XYLOMETAZOLINE DECONGESTANT NASAL DROPS 0.05%W/V CHILDRENS
Active substance(s): XYLOMETAZOLINE HYDROCHLORIDE
Manx Healthcare Clear Nose Drops - Child Formula
Xylometazoline Decongestant Nasal Drops 0.05%w/v Children’s Formula
Read all of this leaflet carefully before you start using this medicine because it contains
This medicine is available without a prescription. However, you still need to use these
Nasal Drops carefully to get the best results from them.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• You must contact a doctor if the symptoms worsen or do not improve after 5 days
• If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you use this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
These drops contain the decongestant xylometazoline hydrochloride and are used to give relief
from blocked noses due to colds, sinusitis and perennial and allergic rhinitis (inflammation of
the mucous membranes in the nose), including hay fever.
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 your child breathe more easily and so feel better.
2. BEFORE YOU USE THIS MEDICINE
This medicine can be given to children from the age of 6 years. However, some children
should not be given this medicine.
Do not use the drops if your child:
• is less than 6 years of age
• is allergic to xylometazoline hydrochloride or any of the other ingredients
• is using similar decongestants, such as ephedrine or phenylephrine
• has heart disease and/or, raised blood pressure
• has diabetes
• has phaeochromocytoma (a tumour of the nerves associated with hormone glands)
• has an overactive thyroid gland
• has glaucoma
• is taking or has taken within the last two weeks a monoamine oxidase inhibitor
(MAOI)(to treat depression)
• is taking beta-blockers (to treat high blood pressure)
• has inflammation of the skin inside the nostrils
• has had recent neurosurgery or nasal surgery
See your doctor before using the drops if your child:
• has experienced a strong reaction (for example difficulty in sleeping or dizziness) with
• is receiving other medication or is under the care of a doctor
Use with other medicines
Do not use:
• with other cough and cold medicine, including other decongestants
• if the child is taking or has taken within the last two weeks a monoamine oxidase
inhibitor (MAOI)(to treat depression)
• with beta-blockers (to treat high blood pressure)
Ask your doctor or pharmacist before using these drops if your child is using any other
medicines including any that you can buy without a prescription.
If your child experiences hallucinations, restlessness, or sleep disturbances, stop
using the drops.
Pregnancy and breast-feeding
Pregnant or breast-feeding women should consult their doctor before using the drops for
HOW TO USE THIS MEDICINE
For children aged 6-12 years of age:
One or two drops of solution in each nostril once or twice daily
Practice using the dropper to develop good dosage control
Clear or wipe the child’s nose
Shake the bottle gently and remove the cap
Tilt the child’s head right back as far as is comfortable and apply one or two drops of
solution to each nostril.
• Do not give your child more than 2 doses (4 drops) in each nostril in any 24 hour period
• Do not exceed the stated dose
• Do not give for more than 5 consecutive days otherwise it may worsen your child’s
condition because of a rebound action
• If symptoms worsen or do not improve after 5 days, speak to your child’s doctor
• Keep away from the eyes
• To avoid the possible spread of infection, these drops should be used by one child only
• See a doctor at once if you think your child has been given too much solution or
has taken it accidentally by mouth
POSSIBLE SIDE EFFECTS
Like all medicines, these drops can cause side effects, although not everybody gets them.
If you notice any of the following reactions your child must stop using the drops and you
must speak to a doctor immediately:
• skin rash, itching, shortness of breath, wheezing and/or swollen face (symptoms of an
allergic hypersensitivity reaction).
Stop using the drops and speak to a doctor if your child has the following reactions:
• paranoid delusions
• sleep disturbance
• abnormal heart beat, palpitations or high blood pressure
The following effects have been reported occasionally:
• burning sensation in the nose or throat
• irritation or dryness in the nose when applying the drops
• nausea and sickness
• problems with vision (temporary)
• difficulty or inability to urinate
• the drops may become less effective and congestion may become worse,
especially if high doses are taken for long periods
If you think your child is reacting badly in any way, they must stop using the drops and see
Reporting of Side Effects
If your child gets 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.
HOW TO STORE THIS MEDICINE
Use by date: Do not use the drops if they are past the expiry date on the bottle
For reasons of hygiene do not use the drops for more than 28 days after first opening
Keep the drops in a cool place below 30°C
Remember: Keep all medicines out of the sight and reach of children
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
What this medicine contains
This medicine contains xylometazoline hydrochloride 0.05%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.
What this medicine looks like and contents of the pack
The nasal drops are a clear and colourless solution. They are available in dropper bottles of
Marketing Authorisation Holder:
Manx Pharma Ltd, Taylor Group House, Wedgnock Lane,Warwick, CV34 5YA, UK.
INyX PHARMA Ltd
9 Arkwright Road Astmoor Industrial Estate Runcorn, Cheshire WA7 1NU
Coughs and colds in children
Children may have at least 8 colds a year and this is normal. They will normally get fewer
colds as they grow older and their immune system builds up. Colds are caused by viruses so
antibiotics will not help. Most colds get better in 5-7 days.
You can follow these steps to help relieve your child’s symptoms:
Fever or feeling hot:
• Give your child more fluids to drink
• Reduce a high temperature and ease pain and discomfort with ibuprofen or
paracetamol medicine in a form suitable for children (ask your pharmacist for
• It may seem distressing but coughing is necessary to help clear phlegm from the
chest or mucus from the back of the throat. To help loosen the phlegm and relax
airways, you can give your child lukewarm clear fluids to drink.
• Plain saline drops and sprays can help unblock the nose.
To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.
This leaflet was last revised in December 2014.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.