Xylometazoline Eg

Package leaflet: Information for the user

XILOMETAZOLINE EG 1 mg/ml nasal spray, solution

Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after 7 days.

Contents of this leaflet

1. What XILOMETAZOLINE EG is and what it is used for
2. What you need to know before using XILOMETAZOLINE EG
3. How to use XILOMETAZOLINE EG
4. Possible side effects
5. How to store XILOMETAZOLINE EG
6. Contents of the pack and other information

1. What XILOMETAZOLINA EG is and what it is used for

This medicinal product contains xylometazoline, a substance that helps constrict the blood vessels of the nasal mucosa, thereby reducing swelling caused by various factors and facilitating breathing.
XILOMETAZOLINA EG 1 mg/ml nasal spray is used for the short-term treatment of nasal congestion with runny nose due to the common cold or sinusitis in children from 12 years of age and in adults.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before using XILOMETAZOLINA EG

DO NOT use XILOMETAZOLINA EG

• if you are allergic to xylometazoline hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a certain type of chronic cold (dry rhinitis);
• if you have recently undergone brain surgery via the nose and mouth (transsphenoidal hypophysectomy) or any other surgery that exposes the outer lining (dura mater) of the brain.

Warnings and precautions
There have been isolated reports of serious adverse reactions (especially respiratory arrest) occurring after the use of therapeutic doses. Overdosing must be absolutely avoided.
Talk to your doctor or pharmacist before using XILOMETAZOLINA EG if:

• you have previously experienced a marked reaction to sympathomimetic agents (medicines such as adrenaline). In this case, the use of XILOMETAZOLINA EG may cause insomnia, dizziness, tremors, irregular heartbeat, or increased blood pressure. If in doubt, consult your doctor or pharmacist;
• you are being treated with monoamine oxidase inhibitors (MAOIs) or other medicines that may potentially increase blood pressure (see section Other medicines and XILOMETAZOLINA EG);
• you have increased intraocular pressure, especially narrow-angle glaucoma;
• you suffer from severe cardiovascular disease (e.g. coronary heart disease, long QT syndrome) and high blood pressure (hypertension);
• you have a tumour of the adrenal gland (pheochromocytoma);
• you have metabolic disorders such as overactive thyroid (hyperthyroidism) or diabetes (diabetes mellitus);
• your prostate is enlarged;
• you suffer from porphyria (a metabolic disorder).

Avoid direct contact with the eyes.
With prolonged treatment with xylometazoline, upon discontinuation of therapy, recurrence of mucosal swelling (swelling of the inner lining of the nose) may occur. To avoid this, treatment duration should be as short as possible.
If you suspect a bacterial infection, consult your doctor, as the infection needs to be appropriately treated. This medicine must not be used by more than one person simultaneously to prevent the risk of spreading infections.

Children
XILOMETAZOLINA EG nasal spray 1 mg/ml must not be used in children under 12 years of age.
For children under 12 years of age, more appropriate dosage forms are available.

Other medicines and XILOMETAZOLINA EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of this medicine is not recommended with certain antidepressants, such as:

• tricyclic or tetracyclic antidepressants;
• MAO inhibitors (monoamine oxidase inhibitors) or if you have taken MAO inhibitors within the last two weeks.

Furthermore, the use of this medicine is not recommended:

• in combination with antihypertensive medicines (e.g. methyldopa) due to the potential hypertensive effects of xylometazoline;
• with other medicines that have potential hypertensive effects (e.g. doxapram, ergotamine, oxytocin), as their hypertensive effects may be potentiated.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
XILOMETAZOLINA EG must not be used during pregnancy unless prescribed by a doctor, and only after the doctor has carefully evaluated the risk/benefit ratio, as safe use of the product during pregnancy has not been sufficiently documented.

Breastfeeding
It is not known whether xylometazoline is excreted in breast milk. Risks to the infant cannot be excluded. Therefore, a decision should be made whether to discontinue breastfeeding or to discontinue/abstain from treatment with XILOMETAZOLINA EG, taking into account the benefits of breastfeeding for the child and the benefits of therapy for you.
Overdosing may reduce milk production; therefore, during breastfeeding, the recommended dose must not be exceeded.

Driving and using machines
When used correctly, this medicine does not affect the ability to drive or operate machinery. However, if you feel drowsy or dizzy during treatment with this medicine, do not drive or operate machinery.

