Zerinodek nasal decongestant
Italy
Table of Contents
Package leaflet: Information for the patient
ZerinoDek Nasal Decongestant 1 mg/g nasal gel
xylometazoline hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
- 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, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after 4 days.
Contents of this leaflet:
- What ZerinoDek Nasal Decongestant is and what it is used for
- What you need to know before using ZerinoDek Nasal Decongestant
- How to use ZerinoDek Nasal Decongestant
- Possible side effects
- How to store ZerinoDek Nasal Decongestant
- Package contents and other information
1. What ZerinoDek Nasal Decongestant is and what it is used for
ZerinoDek Nasal Decongestant contains xylometazoline, which has decongestant properties and is indicated for the treatment of rhinitis, colds, and sinusitis.
Consult 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) or severe hypertension (high blood pressure);
- if you have glaucoma, and particularly closed-angle glaucoma (a condition characterized by increased pressure within the eye);
- if you suffer from prostatic hypertrophy (enlarged prostate) or hyperthyroidism (overactive thyroid);
- if you have undergone brain surgery via the nasal route;
- during and within two weeks after treatment with medicines used to treat depression (antidepressants) (see "Other medicines and ZerinoDek Nasal Decongestant");
- if the child to be treated is under 12 years of age.
Warnings and precautions
Talk to 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 have diabetes;
- if you have heart problems;
- if you have a tumour of the adrenal glands called phaeochromocytoma;
- if you are elderly, due to the risk of urinary retention (difficulty in urinating).
The use, especially prolonged use, of products applied to mucous membranes (for local use) may lead to allergic reactions (sensitization) and cause unwanted effects; if this occurs, stop treatment and consult your doctor. Do not use for prolonged treatments, as this may worsen nasal congestion. Repeated use of the medicine over long periods may be harmful. Prolonged use may alter the normal function of the nasal mucosa and nasal cavities (paranasal sinuses), potentially leading to tachyphylaxis (reduced effectiveness) to the medicine.
Other medicines and ZerinoDek Nasal Decongestant
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
Do not use ZerinoDek Nasal Decongestant simultaneously or within two weeks after taking medicines for depression (tricyclic antidepressants or MAO inhibitors) (see "Do not use ZerinoDek Nasal Decongestant").
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
ZerinoDek Nasal Decongestant must not be used during pregnancy or breastfeeding unless your doctor considers it necessary.
Driving and using machines
The effects on the ability to drive vehicles and operate machinery are unknown.
ZerinoDek Nasal Decongestant contains propyl parahydroxybenzoate
This medicine contains propyl parahydroxybenzoate. It may cause allergic reactions (including delayed reactions).
For those engaged in sports: the product contains substances prohibited in doping and may result in positive
antidoping test results.
3. How to use ZerinoDek Nasal Decongestant
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.
The recommended dose is:
1 application per nostril, 2–3 times daily.
Use in children over 12 years of age
1 application 1–2 times daily.
Use in elderly patients
Consult your doctor.
Method of administration: apply a rice-grain-sized amount of gel inside the nostril.
Caution: never exceed the recommended doses without medical advice.
Do not use for more than 4 days.
Consult your doctor if symptoms recur or if you notice any recent changes in their characteristics.
If you use more ZerinoDek Nasal Decongestant than you should
In case of overdose, especially in children, symptoms such as increased blood pressure (hypertension), increased heart rate (tachycardia), heart rhythm disturbances (arrhythmias), awareness of heartbeat (palpitations), excessive sensitivity to light (photophobia), nausea, dizziness, headache (cephalalgia), insomnia, anxiety, chest tightness, marked sedation which may be associated with reduced body temperature (hypothermia), decreased heart rate (bradycardia), sweating and dizziness may occur, potentially leading to coma requiring immediate emergency measures (seek immediate medical attention or go to the nearest hospital).
In case of accidental ingestion or overdose of ZerinoDek Nasal Decongestant, contact your doctor immediately or go to the nearest hospital.
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.
The side effects associated with ZerinoDek Nasal Decongestant are listed below:
Uncommon frequency (may affect up to 1 in 100 people):
Nosebleed (epistaxis)
Frequency not known (frequency cannot be estimated from the available data):
allergic reactions (hypersensitivity),
headache (cephalae),
difficulty sleeping (insomnia),
high blood pressure (hypertension),
increased heart rate (tachycardia),
awareness of heartbeat (palpitations),
reduced heart rate (bradycardia),
nasal discomfort,
nasal congestion,
nausea,
difficulty urinating (urinary disorder).
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 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 Nasal Decongestant
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What ZerinoDek Nasal Decongestant contains
- The active substance is xylometazoline hydrochloride. 100 g of gel contain 100 mg of xylometazoline hydrochloride.
- The other components are: carbomers, sodium hydroxide, propyl parahydroxybenzoate, eucalyptol, neroli essential oil, purified water.
Description of the appearance of ZerinoDek Nasal Decongestant and contents of the pack
ZerinoDek Nasal Decongestant is available as a nasal gel.
Pack contents: one 15 g tube.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa, 7 – 20121 Milan, Italy
Manufacturer
Montefarmaco S.p.A. - IT - 20016 Pero MI (Italy)
Patient Information Leaflet
ZerinoDek Nasal Decongestant 1 mg/ml nasal spray, solution
xylometazoline hydrochloride
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 any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after 4 days.
