Patient leaflet - XYLOMETAZOLINE DECONGESTANT NASAL DROPS 0.05%W/V CHILDRENS, MANX HEALTHCARE CLEAR NOSE DROPS - CHILD FORMULA
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again
- Ask your pharmacist if you need more information or advice
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
- You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
What is in this leaflet:
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1. What the nasal drops are and what they are used for
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2. What you need to know before you use the nasal drops
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3. How to use the nasal drops
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4. Possible side effects
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5. How to store the nasal drops
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6. Contents of the pack and other information
1. What the nasal drops are and what they are 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.
You must talk to a doctor if you do not feel better or if you feel worse after 5 days.
2. what you need to know before you use the nasal drops is less than 6 years of age
- is allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (see section 6)
- 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
Warnings and precautions
Talk to your doctor or pharmacist before using the nasal drops if your child:
- has experienced a strong reaction (for example difficulty in sleeping or dizziness) with similar medicines
- is receiving other medication or is under the care of a doctor
Other medicines and the nasal drops
Tell your doctor or pharmacist if your child is taking or using, has recently taken or used or might take or use any other medicines, including medicines without a prescription.
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)
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 themselves.
Xylometazoline Decongestant Nasal Drops Children’s Formula contains benzalkonium chloride and sodium
This medicine contains 1.5mg benzalkonium chloride in each 10ml which is equivalent to 1.5mg/10ml. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.
3. how to use the nasal drops
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
These nasal drops, like any other nasal decongestants, should not be used for more than five consecutive days, otherwise it may worsen your child’s condition because of a rebound action. If symptoms persist, consult your doctor.
For children aged 6-12 years of age:
One or two drops of solution in each nostril once or twice daily
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1. Practice using the dropper to develop good dosage control
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2. Clear or wipe the child’s nose
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3. Shake the bottle gently and remove the cap
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4. 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
- Keep away from the eyes
- To avoid the possible spread of infection, these drops should be used by one child only
Not recommended for use in children under 6 years of age.
To avoid the possible spread of infection, these drops should be used by one person only.
If you use more nasal drops than you should
Consult your doctor if you think that you have used too much solution or have taken it accidentally by mouth.
If you forget to use the nasal drops
If you forget to use the nasal drops, use as soon as you remember. If it is almost time for your next dose, wait until that is due and then continue as normal. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on this use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following reactions on your child you 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:
- hallucinations
- paranoid delusions
- irritability
- anxiety
- restlessness
- excitability
- 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
- headache
- problems with vision (temporary)
- rash
- 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 a doctor.
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:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store the nasal drops
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.
Store below 30°C.
For reasons of hygiene do not use the drops for more than 28 days after first opening the bottle
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 environment.
6. contents of the pack and other informationthe nasal drops contain xylometazoline hydrochloride 0.05%w/v as the active ingredient. it also contains benzalkonium chloride, disodium edetate, sodium phosphate dihydrate, sodium acid phosphate, sodium chloride and water.
What the nasal drops look like and contents of the pack
The nasal drops are a clear and colourless solution. They are available in dropper bottles of 10ml.
MA Holder:
Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, UK.
Manufacturer:
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 advice).
Cough:
- 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.
Breathing:
- Plain saline drops and sprays can help unblock the nose.
Other formats
To request a copy of this leaflet in Braille, large print or audio please call 01926 482511.
This leaflet was last revised in September 2019