ZERINODEK 0.1% Spray do nosa, roztwór

Treść ulotki

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

ZerinoDek Decongestionante Nasale 1 mg/g nasal gel

xilometazolina cloridrato

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 to do.

• 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 4 days.

Contents of this leaflet:

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

1. What is ZerinoDek Nasal Decongestant and what is it used for

ZerinoDek Nasal Decongestant contains xylometazoline which has decongestant properties and is indicated
for the treatment of rhinitis, colds and sinusitis.
See your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using ZerinoDek Nasal Decongestant

Do not use ZerinoDek Nasal Decongestant

• 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 severe heart diseases (e.g. long QT syndrome) and severe hypertension (high blood pressure);
• if you have glaucoma and in particular closed-angle glaucoma (a disease characterized by an increase in pressure in the eye);
• if you suffer from prostatic hypertrophy (enlarged prostate) and hyperthyroidism (increased thyroid activity);
• if you have undergone brain surgery via the nasal route;
• during and for the two weeks following therapy with medicines used to treat depression (antidepressants) (see “Other medicines and ZerinoDek Nasal Decongestant”);
• if the child to be treated is less than 12 years old.

Warnings and precautions
Consult your doctor or pharmacist before using ZerinoDek Nasal Decongestant.
Use this medicine only after consulting your doctor:

• if you suffer from hypertension (high blood pressure);
• if you suffer from diabetes;
• if you have heart problems;
• if you have a tumor of the adrenal glands, called pheochromocytoma;
• if you are elderly, due to the risk of urinary retention (difficulty urinating). The use, especially if prolonged, of products applied to the mucous membranes (for local use) can give rise to allergic reactions (sensitization) and produce undesirable effects; in this case, discontinue treatment and consult your doctor. Do not use for prolonged treatments because there could be a worsening of nasal congestion. Repeated use of the medicine for long periods may be harmful. Prolonged use may alter the normal function of the nasal mucosa and nasal cavities (paranasal sinuses), also inducing tolerance (reduction in efficacy) to the medicine.

Other medicines and ZerinoDek Nasal Decongestant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not use ZerinoDek Nasal Decongestant at the same time or within two weeks
of taking medicines against depression (tricyclic antidepressants or MAO inhibitors) (see
" Do not use ZerinoDek Nasal Decongestant").

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
ZerinoDek Nasal Decongestant should not be used during pregnancy and breastfeeding with
breast milk, unless your doctor considers it necessary.

Driving and using machines
The effects on the ability to drive and operate machines are unknown.

ZerinoDek Nasal Decongestant contains propyl para-hydroxybenzoate
This medicine contains propyl para-hydroxybenzoate. It may cause allergic reactions (including
delayed reactions).

For those who play sports: the product contains substances prohibited for doping and may determine positivity

to doping tests.

3. How to use ZerinoDek Decongestionante Nasale

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
1 application per nostril, 2-3 times a day.

Use in children over 12 years
1 application 1-2 times a day.

Use in the elderly
Consult your doctor.

Method of use:apply the gel in an amount equal to a grain of rice inside the nostril.

Warning:do not exceed the indicated doses without medical advice .
Do not use for more than 4 days.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change in its characteristics.

If you use more ZerinoDek Decongestionante Nasale than you should
In case of overdose, especially in children, an increase in blood pressure (hypertension), an increase in the number of heartbeats (tachycardia), alterations in heart rhythm (arrhythmias), perception of heartbeat (palpitations), excessive sensitivity to light (photophobia), nausea, dizziness, headache (cephalalgia), insomnia, anxiety, chest tightness, marked sedation which may be associated with a reduction in body temperature (hypothermia), reduction in the number of heartbeats (bradycardia), sweating and dizziness may occur, and which can lead to coma requiring the adoption of adequate emergency measures (immediately consult a doctor or the nearest hospital).
In case of accidental ingestion/intake of an excessive dose of ZerinoDek Decongestionante Nasale, immediately inform your doctor or go to the nearest hospital.
If you have any doubts 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.
The side effects associated with ZerinoDek Decongestionante Nasale are listed below:
Uncommon frequency (may affect up to 1 in 100 people):
Nosebleed (epistaxis)
Frequency not known (the frequency cannot be estimated from the available data):
allergic reactions (hypersensitivity),
headache (cephalalgia),
difficulty sleeping (insomnia),
high blood pressure (hypertension),
fast heartbeat (tachycardia),
awareness of heartbeat (palpitations),
slow heartbeat (bradycardia),
nasal discomfort,
nasal congestion,
nausea,
difficulty urinating (micturition disorder).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 ZerinoDek Decongestionante Nasale