Contents of this leaflet:
- What ZerinoDek Nasal Decongestant is and what it is used for
- What you need to know before using ZerinoDek Nasal Decongestant
- How to use ZerinoDek Nasal Decongestant
- Possible side effects
- How to store ZerinoDek Nasal Decongestant
- Contents of the pack and other information
1. What ZerinoDek Nasal Decongestant is and what it is used for
ZerinoDek Nasal Decongestant contains xylometazoline, which has decongestant properties, and is indicated for the treatment of rhinitis, colds, and sinusitis.
Consult your doctor if you do not feel better or if you feel worse after 4 days of treatment.
2. What you should 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) or severe hypertension (high blood pressure);
- if you have glaucoma, and in particular closed-angle glaucoma (a condition characterized by increased pressure in the eye);
- if you have prostate enlargement (prostatic hypertrophy) or hyperthyroidism (overactive thyroid);
- if you have undergone brain surgery via the nasal route;
- during and within two weeks after treatment with antidepressant medicines (see "Other medicines and ZerinoDek Nasal Decongestant");
- if the child to be treated is under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using ZerinoDek Nasal Decongestant.
Use this medicine only after consulting your doctor:
- if you have hypertension (high blood pressure), even if not severe;
- if you have diabetes;
- if you have heart problems;
- if you have a tumour of the adrenal glands called phaeochromocytoma;
- if you are elderly, due to the risk of urinary retention (difficulty urinating).
Use, especially prolonged use, of products applied to mucous membranes (for local use) may lead to allergic reactions (sensitization) and cause unwanted effects; in such a case, stop treatment and consult your doctor. Do not use for prolonged treatments, as this may worsen nasal congestion. Repeated use of the medicine over long periods may be harmful. Prolonged use may alter the normal function of the nasal mucosa and nasal cavities (paranasal sinuses), possibly leading to drug dependence (reduced effectiveness). The benzalkonium chloride (BAC) contained as a preservative in this medicine is irritating and may cause local skin reactions; especially when used for long periods, it may cause swelling of the nasal mucosa. If you suspect such a reaction (persistent nasal congestion), you should consult your doctor to consider switching to another medicine (see "ZerinoDek Nasal Decongestant contains benzalkonium chloride").
Other medicines and ZerinoDek Nasal Decongestant
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any of the following medicines:
- epinephrine (adrenaline). Do not use ZerinoDek Nasal Decongestant at the same time as, or within two weeks after taking antidepressant medicines (tricyclic antidepressants or MAO inhibitors) (see "Do not use ZerinoDek Nasal Decongestant").
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
ZerinoDek Nasal Decongestant should not be used during pregnancy and breastfeeding unless your doctor considers it necessary.
Driving and using machines
The effects on the ability to drive vehicles and use machinery are unknown.
ZerinoDek Nasal Decongestant contains benzalkonium chloride
This medicine contains benzalkonium chloride (BAC), which may 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 consider switching to another medicine (see "Warnings and precautions").
For those engaged in sports: the product contains substances prohibited in doping and may lead to positive results in anti-doping tests.
3. How to use ZerinoDek Nasal Decongestant
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.
The recommended dose is 1-2 sprays per nostril, two to three times a day.
Use in children over 12 years of age
The recommended dose is 1 spray per nostril, 1-2 times a day.
Use in elderly patients
Consult your doctor.
Instructions for use: to spray the preparation, press the spray valve, holding the container between your index finger, middle finger, and thumb.
When using the spray for the first time, press the pump 2 or 3 times without inhaling (not into the nose) to ensure a regular spray.
Caution: never exceed the recommended doses without medical advice.
Do not use for more than 4 days.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.
If you use more ZerinoDek Nasal Decongestant than you should
In case of overdose, especially in children, symptoms may include increased blood pressure (hypertension), increased heart rate (tachycardia), disturbances in heart rhythm (arrhythmias), awareness of heartbeat (palpitations), excessive sensitivity to light (photophobia), nausea, dizziness, headache (cephalalgia), insomnia, anxiety, chest tightness, marked sedation which may be associated with reduced body temperature (hypothermia), decreased heart rate (bradycardia), sweating and dizziness, potentially leading to coma requiring immediate emergency measures (seek medical help immediately or go to the nearest hospital).
In case of accidental ingestion or overdose of ZerinoDek Nasal Decongestant, contact your doctor immediately or go to the nearest hospital.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects associated with ZerinoDek Nasal Decongestant are listed below:
Uncommon frequency (may affect up to 1 in 100 people):
Nosebleed (epistaxis).
Frequency not known (frequency cannot be estimated from the available data):
allergic reactions (hypersensitivity),
headache (cephalaea),
difficulty sleeping (insomnia),
high blood pressure (hypertension),
increased heart rate (tachycardia),
awareness of heartbeat (palpitations),
reduced heart rate (bradycardia),
nasal discomfort,
nasal congestion,
nausea,
difficulty urinating (urinary disorder).
Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via 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 Nasal Decongestant
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What ZerinoDek Nasal Decongestant contains
- The active substance is xylometazoline hydrochloride. 100 ml of solution contain 100 mg of xylometazoline hydrochloride.
- The other components are: eucalyptol, Neroli essential oil, monopotassium phosphate, disodium 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 spray pump.
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa, 7 – 20121 Milano, Italy
Manufacturer
UNITHER LIQUID MANUFACTURING - F – 31770 Colomiers (France)