Xylogel Nasal gel for children ROUTINE 0.05% 10 g

Producer:

WARSAW PHARMACY PLANT POLFA SA

Indications:

Xylogel with a concentration of 0.5% xylometazoline can be administered to children with allergic rhinitis as well as acute otitis media in order to unblock the Eustachian tube.

Xylogel for children is administered locally, into the nose in the supportive treatment of acute rhinitis of viral or bacterial origin and acute or chronic exacerbating sinusitis.

Composition:

Active substance :  xylometazoline hydrochloride .

1 g of gel contains 0.5 mg of xylometazoline hydrochloride.

Excipients: sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate, benzalkonium chloride solution, sorbitol, hydroxyethylcellulose, glycerol, purified water.

Dosage:

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• The dosage of Xylogel for children aged 3-12 years is 1 dose of gel in each nostril every 8 to 10 hours.

The medicinal product is always administered into the nose, including in otitis media. The medicine should not be used for longer than 3 to 5 days. After the first filling of the dispenser, the medicine should be used within 12 weeks. For hygienic reasons, the package should only be used by one patient. More details on how to use the dispenser can be found in the patient leaflet included in the medicine package.

Contraindications:

Do not use Xylogel for children in case of hypersensitivity to any of the ingredients of the product and in atrophic rhinitis. Do not use in children under 3 years of age. Do not use Xylogel for children during pregnancy. Breastfeeding patients should consult a doctor before using the drug.

Side effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon side effects (affects less than 1 in 100 people) include nosebleed. Very rare side effects (affects less than 1 in 10,000 people) include: headache, insomnia; nausea; weakness, tiredness; allergic reactions.

Warnings and precautions:

Special caution should be exercised when using Xylogel for children in patients who have experienced symptoms such as insomnia, dizziness, tremor, heart rhythm disturbances and high blood pressure after taking other similarly acting drugs (sympathomimetics). Caution should also be exercised in patients with circulatory system diseases (e.g. hypertension, angina pectoris), heart diseases (e.g. long QT syndrome), diabetes, closed-angle glaucoma, prostatic hyperplasia, hyperthyroidism. Patients with these diseases should consult a doctor before using the drug. The drug contains benzalkonium chloride, which may cause irritation or swelling inside the nose, especially if used for a long time. The shelf life of the product after first opening the bottle is 12 weeks. Store at a temperature below 25 degrees C. Protect from light. Store out of reach of children.

Use of other medications:

Tell your doctor about all the medicines you are taking, have recently taken or are planning to take.

Xylogel for children may interact with:

• tricyclic antidepressants (TCAs),
• MAO inhibitors,
• ephedrine, pseudoephedrine (drugs from the sympathomimetic group).

Responsible entity

WARSAW PHARMACY PLANT POLFA SA

Before use, read the leaflet, which contains indications, contraindications, data on adverse effects and dosage, and information on the use of the medicinal product, or consult a doctor or pharmacist, as any drug used improperly may threaten your life or health.