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
Store at a temperature below 30°C.
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 ZerinoDek Nasal Decongestant contains

• The active ingredient is xylometazoline hydrochloride. 100 g of gel contain 100 mg of xylometazoline hydrochloride.
• The other ingredients are: carbomers, sodium hydroxide, propyl parahydroxybenzoate, eucalyptus oil, Neroli essence, purified water.

Description of the appearance of ZerinoDek Nasal Decongestant and contents of the pack
ZerinoDek Nasal Decongestant is presented in the form of a nasal gel.
The pack contains a tube of 15 g.

Marketing Authorisation Holder
Zentiva Italia S.r.l. Via P. Paleocapa, 7 – 20121 Milano

Manufacturer
Montefarmaco S.p.A. - IT - 20016 Pero MI (Italy)

ZerinoDek Decongestionante Nasale 1 mg/ml nasal spray, solution

xilometazoline hydrochloride

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 to.

• 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 4 days.

Contents of this leaflet:

• 7. What ZerinoDek Decongestionante Nasale is and what it is used for
• 8. What you need to know before using ZerinoDek Decongestionante Nasale
• 9. How to use ZerinoDek Decongestionante Nasale
• 10. Possible side effects
• 11. How to store ZerinoDek Decongestionante Nasale
• 12. Contents of the pack and other information

1. What is ZerinoDek Nasal Decongestant and what is it used for

ZerinoDek Nasal Decongestant contains xylometazoline which has decongestant properties and is indicated
for the treatment of rhinitis, colds and sinusitis.
See your doctor if you do not feel better or if you feel worse after 4 days of treatment.

2. What you need to know before using ZerinoDek Nasal Decongestant

Do not use ZerinoDek Nasal Decongestant

• 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 severe heart diseases (e.g. long QT syndrome) and severe hypertension (high blood pressure);
• if you have glaucoma and in particular closed-angle glaucoma (a disease characterized by an increase in pressure in the eye);
• if you suffer from prostatic hypertrophy (enlarged prostate) and hyperthyroidism (increased thyroid activity);
• if you have undergone brain surgery via the nasal route;
• during and for the two weeks following therapy with medicines against depression (antidepressants) (see “Other medicines and ZerinoDek Nasal Decongestant”);
• if the child to be treated is less than 12 years old.

Warnings and precautions
Consult your doctor or pharmacist before using ZerinoDek Nasal Decongestant.
Use this medicine only after consulting your doctor:

• if you suffer from hypertension (high blood pressure) even if not severe;
• if you suffer from diabetes;
• if you have heart problems;
• if you have a tumor of the adrenal glands, called pheochromocytoma;
• if you are elderly, due to the risk of urinary retention (difficulty urinating). The use, especially if prolonged, of products applied to the mucous membranes (for local use) can give rise to allergic reactions (sensitization) and produce undesirable effects; in this case, discontinue treatment and consult your doctor. Do not use for prolonged treatments because there could be a worsening of nasal congestion. Repeated use of the medicine for long periods can be harmful. Prolonged use can alter the normal function of the nasal mucosa and nasal cavities (paranasal sinuses), also inducing tolerance (reduction in efficacy) to the medicine. Benzalconium chloride (BAC) contained as a preservative in this medicine is irritating and can cause local skin reactions; especially when used for long periods, it can cause swelling of the nasal mucosa. If you suspect such a reaction (persistent nasal congestion), you should consult your doctor to choose another medicine (see “ZerinoDek Nasal Decongestant contains benzalkonium chloride”).

