NASIC

NASIC OK nasal spray

Important notes (mandatory information)

nasic O.K. Nasal Spray, solution. 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 O.K. Nasal Spray, solution for use in adults and children aged 6 and over
Active ingredient: Xylometazoline hydrochloride 0.1% + Dexpanthenol 5%
nasic O.K. does not contain any preservatives

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 section 4.
• If you do not feel better or if you feel worse after 1 day, consult your doctor.

What this package leaflet contains

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

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

nasic 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 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 O.K. is intended for adults and children aged 6 and over.

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

nasic 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 6 years of age.

Warnings and precautions

Special care must be taken when using nasic O.K.:

• if you are being treated with monoamine oxidase inhibitors (MAO inhibitors) as well as other potentially blood pressure-raising medicines (e.g. doxapram, ergotamine, oxytocin),
• if you are being treated with blood pressure-lowering medicines (e.g. methyldopa),
• 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 disorder porphyria,
• in the case of an enlarged prostate (prostate hyperplasia).

The use of the medicine in the case of chronic rhinitis may only be carried out under medical supervision due to the risk of atrophy of the nasal mucosa. Please talk to your doctor or pharmacist before using nasic O.K.

Children

Long-term use and overdose, particularly in children, must be avoided. Use at a higher dosage may only be carried out under medical supervision. nasic O.K. contains a concentration of active ingredient that is intended for adults and children aged 6 and over and is therefore not suitable for infants and toddlers under 6 years of age. For the age group of children between 2 and 6 years, corresponding nasal sprays with a lower content of the decongestant active ingredient xylometazoline hydrochloride are available.

Use of nasic 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 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 other potentially blood pressure-raising medicines (e.g. doxapram, ergotamine, oxytocin), an increase in blood pressure can occur due to effects on cardiovascular functions. A combination with blood pressure-lowering medicines (e.g. methyldopa) should not be used due to the potential blood pressure-raising effect of xylometazoline.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. nasic O.K. should not be used during pregnancy, as 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, as 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 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, adults and children aged 6 and over should use one spray of nasic O.K. in each nostril up to 3 times a day as required. The dosage depends on individual sensitivity and clinical effect.

Method of administration

nasic O.K. is intended for use in the nose. Remove the protective cap. Pump several times before using for the first time until an even spray mist is produced. Insert the spray head into the nostrils as vertically as possible and pump once in 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 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 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 their doctor before using nasic O.K. Please talk to your doctor or pharmacist if you have the impression that the effect of nasic O.K. is too strong or too weak.

If you have used more nasic 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 O.K.

Do not use double the amount 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:	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), headache, cramps (particularly in children)

Heart disorders

Rare: palpitations, accelerated 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 ensure that more information on the safety of this medicine is made available.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What nasic O.K. contains

The active ingredients are xylometazoline hydrochloride and dexpanthenol. 10 g of solution contain 10 mg of xylometazoline hydrochloride and 500 mg of dexpanthenol. One spray of 0.1 ml of solution (equivalent to 0.10 g) contains 0.1 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 O.K. does not contain any preservatives.

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

Multi-dose container with spray pump. nasic 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 lower concentration of active ingredient that is suitable for children between 2 and 6 years of age.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne
Tel.: 0800/1652-200
Fax: 0800/1652-700
E-mail: dialog@ca$sella-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 10/2016.

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.