Package Leaflet: Information for the User

Manx Healthcare Clear Nose Drops - Child Formula Xylometazoline Decongestant Nasal Drops 0.05%w/v Children’s Formula

Xylometazoline Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information.

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

1.    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 similar medicines

•    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 themselves.

3.    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

1.    Practice using the dropper to develop good dosage control

2.    Clear or wipe the child’s nose

3.    Shake the bottle gently and remove the cap

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

•    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

4.    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:

•    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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. 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 the bottle

•    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 environment.

6. FURTHER INFORMATION 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 10ml.

Marketing Authorisation Holder:

Manx Pharma 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 December 2014.