Xylometazolin Nasal Aerosol 10 ml

Intranasal administration

Read the leaflet before using the drug.

Dosage
Age Adults and children 10 years and older / Amount 1-2 doses / Frequency Maximum 3 times daily.
Storage: Store at ambient temperature
Packaging: box

Each aerosol dose (equivalent to 0.09 ml of solution) contains 0.09 mg xylometazoline hydrochloride. 1 ml of solution contains 1 mg xylometazoline hydrochloride, Excipients: citric acid monohydrate, sodium citrate, glycerol 85%, water for injection

Teva Pharmaceuticals Polska Sp. z o.o.

Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 street
00-113 Warsaw

Keep out of sight and reach of children.

Recommended: 10 years/years/years

Read the leaflet carefully before using this medication, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 7 days or if the patient feels worse, contact your doctor.

Table of contents of the leaflet:
1. what is Xylometazolin Teva and what is it used for?
2. important information before using Xylometazolin Teva
3. how to use Xylometazolin Teva
4 Possible side effects
5. how to store Xylometazolin Teva
6. package contents and other information

1 What is Xylometazolin Teva and for what purpose it is used.

If there is no improvement after 7 days of using the drug, or if you feel worse, you should contact your doctor.

Xylometazolin Teva contains an active substance called xylometazoline. It is a topical decongestant drug that reduces congestion of the mucous membrane and relieves the feeling of a "clogged" nose. The drug reduces the swelling of the nasal mucosa.

Xylometazolin Teva is used for the short-term treatment of symptoms of nasal obstruction caused by nasal mucositis or sinusitis.

Xylometazolin Teva 1 mg/mL is intended for adults and children 10 years of age
and older.

3 How to use the drug Xylometazolin Teva

Always use this drug according to the recommendations of your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Unless otherwise prescribed by your doctor, the typical dose for adults and children aged 10 years and older is 1-2 doses of Xylometazolin Teva aerosol 1 mg/mL into each nasal orifice, as needed, but up to a maximum of 3 times a day.

Directions for use
After removing the protective cap, place the tip of the applicator in the nasal opening and press the pump once. When administering the drug, breathe gently through the nose. After use, wipe the dispenser thoroughly with a clean tissue and reapply the protective cap.

Patients are advised to gently clean their nose before using the drug. The last daily dose is best administered before bedtime.

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

Notes:
Before the first administration and after a break in treatment lasting more than 15 days, press the pump several times until a fine mist is released. At the next application, the pump will be ready for immediate use.

Duration of treatment
Xylometazolin Teva should not be used for more than 7 days, unless otherwise instructed by your doctor.

Wait a few days before using the drug again.

In the case of chronic rhinitis, the drug can be used only under the supervision of a doctor, due to the danger of atrophy of the nasal mucosa (damage to the skin inside the nose).

If you feel that the effect of Xylometazolin Teva is too strong or too weak, consult your doctor or pharmacist.

Use of a larger dose of Xylometazolin Teva than recommended.
In case of significant overdose or inadvertent use, both in children and adults, seek immediate medical attention. It is necessary to undertake observation and hospital treatment.

The following side effects may occur:
- dilated or constricted pupils
- nausea and vomiting
- pallor, bruising of the skin and lips
- fever, sweating or decreased body temperature
- circulatory problems, such as an excessively slow, accelerated or irregular heartbeat, an increase or decrease in blood pressure
- respiratory arrest (apnea)
- sluggishness, drowsiness, coma
- anxiety, agitation, hallucinations and seizures.

Overdose, especially in children, can often lead to the following symptoms: convulsions and coma, slowed heart rate, respiratory arrest (apnea) and increased blood pressure, which may be followed by a drop in blood pressure.

Omission of Xylometazolin Teva medication.
Do not use a double dose to make up for a missed dose. Take the next dose according to the dosage schedule described in the leaflet.

If you have any further doubts about the use of this medicine, ask your doctor or pharmacist.

5 How to store the drug Xylometazolin Teva

Store the drug out of sight and reach of children.

Do not use this drug after the expiration date on the folding cardboard box and on the label on the bottle. The expiration date means the last day of the given month.

