NASENDUO

NASENDUO Nasal Spray Children

Important notes (mandatory information)

NasenDuo Nasal Spray Children. Areas of application: for decongesting the nasal mucosa in the case of a cold and for the supportive treatment of healing skin and mucous membrane damage (lesions), paroxysmal rhinitis (rhinitis vasomotorica) and for treating nasal breathing difficulties after surgical interventions on the nose.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

NasenDuo Nasal Spray Children 0.5 mg/ml + 50 mg/ml Nasal Spray, solution for use in children between 2 and 6 years of age
Active ingredients: Xylometazoline hydrochloride/dexpanthenol

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor, pharmacist or healthcare professional.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS NASENDUO NASAL SPRAY CHILDREN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING NASENDUO NASAL SPRAY CHILDREN?
3. HOW IS NASENDUO NASAL SPRAY CHILDREN USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NASENDUO NASAL SPRAY CHILDREN BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NASENDUO NASAL SPRAY CHILDREN AND WHAT IS IT USED FOR?

NasenDuo Nasal Spray Children contains the active ingredients xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts the blood vessels and thereby causes the nasal mucosa to decongest. The additionally contained active ingredient dexpanthenol is a derivative of pantothenic acid, which promotes wound healing and protects the mucous membranes. For decongesting the nasal mucosa in the case of a cold and for the supportive treatment of healing skin and mucous membrane damage (lesions), paroxysmal rhinitis (rhinitis vasomotorica) and for treating nasal breathing difficulties after surgical interventions on the nose. For use in children between 2 and 6 years of age. If you do not feel better or if you feel worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING NASENDUO NASAL SPRAY CHILDREN?

NasenDuo Nasal Spray Children must not be used:

• if you are allergic to xylometazoline hydrochloride or dexpanthenol or any of the other ingredients of this medicine listed in section 6.
• if you suffer from a dry cold (a chronic cold that leads to dry inflammation of the nasal mucosa with crust formation).
• if you have recently undergone neurosurgery (transsphenoidal hypophysectomy or other surgical interventions that expose the meninges).
• in children under 2 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before using NasenDuo Nasal Spray Children:

• if you are being treated with certain medicines for depression, known as monoamine oxidase inhibitors (MAO inhibitors), or with other medicines that could potentially increase blood pressure (e.g. doxapram, ergotamine, oxytocin).
• if you are being treated with blood pressure-lowering medicines (e.g. methyldopa).
• if you have increased intraocular pressure, especially narrow-angle glaucoma.
• if you have a heart condition (e.g. long QT syndrome), coronary heart disease or high blood pressure (hypertension).
• if you have a tumour of the adrenal gland (phaeochromocytoma).
• if you have a metabolic disorder such as an overactive thyroid gland (hyperthyroidism) and diabetes.
• if you have a metabolic disorder known as porphyria (a metabolic disorder that affects the skin and/or nervous system).
• if your prostate is enlarged (prostate hyperplasia).

The use in the case of chronic rhinitis may only be carried out under medical supervision due to the atrophy of the nasal mucosa (tissue in the nose).

Children

NasenDuo Nasal Spray Children must not be used in children under 2 years of age. Long-term use and overdose, especially in children, must be avoided. Use at a higher dosage may only be carried out under medical supervision.

Use of NasenDuo Nasal Spray Children together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. If NasenDuo Nasal Spray Children is used at the same time as certain mood-elevating medicines (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants) and blood pressure-increasing medicines (e.g. doxapram, ergotamine, oxytocin), blood pressure may increase due to effects on cardiovascular function. Due to the possible vasoconstrictive (blood pressure-increasing) effect of xylometazoline, this medicine must not be used together with medicines that lower blood pressure (e.g. methyldopa).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

There is insufficient data on the use of xylometazoline hydrochloride and dexpanthenol in pregnant women. Therefore, NasenDuo Nasal Spray Children should not be used during pregnancy.

Breast-feeding

It is not known whether xylometazoline and dexpanthenol pass into human breast milk. A risk to the infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from treatment with NasenDuo Nasal Spray Children. The benefit of breast-feeding for the child and the benefit of therapy for the woman must be taken into account.

Fertility

There is insufficient data on the effects of xylometazoline and/or dexpanthenol on fertility in humans.

