Flunase Aqueous 50 Microgram Nasal Spray
Package Leaflet: Information for the User Flunase Aqueous 50 microgram Nasal Spray
Fluticasone Propionate
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Flunase Nasal Spray is and what it is used for
2. Before you use your Flunase Nasal Spray
3. How to use Flunase Nasal Spray
4. Possible side effects
5. How to store Flunase Nasal Spray
6. Further information
1. WHAT FLUNASE NASAL SPRAY IS AND WHAT IS IT USED FOR
Your medicine is called Flunase Aqueous 50 microgram Nasal Spray (described as ‘Flunase Nasal Spray’ throughout this leaflet) and contains 50 micrograms of the active ingredient, fluticasone propionate, in each spray. Fluticasone propionate is one of a group of medicines known as corticosteroids.
Flunase Nasal Spray has anti-inflammatory properties. When sprayed into your nose it will reduce swelling and irritation. It is used to prevent and treat seasonal allergic rhinitis (e.g. hayfever) and perennial rhinitis (e.g. blocked or runny nose and sneezing and itching caused by house dust mites or animals such as cats and dogs). It can be used by adults and children of 4 years of age and over.
2. BEFORE YOU USE YOUR FLUNASE NASAL SPRAY Do not use Flunase Nasal Spray:
• if you are allergic (hypersensitive) to fluticasone propionate or any of the other ingredients in Flunase Nasal Spray.
Take special care with Flunase Nasal Spray:
• if you have ever had an operation to your nose.
• if you are suffering or have recently suffered from an infection of the nasal airways.
• if you are suffering or have recently suffered from any type of untreated infection or from tuberculosis or ocular herpes.
• if you have recently been treated with injected steroids, or you have been taking oral steroids for a long time.
Flunase Nasal Spray will usually control seasonally allergy rhinitis (hay fever) however if you are exposed to excessive amounts of pollen additional therapy may be helpful for controlling other symptoms such as itching eyes. Please consult your doctor in such an event.
Taking other medicines
Some medicines can interfere with Flunase Nasal Spray, in particular tell your doctor or pharmacist if you are taking:
• Any medicines used in the treatment of fungal infections (e.g. ketoconazole)
• Any antiviral medicine such as those used to treat HIV infection (e.g. ritonavir)
Please tell your doctor or your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant, planning to become pregnant or breastfeeding. Ask you doctor for advice before taking any medicine.
Driving and using machines
The medicinal product has no or negligible influence on the ability to drive and use machines.
Important information about some of the ingredients of Flunase Nasal Spray
Flunase Nasal Spray contains the ingredient benzalkonium chloride (40 micrograms per delivered dose) which is an irritant and may cause skin reactions. If used for longer periods, the preservative benzalkonium chloride may cause nasal mucosa swelling. In case of such a reaction (persistently congested nose) medicinal products for nasal use without preservative should be used if possible. It may also cause bronchospasm. Unless such products are available another pharmaceutical form should be taken.
3. HOW TO USE FLUNASE NASAL SPRAY
Always use Flunase Nasal Spray exactly as your doctor has told you to. You should check with your doctor if you are not sure.
The usual dose is as follows:
Adults (including the elderly) and children of 12 years of age and over:
When you first start using Flunase Nasal Spray you normally take two sprays in each nostril once a day, preferably in the morning. Your doctor may increase this to a maximum of two sprays into each nostril twice a day.
Once your symptoms are under control your doctor may reduce your dose to one spray into each nostril once a day. If the use of such a reduced dose signals a worsening in your symptoms, your dose may be increased back to the starting dose.
Children between ages of 4 and 11:
For children aged between 4-11 years old the dose is normally one spray in each nostril once a day, preferably in the morning. Your doctor may increase this to a maximum of one spray into each nostril twice a day.
This product is not suitable for children under 4 years old
Your doctor will prescribe the lowest dose of Flunase Nasal Spray capable of effectively controlling your symptoms.
It may take a few days for this medicine to work. Do not stop using your medication unless you are told to by a doctor.
You must not take a larger dose, or use your Flunase Nasal Spray more often, than is prescribed by your doctor. It is important not to use more of your medicine than your doctor has told you to.
If your eyes remain itchy or watery as a result of hayfever despite using this medicine tell your doctor. He/she may be able to give you another medicine to treat your eye symptoms.
Before you use your nasal spray
Your Flunase Nasal Spray has a dust cap that protects the nozzle and keeps it clean - this must be taken off prior to using the spray and then replaced after use.
When your Flunase Nasal Spray is new the bottle must be primed as follows:-
1. Shake the bottle gently and then remove the dust cap.
2. Hold the bottle upright with your thumb under the bottle and your index finger and middle finger on either side of the nozzle. Ensure that the nozzle is pointing away from you when you do this.
3. Press down with fingers in order to pump the spray.
4. Repeat steps 2 and 3 until a further five times - the bottle is now primed.
If you have not used your Flunase Nasal Spray for 7 days prime until a fine mist is produced.
If after attempting to prime the bottle the spray still does not work and you think it may be blocked you may clean the spray using the following procedure:-
Cleaning your nasal spray
1. Remove the dust cap.
2. Pull the white collar upwards to remove the nozzle.
3. Place the nozzle and dust cap in warm water and soak for a few minutes, and then rinse by placing under a running tap.
