NASIC

NASIC for children OK nasal spray

Important notes (mandatory information)

nasic for Children O.K. Nasal Spray. 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

nasic for Children O.K. Nasal Spray, solution for use in children between 2 and 6 years of age. nasic for Children O.K. does not contain any preservatives.
Active ingredients: Xylometazoline hydrochloride 0.05 % + Dexpanthenol 5 %,

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 instructed by your doctor or pharmacist.

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

What this package leaflet contains

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

1. WHAT IS NASIC FOR CHILDREN O.K. AND WHAT IS IT USED FOR?

nasic for Children O.K. is a nasal spray. The active ingredient it contains, xylometazoline hydrochloride, constricts the blood vessels and thereby causes the nasal mucosa to decongest. The additional active ingredient, dexpanthenol, is a derivative of pantothenic acid, which promotes wound healing and protects the mucous membrane. nasic for Children O.K. is used to decongest 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. nasic for Children O.K. is intended for children between 2 and 6 years of age.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING NASIC FOR CHILDREN O.K.?

nasic for Children O.K. must not be used:

• if you are hypersensitive (allergic) to the active ingredients xylometazoline hydrochloride or dexpanthenol or to any of the other ingredients listed in section 6 of this medicine,
• if you have a dry inflammation of the nasal mucosa with crust formation (rhinitis sicca),
• after surgical removal of the pituitary gland through the nose (transsphenoidal hypophysectomy) or other surgical interventions that expose the meninges,
• in infants and toddlers under 2 years of age.

Warnings and precautions

Special care should be taken when using nasic for Children O.K.:

• if you are being treated with monoamine oxidase inhibitors (MAO inhibitors) as well as other medicines that could potentially increase blood pressure,
• in the case of increased intraocular pressure, particularly glaucoma (narrow-angle glaucoma),
• in patients with severe cardiovascular diseases (e.g. coronary heart disease) and high blood pressure (hypertension),
• in patients with a tumour of the adrenal gland (phaeochromocytoma),
• in the case of metabolic disorders, such as an overactive thyroid gland (hyperthyroidism) and diabetes mellitus,
• in the case of the metabolic disease porphyria,
• in the case of an enlarged prostate (prostate hyperplasia).

Use in the case of chronic rhinitis may only take place under medical supervision due to the risk of atrophy of the nasal mucosa. Please talk to your doctor or pharmacist before using nasic for Children O.K.

Children

Long-term use and overdose, particularly in children, should be avoided. Use at a higher dosage may only take place under medical supervision. nasic for Children O.K. contains a concentration of active ingredients that is intended for children between 2 and 6 years of age and is therefore not suitable for infants and toddlers under 2 years of age.

Use of nasic for Children O.K. together with other medicines

Please inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. When nasic for Children O.K. is used at the same time as certain mood-elevating medicines (monoamine oxidase inhibitors of the tranylcypromine type or tricyclic antidepressants) as well as medicines that increase blood pressure, an increase in blood pressure can occur due to effects on cardiovascular function.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. nasic for Children O.K. should not be used during pregnancy, because there is insufficient data available on the use of the active ingredient xylometazoline hydrochloride in pregnant women. It should also not be used during breast-feeding, because it is not known whether the active ingredient xylometazoline hydrochloride passes into breast milk.

Driving and operating machinery

No impairments are to be expected if used as intended.

3. HOW SHOULD NASIC FOR CHILDREN O.K. BE 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.

Dosage

Unless otherwise prescribed by your doctor, children aged 2 - 6 years should receive one spray of nasic for Children O.K. into each nostril up to 3 times a day as needed. The dosage depends on individual sensitivity and clinical effect.

Method of administration

nasic for Children O.K. is intended for use in the nose. Remove the protective cap. Pump several times before the first use until an even spray mist is produced. Insert the spray head into the nostrils as vertically as possible and pump once into each nostril. Wipe the spray head for hygienic reasons after use and replace the protective cap. The dosing spray is ready to use immediately for all further applications.

Duration of use

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

If you have used more nasic for Children O.K. than you should

e.g. as a result of an overdose or accidental ingestion, the following effects can occur: constriction of the pupils (miosis), dilation of the pupils (mydriasis), fever, sweating, pallor, blue lips (cyanosis), nausea, cramps, cardiovascular problems, such as heart rhythm disorders (tachycardia, bradycardia, cardiac arrhythmia), circulatory collapse, cardiac arrest, high blood pressure (hypertension), impaired lung function (pulmonary oedema, respiratory problems), mental disorders. In addition, drowsiness, a decrease in body temperature, a decrease in heart rate, shock-like drop in blood pressure, respiratory arrest and unconsciousness (coma) can occur. If you suspect an overdose, please contact your doctor immediately. They can initiate any necessary measures.

If you forget to use nasic for Children O.K.

Do not use double the amount the next time, but continue using it 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:	fewer than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects Immune system disorders

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

Psychiatric disorders

Very rare: restlessness, insomnia, hallucinations (particularly in children)

Nervous system disorders

Very rare: tiredness (drowsiness, sedation), headaches, cramps (particularly 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 (middle chest cavity)

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 notice any side effects, consult 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, Department 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 NASIC FOR CHILDREN O.K. 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. The shelf life after first opening is 12 weeks.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What nasic for Children O.K. contains

The active ingredients are xylometazoline hydrochloride and dexpanthenol. 10 g of solution contain 5 mg of xylometazoline hydrochloride and 500 mg of dexpanthenol. One spray of 0.1 ml of solution (equivalent to 0.10 g) contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol. The other ingredients are: potassium dihydrogen phosphate, sodium monohydrogen phosphate dodecahydrate (Ph. Eur.), purified water. nasic for Children O.K. does not contain any preservatives.

What nasic for Children O.K. looks like and contents of the pack

Multi-dose container with spray pump. nasic for Children O.K. is a clear, colourless solution and is available in the original pack with 10 ml of nasal spray. This nasal spray is also available with a higher concentration of active ingredients suitable for adults and school children.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne
Tel.: 0800/16 52-200
Fax: 0800/ 16 52-700
E-mail: dialog@cassella-med.eu
(Please contact Cassella-med for any questions.)

Manufacturer

Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin

This package leaflet was last revised in February 2015.

Source: Information from the package leaflet
Status: 10/2017
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.