3. How to use XILOMETAZOLINA EG

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended dose or duration of treatment.

Dosage
The recommended dose for children from 12 years of age and adults is 1 spray of XILOMETAZOLINA EG nasal spray into each nostril, up to three times a day.
The use of XILOMETAZOLINA EG 1 mg/ml is not recommended in children under 12 years of age.
A nasal spray containing 0.5 mg/ml of xylometazoline is available for children aged between 2 and 12 years.

Method of administration
XILOMETAZOLINA EG is intended for nasal use.
Before applying the nasal spray, gently blow your nose. It is advisable to apply the last dose of the day before going to bed.
After removing the protective cap, insert the nozzle into the nostril and press the pump once. Breathe gently through the nose during spraying. Repeat the procedure for the other nostril. After use, clean the nozzle carefully with clean tissue paper before replacing the cap.

Attention
Remove the plastic cap from the nozzle. When using the spray for the first time, prime the pump by pressing it at least five times without spraying into the nose, until a uniform spray is obtained. For subsequent uses, the spray will be ready for immediate use.
However, repeat this procedure if the spray has not been used for several days. Follow these instructions:

• 4–14 days of non-use: 1 priming spray;
• more than 14 days of non-use: 5 priming sprays.

For hygienic reasons and to avoid infections, each nasal spray container should be used by only one person.

Duration of treatment
XILOMETAZOLINA EG should not be used for more than 7 days unless otherwise prescribed by a doctor.
Wait several days before reusing this medicine.
The treatment duration should be as short as possible. After prolonged use, the nasal mucosa (the inner lining of the nose) may swell again. The recommended dose must not be exceeded.
Patients suffering from chronic cold should use this medicine only under medical supervision due to the risk of developing nasal mucosal atrophy.
Consult your doctor if you feel that the effect of XILOMETAZOLINA EG is too strong or too weak.

If you use more XILOMETAZOLINA EG than you should
Contact your doctor immediately in case of significant overdose or accidental ingestion, in both children and adults. The patient must be hospitalized and monitored.
The following effects may occur:

• dilated or constricted pupils;
• malaise (nausea) and vomiting;
• pallor, bluish skin and lips;
• fever, sweating, or even decreased body temperature;
• circulatory problems, such as abnormally slow, fast, or irregular heartbeat, increased or decreased blood pressure;
• cessation of breathing (apnea);
• fluid in the lungs (pulmonary edema);
• lethargy, drowsiness, and coma;
• anxiety, agitation, hallucinations, and seizures (convulsions).

In particular, in children, overdose may lead to seizures and coma, slowed heartbeat, cessation of breathing (apnea), increased blood pressure followed by a drop in pressure.

If you forget to use XILOMETAZOLINA EG
Do not use a double dose to make up for a missed dose. Continue with your regular dosing schedule.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. 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 nasal blockage (increased nasal congestion) as soon as the decongestant effect wears off, nosebleeds.

Rare: may affect up to 1 in 1,000 people

• Noticeable 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, seizures (especially in children);
• Cardiac arrhythmias;
• Tiredness (drowsiness/stupor, sedation; mostly in children).

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

5. How to store XILOMETAZOLINE EG

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and on the bottle after the word EXP. The expiry date refers to the last day of that month.
Period of validity after first opening the bottle:
Once the bottle has been opened, this medicine must be used within a maximum of 12 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What XILOMETAZOLINA EG contains

• The active substance is xylometazoline hydrochloride. 1 ml of nasal spray, solution contains 1 mg of xylometazoline hydrochloride. Each spray (corresponding to approximately 0.09 ml of solution) contains 0.09 mg of xylometazoline hydrochloride.
• The other components are purified sea water, monobasic potassium phosphate, purified water.

Description of the appearance of XILOMETAZOLINA EG and pack contents
Clear, colourless solution.
XILOMETAZOLINA EG 1 mg/ml nasal spray is available in 10 ml and 15 ml packs of nasal spray, solution in a polyethylene bottle with a polyethylene and polypropylene spray pump system.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan, Italy
Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9 AC Etten-Leur 4879 (The Netherlands)

This medicinal product is authorised in the European Economic Area countries under the
following names:
NL Xylomare 0.5 mg/ml nasal spray, solution
Xylomare 1 mg/ml nasal spray, solution
ES Snup 1 mg/ml solution for nasal spray
IT Xilometazolina EG
PL SNUP