Klosterfrau taxofit® neo-angin® dolo-angin® neo-bronchol® sinu-panthol® nasic® Soledum® Aria Bedan® Laxacur® Valerian Cynara® Ameu® Kira® Kwai® Ginkyo® Sedonium® MedEctoin

Product Characteristics

nasic® for children nasal spray
For children aged 2 to 6 years.

Active substances: Xylometazoline hydrochloride and dexpanthenol

Nasal spray with sprayer device

Dear parents, dear patient,

Read this entire leaflet carefully because it contains important information relating to the administration of this drug. Consult your doctor or pharmacist if you have any questions.


Composition

Pharmaceutically active ingredients:
10 g solution contain 5.0 mg xylometazoline hydrochloride and 500 mg dexpanthenol.

Other ingredients:
2 mg benzalkonium chloride, potassium dihydrogen phosphate, sodium monohydrogen phosphate, purified water.

One spray dose with 0.1 ml solution (equivalent to 0.10 g) contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol.

Pharmaceutical form and contents
Solution; nasal spray
10 ml (N1)

Rhinologic, alpha-sympathomimetic drug.
Xylometazoline has vasoconstricting properties and thus causes a reduction of mucous membrane swelling.
Dexpanthenol is a derivative of the vitamin pantothenic acid, which is characterised by pro-healing and mucosa-protecting properties.

(In case of queries, please contact Cassella-med.)

Marketing authorisation holder:
Cassella-med
Gereonsmühlengasse 1
50670 Köln
Phone: 0221 / 12 01 57
Fax: 0221 / 1652-513
E-mail: cmed@cassella-med.de

Artesan Pharma
Wendlandstr. 1
29439 Lüchow
Phone: 05841 / 939-0
Fax: 05841 / 939-200

Manufacturer:
M.C.M. Klosterfrau Vertriebs-GmbH
Plant Soledum / Bad Segeberg
Ziegelstr. 119
23795 Bad Segeberg
Phone: 04551 / 82204
Fax: 04551 / 84593

Therapeutic indications
For the reduction of swelling of the nasal mucous membrane in common cold diseases and for supporting healing of skin and mucous membrane lesions, attacks of vasomotoric rhinitis and for treatment of the obstruction of nasal breathing after nasal surgery. nasic® for children is for children aged 2 to 6 years.

Contraindications
Who must not use nasic® for children?
Do not use this medicine:

• if you are hypersensitive to one of the ingredients of nasic® for children,
• in case of dry inflammation of the nasal mucous membrane with formation of crusts (Rhinitis sicca),
• in babies and infants under 2 years.
  

Due to the benzalkonium chloride content as preservative, nasic® for children may not be used in case of known hypersensitivity against this substance.

When do you need to consult your doctor before using nasic® for children?
Cases in which nasic® for children must only be used under certain conditions and with particular caution are listed below. Please consult your doctor. This also applies if you have a history of the following:
This medicine may only be used after strict benefit-risk assessment in the case of:

• patients who are treated with monoamine oxidase inhibitors (MAO inhibitors) and other potential hypertensors,
• increased intraocular pressure, particularly congestive glaucoma,
• serious cardiocirculatory diseases (e.g. coronary heart disease, hypertension),
• pheochromocytoma,
• metabolism disorders (e.g. hyperthyreosis, diabetes).
  

What is there to consider during pregnancy and lactation?
nasic® for children should not be used during pregnancy, since insufficient studies are available on the effects on the unborn child. Use during pregnancy should also be avoided, since it is unknown whether the active ingredient xylometazoline hydrochloride passes into mother’s milk.

What is there to consider in children?
Long-term use and overdoses must be avoided, particularly in children. The use in children aged 2 to 6 and in higher doses must be done under a doctor’s supervision.

Precautionary measures for administration and warnings
Permanent use of nasic® for children may cause chronic swelling and eventually shrinkage of the nasal mucosa.

