Xylolin is used for the application in the nose to give relief from: 

·   Nasal congestion (blocked nose, including colds)

·   Perennial and allergic rhinitis (recurring inflammation of the nasal mucous membranes, including hay fever)

·   Sinusitis.

Xylolin contains the active ingredient Xylometazoline Hydrochloride which helps to open up and clear the nasal passages by reducing the excessive nasal secretions and returning the swollen blood vessels to their normal size.

DO NOT use the spray in the following cases:

· The person who will take the medicine is under 6 years of age. This medicine should not be used for the treatment of cough and cold symptoms in children below 6 years.

·   If your child is allergic to xylometazoline hydrochloride or any of the other ingredients in the spray (see Section 6: “Further Information”)

·   If your child has an inflamed nasal passage

·   If your child is allergic to other decongestants

·   If your child has had recent neurosugery or nasal surgery

·   If your child has heart disease or hypertension

·   If your child has diabetes

·   If your child has hyperthyroidism (overactive thyroid gland)

·   If your child has closed angle glaucoma

·   If your child has phaeochromocytoma (a tumour of the nerves associated with the hormone glands)

·   If your child taking monoamine oxidase inhibitors (MAOIs) or has stopped taking them in the last 14 days

·   If your child Is taking beta blockers

Take special care

Before giving the spray tell your doctor if your child:

·   Has heart or circulatory disease

·   Is taking any other medicine or is under doctor's care

If your child experiences hallucinations, restlessness or sleep disturbances stop using Xylolin.

Do not to give your child Xylolin for more than 5 days in a row. Keep away from the eyes.

Other medicines and Xylolin

Do not give the spray if your child is using other decongestants. Please tell your doctor or pharmacist if your child is taking or has recently taken any medicines (especially antidepressants, moclobemide, medicines for high blood pressure or heart problems, appetite suppressants, oxytocin or ergot alkaloids) including those obtained without a prescription.

Important information about some of the ingredients of Xylolin:

Benzalkonium chloride:

(A preservative), it is an ingredient in Xylolin which might cause swelling of nasal mucosa, especially during long-term use.

Always give Xylolin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage:

·   For children aged 6-12 years: 1 to 2 spray in each nostril once or twice daily. Not more than 2 doses should be given in any 24 hours.

Do not use in children under 6 years of age.

Administration:

1.    Clear your child nose.

2.    Remove the protective cap. Before the first application, perform several pumping actions till an even spray emerges (see fig. 1).

1.    Let your child lean forward slightly and insert the nozzle into a nostril.

2.    Press firmly on the finger pad and let your child sniff at the same time, then withdraw the nozzle before releasing the pressure on the bottle (see fig. 2).

3.    Repeat for the other nostril.

4.    Replace the protective cap after use.

Parents or carers should seek medical attention if the child’s condition worsens.

To avoid possible spread of infection, this pack should only be used by one person.

For reasons of hygiene do not use this bottle for more than 28 days after     opening it.

Do not exceed the recommended dosage.

Do not give with any other cough and cold medicines.

If you give your child more Xylolin than you should

If you give your child more Xylolin than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to give Xylolin to your child

If you forget to give your child a dose, give it as soon as you remember it.

Do not give your child a double dose to make up for the forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Xylolin can cause side effects, although not everyone gets them. Your child may experience the following side effects with this medicine.

Local discomfort may be felt after applying the spray if your child has sensitive nasal passages.

If your child experiences hallucinations, restlessness or sleep disturbances stop giving Xylolin.

Occasionally the following side effects have been reported:

·   A burning sensation in the nose and throat

·   Local irritation

·   Nausea

·   Headache

·   Dryness of the nasal membranes

Palpitations, changes in heart rhythm or increased blood pressure may also occur especially if your child has heart problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222,

Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

-    Keep out of the reach and sight of children.

-    Do not give Xylolin after the expiry date which is stated on the carton and on the inner label.

-    Store below 30°C.

-    Do not give Xylolin if you notice any visible sign of deterioration.

-    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.