Xylometazoline + dexpanthenol teva

Package leaflet: Information for the user

Xylometazoline + Dexpanthenol Teva, (1 mg + 50 mg)/mL,
nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
For use in adults and children over 6 years of age.
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet, or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Xylometazoline + Dexpanthenol Teva is and what it is used for
2. Important information before using Xylometazoline + Dexpanthenol Teva
3. How to use Xylometazoline + Dexpanthenol Teva
4. Possible side effects
5. How to store Xylometazoline + Dexpanthenol Teva
6. Contents of the pack and other information

1. What Xylometazoline + Dexpanthenol Teva is and what it is used for

Xylometazoline + Dexpanthenol Teva contains two active substances: xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts blood vessels, thereby reducing swelling of the nasal mucosa. The active ingredient dexpanthenol is a derivative of pantothenic acid, a vitamin that supports wound healing and provides protective action on mucous membranes.
Xylometazoline + Dexpanthenol Teva is used to reduce swelling of the nasal mucosa in nasal catarrh and as supportive treatment in healing of skin and mucosal lesions, as well as in the treatment of episodic nasal discharge (vasomotor rhinitis) and in the treatment of impaired nasal breathing following nasal surgery.
Xylometazoline + Dexpanthenol Teva is indicated for use in adults and children over 6 years of age.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using Xylometazoline + Dexpanthenol Teva

When not to use Xylometazoline + Dexpanthenol Teva:

• if the patient is allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has dry rhinitis (a chronic form of rhinitis causing dry inflammation of the nasal mucosa with formation of crusts),
• if the patient has recently undergone neurosurgery (transsphenoidal resection of the pituitary gland or any other surgical procedure exposing the dura mater of the brain),
• in children aged 6 years and younger.

Warnings and precautions
Before starting treatment with Xylometazoline + Dexpanthenol Teva, consult a doctor or pharmacist if:

• the patient is taking certain antidepressant medicines known as monoamine oxidase inhibitors (MAO inhibitors) or other medicines that may increase blood pressure (e.g. doxapram, ergotamine, oxytocin),
• the patient is taking medicines for lowering blood pressure (e.g. methyldopa),
• the patient has increased intraocular pressure, especially if suffering from narrow-angle glaucoma,
• the patient has severe cardiovascular disorders (e.g. long QT syndrome) or high blood pressure (hypertension),
• the patient has a phaeochromocytoma (a tumour of the adrenal gland),
• the patient has metabolic disorders such as hyperthyroidism or diabetes,
• the patient has a metabolic disorder called porphyria (a metabolic disorder affecting the skin and/or nervous system),
• the patient has prostate enlargement (prostatic hyperplasia).

Use of this medicine in chronic rhinitis should be under medical supervision due to possible damage to the nasal mucosa (tissue inside the nose).
Children
Do not use in children aged 6 years and younger. For children aged 2 to 6 years, a suitable nasal spray with a lower concentration of xylometazoline hydrochloride (a mucosa-constricting substance) is available.
Prolonged use or use in doses higher than recommended should be avoided, especially in children. Higher doses should only be administered after consultation with a doctor.
Xylometazoline + Dexpanthenol Teva and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines planned for future use.
Concurrent use of Xylometazoline + Dexpanthenol Teva with certain medicines, such as mood-enhancing medicines (e.g. tranylcypromine-type MAO inhibitors or tricyclic antidepressants), as well as with medicines that may potentially increase blood pressure (e.g. doxapram, ergotamine, oxytocin), may lead to elevated arterial blood pressure due to effects on the cardiovascular system.
Do not use this medicine simultaneously with medicines that lower blood pressure (e.g. methyldopa), due to the possible vasoconstrictive effect of xylometazoline (which may increase 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.
Due to lack of safety data, this medicine should not be used in pregnant women.
It is unknown whether xylometazoline hydrochloride passes into breast milk; therefore, Xylometazoline + Dexpanthenol Teva should not be used during breastfeeding.
Driving and operating machinery
If Xylometazoline + Dexpanthenol Teva is used as directed, no negative effect on the ability to drive or operate machinery is expected.

3. How to use Xylometazoline + Dexpanthenol Teva

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
If a doctor has not prescribed otherwise, the recommended dose for adults and children over 6 years of age is one spray of Xylometazoline + Dexpanthenol Teva into each nostril, as needed, but
not more than three times daily. The dosage depends on individual sensitivity and the patient's response to the medicine.