4. Shake off the excess water and allow the nozzle and dust cap to dry in a warm (not hot) place.
5. Re-fit the nozzle.
6. ‘Prime’ the bottle as necessary by pumping the spray a few times until a fine mist is produced.
• You should clean your nasal spray at least once a week to stop it from getting blocked up. Additional cleaning is required when your spray becomes blocked.
• You must NEVER attempt to unblock or enlarge the spray hole with a pin or other sharp object because this will destroy the spray mechanism.
Using your nasal spray
1. Shake the bottle and remove the dust cap.
2. Gently blow your nose.
3. Close one nostril by pressing your finger against it and place the nozzle of the spray in your other nostril. Tilt your head forward slightly so that the bottle is kept upright.
4. Breathe in slowly through your open nostril and, at the same time, press the collar of the nozzle down firmly with your fingers to squirt a spray of fine mist into your nostril.
5. Breathe out through your mouth. Repeat step 4 to take a second spray into the same nostril.
6. Remove the nozzle from this nostril and breathe out through your mouth.
7. Repeat steps 3 to 6 with your other nostril.
After using your nasal spray
• Wipe the nozzle carefully with a clean tissue and put the dust cap back on.
If you use more Flunase Nasal Spray than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse.
If you accidentally use more Flunase Nasal Spray than you were told to use please inform your doctor.
Take this leaflet, and your Flunase Nasal Spray, to show the doctor.
If you forget to use Flunase Nasal Spray
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose at the right time, take it as soon as you remember. If it is almost time to take the next dose, wait until then and then carry on as before.
If you stop using Flunase Nasal Spray
Your nose symptoms may only start to improve after you have been using your medicine for a few days - therefore it is very important that you use your medicine regularly as prescribed, and that you keep using your medicine unless your doctor tells you to stop, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flunase Nasal Spray can cause side effects, although not everybody gets them.
If you are using high doses of Flunase Nasal Spray you may require extra steroids in times of extreme stress, or during admission to hospital after a serious accident or injury, or before a surgical operation. Your doctor may decide to give you extra steroid medication during this period in the form of tablets or injection if you are in hospital.
Treatment with nasal corticosteroids may affect the production of steroids in the body. The likelihood of such an incidence is increased by use of a high dose over a long period of time. Such an effect is that children may grow more slowly than others, and therefore children receiving treatment with nasal corticosteroids over a long period of time will have their height checked regularly by their doctor. Your doctor will help prevent this happening by prescribing the lowest dose of steroid capable of adequately controlling your symptoms.
Some side effects are more serious than others and if you should experience any of the following events you should discontinue taking Flunase Nasal Spray and consult with your doctor as soon as possible:-
Side effects occurring very commonly (probably affecting more that 1 in 10 patients taking the Flunase Nasal Spray)
• epistaxis (nose bleeds).
Side effects occurring commonly (probably affecting up to 1 in 10 patients taking the Flunase Nasal Spray)
• headache.
• unpleasant taste in the mouth or an unpleasant smell in the nose.
• dryness and irritation of the throat and nasal passages and sneezing.
Side effects occurring rarely (probably affecting fewer than 1 in every 1,000 patients taking Flunase Nasal Spray)
• severe allergic reaction giving rise to the sudden onset of a rash, swelling (usually of the tongue, face or lips) or difficulty in breathing.
• bronchospasm (the narrowing of the airways in the lungs).
Side effects occurring very rarely (probably affecting fewer than 1 in every 10,000 patients taking the Flunase Nasal Spray)
• glaucoma (raised pressure in the eye) and cataracts (clouding of the lens in the eye) have been reported following prolonged treatment.
• perforation of the nasal septum (the dividing partition in the nose) and ulceration to the nose’s mucus membranes - although these usually impact on patients who have had previous surgery to the nose.
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 FLUNASE NASAL SPRAY
Keep out of the reach and sight of children.
Do not use Flunase Nasal Spray after the expiry date stated on the bottle and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Discard after 3 months after first use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help protect the environment.
6. FURTHER INFORMATION What Flunase Nasal Spray contains
The active substance is fluticasone propionate.
Each metered spray contains 50 micrograms of fluticasone propionate .
The other ingredients are glucose anhydrous, dispersible cellulose, phenylethyl alcohol, benzalkonium chloride solution (40 micrograms per delivered dose), polysorbate 80, and purified water.
What Flunase Nasal Spray looks like and contents of the pack
Flunase Nasal Spray consists of a white, opaque suspension contained within an amber glass multi-dose bottle fitted with an atomising metering pump to create the spray. Each bottle of Flunase Nasal Spray contains suspension capable of delivering 60 or 120 or 150 sprays, although not all pack sizes may be placed on the market.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: IVAX Pharmaceuticals UK, Ridings Point, Whistler Drive, Castleford, West Yorkshire WF10 5HX, UK.
Manufacturer: Teva Czech Industries s.r.o., Opava, Czech Republic.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Spain
United Kingdom
Nasotricin 50 mcg suspension pulverization nasal Flunase Aqueous 50 mcg Nasal Spray