Otriven 0.1% dosing spray without preservatives, 15 ml

Upute za korištenje Otriven 0.1% dosing spray without preservatives, 15 ml

Important notes (compulsory information):

Otriven ® against cold 0.1% dosing spray without preservatives. Active substance: xylometaazoline hydrochloride. Areas of application: For the cogwheeling of the nasal mucosa in nochrax, unlimited fluids (rhinitis Vasomotorica), allergic snap (rhinitis allergy). To facilitate the secretion flow at nasal sinus inflammation as well as in tube means ear cabarrh in conjunction with cold. This preparation is intended for adults and schoolchildren.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Otriven ® 0.1% dosing spray without preservatives
Nasal spray, solution
For adults and schoolchildren
Xylometazoline hydrochloride

Read all of the use information carefully because it contains important information for you. This medicine is available without medical prescription. In order to achieve the best possible treatment success, Otriven 0.1% dosing spray without preservatives, however, be used in accordance with properly.

• Lift the use information. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms aggravate or no improvement after 7 days, you will definitely see a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This information information includes

1. What is Otriven 0.1% dosing spray without preservatives and what is it used for?
2. What do you need to consider before using Otriven 0.1% dosing spray without preservatives?
3. What is Otriven 0.1% dosing spray without preservatives?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. What is Otriven 0.1% dosing spray without preservatives?
6. ADDITIONAL INFORMATION

1. What is Otriven 0.1% dosing spray without preservatives and what is it applied for?

Otriven 0.1% dosing spray without preservatives is a means for use in the nose (rhinology) and contains the alpha sympathomimetics xylometazoline. Xylometaazoline has vascular-consuming properties and thereby causes mucosal exhaust.

Field of use:
For the decuning of the nasal mucosa in cold, unlimited fluid tap (rhinitis Vasomotorica), allergic snap (rhinitis allergy). To facilitate the secret inflammation for inflammation of the nasal sinuses and at catarrh of the tube means ear in combination with cold. Otriven 0.1% dosing spray without preservatives is intended for adults and schoolchildren.

2. What do you need to consider before using Otriven 0.1% dosing spray without preservatives?

Otriven 0.1% dosing spray without preservatives must not be used:

• if you hypersensitive (allergic) against xylometazol or any of the other ingredients of Otriven 0.1% dosing spray without preservatives are
• in a certain form of chronic cold (Rhinitis Sicca)
• at state after operative removal of the pineal gland through the nose (transSphenoidal hypophysectomy) or other surgical interventions that expose the meninges
• in children under 6 years.

Take special care with the application of Otriven 0.1% dosing spray without preservatives is required:
For the following disorders and situations you are allowed to Otriven 0.1% dosing spray without preservatives only after consulting with your doctor:

• at an increased intraocular pressure, in particular bottleneck glaucoma
• serious cardiovascular diseases (e.g. Coronary heart disease) and hypertension (hypertension)
• if they are treated with monoamino oxidase inhibitors (Mao-inhibitors) and other potentially blood pressure-enhancing medicines
• Tumor of the adrenalness (pheochromocytom)
• Metabolic disorders, such as e.g. Over-function of the thyroid gland (Hyperthyroid) and diabetes mellitus)
• Prostate enlargement
• Metabolic disease (porphyria)
• The continuous use of mucous membrane exhaustive medicines can lead to chronic swelling and finally to the shrinkage of the nasal mucosa.

What should be considered in children and elderly people?
Otriven 0.1% dosing spray without preservatives must not be used in children under 6 years.

When using Otriven 0.1% dosing spray without preservatives with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines. With simultaneous use of Otriven 0.1% dosing spray without preservatives and certain mood-enhancing medicines (MAO-inhibitors of the tranylcypromin type or tricyclic antidepressants) and blood pressure-enhancing medicines can be used by effects on heart and circulatory functions an increase in blood pressure occur.

Pregnancy and breast feeding period:
Because the safety of an application of Otriven 0.1% dosing spray without preservatives in pregnancy and lactation is not sufficiently occupied, may you Otriven 0.1% dosing spray without preservatives apply only to advice from your doctor and only after this has made a careful benefit / risk balancing. During pregnancy and lactation, the recommended dosage must not be exceeded, as an overdose may affect the blood supply of the unborn child or to reduce milk production.

Driveion and use of machines:
For intended use, no impairments are to be expected.

3. What is Otriven 0.1% dosing spray without preservatives?

Use Otriven 0.1% dosing spray without preservatives always exactly after the instructions of this user information. Please ask your doctor or pharmacist if you are not sure.

