XILOMETAZOLINA 1 mg /Ml Nasal Spray, Solution

Зміст інструкції

1. XILOMETAZOLINA EG 1 mg/ml nasal spray, solution
   1. What is XILOMETAZOLINA EG and what it is used for
   2. What you need to know before using XILOMETAZOLINA EG
   3. How to use XILOMETAZOLINA EG
   4. Possible side effects
   5. How to store XILOMETAZOLINA EG
   6. Contents of the pack and other information

XILOMETAZOLINA EG 1 mg/ml nasal spray, solution

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
See a doctor if you do not feel better or if your symptoms worsen after 7
days.

Contents of this leaflet

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

1. What is XILOMETAZOLINA EG 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 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.
See a 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 form of chronic cold (dry rhinitis);
• if you have recently undergone 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 have been isolated reports of serious adverse reactions (especially respiratory arrest) occurring
following the use of therapeutic doses. Overdosage must be absolutely avoided.
Consult your doctor or pharmacist before using XILOMETAZOLINA EG if:

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

Avoid direct contact with the eyes.
In case of prolonged treatment with xylometazoline, upon discontinuation of therapy, a
return of mucosal swelling (swelling of the inner lining of the
nose) may be observed. To avoid this, the duration of treatment should be as short as possible.
If you believe you have a bacterial infection, consult 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 spread of infections.

Children
XILOMETAZOLINA 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.

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 in the last two weeks.

In addition, the use of this medicine is not recommended:

• in association with anti-hypertensive medicines (e.g. methyldopa) due to the potential hypertensive effects of xylometazoline;
• with other medicines with potential hypertensive effects (e.g. doxapram, ergotamine, oxytocin) as a potentiation of their respective hypertensive effects is possible.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
XILOMETAZOLINA EG should not be used by pregnant women unless
prescribed by a doctor and only after the doctor has carefully
evaluated the risk/benefit ratio, as the 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 infants cannot be excluded. It is therefore advisable to decide whether to continue/discontinue breastfeeding or
continue/discontinue therapy with XILOMETAZOLINA EG, taking into account the benefits
of breastfeeding for the child and the benefits of therapy for you.
An overdose may cause a reduction in milk production; therefore, during
breastfeeding, the recommended dose should not be exceeded.

Driving and operating machinery
If taken correctly, this medicine does not affect the ability to drive vehicles or
operate machinery. However, if you feel drowsy or dizzy during treatment with this
medicine, do not drive vehicles and do not operate machinery.

3. How to use XILOMETAZOLINA EG

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Do not exceed the recommended dosage and duration of therapy.

Dosage
The recommended dose in children 12 years of age and older and in adults is 1 spray of
XILOMETAZOLINA EG nasal spray in each nostril for a maximum of 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 recommended to apply the last
dose of each day before bedtime.
After removing the protective cap, insert the nozzle into the nostril and press the dispenser once. Breathe gently through your nose during vaporisation. Repeat the procedure
for the other nostril. After use, carefully clean the nozzle with a clean tissue before
replacing the cap.
Attention
Remove the plastic cap from the nozzle. When using the spray for the first time, press
the dispenser into the air for at least five times, until a uniform spray is emitted.
For subsequent applications, the dispenser will be ready for immediate use.
However, you should repeat the procedure if the spray has not been used for a few days. Follow
the following:

• 4-14 days of non-use: 1 spray into the air;
• more than 14 days of non-use: 5 sprays into the air.

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

Duration of treatment
XILOMETAZOLINA EG should not be used for more than 7 days unless your doctor tells you to.
Wait a few days before reusing this medicine.
The duration of therapy should be as short as possible. After long-term treatment, it is
possible that the nasal mucosa (the inner lining of the nose) may swell again. The recommended
dose should not be exceeded.
Those who suffer from chronic colds may use this medicine only under
medical supervision, due to the risk of developing atrophy of the nasal mucosa.
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 needs to be hospitalised and
monitored.
The following effects may occur:

• dilated or constricted pupils;
• feeling unwell (nausea) and vomiting;
• paleness, bluish discoloration of the skin and lips;
• fever, sweating or even a drop in body temperature;
• circulatory problems, such as a heartbeat that is too slow, too fast or irregular, increased or decreased blood pressure;
• cessation of breathing (apnea);
• fluid in the lungs (pulmonary edema);
• lethargy, drowsiness and coma;
• anxiety, excitement, hallucinations and seizures (convulsions).

Especially in children, overdose may be associated with seizures and coma,
slowing of the heartbeat, cessation of breathing (apnea) and an increase in
pressure, with a subsequent decrease in the same.

If you forget to use XILOMETAZOLINA EG
Do not use a double dose to make up for a missed dose, but continue as prescribed
in the dosage schedule.
If you have any further questions on the use of this medicine, ask 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 skin and mucous membranes);
• strong sensation of nasal obstruction (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 newborns);
• restlessness, insomnia, hallucinations (especially in children);
• headache, convulsions (especially in children);
• cardiac arrhythmias;
• fatigue (drowsiness/somnolence, sedation; mostly in children).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 XILOMETAZOLINA 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 which is stated on the packaging and the bottle
after the wording EXP. The expiry date refers to the last day of that month.

Shelf life after first opening of the bottle:
Once opened, this medicine must be used for a maximum of 12 months.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What XILOMETAZOLINA EG contains

• The active ingredient is xylometazoline hydrochloride. 1 ml of nasal spray, solution contains 1 mg of xylometazoline hydrochloride. Each spray (equivalent to approximately 0.09 ml of solution) contains 0.09 mg of xylometazoline hydrochloride.
• The other ingredients are purified seawater, monobasic potassium phosphate, purified water.

Description of the appearance of XILOMETAZOLINA EG and contents of the pack
Clear, colorless solution.
XILOMETAZOLINA EG 1 mg/ml nasal spray is available in pack sizes of 10 ml and 15 ml 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 Milano

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9 AC Etten-Leur 4879 (Netherlands)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
NL Xylomare 0.5 mg/ml neusspray, solution
Xylomare 1 mg/ml, neusspray solution
ES Snup 1 mg/ ml solution for nasal spray
IT Xilometazolina EG
PL SNUP