Sandoz Xylometazoline 1mg/ml drops 10 Milliliters

Sandoz Xylometazoline 1mg/ml drops
RVG 55141 UAD

Xylometazoline HCl Sandoz® nasal drops 1.0 mg/ml, nasal drops, solution
This medicine provides fast and long-lasting relief from nasal congestion. It reduces swelling of the nasal mucosa and thus helps keep the nasal passages clear, allowing you/your child to breathe more easily. The effect of this medicine starts within 2 minutes and lasts up to 12 hours

Xylometazoline HCl Sandoz nasal drops 1.0 mg/ml is intended for adults and children from 12 years of age.
This medicine is not suitable for children under 12 years of age.

What is this medicine used for
You use Xylometazoline HCl Sandoz nasal drops when you or your child has a blocked nose.

Do not use if
• You are/your child is allergic to one of the substances in this medicine.
• You/your child has recently undergone nasal surgery; in that case, consult your doctor before using Xylometazoline HCl Sandoz nasal drops.
• Xylometazoline HCl Sandoz nasal drops 0.5 mg/ml may not be used by children under 2 years of age.
• Xylometazoline HCl Sandoz nasal drops 1.0 mg/ml may not be used by children under 12 years of age.

Extra cautious with
Warning:
#Do not use for more than 7 consecutive days, then do not use for one month. Prolonged use worsens the symptoms.
#Do not use in children under 2 years of age without consulting a doctor.
#Do not use in the elderly without consulting a doctor.
#Do not use without consulting a doctor if you also use medicines for depression.
#Do not use with high blood pressure, heart disease, overactive thyroid, enlarged prostate, diabetes and glaucoma (increased eyeball pressure) without consulting a doctor.
#Avoid repeated use during pregnancy.
#Avoid contact with the eyes.

Use during pregnancy and breastfeeding
During pregnancy: Not preferred, consult your doctor
During breastfeeding: Not preferred, consult your doctor

Other information
Consult your GP:
#People who have needed or have been using nasal spray with xylometazoline, oxymetazoline or tramazoline daily for a long time.
#Babies with a blocked nose where physiological saline solution and removing the mucus with a nasal aspirator have insufficient effect, especially if problems with drinking arise.
#People with symptoms on only one side of the nose.
#People who are distressed or short of breath.
#People whose symptoms have not decreased after two weeks.

Do not use in:
Narrow-angle glaucoma, high blood pressure, heart or thyroid conditions, diabetes. Sensitivity to adrenaline-like substances. Do not use together with medicines for depression.

Use in:
For the treatment of nasal conditions. It reduces the swelling of the nasal mucosa.

Active ingredients
One milliliter of solution contains 1.0 mg xylometazoline hydrochloride

Excipients
benzalkonium chloride and disodium edetate dihydrate
(preservatives), sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate,
sodium chloride and purified water.

Dosage
• may not be used in children under 12 years of age.
The recommended dosage is:
Adults and children from 12 years of age:
Two to four drops in each nostril, three times a day. There should be 8 to 10 hours between two administrations
No more than three administrations per nostril per day.

Maximum dosage
3x per 24 hours

Directions for use
1. Blow your nose.
2. Practice with the dropper before use so that you get good control over the dose.
3. Tilt your head back – no further than is comfortable – or, if you are lying in bed, let your head hang over the
edge.
4. Administer the drops without letting the dropper touch the nose. Keep your head tilted back for a moment longer so that the
drops can spread in the nose.
5. If the drops have not entered the nose, administer them again.
6. If a small amount of the drops has entered the nose, do not administer any more drops
further.
7. Repeat this procedure in the other nostril.
8. Clean the dropper and let it dry before putting it back in the bottle.
To prevent the spread of infection, the bottle may only be used by one person

Read the package leaflet before use
Read the package leaflet before use.
Pay attention to the maximum daily dose.

Responsible for placing on the market
Sandoz B.V., Veluwezoom 22, 1327 AH Almere