Xylometazoline Decongestant Nasal Spray 0.1% W/V
Package Leaflet: Information for the User
Manx Healthcare Clear Nose Spray
Xylometazoline hydrochloride 0.1%w/v
Please read this leaflet carefully before you start to use this nasal spray, and keep it somewhere handy for reference. If you have any questions or are not sure about anything ask your doctor or pharmacist.
What is in the nasal spray?
The name of this medicine is Clear Nose Spray 0.1% w/v. It contains xylometazoline hydrochloride BP 0.1% w/v as the active ingredient. It also contains benzalkonium chloride
0.015% w/v as the preservative, disodium edetate, sodium phosphate dihydrate, sodium acid phosphate, sodium chloride and water.
It is available in bottles of 10ml.
How does the nasal spray work?
This spray contains a nasal decongestant. Nasal decongestants help clear blocked noses associated with a number of conditions including colds, sinusitis, and hay fever.
A blocked nose, such as occurs with a cold, is caused by excessive nasal secretions and the swelling up of many tiny blood vessels that line the nose. The air passages become narrower and the nasal secretions may block the nose completely.
The nasal decongestant in this product helps to open up the nasal passages by reducing the excessive nasal secretions and reducing the swollen blood vessels to their normal size. It will help you breathe more easily and so feel better. The effects start within minutes and last for up to about 10 hours.
What is the nasal spray used for?
It is used to relieve the symptoms of nasal congestion, perennial and allergic rhinitis [including hay fever] and sinusitis.
Check before you use the spray
Do not use the spray:
• If you are allergic to xylometazoline hydrochloride or any of the other ingredients
• if you are pregnant or breast feeding
• for children under 12 years of age
• if you have vasomotor rhinitis or atrophic rhinitis
• if you have had trans-sphenoidal hypophysectomy or surgery exposing the dura-mater See your doctor before using the spray if:
• you have heart disease, raised blood pressure, diabetes, an overactive thyroid gland, or are under a doctor’s care for another illness.
• you have experienced a strong reaction [for example difficulty in sleeping or dizziness] with similar medicines.
• ask your doctor or pharmacist before using the spray if you are using any other
medicines including any that you can buy without a prescription. Use with medicines known as "sympathomimetics", such as ephedrine or phenylephrine, may increase the risk of side-effects. Do not use this nasal spray if you are taking or have taken within the last two weeks a medicine known as a "monoamine oxidase inhibitor".
How to use the spray
For adults and children over 12 years of age:
One application in each nostril 2 or 3 times daily
1. Clear the nose.
2. Shake the bottle gently and remove the cap.
3. Hold spray with your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle as shown in the diagram.
4. Close one nostril and put the nozzle in the other nostril. Tilt your head forward slightly and keep the spray upright.
5. Start to breathe in through your nose and while breathing in press down with your fingers once to release a spray.
6. Repeat steps 4 and 5 with the other nostril.
7. Wipe the nozzle with a clean tissue or handkerchief and replace the cap.
Consult your doctor if you think that you have used too much solution or have taken it accidentally by mouth.
This nasal spray, like any other nasal decongestants, should not be used for more than seven consecutive days, otherwise it may worsen your condition because of a rebound action. If symptoms persist, consult your doctor.
To avoid the possible spread of infection, this spray should be used by one person only.
Will the nasal spray suit me?
Some people with sensitive nasal passages may experience a burning sensation or irritation when applying the spray. Nausea and headache may occasionally occur in a few people
If you think you are reacting badly in any way, stop using the spray and see your doctor.
Reporting of side effects
If you get any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Storing the nasal spray
Use by date: Do not use the spray if it is past the expiry date on the bottle. For reasons of hygiene do not use the spray for more than 28 days after first opening the bottle.
Keep the spray in a cool place below 30°C.
Remember: Keep all medicines out of reach of children.
Warning: Do not exceed the recommended dose.
Date of preparation:
Product Licence Holder:
Manx Pharma Limited.
Taylor Group House Wedgnock Lane Warwick CV34 5YA
Manufacturer:
INyX PHARMA Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
Prepared and packaged for:
Manx Healthcare Limited,
Taylor Group House Wedgnock Lane Warwick CV34 5YA