NASAL SPRAY AL 0.05%

Important Information (Mandatory Information)

Nasenspray AL 0.05% Active substance: Xylometazoline hydrochloride 0.5 mg/ml solution. Areas of application: to reduce swelling of the nasal mucosa in case of runny nose, episodic runny nose (rhinitis vasomotorica) and allergic runny nose (rhinitis allergica)

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


Instructions for use: Information for the user
Nasenspray AL 0.05%
For use in children from 2 to 6 years of age
Active substances: Xylometazoline hydrochloride 0.5 mg/ml solution

Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment success, Nasenspray AL 0.05% must be used as directed.
o Keep this leaflet. You may want to read it again later.
o Ask your pharmacist if you need more information or advice.
o If your symptoms worsen or do not improve after 7 days, you must consult a doctor in any case.
o If any of the listed side effects affects you significantly or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This leaflet contains

1. WHAT IS NASENSPRAY AL 0.05% AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING NASENSPRAY AL 0.05%?
3. HOW TO USE NASENSPRAY AL 0.05%?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE NASENSPRAY AL 0.05%?
6. FURTHER INFORMATION

1. WHAT IS NASENSPRAY AL 0.05% AND WHAT IS IT USED FOR?
Nasenspray AL 0.05% is a medicine for use in the nose (rhinological agent) and contains the alpha-sympathomimetic xylometazoline. Xylometazoline has vasoconstrictive properties and thereby causes decongestion of the mucous membrane.
Nasenspray AL 0.05%

is used to reduce swelling of the nasal mucosa in case of

o Runny nose.
o Episodic runny nose (rhinitis vasomotorica).
o Allergic runny nose (rhinitis allergica).
Nasenspray AL 0.05% is intended for children from 2 to 6 years of age.

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING NASENSPRAY AL 0.05%?
Nasenspray AL 0.05%

must not be used

o if you are hypersensitive (allergic) to the active substance xylometazoline hydrochloride, benzalkonium chloride or any of the other ingredients of Nasenspray AL 0.05%.
o in a certain form of chronic runny nose (rhinitis sicca).
o after surgical removal of the pineal gland through the nose (transsphenoidal hypophysectomy) or other surgical interventions that expose the meninges.
o in infants and young children up to 2 years of age.

Special care is required when using Nasenspray AL 0.05%
There are isolated reports of serious side effects (especially respiratory arrest) when using the recommended dose. Exceeding the dose must be avoided at all costs.

In the following diseases and situations, you may use Nasenspray AL 0.05%

only after consultation with your doctor

o in case of increased intraocular pressure, especially narrow-angle glaucoma.
o in case of severe cardiovascular diseases (e.g. coronary heart disease) and high blood pressure (hypertension).
o if you are being treated with monoamine oxidase inhibitors (MAOIs) and other potentially blood pressure-increasing medicines.
o in case of a tumor of the adrenal gland (pheochromocytoma).
o in case of metabolic disorders, such as overactive thyroid (hyperthyroidism) and diabetes (diabetes mellitus).
o in case of prostate enlargement.
o in case of the metabolic disease porphyria.
Continuous use of decongestant nasal sprays can lead to chronic swelling and ultimately to the loss of the nasal mucosa.

When using Nasenspray AL 0.05% with other medicines
Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, including medicines obtained without a prescription.
With simultaneous use of Nasenspray AL 0.05% and certain mood-elevating medicines (MAOIs of the tranylcypromine type or tricyclic antidepressants) as well as blood pressure-increasing medicines, an increase in blood pressure can occur due to effects on cardiovascular functions.
Please note that this information may also apply to recently used medicines.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking/using any medicine. Since the safety of using Nasenspray AL 0.05% during pregnancy and breast-feeding has not been sufficiently proven, you may only use Nasenspray AL 0.05% on the advice of your doctor and only after they have made a careful benefit/risk assessment. During pregnancy and breast-feeding, the recommended dosage must not be exceeded, as an overdose can impair the blood supply to the unborn child or reduce milk production.

Driving and using machines
No impairments are to be expected when used as intended.

Important information about certain other ingredients of Nasenspray AL 0.05%
The preservative contained in Nasenspray AL 0.05% (benzalkonium chloride) can cause swelling of the nasal mucosa, especially with prolonged use. If such a reaction is suspected (persistently blocked nose), a medicine for use in the nose without a preservative should be used if possible. If such medicines for use in the nose without a preservative are not available, another dosage form should be considered.

