50 micrograms/dose Nasal spray, suspension
fluticasone propionate
What Reason is and what it is used for
Reason contains fluticasone propionate, a corticosteroid ( cortisone ), which reduces inflammation and symptoms caused by allergies.
The reason is used for adults and adolescents over 12 years of age against the runny nose and nasal congestion caused by allergies to e.g. pollen (hay fever), animal, or dus,t and in the case of vasomotor rhinitis (runny nose).
The reason is used for children aged 8 to 12 years against the runny nose and nasal congestion caused by allergies to e.g. pollen (hay fever).
The full effect comes only after a few days of regular treatment.
Fluticasone propionate contained in Reason may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Reason
Do not use Reason
- 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 or pharmacist before using Reason:
- if you have a fever or infection in your nose or sinuses
- if you have recently had nose surgery or have injured your nose or have sores in your nose
- if you have previously been treated with cortisone tablets or cortisone injections, you may regain allergic symptoms from your eyes after switching to Reason. Complementary treatment may then be needed.
Talk to your doctor if you experience
- blurred vision or other visual disturbances.
- Side effects affecting the whole body (systemic side effects):
When nasal sprays containing corticosteroids are used in high doses for long periods, side effects can occur due to the drug being absorbed into the body. This effect is less likely to occur when used in the nose compared to when corticosteroids are given orally and this effect may vary between patients and for different medicines containing corticosteroids. Possible systemic side effects may include Cushing’s syndrome (a set of symptoms caused by high levels of the hormone et cortisol rushing-like symptoms (eg, lunar face), adrenal insufficiency, cataracts, glaucoma, and more rarely a range of psychological or behavioral disorders including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression.
Children and young people
Treatment with nasal corticosteroids (such as Reason) for long periods may cause stunted growth. Your doctor will monitor your child’s height regularly and ensure that your child receives the lowest possible effective dose.
Other possible systemic side effects are depression or aggression.
Other drugs and Reason
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some other medicines may increase the effect of Reason and your doctor may want to monitor you closely:
- if you are using any type of antiviral medicine known as a protease inhibitor (eg ritonavir for HIV ) or medicines containing cobicistat (antiviral) that may increase the effect of fluticasone propionate.
- if you are taking certain medicines for fungal infections (eg ketoconazole, itraconazole).
Pregnancy, breastfeeding, and fertility
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 Rinason 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 are fit to 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 and/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.
Rinason contains benzalkonium chloride
This medicine contains 2 micrograms of benzalkonium chloride per dose. Benzalkonium chloride may irritate and swell inside the nose, especially with prolonged use of the medicine.
How to use Reason
For nasal use only.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage one is determined by the doctor who adjusts it individually for you.
Adults and adolescents over 12 years
The recommended dose is 1-2 sprays in each nostril once a day, preferably in the morning.
Use for children and adolescents
Children from 8 to 12 years against the runny nose and nasal congestion caused by allergies to e.g. pollen (hay fever)
The recommended dose is 1 spray in each nostril once a day, preferably in the morning. Higher doses should not be given.
Children under 8 years
Do not use it for children under 8 years.
Before using your nasal spray
If you have a new bottle or a bottle that you have not used in a while, you need to prepare it to ensure that you get the right dose of the medicine. Prepare the spray according to the following points:
- Shake the bottle and remove the protective cap.
- Hold the bottle upright and spray in the air;
- 5 times if you have a new bottle.
- 1 time if you have not used the bottle for a while.
Using the nasal spray
- Shake the bottle and remove the protective cap.
- Sniff your nose.
- Tap one nostril with your finger and place the nasal applicator in the other nostril. Tilt your head slightly forward and hold the bottle upright.
- Inhale slowly through the nose. While inhaling, press the collar of the bottle down firmly with your fingers.
- Exhale through the mouth.
- Repeat steps 3 to 5 for the other nostril.
- Wipe the nasal applicator and protective cap with a clean, dry handkerchief after each use. Clean the nasal applicator and protective cap with water once a week and allow the parts to air dry at room temperature.
Duration of treatment
Reason does not have an immediate effect but reaches its greatest effect after a few days of regular use. In the case of hay fever, the treatment should, if possible, be started before the pollen season begins.
If you use more Rinason 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. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Reason
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Rinason and contact a doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing
- drop in blood pressure.
These symptoms can be signs of severe hypersensitivity reactions such as angioedema and anaphylaxis which are very rare side effects (may affect up to 1 in 10,000 people).
Other side effects that may occur include:
Very common (may affect more than 1 user in 10)
- Sneezing can occur immediately after spraying
- Slightly blood-mixed nasal secretions
Common (may affect up to 1 in 10 people)
- Headache
- Unpleasant taste or odor that may be due to the underlying disease or the properties of the drug
- Dryness or irritation of the nose or throat
Very rare (may affect up to 1 in 10,000 people)
- Sores on the nasal mucosa, holes in the nasal septum
- Glaucoma ( glaucoma ), increased pressure in the eye, cataracts (cataracts)
Has been reported (occurs in an unknown number of users)
- Dimsyn
- Sores in the nose
How to store Reason
Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date which is stated on the label and package after EXP. The expiration date is the last day of the specified month.
An opened bottle should be used within 3 months.
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.
Contents of the pack and other information
Content declaration
- The active substance is fluticasone propionate. Each dose contains 50 micrograms of fluticasone propionate.
- The other ingredients are benzalkonium chloride, glucose, microcrystalline cellulose (E460i), carmellose sodium (E466), phenyl ethyl alcohol, polysorbate 80, and water.
What the medicine looks like and the contents of the pack
The reason is a white opaque suspension.
The reason is packaged in a bottle equipped with a spray pump and a protective cap and is available in pack sizes of 60, 120, 360 (3 x 120), or 150 doses.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
2care4 Generics ApS
Stenhuggervej 12-14
6710 Esbjerg V
Denmark
Manufacturer
Basic Pharma Manufacturing BV
Mayor Lemmensstraat 352
6163 JT Geleen
Netherlands