Driving and using machines

No side effects are to be expected if used as intended.

3. HOW IS NASENDUO NASAL SPRAY CHILDREN USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose for children between 2 and 6 years of age is up to 3 sprays of NasenDuo Nasal Spray Children into each nostril as needed, up to 3 times a day. The dosage depends on individual sensitivity and clinical effect.

Method of administration

This medicine is intended for use in the nose. After removing the protective cap, insert the spray nozzle into the nostril and press the pump once. Breathe calmly through the nose during spraying. After use, carefully wipe the spray head with a clean paper towel and replace the protective cap.

Notes

Before using the nasal spray for the first time and after a treatment break of more than 7 days, press the pump several times until an even spray mist is dispensed. The dosing spray is ready for use immediately for subsequent applications.

Blow your nose gently before using the nasal spray. It is recommended to use the last dose of the day before going to bed. For reasons of hygiene and to avoid infections, a spray bottle should only be used by one person.

Duration of use

NasenDuo Nasal Spray Children should not be used for longer than 7 days, unless the doctor expressly orders further use. Re-use should only take place after a break of several days. The doctor should always be consulted about the duration of use in children. Continuous use of this medicine can lead to chronic swelling and ultimately to atrophy of the nasal mucosa. Patients with increased intraocular pressure (glaucoma, especially narrow-angle glaucoma) should consult a doctor before using this medicine. Please talk to your doctor or pharmacist if you have the impression that the effect of NasenDuo Nasal Spray Children is too strong or too weak.

If you have used more NasenDuo Nasal Spray Children than you should e.g. as a result of an overdose or accidental ingestion, the following effects may occur

pupil constriction (miosis), pupil dilation (mydriasis), fever, sweating, pallor, blue lips (cyanosis), nausea, cramps, cardiovascular disorders, such as heart rhythm disorders (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension); lung function disorders (pulmonary oedema, respiratory disorders), mental disorders. In addition, drowsiness, lowering of body temperature, reduced heart rate, shock-like drop in blood pressure, respiratory arrest and unconsciousness (coma) may occur. If you suspect an overdose, please contact your doctor immediately. He/she can initiate any necessary measures.

If you forget to use NasenDuo Nasal Spray Children

Do not use double the dose the next time, but continue using as described in the dosage instructions.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Immune system disorders

Uncommon: Allergic (hypersensitivity) reactions (swelling of the skin and mucous membranes, rash, itching).

Psychiatric disorders

Very rare: Restlessness, insomnia, delusions (especially in children).

Nervous system disorders

Very rare: Fatigue (drowsiness, sedation), headache, cramps (especially in children).

Heart disorders

Rare: Palpitations, rapid heart rate (tachycardia).
Very rare: Heart rhythm disorders (arrhythmias).

Vascular disorders

Rare: High blood pressure (hypertension).

Respiratory, thoracic and mediastinal disorders

Very rare: Increased swelling of the mucous membrane after the effect has worn off, nosebleeds.
Frequency not known: Burning and dryness of the nasal mucosa, sneezing.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD NASENDUO NASAL SPRAY CHILDREN BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the label after "Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. After opening, NasenDuo Nasal Spray Children should be used within 6 months. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What NasenDuo Nasal Spray Children contains

The active ingredients are: Xylometazoline hydrochloride/dexpanthenol. One spray (equivalent to 0.1 ml solution) contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol. 1 ml solution contains: 0.5 mg xylometazoline hydrochloride and 50 mg dexpanthenol. The other ingredients are: Potassium dihydrogen phosphate, disodium hydrogen phosphate, water for injections.

How NasenDuo Nasal Spray Children looks like and contents of the pack

A bottle with 10 ml solution contains at least 90 individual sprays. NasenDuo Nasal Spray Children is a clear, almost colourless solution in a 10 ml round plastic bottle with snap connection with 10 ml solution, which is closed with a spray pump with nasal adapter and protective cap.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren

This package leaflet was last revised in February 2020.

Source: Information from the package leaflet
Status: 07/2020
Areas of application: for decongesting the nasal mucosa in the case of a cold and for the supportive treatment of healing skin and mucous membrane damage (lesions), paroxysmal rhinitis (rhinitis vasomotorica) and for treating nasal breathing difficulties after surgical interventions on the nose.