Route of administration The medicine is intended for nasal use. After removing the protective cap, insert the spray nozzle (applicator) into the nostril and press the pump once. While spraying, breathe gently through the nose. After each use, carefully wipe the spray tip with a clean tissue and replace the protective cap.

Warning
Before first use, or if the spray has not been used for more than 7 days, press the pump several times until a uniform spray appears. For subsequent applications, the metered nasal spray is ready for immediate use.
Before using the nasal spray, gently blow the nose. It is recommended to take the last dose each day before going to bed.
For hygienic reasons and to avoid infection, each bottle with the applicator should be used by only one person.

Duration of treatment
Do not use Xylometazoline + Dexpanthenol Teva for longer than 7 days unless your doctor has explicitly advised continued use.
Re-treatment should only be resumed after a break of several days.
When used in children, always consult a doctor regarding the duration of treatment.
Continuous use of Xylometazoline + Dexpanthenol Teva may lead to chronic swelling and ultimately may cause atrophy of the nasal mucosa.
Patients with increased intraocular pressure (glaucoma, particularly narrow-angle glaucoma) should consult a doctor before using this medicine.
If the effect of Xylometazoline + Dexpanthenol Teva is too strong or too weak, consult a doctor or pharmacist.

Use of a higher than recommended dose of Xylometazoline + Dexpanthenol Teva
If a higher than recommended dose of Xylometazoline + Dexpanthenol Teva is used, or if the product is accidentally swallowed orally, the following symptoms may occur: constriction of the eye pupils (miosis), dilatation of the pupils, fever, sweating, pallor, bluish discoloration of the lips (cyanosis), nausea, convulsions, cardiovascular disorders such as heart rhythm disturbances (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (arterial hypertension); pulmonary complications (pulmonary edema, respiratory disturbances), and psychiatric disturbances. Additionally, drowsiness, decreased body temperature, slowed heart rate, shock-like drop in arterial blood pressure, respiratory arrest, and loss of consciousness (coma) may occur.
If an overdose is suspected, contact a doctor immediately. If necessary, the doctor will initiate appropriate treatment.

Missed dose of Xylometazoline + Dexpanthenol Teva
Do not use a double dose to make up for a missed dose. Continue treatment according to the instructions provided.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is defined according to the following convention:
Very common: may occur in more than 1 in 10 patients,
Common: may occur in up to 1 in 10 patients,
Uncommon: may occur in up to 1 in 100 patients,
Rare: may occur in up to 1 in 1,000 patients,
Very rare: may occur in up to 1 in 10,000 patients,
Frequency not known: frequency cannot be estimated from the available data.

Immune system disorders:
Uncommon: allergic reactions (hypersensitivity) - skin and mucosal swelling, skin rash, itching

Psychiatric disorders:
Very rare: restlessness, insomnia, hallucinations (especially in children)

Nervous system disorders:
Very rare: fatigue (drowsiness, sedation), headache, convulsions (especially in children)

Cardiac disorders:
Rare: palpitations, increased heart rate (tachycardia)
Very rare: heart rhythm disorders (arrhythmia)

Vascular disorders:
Rare: increased blood pressure (hypertension)

Respiratory, thoracic and mediastinal disorders:
Very rare: increased nasal mucosal swelling after the medicine wears off, nosebleeds
Frequency not known: burning sensation and dryness of the nasal mucosa, sneezing

Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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 the medicine.

5. How to store Xylometazoline + Dexpanthenol Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label following "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Shelf-life after first opening the container: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Xylometazoline + Dexpanthenol Teva contains
The active substances are: xylometazoline hydrochloride + dexpanthenol.
One spray (0.1 mL of solution) contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
1 mL of solution contains: xylometazoline hydrochloride 1 mg and dexpanthenol 50 mg.
Other components of the medicine are:

• Potassium dihydrogen phosphate
• Disodium hydrogen phosphate heptahydrate
• Water for injections

What Xylometazoline + Dexpanthenol Teva looks like and contents of the pack
One bottle contains 10 mL of solution, providing at least 90 single sprays.
Xylometazoline + Dexpanthenol Teva is a clear, almost colourless solution in a 10 mL round plastic bottle containing 10 mL of solution, sealed with a spray pump (applicator) and a protective cap.
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o.
(PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Xylometazolin/Dexpanthenol Teva 1 mg/mL + 50 mg/mL Nasenspray Lösung
Poland: Xylometazoline + Dexpanthenol Teva
For further information about this medicine and its names in other Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.,
Emilii Plater 53 Street,
00-113 Warsaw,
Phone: (22) 345 93 00