Other medicines and ZerinoDek Nasal Decongestant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the
following medicines:

• epinephrine (adrenaline). Do not use ZerinoDek Nasal Decongestant at the same time or within two weeks of taking medicines against depression (tricyclic antidepressants or MAO inhibitors) (see “Do not use ZerinoDek Nasal Decongestant”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
ZerinoDek Nasal Decongestant should not be used during pregnancy and breastfeeding with
breast milk, unless your doctor considers it necessary.

Driving and operating machinery
No effects on the ability to drive and operate machinery are known.

ZerinoDek Nasal Decongestant contains benzalkonium chloride
This medicine contains benzalkonium chloride (BAC) which can cause swelling of the
nasal mucosa, especially when used for long periods. If you suspect such a reaction (persistent nasal
congestion), you should consult your doctor to choose another medicine (see “Warnings and
precautions”).

For those who engage in sports: the product contains substances prohibited for doping and can result in positive

anti-doping tests.

3. How to use ZerinoDek Decongestionante Nasale

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 1-2 sprays per nostril, two to three times a day.

Use in children over 12 years
The recommended dose is 1 spray per nostril, 1-2 times a day.

Use in the elderly
Consult your doctor.

Method of use:to spray the preparation, press the spray valve while holding the package between your index, middle and thumb.
When using the package for the first time, press 2 or 3 times into the air (not into the nostrils) to obtain a
regular spray.

Warning:do not exceed the indicated doses without medical advice .
Do not use for more than 4 days.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent change
in its characteristics.

If you use more ZerinoDek Decongestionante Nasale than you should
In case of overdose, especially in children, an increase in blood pressure (hypertension), an increase in heart rate (tachycardia), changes in heart rhythm (arrhythmias), perception of heartbeat (palpitations), excessive sensitivity to light (photophobia),
nausea, dizziness, headache, insomnia, anxiety, chest tightness, marked sedation which may
be associated with a reduction in body temperature (hypothermia), reduction in heart rate (bradycardia), sweating and dizziness and which can lead to coma requiring the adoption of adequate
emergency measures (immediately consult a doctor or the nearest hospital).
In case of accidental ingestion/intake of an excessive dose of ZerinoDek Decongestionante
Nasale, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about 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.
The side effects associated with ZerinoDek Decongestionante Nasale are listed below:
Uncommon frequency (may affect up to 1 in 100 people):
Nosebleed (epistaxis).
Frequency not known (the frequency cannot be estimated from the available data):
allergic reactions (hypersensitivity),
headache (cephalalgia),
difficulty sleeping (insomnia),
high blood pressure (hypertension),
fast heartbeat (tachycardia),
awareness of heartbeats (palpitations),
slow heartbeat (bradycardia),
nasal discomfort,
nasal congestion,
nausea,
difficulty urinating (micturition disorder).

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 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 ZerinoDek Decongestionante Nasale

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
Store at a temperature below 25°C.
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 ZerinoDek Nasal Decongestant contains

• The active ingredient is xylometazoline hydrochloride. 100 ml of solution contains 100 mg of xylometazoline hydrochloride.
• The other ingredients are: eucalyptus oil, Neroli essence, monobasic potassium phosphate, dibasic sodium phosphate dihydrate, sodium chloride, disodium edetate, benzalkonium chloride, polysorbate 20, purified water.

Description of the appearance of ZerinoDek Nasal Decongestant and contents of the pack
Nasal spray
The pack contains a 10 g bottle with a spray valve.

Marketing Authorisation Holder
Zentiva Italia S.r.l. Via P. Paleocapa, 7 – 20121 Milano

Manufacturer
UNITHER LIQUID MANUFACTURING - F – 31770 Colomiers (France)