Xylolin is 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 if you:

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

·    Are allergic to other decongestants

·    Have had recent neurosurgery.

Do not use this spray for children under 12 years old.

Take special care

Before using the spray, tell your doctor if you:

·    Have an overactive thyroid gland (hyperthyroidism)

·    Have glaucoma

·    Have diabetes mellitus

·    Have heart or circulatory disease

·    Are pregnant or breast-feeding.

·    Have hypertension

Do not take decongestants for more than 7 days in a row.

Using other medicines

Please tell your doctor or pharmacist before using Xylolin if you are taking or have recently taken any medicines (especially monoamine oxidase inhibitors or other antidepressants) including those obtained without a prescription.

Pregnancy or breast-feeding

If you are pregnant or breast-feeding, consult your doctor before using Xylolin.

Ask your doctor or pharmacist for advice before taking any medicine.

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

Dosage:

For Adults and Children over 12 years of age: 1 spray in each nostril        1 to 3 times daily.

Administration:

1.   Clear your nose.

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

3.   Lean forward slightly and insert the nozzle into a nostril.

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

5.   Repeat for the other nostril.

6.   Replace the protective cap after use.

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 one month after opening it.

Do not exceed the recommended dosage.

If you use more Xylolin than you should

If you use more Xylolin than you should, tconsult your doctor or pharmacist.

If you forget to use Xylolin 

·    If you forget to use a dose, take it as soon as you remember it.

·    Do not take 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 everybody gets them. Local discomfort may be felt after applying the spray if you have sensitive nasal passages.

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

·    Temporary and passing visual disturbances

·    Allergic reactions.

Cardiovascular effects, for example, palpitations may also occur especially if you have 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 Center (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 use Xylolin after the expiry date which is stated on the carton and on the inner label.

-   Store below 30°C. After opening use within one month.

-   Do not use 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.