Xylozolin 0,5 mg/ml, neusspray, oplossing

{(Invented) name strength pharmaceutical form} contains the active ingredient xylometazoline, which is a topical decongestant that relieves nasal congestion. A decongestant reduces the swelling of the nasal mucosa.

{(Invented) name strength pharmaceutical form} is used for temporary symptomatic treatment of nasal congestion due to rhinitis or sinusitis.

{(Invented) name 0.5 mg/ml pharmaceutical form} is intended for children between 2 and 10 years of age.

{(Invented) name 1 mg/ml pharmaceutical form} is intended for adults as well as for children 10 years of age and older.

Do NOT use {(Invented) name strength pharmaceutical form}

• if you are allergic (hypersensitive) to xylometazoline or any of the other ingredients of {(Invented) name strength pharmaceutical form} (see section 6).
• if you have recently had neurosurgery (transsphenoidal hypophysectomy or other surgery exposing the meninx)
• if you suffer from dry rhinitis (a form of chronic rhinitis that causes dry inflammation of the nasal mucous membrane with formation of crusts).

{(Invented) name 0.5 mg/ml pharmaceutical form}

• in children younger than 2 years of age. {(Invented) name 1 mg/ml pharmaceutical form}
• in children below 10 years of age.

Take special care with {(Invented) name strength pharmaceutical form}

Ask your doctor for advice:

• if you are being treated with certain drugs for depression known as monoamine oxidase inhibitors (MAO inhibitors) or other medicinal products that may increase blood pressure.
• if you suffer from coronary heart disease or high blood pressure.
• if you suffer from an adrenal tumor (phaeochromocytoma).
• if you suffer from metabolic disorders such as thyroid hyperfunction (hyperthyroidism), or diabetes
• if you have an enlarged prostate.
• if you suffer from porphyria (a metabolic disorder that affects the skin and/or nervous system).
• if you suffer from increased pressure inside the eye, particularly narrow-angle glaucoma. Direct contact with the eyes should be avoided.

Long-term use of Xylometazoline nasal spray (longer than 7 days) may lead to chronic swelling and ultimately to the wasting away of the nasal mucous membrane (tissue inside the nose).

Use in children

{(Invented) name 0.5 mg/ml pharmaceutical form}

{(Invented) name 0.5 mg/ml pharmaceutical form} must not be used in infants, toddlers and children below 2 years of age.

{(Invented) name 1 mg/ml pharmaceutical form}

{(Invented) name 1 mg/ml pharmaceutical form} must not be used by children younger than 10 years of age.

Taking/Using other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.

Combined use of {(Invented) name strength pharmaceutical form} and certain drugs for depression (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as high blood pressure (hypertension) medications can lead to a rise in blood pressure.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Since the safety of use of {(Invented) name strength pharmaceutical form} during pregnancy and breast- feeding has not been sufficiently documented, you may use {(Invented) name strength pharmaceutical form} only upon the recommendation of your doctor and only after a careful risk-benefit evaluation. As overdosing may affect the blood supply to the unborn child or lead to a reduction of milk production, the recommended dose must not be exceeded during pregnancy and breast-feeding.

Driving and using machines

This medicine should not affect your ability to drive or operate machinery.

Like all medicines {(Invented) name strength pharmaceutical form} can cause side effects, although not everybody gets them.

The following frequency conventions are used in the evaluation of side effects:

Very common	affects more than 1 user in 10
Common	1 to 10 users in 100
Uncommon	1 to 10 users in 1,000
Rare	1 to 10 users in 10,000
Very rare	less than 1 user in 10,000
Not known	Frequency cannot be estimated from available data

Common

• slight temporary irritation symptoms such as stinging or dryness of the nasal mucosa (tissue inside the nose) and/or throat.
• sneezing

Uncommon

• hypersensitivity reactions (skin rash, itching, swelling of skin and and mucous membranes)
• after the effect has subsided increased sensation of a “blocked” nose
• nosebleed

Rare

• feeling your heart beat (palpitations)
• increased heart rate
• increase in blood pressure
• feeling sick (nausea)

Very rare

• nervousness (restlessness)
• difficulty falling or staying asleep (insomnia)
• sleepiness/drowsiness (mainly in children)
• headache
• dizziness
• hallucinations or fits (mainly in children)
• irregular heart beat
• stop breathing (apnoea) in infants and neonates

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What {(Invented) name strength pharmaceutical form} contains

• The active substance is xylometazoline hydrochloride. {(Invented) name 0.5 mg/ml pharmaceutical form} One spray (equivalent to 0.09 ml solution) contains 0.045 mg xylometazoline hydrochloride. {(Invented) name 1 mg/ml pharmaceutical form} One spray (equivalent to 0.09 ml solution) contains 0.09 mg xylometazoline hydrochloride.
• The other ingredients are: citric acid monohydrate, sodium citrate dihydrate, glycerol 85%, water for injections.

What {(Invented) name strength pharmaceutical form} looks like and contents of the pack

{(Invented) name 0.5 mg/ml pharmaceutical form} is a clear, almost colourless solution available in a brown glass bottle containing 10 ml (not less than 90 actuations) or 2x10 ml (not less than 2x90 actuations) of solution sealed with a spray pump with a nose adapter and a protecting cap.

{(Invented) name 1 mg/ml pharmaceutical form} is a clear, almost colourless solution available in a brown glass bottle containing 10 ml (not less than 90 actuations), 15 ml (not less than 135 actuations) or 2x10 ml (not less than 2x90 actuations) of solution sealed with a spray pump with a nose adapter and a protecting cap.

< Not all pack sizes may be marketed >

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pharmachemie BV

Swensweg 5

2031 GA Haarlem

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Duitsland

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Nederland

Teva Czech Industries s.r.o. Ostravska 29, c.p. 305 74770 Opava-Komarov

Tsjechië

Teva Operations Poland Sp. z o.o. ul. Mogilska 80. 31-546, Krakow

Polen

Teva Operations Poland Sp. z o.o

Ul. Sienkiewicza 25. 99-300, Kutno

Polen

In het register ingeschreven onder
Xylozolin 0,5 mg/ml, neusspray, oplossing:	RVG 109042.
Xylozolin 1 mg/ml, neusspray, oplossing:	RVG 109043.

This medicinal product is authorised in the Member States of the EEA under the following names:

<to be completed nationally>

This leaflet was last approved in September 2012.

Version:

R07