3. HOW TO USE NASENSPRAY AL 0.05%?
Always use Nasenspray AL 0.05% exactly as directed in this leaflet. Please check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the usual dose is: For children aged 2 - 6 years, 1 spray of Nasenspray AL 0.05% is administered into each nostril as needed up to 3 times daily.

Method of administration
Nasenspray AL 0.05% is intended for nasal use. For hygienic reasons and to avoid infections, the medicine should only be used by the same patient. The bottle must be kept upright during use. Before first use, press the spray attachment down several times until a uniform spray mist is released. For all subsequent applications, the nasal spray is functional from the very first pump. Insert the spray opening into the nostril and press the spray attachment down firmly once. Breathe in gently through the nose while spraying.

Duration of use
Nasenspray AL 0.05% should not be used for longer than 7 days, unless ordered by a doctor. A new application should only be made after a break of several days. Use in chronic runny nose may only be carried out under medical supervision due to the risk of loss of the nasal mucosa. Please talk to your doctor or pharmacist if you have the impression that the effect of Nasenspray AL 0.05% is too strong or too weak.

If you have used more Nasenspray AL 0.05% than you should
Poisoning can occur through significant overdose or accidental ingestion of the medicine. In this case, you should inform your doctor immediately. The clinical picture of poisoning with Nasenspray AL 0.05% can be confusing, as phases of stimulation can alternate with phases of suppression of the central nervous system and the cardiovascular system. Especially in children, overdose often leads to central nervous system effects with convulsions and coma, slow heartbeat, respiratory arrest, and an increase in blood pressure, which can be followed by a drop in blood pressure. Symptoms of central nervous system stimulation are anxiety, excitement, hallucinations, and convulsions. Symptoms resulting from inhibition of the central nervous system are lowering of body temperature, lethargy, drowsiness, and coma. The following other symptoms may occur: pupil constriction (miosis), pupil dilation (mydriasis), fever, sweating, paleness, bluish discoloration of the skin due to a decrease in oxygen content in the blood (cyanosis), palpitations, respiratory depression and respiratory arrest (apnea), nausea and vomiting, psychogenic disorders, increase or decrease in blood pressure, irregular heartbeat, too fast/too slow heartbeat.
In case of poisoning, a doctor must be informed immediately. Monitoring and therapy in a hospital are necessary.

If you forget to use Nasenspray AL 0.05%
Do not use a double dose if you have forgotten the previous application, but continue with the application according to the dosage instructions.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?
Like all medicines, Nasenspray AL 0.05% can have side effects, although not everyone gets them.

The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Possible side effects
Heart diseases
Rare: palpitations, accelerated heart activity (tachycardia), increase in blood pressure.
Very rare: cardiac arrhythmias.

Nervous system disorders
Very rare: restlessness, insomnia, fatigue (drowsiness, sedation), headache, hallucinations (primarily in children).

Respiratory, thoracic and mediastinal disorders
Common: burning and dryness of the nasal mucosa, sneezing.
Uncommon: after the effect wears off, increased feeling of a "blocked" nose, nosebleeds.
Very rare: respiratory arrest in young infants and newborns.

Musculoskeletal, connective tissue and bone disorders
Very rare: convulsions (especially in children).

Immune system disorders
Uncommon: hypersensitivity reactions (skin rash, itching, swelling of skin and mucous membrane).

Please inform your doctor or pharmacist if any of the listed side effects affects you significantly or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE NASENSPRAY AL 0.05%?
Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the folding box and the label after "Expiry date". The expiry date refers to the last day of that month. No special storage conditions are required for this medicine. After opening, Nasenspray AL 0.05% can be kept for 6 months if stored properly!

6. FURTHER INFORMATION
What Nasenspray AL 0.05% contains
The active substance is xylometazoline hydrochloride. 1 ml of solution contains 0.5 mg of xylometazoline hydrochloride. The other ingredients are: benzalkonium chloride, glycerol, citric acid monohydrate, sodium citrate 2 H2O, purified water.

What Nasenspray AL 0.05% looks like and contents of the pack
Clear, colorless solution.
Nasenspray AL 0.05% is available in packs containing 10 ml of solution.

Pharmaceutical Entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18,
61118 Bad Vilbel

This leaflet was last revised in May 2012.

Source: Information from the package leaflet
Status: 12/2014
Active substance: Xylometazoline hydrochloride 0.5 mg/ml solution. Areas of application: to reduce swelling of the nasal mucosa in case of runny nose, episodic runny nose (rhinitis vasomotorica) and allergic runny nose (rhinitis allergica)