XYLOMETAZOLINA EG 1 MG/ML NASAL SPRAY SOLUTION 10 ML PE BOTTLE

Name
Xylometazoline EG 1 mg/ml nasal spray, solution


What it is and what it is used for
This medicine contains xylometazoline, a substance that helps to constrict the blood vessels in the nasal mucosa, reducing swelling due to various causes and making breathing easier.

Xylometazoline EG 1 mg/ml nasal spray is used for the short-term treatment of nasal congestion with a runny nose due to the common cold or sinusitis in children from 12 years of age and in adults.

Contact your doctor if you do not feel better or if you feel worse after 7 days.


What you need to know before taking the medicine
DO NOT use Xylometazoline EG
• if you are allergic to xylometazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a certain form of chronic cold (dry rhinitis);
• if you have recently had brain surgery through the nose and mouth (transsphenoidal hypophysectomy) or other surgery that exposes the outer covering (dura mater) of the brain.


Warnings and precautions
There are isolated reports of serious adverse reactions (especially respiratory arrest) occurring following the use of therapeutic doses. Overdosage should be absolutely avoided.
Talk to your doctor or pharmacist before using Xylometazoline EG if:
• have had a severe reaction to sympathomimetic agents (medicines such as adrenaline) in the past. In this case, the use of Xylometazoline EG may cause insomnia, dizziness, tremors, irregular heartbeat or increased blood pressure. If you are not sure, ask your doctor or pharmacist;
• are being treated with monoamine oxidase inhibitors (MAOIs) or other medicines that can potentially cause an increase in blood pressure (see section Other medicines and Xylometazoline EG);
• suffers from increased eye pressure, especially narrow-angle glaucoma;
• suffer from severe cardiovascular disease (e.g. coronary heart disease, long QT syndrome) and high blood pressure (hypertension);
• has a tumor of the adrenal gland (pheochromocytoma);
• have metabolic disorders such as an overactive thyroid (hyperthyroidism) and diabetes (diabetes mellitus);
• his prostate is enlarged;
• suffers from porphyria (a metabolic disorder).

Avoid direct contact with eyes.

In case of prolonged treatment with xylometazoline, the recurrence of mucosal swelling (swelling of the inner lining of the nose) may be observed upon discontinuation of therapy. To avoid this, the duration of treatment should be as short as possible .
If you think you have a bacterial infection, please contact your doctor as the infection needs to be treated appropriately. This medicine should not be used by more than one person at the same time to prevent the risk of spreading infections.

Children
Xylometazoline EG nasal spray 1 mg/ml should not be used in children under 12 years of age. More appropriate dosages are available for children under 12 years of age.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: May affect up to 1 in 10 people
• burning and dryness of the nasal mucosa, sneezing.

Uncommon: may affect up to 1 in 100 people
• hypersensitivity reactions (skin rashes, itching, swelling of the skin and mucous membranes);
• strong sensation of blocked nose (increased nasal congestion) as soon as the decongestant effect wears off, nosebleeds.

Rare: may affect up to 1 in 1,000 people
• obvious heartbeat, increased heart rate (tachycardia);
• nausea;
• increased blood pressure.

Very rare: may affect up to 1 in 10,000 people
• respiratory arrest (reported following the use of xylometazoline in young children and neonates);
• restlessness, insomnia, hallucinations (especially in children);
• headache, convulsions (especially in children);
• cardiac arrhythmias;
• tiredness (drowsiness/sleepiness, sedation; mostly in children).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.