Patients with glaucoma, particularly congestive glaucoma, should consult their doctor prior to using nasic® for children.

What is there to consider when driving, operating machines or working without safe support?
In the case of long-term use or higher doses of nasic® for children, effects on cardiocirculatory function or the nervous system cannot be excluded. In this case, the ability to drive vehicles and operate machines may be impaired. Please note that alcohol may further impair your ability to actively participate in traffic.

Interactions with other drugs
What other drugs affect the action of nasic® for children?
When simultaneously using nasic® for children and certain antidepressant drugs (MAO inhibitors of the tranylcypromine type or tricyclic antidepressants), blood pressure may increase due to the effects on the cardiocirculatory function.

Please note that these details may also apply to drugs that were recently taken.

Dosage instruction, method and duration of application
The following instructions apply unless your doctor has prescribed nasic® for children otherwise. Please follow your doctor’s instructions since nasic® for children will not have the desired effect.
Do not exceed the recommended doses and periods of use.

How much and how often should you use nasic® for children?
If not prescribed otherwise, children aged 2 to 6 years are administered up to 3 times daily, as required, one spray dose of nasic® for children into each nostril, holding the vial upright. The dosage depends on the individual sensitivity and the clinical effect.

How and when should you use nasic® for children?
Pull off the longer protection cap. Unscrew the cap from the glass vial and screw on the spray cap. Now take off the protection cap from the spray cap. Pump several times prior to the first use, until an even spray fog is generated.

Insert the sprayer as upright as possible into the nostril and pump once. After use, swipe the sprayer for hygienic reasons and put the protection cap back on. For all other uses, the sprayer is immediately ready to use.

How long should you use nasic® for children?
Do not use nasic® for children longer than 7 days, except if your doctor prescribes it.
You should always ask your doctor for the duration of application in children.

Overdosing and other application errors
What should you do if you used too much of nasic® for children (intended or accidental overdose)?

As a result of an overdose or accidental oral ingestion, the following effects may occur:
Pupil dilatation (mydriasis), sickness, vomiting, blue colouration of lips (cyanosis), fever, cramps, cardiocirculatory disorders (tachycardia, cardiac arrhythmia, circulatory failure, cardiac arrest, hypertension), pulmonary function disorders (pneumoedema, respiratory disorders), psychic disorders.
Furthermore, somnolence, reduction of the body temperature, reduction of the heart rate, drop of blood pressure similar to a shock, respiratory arrest and coma may occur.

Therapy measures are the administration of medical coal, gastrolavage or oxygen ventilation. If required, hypertension, fever and cramps must be treated.

What should you note when you used too little of nasic® for children?
Do not use the double quantity the next time but continue the therapy as described in the dosage instructions.

Side effects
Which side effects may occur when using nasic® for children?
Respiratory tract:
Particularly in sensitive patients, nasic® for children may cause slight transient irritation symptoms (burning sensation or dryness of the nasal mucous membrane).

In individual cases, an increased swelling of the mucous membrane may occur after regression of the effect (reactive hyperaemia).

Longer or more frequent use as well as higher doses of nasic® for children may cause irritation symptoms (burning sensation or dryness of the mucous membrane) and increased swelling of the mucous membrane, which is worsened by increased drug use (Rhinitis medicamentosa). This effect may occur already after 5 days of treatment and, if the treatment is continued, it can result in permanent damage to the mucous membrane with crust formation (Rhinitis sicca).

Nervous system:
Very rarely or in individual cases, headaches, sleeplessness or tiredness occurs.

Heart and circulation:
Rarely to occasionally there are effects on heart and circulation, as e.g. palpitation, increased heart rate, increase of blood pressure.

If you observe any side effects that are not mentioned in this package leaflet, please immediately inform you doctor or pharmacist.

Storing the medication
The expiry date of this package is printed on the box and the label.
Do not use this package after this date!

Shelf life after opening of the container: 12 weeks

Keep all medicines out of the reach of children.

Information current as of:
October 2002

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