The medicinal product does not require special storage conditions.

After the first opening, the drug Xylometazolin Teva should be used within 1 year.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.

4 Possible side effects

Like any drug, this medication may cause side effects, although they will not occur in everyone.

Adverse effects have been rated according to the following frequencies:

Very common: may occur in more than 1 in 10 people
Frequent: may occur in no more than 1 in 10 people
Uncommon: may occur in no more than 1 in 100 people
Rare: may occur in not more than 1 in 1000 people
Very rare: may occur in not more than 1 in 10,000 persons
Unknown: frequency cannot be determined from available data

Frequently
- slight, transient symptoms of irritation, such as burning or dryness of the nasal mucosa (tissue inside the nose) and/or throat
- sneezing

Uncommon
- hypersensitivity reactions (skin rash, itching, swelling of the skin and mucous membranes)
- after cessation of action, a strong feeling of "congestion" of the nose
- Nose bleeding

Rarely
- accelerated heart rate
- increase in blood pressure
- palpitations
- nausea

Very rarely
- nervousness (impatience)
- difficulty falling asleep or sleeping (insomnia)
- drowsiness/sleepiness (mainly in children)
- headache
- dizziness
- hallucinations or seizures (mainly in children)
- irregular heart rate
- respiratory arrest (apnea) in infants and newborns

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.

6 Package contents and other information

What the drug Xylometazolin Teva contains
- The active substance of the drug is xylometazoline hydrochloride.
Each dose (corresponding to 0.09 ml of solution) contains 0.09 mg of xylometazoline hydrochloride.
- The other ingredients are: citric acid monohydrate, sodium citrate, glycerol 85%, water for injection.

What the drug Xylometazolin Teva looks like and what it contains in the package.

Xylometazolin Teva 1 mg/ml is a clear, nearly colorless solution available in a brown glass bottle containing 10 ml (no less than 90 doses) of solution with a spray pump, nasal applicator and protective lid in a cardboard box.

Not all package sizes are required to be on the market.

2 Important information before using Xylometazolin Teva.

When NOT to use Xylometazolin Teva drug
- if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of the drug (listed in section 6),
- if the patient has recently undergone neurosurgery (transsphenoidal removal of the pituitary gland or other surgery proceeding with exposure of the dura),
- if the patient suffers from dry rhinitis (a form of chronic rhinosinusitis causing dry inflammation of the nasal mucosa accompanied by scab formation),
- In children under 10 years of age.

Warnings and precautions
Discuss with your doctor or pharmacist before taking Xylometazolin Teva:
- if you are taking certain antidepressants called monoamine oxidase inhibitors (MAO inhibitors) or other medications that may increase blood pressure,
- if you have heart disease (such as long QT syndrome), coronary artery disease or hypertension,
- an adrenal tumor (pheochromocytoma),
- metabolic disorders such as hyperthyroidism or diabetes,
- prostatic proliferation,
- porphyria (a metabolic disorder that affects the skin and/or nervous system),
- elevated intraocular pressure, especially narrow-angle glaucoma. Direct contact with the eyes should be avoided.

Prolonged use of nasal spray containing xylometazoline (longer than 7 days) may lead to chronic swelling and eventually damage to the nasal mucosa (tissue inside the nose).

Children
Xylometazolin Teva 1 mg/ml is not intended for use in children under 10 years of age.

Xylometazolin Teva and other medications
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.

Concomitant use of Xylometazolin Teva with certain antidepressants (tranylcypromine-type MAO inhibitors or tricyclic antidepressants), as well as drugs that raise blood pressure, may lead to elevated blood pressure.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.

Since the safety of Xylometazolin Teva during pregnancy and breastfeeding has not been sufficiently documented, Xylometazolin Teva should be used only after consultation with a doctor and after careful consideration of the benefit/risk ratio. Overdose may interfere with fetal blood supply or reduce milk secretion, and therefore the recommended dose should not be exceeded during pregnancy and lactation.

Driving and operating machinery
The drug should not affect the ability to drive or operate machinery.

Xylometazolin Teva, 1 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum