ALLERGODIL

ALLERGODIL acute nasal spray

Important notes (mandatory information)

Allergodil akut nasal spray. Active ingredient: Azelastine hydrochloride. Areas of application: For the symptomatic treatment of hay fever (seasonal allergic rhinitis) in adults, adolescents and children aged 6 years and over.

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


Patient information: Information for users
Allergodil® akut nasal spray
1 mg / 1 ml nasal spray, solution
Azelastine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed 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 experience any side effects, talk to 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 even worse after 2 days, contact your doctor.

What is in this leaflet
1. WHAT IS ALLERGODIL AKUT NASAL SPRAY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ALLERGODIL AKUT NASAL SPRAY?
3. HOW TO USE ALLERGODIL AKUT NASAL SPRAY?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ALLERGODIL AKUT NASAL SPRAY?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ALLERGODIL AKUT NASAL SPRAY AND WHAT IS IT USED FOR?

Allergodil akut nasal spray is an antiallergic / antihistamine and contains the active ingredient azelastine hydrochloride.

Allergodil akut nasal spray is used for the symptomatic treatment of hay fever (seasonal allergic rhinitis) in adults, adolescents and children aged 6 years and over.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ALLERGODIL AKUT NASAL SPRAY?

Allergodil akut nasal spray must not be used,
if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Please talk to your doctor or pharmacist before using Allergodil akut nasal spray.

Children
Allergodil akut nasal spray should not be used in children under 6 years of age.

Elderly
There are no special instructions for elderly patients.

Use of Allergodil akut nasal spray together with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Interactions with other medicines have not been observed so far.

Use of Allergodil akut nasal spray together with food, drink and alcohol
Interactions with food and beverages have not been observed so far. In general, however, alcohol should not be consumed during drug treatment.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Although there is no evidence from animal studies of a harmful effect on the fetus beyond the therapeutic dosage range, it is in line with the current general view on the use of medicines not to use Allergodil akut nasal spray in the first trimester of pregnancy.

Breast-feeding
Since sufficient experience is not yet available, Allergodil akut nasal spray should not be used during breast-feeding.

Driving and using machines
When using Allergodil akut nasal spray, complaints such as fatigue, lassitude, exhaustion, dizziness or weakness, which can also be caused by the disease process, are possible in individual cases. In these cases, the ability to drive a motor vehicle and operate machinery may be impaired. This applies to an even greater extent in combination with alcohol and medications that can impair responsiveness.

3. HOW TO USE ALLERGODIL AKUT NASAL SPRAY?

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.

The recommended dose is: 2 times a day (morning and evening) 1 spray of Allergodil akut nasal spray per nostril (equivalent to 0.56 mg azelastine hydrochloride/day).

Method of administration
Allergodil akut nasal spray should be used with the head held upright

1. After removing the protective cap...
2. ...pump several times only on first use until an even spray mist is emitted.
3. Spray one spray per nostril with the head held upright.
4. Replace protective cap.

Duration of use
The duration of use of Allergodil akut nasal spray depends on the type, severity and course of the symptoms.
Allergodil akut nasal spray is suitable for long-term treatment.

Please talk to your doctor or pharmacist if you have the impression that the effect of Allergodil akut nasal spray is too strong or too weak.

If you have used more Allergodil akut nasal spray than you should
Allergodil akut nasal spray is used locally in the nose. Due to the low amount of active ingredient, poisoning symptoms are not to be expected even in the event of extreme local overdose. However, if large amounts are accidentally swallowed (e.g. the contents of the bottle by a child), a doctor should be consulted in any case. There is no experience in humans after administration of toxic (very high, poisonous) doses of azelastine hydrochloride. However, based on animal experimental findings, central nervous symptoms (e.g. restlessness, agitation or severe, persistent fatigue or drowsiness) can be expected in the event of extreme overdose and intoxication (poisoning). Treatment should therefore be symptomatic.

If you forget to use Allergodil akut nasal spray
If you forget to use Allergodil akut nasal spray once, no special measures are necessary. Continue therapy with the same dosage at the next scheduled time. If necessary, you can also use Allergodil akut nasal spray between two scheduled times.

If you stop using Allergodil akut nasal spray
Treatment with Allergodil akut nasal spray should be continued regularly until the symptoms have subsided. If you stop using Allergodil akut nasal spray, you must expect the typical symptoms of your illness to reappear soon.

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

Common: Bitter taste usually due to improper use (head tilted back, see dosage instructions), which can sometimes cause nausea
Uncommon: Irritation of the already inflamed nasal mucosa (burning, tingling), sneezing, nosebleeds
Rare: Nausea
Very rare: Hypersensitivity reactions, rash, itching, hives, fatigue (lassitude, exhaustion), dizziness or weakness, which can also be caused by the disease process itself

Countermeasures
The above side effects usually occur temporarily. Therefore, no special countermeasures are to be taken.

If you experience a bitter taste in your mouth after using Allergodil akut nasal spray, you can counteract this with a non-alcoholic beverage (e.g. juice, milk).

Reporting of side effects
If you experience any side effects, talk to 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, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn (website: http://www.bfarm.de). By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE ALLERGODIL AKUT NASAL SPRAY?

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month indicated.

Storage conditions
Do not store below 8 °C.

Note on shelf life after opening
Allergodil akut nasal spray should not be used for more than 6 months after opening the bottle.

Do not use this medicine if you notice the following

If Allergodil akut nasal spray is accidentally stored below +8 °C (e.g. in the refrigerator) for an extended period of time, the active ingredient of Allergodil akut nasal spray will begin to crystallize out. This crystal formation ("flocculation") is visible when the bottle is held up to the light. This solution should not be used. However, if the solution is stored at room temperature for a longer period of time (several hours), the crystals will dissolve completely again. This clear solution (no more flocculation visible) can then be used further. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This helps to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Allergodil akut nasal spray contains
The active ingredient is azelastine hydrochloride.
1 spray of 0.14 ml contains 0.14 mg azelastine hydrochloride.

The other ingredients are

Sodium edetate, hypromellose, sodium monohydrogen phosphate dodecahydrate, citric acid, sodium chloride, purified water.

What Allergodil akut nasal spray looks like and contents of the pack
Allergodil akut nasal spray is a clear, colorless solution for spraying into the nose (nasal use).

Allergodil akut nasal spray is available in a brown glass bottle with a spray pump.
Pack sizes: 5, 10, 20 ml nasal spray, solution
Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer
Pharmaceutical entrepreneur
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Telephone (06172) 888-01
Telefax (06172) 888-27 40
medinfo@medapharma.de

Manufacturer
MEDA Manufacturing GmbH
Neurather Ring 1
51603 Köln
Telephone: (0221) 6472-0
Telefax: (0221) 6472 -606

This leaflet was last revised in September 2014.

Source: Information from the package leaflet
Status: 08/2015