XYLOMETAZOLINE TEVA

Patient Information Leaflet

Xylometazolin Teva, 1 mg/ml, nasal spray, solution
Xylometazolini hydrochloridum
Please read carefully all the information in this leaflet before using this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if your symptoms worsen, consult your doctor.

Table of contents:

1. What Xylometazolin Teva is and what it is 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. Contents of the pack and other information

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

If there is no improvement after 7 days of treatment, or if you feel worse, consult your doctor.
Xylometazolin Teva contains an active substance called xylometazoline. It is a locally acting decongestant which reduces congestion of the nasal mucosa and relieves the feeling of a "blocked" nose. The medicine reduces swelling of the nasal mucosa.
Xylometazolin Teva is used for the short-term treatment of nasal congestion caused by rhinitis or acute sinusitis.
Xylometazolin Teva 1 mg/ml is intended for adults and children aged 10 years and older.

2. Important information before using Xylometazolin Teva

When NOT to use Xylometazolin Teva

• if the patient is allergic to xylometazoline hydrochloride or any of the other ingredients of the medicine (listed in section 6),
• if the patient has recently undergone neurosurgery (transsphenoidal removal of the pituitary gland or any other procedure involving exposure of the dura mater),
• if the patient suffers from atrophic rhinitis (a form of chronic inflammation of the nasal mucosa causing dryness of the nasal mucosa, associated with crust formation),
• in children under 10 years of age.

Warnings and precautions
Before starting treatment with Xylometazolin Teva, consult your doctor or
pharmacist:

• if the patient is taking certain antidepressants known as monoamine oxidase inhibitors (MAO inhibitors) or other medicines that may increase blood pressure,
• if the patient has heart disease (e.g. long QT syndrome), coronary artery disease or hypertension,
• pheochromocytoma (adrenal gland tumor),
• metabolic disorders such as hyperthyroidism or diabetes,
• benign prostatic hyperplasia,
• porphyria (a metabolic disorder affecting the skin and/or nervous system),
• increased intraocular pressure, especially narrow-angle glaucoma. Avoid direct contact with eyes.

Prolonged use of a nasal spray containing xylometazoline (longer than 7 days) may
lead to chronic swelling and, ultimately, 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 medicines
Tell your doctor or pharmacist about all medicines you are currently taking or
have recently taken, as well as any medicines you plan to take.
Concomitant use of Xylometazolin Teva with certain antidepressants
(MAO inhibitors such as tranylcypromine or tricyclic antidepressants),
as well as medicines that raise blood pressure, may lead to increased
arterial blood pressure.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
As the safety of using Xylometazolin Teva during pregnancy and breastfeeding has not been sufficiently documented, the medicine may be used
only after consultation with a doctor and careful consideration of the benefit-risk ratio.
Overdose may impair fetal blood supply or reduce milk production; therefore, during pregnancy and breastfeeding the recommended dose must not be exceeded.
Driving and operating machinery
This medicine is unlikely to affect the ability to drive or operate machinery.
3. How to use Xylometazolin Teva
This medicine should always be used according to the instructions given by the doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Unless otherwise prescribed by a doctor, the usual dose for adults and children aged 10 years and older
is 1-2 sprays of Xylometazolin Teva 1 mg/ml into each nostril, as needed, but maximum 3 times daily.
Method of administration

protective cap
After removing the protective cap, insert the
applicator tip into the nostril and
press the pump once. During administration,
breathe gently through the nose. After use,
wipe the nozzle thoroughly with a clean
tissue and replace the
protective cap.
Before using the medicine, patients are advised to gently clear the nose. The last daily dose
should preferably be taken before going to sleep.
For hygienic reasons and to avoid infection, each bottle of nasal spray should
be used by only one person.
Notes:
Before first use and after an interruption in treatment lasting more than 15 days, prime the pump several times until a fine mist is released. For subsequent use, the pump will be ready for immediate use.
Duration of treatment
Xylometazolin Teva must not be used for longer than 7 days, unless otherwise directed by a doctor.
Before reapplying the medicine, wait several days.
In cases of chronic rhinitis, the medicine should be used only under medical supervision due to the risk of atrophy of the nasal mucosa (damage to the skin inside the nose).
If the patient feels that the effect of Xylometazolin Teva is too strong or too weak,
consult a doctor or pharmacist.
Use of more than the recommended dose of Xylometazolin Teva
In case of significant overdose or accidental ingestion, both in children and adults, seek immediate medical advice. Observation and hospital treatment may be necessary.
The following adverse effects may occur:

• dilated or constricted pupils
• nausea and vomiting
• pallor, cyanosis of the skin and lips
• fever, sweating or decreased body temperature
• circulatory problems, e.g. too slow, rapid or irregular heartbeat, increased or decreased blood pressure
• respiratory arrest (apnea)
• lethargy, drowsiness, coma
• anxiety, agitation, hallucinations and seizures.

Overdose, especially in children, may frequently lead to the following
symptoms: seizures and coma, slowed heart rate, respiratory arrest (apnea), and
elevated blood pressure, followed by a drop in blood pressure.
Missed dose of Xylometazolin Teva
Do not use a double dose to make up for a missed dose. Take the next dose according to the dosing schedule described in the leaflet.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects have been classified according to the following frequency of occurrence:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data

Common

• mild, transient irritation symptoms 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)
intense sensation of nasal congestion after the effect wears off
nosebleeds

Rare

• increased heart rate
• elevated blood pressure
• palpitations
• nausea

Very rare

• nervousness (irritability)
• difficulty falling asleep or staying asleep (insomnia)
• drowsiness/sleepiness (mainly in children)
• headache
• dizziness
• hallucinations or seizures (mainly in children)
• arrhythmia
• respiratory arrest (apnea) in infants and newborns

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Xylometazolin Teva
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer cardboard box and on the label of the bottle. The expiry date refers to the last day of the specified month.
This medicinal product does not require any special storage conditions.
After first opening, Xylometazolin Teva should be used within 1 year.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Xylometazolin Teva contains

• The active substance is xylometazoline hydrochloride. Each dose (corresponding to 0.09 ml of solution) contains 0.09 mg of xylometazoline hydrochloride.
• Other ingredients are: citric acid monohydrate, sodium citrate, glycerol 85%, water for injections.

What Xylometazolin Teva looks like and contents of the pack
Xylometazolin Teva 1 mg/ml is a clear, almost colourless solution available in a brown glass bottle containing 10 ml (not less than 81 doses) of solution with a spray pump, nasal applicator and protective cap, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o, ul. Mogilska 80, 31-546 Kraków
Merckle GmbH, Ludwig-Merckle Strasse 3, DE-89143 Blaubeuren, Germany
Pharmachemie B.V., Svensweg 5, NL-2031 GA Haarlem, The Netherlands
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium Xyloteva 1.0 mg/ml Neusspray, solution
Bulgaria Xylometazolin Teva 1 mg/ml nasal spray, solution
Estonia Xylometazoline Teva 1.0 mg/ml
The Netherlands Xylometazoline HCl Teva 1.0 mg/ml, nasal spray, solution
Lithuania Xylometazoline Teva 1 mg/ml nasal spray, nasal spray
Latvia Xylometazoline TEVA 1 mg/ml nasal aerosol, solution
Germany Nasenspray Erwachsene AbZ 1.0 mg/ml Nasenspray Lösung
Poland Xylometazolin Teva
Slovakia Lyntol 1.0 mg/ml