular treatment.
What You Need To Know Before Using Otrason
In most cases, you will be helped by Otrason for your problems with pollen allergy, but in some cases, when the pollen levels are extra high, you may need further treatment.
Consult a doctor if this applies to you.
Do not use Otrason
- If you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Talk to your doctor before using Otrason if you have any of the following conditions:
- Fungal or herpes infection in the nose
- If you have a fever or infection in your nose or sinuses
- Recently had surgery on the nose or has injured the nose or has sores in the nose
- Pulmonary tuberculosis
- Severe liver disease.
In case of allergic symptoms from the eyes or during the first days when using Otrason, additional treatment may be needed.
If you are already using cortisone (for inhalation, tablets, or cream/ointment), e.g., for asthma or eczema, do not use Otrason nasal spray without consulting your doctor. Contact a doctor if you experience blurred vision or other visual disturbances.
Other Drugs And Otrason
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including those obtained without a prescription.
Some other medicines may increase the effect of Otrason, and your doctor may want to monitor you closely if you are taking these medicines, e.g., some medicines for HIV:
- Ritonavir
- Cobicistat, or some medicines for fungal infections:
- Ketoconazole
- Itraconazole
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Limited experience of use during pregnancy. Therefore, consult a physician before using Otrason during pregnancy.
It is not known if fluticasone propionate passes into breast milk. Therefore, consult a physician before regular use during breastfeeding.
Driving And Using Machines
You are responsible for assessing whether you can drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Otrasonl Contains Benzalkonium Chloride
OtrasonThis medicine contains 0.02 mg of benzalkonium chloride as a dose of spray solution. Benzalkonium chloride may irritate the skin and cause swelling of the skin reaction inside the nose, especially with prolonged use of the medicine.
How To Use Otrason
- For nasal use only.
- Always use this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose for adults and children from 12 years:
- 1-2 sprays in each nostril once daily for a maximum of 3 months. This dosage should not be exceeded.
- Start with 2 sprays in each nostril once a day, preferably in the morning. When you have improved, and the symptoms are under control, the dose is reduced by one to 1 spray in each nostril once a day.
- Otrason often provides relief after a few hours, but the full effect is obtained only after a few days of regular use.
If you have not improved after 14 days of regular use, consult a doctor. Also, consult a doctor if the medicine needs to be used daily for more than 3 months.
Feel free to try to end the treatment if you think the pollen season is over or if there are very low levels of pollen in the air.
Shake the nasal spray before use. Otherwise, see the operating instructions.
Use In Children And Adolescents
- Do not use in children under 12 years of age without a doctor’s instruction.
- If you have been prescribed Otrason, your doctor will decide on a dose that is right for you.
Follow your doctor’s prescription carefully.
If You Use More Otrason Than You Should
You must take a dose as stated on the package label or as your doctor advised. Use only the amount prescribed by your doctor. Using too little or too much can make your symptoms worse.
If you have ingested too much medicine or if, e.g., a child has ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If You Forget To Use Otrason
Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Otrason Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
The following side effects may occur:
Very common (may affect more than 1 user in 10):
- Sneezing immediately after spraying
- Slightly blood-mixed nasal secretions.
Common (may affect up to 1 in 10 people):
- Dryness/irritation of the nose
- Headache
- Unpleasant odor or taste may be due to the underlying disease or the properties of the drug.
Very rare (may affect up to 1 in 10,000 people):
- Hypersensitivity reactions include skin rash, bronchospasm, swelling of the face, oral cavity, and throat, and anaphylactic reactions/shock (a type of allergic reaction/shock). Contact a doctor immediately.
- Sores on the nasal mucosa and holes in the nasal septum. The cause of these side effects is unclear.
- Glaucoma ( glaucoma ), increased pressure in the eye, cataracts (cataracts).
Has been reported (occurs in an unknown number of users):
- Dimsyn
- Sores in the nose.
Reporting of side effects are
Talk to your doctor, pharmacist, or nurse if you get any side effects. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
How To Store Otrason
- Keep this medicine out of sight and reach of children.
- Do not store above 30 ° C
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
As drug residues can remain in empty packages, they should not be thrown in the rubbish, but the empty packages should also be returned to pharmacies.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is fluticasone propionate.
- The other ingredients are anhydrous glucose, Avicel RC 591 (microcrystalline cellulose + sodium carboxymethylcellulose), preservatives (benzalkonium chloride 20 micrograms, phenethanol 0.25 microliters), Polysorbate 80, hydrochloric acid (for pH adjustment), purified water.
What The Medicine Looks Like And Contents Of The Pack
The medicine is packaged in a glass bottle with a dosing pump, nasal applicator, and protective cap. Otrason is available without a prescription in packs of 1 x 60 doses and 1 x 120 doses.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Consumer Healthcare ApS
PO Box 61
2610 Rødovre
Denmark
Tel: 020-100579
Manufacturer
Glaxo Wellcome SA
Avenida de Extremadura 3
09400 Aranda de Duero (Burgos)
Spain
Läkemedelsverket
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se