Xylometazoline Decongestant Nasal Drops 0.1% Adult Formula
Package Leaflet: Information for the User
Xylometazoline Decongestant Nasal Drops 0.1%w/v Adult Formula Xylometazoline hydrochloride 0.1%w/v
Please read this leaflet carefully before you start to use these nasal drops, 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 drops?
The name of this medicine is Xylometazoline Decongestant Nasal Drops 0.1%w/v Adult Formula. 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 do the nasal drops work?
These drops contain 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 are these nasal drops used for?
They are used to relieve the symptoms of nasal congestion, perennial and allergic rhinitis [including hay fever] and sinusitis.
Check before you use the drops.
Do not use the drops:
• 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 drops 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 these drops 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 these nasal drops if you are taking or have taken within the last two weeks a medicine known as “monoamine oxidase inhibitor".
How to use these drops
For adults and children over 12 years of age:
2 or 3 drops of solution in each nostril 2 or 3 times daily
1. Clear the nose
2. Shake the bottle gently and remove the cap
3. Lean head right back as far as is comfortable and apply two or three drops of solution to each nostril.
Consult your doctor if you think that you have used too much solution or have taken it accidentally by mouth.
These nasal drops, 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, these drops should be used by one person only.
Will the nasal drops suit me?
Some people with sensitive nasal passages may experience a burning sensation or irritation when applying the drops. Nausea and headache may occasionally occur in a few people.
If you think you are reacting badly in any way, stop using the drops 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 drops
Use by date: Do not use the drops if it is past the expiry date on the bottle. For reasons of hygiene do not use the drops for more than 28 days after first opening the bottle.
Keep the drops 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: May 2015
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