Dosage:
Unless otherwise prescribed by the doctor, the usual dose is: in adults and schoolchildren, as needed up to 3 times a day ever a spray bump Otriven 0.1% metering spray without preservatives inserted into each nasal opening. Otriven 0.1 % Dosing spray without preservatives is for schoolchildren over 6 Years and adults are suitable. It must not be used in children of the age group under 6 years. For children from 2-6 Years are preparations with 0.05% xylometazoline hydrochloride as well as for infants and toddlers preparations with 0.025% Xylometazoline hydrochloride available.

Type of application:
Otriven 0.1% dosing spray without preservatives is intended for nasal application. It is advisable to thoroughly sweep the nose before using the preparation.

Use:
Remove the protective cap. Before the first application, pump several times until the leakage of a uniform spray. For all other applications, the dosing spray is ready to use immediately. Insert the spray opening into the nostril and pump once (Fig. 2). Inhaled easily through the nose during the spraying process. After application, restart the protective cap. The last application on each day of treatment should be conveniently done before bedtime. For hygienic reasons and to avoid infections, it should be noted that each dosing unit can only be used by a patient.

Duration of application:
Otriven 0.1% dosing spray without preservatives should not be used for more than 7 days, unless on a medical order. A newshould only take place after a break of several days. The application in chronic couple may take place because of the risk of shrinkage of the nasal mucosa only under medical control. Please talk to your doctor or pharmacist if you have the impression that the effect of Otriven 0.1% dosing spray without preservatives is too strong or too weak.

If you have a larger amount of Otriven 0.1% dosing spray without preservatives used as they should,
If you immediately inform your doctor. Poisoning can occur due to significant overdose or accidental occupancy of the medicinal product. The clinical image of poisoning with xylometazoline may be confusing because phases of stimulation can alternate with phases of suppression of the central nervous system and the cardiovascular system. Especially in children, after overdose, it often leads to central nervous effects with cramps and coma, slow heartbeat, respiratory arrest and an increase in blood pressure, which can be replaced by blood pressure drop. Symptoms of stimulation of the central nervous system are anxiety feeling, excitement, hallucination and cramping. Symptoms due to inhibition of the central nervous system are lowering body temperature, lethargy, drowsiness and coma. The following additional symptoms can occur: Pupil narrowing (MIOSIS), pupil expansion (Mydriasis), fever, sweating, paleness, bluish discoloration of the skin due to the decrease in oxygen content in the blood (cyanosis), Heartock, respiratory depression and respiratory arrest (apnea), nausea and vomiting, psychogenic disorders, increase or humiliation of blood pressure, irregular heartbeat, too faster / too slow heartbeat. In poisoning, a doctor is immediately informed, monitoring and therapy in the hospital are necessary.




If you use the application of Otriven 0.1% dosing spray without preservatives have forgotten:
Do not apply twice the dose if you forget the previous application, but continue with the application according to dosing instructions.

4. Which side effects are possible?

How all medicines can Otriven 0.1% dosing spray without preservatives have side effects, but they do not have to occur each other.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Possible side effects:
Diseases of the nervous system:
rare: restlessness, insomnia, fatigue (somnolence, sedation), headache, hallucinations (primarily in children).

Heart infection:
Rare: palpitations, accelerated heart activity (tachycardia), Blood pressure increase.
Very rare: cardiac arrhythmias.

Diseases of the Atemweqe, thoracic and mediastinal disorders:
Often: burning and dryness of the nasal mucosa, sneezing. Occasionally: After decaying the effect greater feeling of a clogged nose, nosebleed.
Very rare: respiratory arrest at young infants and newborns.

Skeletal muscles. Connective tissue and bone sickness:
Very rare: cramps (especially in children).

Diseases of the immune system:
Occasionally: Hypersensitivity reactions (rash, itching, swelling of skin and mucosa).

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. What is Otriven 0.1% dosing spray without preservatives?

Store drug out of reach of children. You may not use the medicinal product after the expiration date specified on the folding box and the label.

Storage induction:
Do not store over 30 ° C. Note on durability after a break after a break 6 months durable.

6. Further information

What Otriven 0.1% dosing spray without preservatives contains:
The active ingredient is xylometaazoline hydrochloride.
1 ml of solution contains 1 mg of xylometaazoline hydrochloride. 1 spray 0.09 ml solution contains 0.09 mg of xylometaazoline hydrochloride.

The other ingredients are:
Purified water; Glycerol 85%; Sodium citrate; Citric acid monohydrate.

Appearance of Otriven 0.1% dosing spray without preservatives and content of the pack:
Clear, almost colorless solution original pack to 15 ml nasal spray, solution

Pharmaceutical entrepreneur and manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich
Barthstraße 4
80339 Munich
Telephone (089) 78 77-209
Fax (089) 78 77-304
E-mail: [email protected]

This information information was last revised in June 2016.

Source: Information of the leaflet
Status: 04/2017