ALLERGODIL

ALLERGODIL acute duo 4ml AT acute/10ml NS acute

Important notes (mandatory information)

Allergodil akut Duo, eye drops + nasal spray. Active ingredient: Azelastine hydrochloride. Areas of application: for the symptomatic treatment of seasonal allergic rhinoconjunctivitis (e.g. hay fever in combination with allergic conjunctivitis) in adults, adolescents and children aged 6 and over.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Allergodil akut Duo,

Eye drops

0.5 mg/ml eye drop solution, nasal spray: 1 mg/ml nasal spray, solution
Active ingredient: 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 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 leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 days, consult your doctor.

What this leaflet contains

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

1. WHAT IS ALLERGODIL AKUT DUO AND WHAT IS IT USED FOR?

Allergodil akut Duo is an antiallergic/antihistamine and contains the active ingredient azelastine hydrochloride. Allergodil akut Duo is used for the symptomatic treatment of seasonal allergic rhinoconjunctivitis (e.g. hay fever in combination with allergic conjunctivitis) in adults, adolescents and children aged 6 and over.

2. WHAT SHOULD YOU CONSIDER BEFORE USING ALLERGODIL AKUT DUO?

Allergodil akut Duo must not be used:

• if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine listed in section 6.
• in children under 6 years of age, as there are no sufficient studies on dosage and pharmacokinetics.

Warnings and precautions

Please talk to your doctor or pharmacist before using Allergodil akut Duo.

Eye drops

The eye drops are not suitable for treating eye infections. Please contact your doctor or pharmacist if symptoms worsen or persist for more than 48 hours despite using Allergodil akut Duo.

Notes for patients with hepatic or renal insufficiency

There is insufficient experience with the treatment of patients with hepatic and/or renal insufficiency with Allergodil akut Duo.

Use of Allergodil akut Duo with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Interactions with other medicines have not been observed to date. The concomitant use of Allergodil akut Duo with other antihistamines and/or centrally acting medicines should only be done after consultation with the attending physician.

Use of Allergodil akut Duo with food, drink and alcohol

Interactions with food have not been observed to date. Simultaneous consumption of alcohol while taking antihistamines may, under certain circumstances, trigger central nervous system side effects and should be avoided.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, 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

There is insufficient experience with the use of azelastine hydrochloride during pregnancy. Therefore, Allergodil akut Duo should not be used as a precaution during the first three months of pregnancy. In the second and third trimesters of pregnancy, Allergodil akut Duo may only be used if it is absolutely necessary and under medical supervision.

Breastfeeding

Since the active ingredient is excreted in small amounts in breast milk, Allergodil akut Duo should not be used during breastfeeding.

Driving and operating machinery

When using Allergodil akut Duo, complaints such as fatigue, lassitude, exhaustion, dizziness or a feeling of weakness, which may also be caused by the disease process, have been reported very rarely. In these cases, the ability to drive a motor vehicle, work without a secure footing and operate machinery may be impaired. Please note in particular that alcohol can further impair your ability to drive.

Eye drops

Patients with allergic conjunctivitis often suffer from watery and itchy eyes, which can impair vision. The use of eye drops, even when used as directed, can impair vision immediately after instillation into the conjunctival sac and thus affect the ability to drive, operate machinery or work without a secure footing. You should therefore wait until your vision has returned to normal after instillation. The eye drops contain benzalkonium chloride, a preservative Benzalkonium chloride can cause eye irritation. Contact lenses must be removed before use and may not be reinserted until at least 15 minutes after use. Avoid contact with soft contact lenses. Benzalkonium chloride can discolour soft contact lenses.

3. HOW TO USE ALLERGODIL AKUT DUO?

Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Treatment and prevention of symptoms of seasonal allergic eye complaints:

• Eye drops

  For use on the eye. The recommended dose is: 1 drop in each eye 2 times a day (morning and evening). In case of severe symptoms, this dose can be increased to 1 drop per eye up to 4 times a day. On days with high allergen exposure, the eye drops should be used in the morning after getting up.

Symptomatic treatment of hay fever:

• Nasal spray: Nasal application. The recommended dose is: 1 spray per nostril 2 times a day (morning and evening).

For adults, adolescents and children aged 6 and over

The same dosage applies.

Method of administration:

• Eye drops

  Take a clean tissue and remove any tears from the lower eyelid. Unscrew the bottle. Tilt your head back slightly, gently pull the lower eyelid away from the eye and carefully drop one drop into the conjunctival sac. Make sure that the dropper tip does not touch the eye. Release the lower eyelid and press gently against the nose from the corner of the eye (see Fig. 4). Blink slowly several times to spread the drop over the eyeball. Then remove any excess eye drops. Repeat the procedure for the other eye.
• Nasal spray: The nasal spray should be used with the head held upright. After removing the protective cap, pump several times only on first use until an even spray mist is emitted. Spray one spray per nostril with the head held upright. Replace the protective cap. Keep your head upright after use. If the nasal spray is used incorrectly (with the head tilted back), a bitter taste may occur, which may cause nausea in some cases.

Duration of use

You should continue treatment with Allergodil akut Duo even after the symptoms have subsided for as long as you are exposed to the allergy-causing substances (e.g. pollen). Allergodil akut Duo can be used until the symptoms subside. The duration of use depends on the type, severity and course of the symptoms. The nasal spray is suitable for long-term treatment. The eye drops should not be used continuously for more than 6 weeks without consulting a doctor. The shelf life of the bottles after opening must be observed.

If you have used more Allergodil akut Duo than you should

No specific overdose reactions are known after application to the eye and nose and are not to be expected with this type of application. Due to the low amount of active ingredient, even in the case of extreme local overdose, no poisoning symptoms are to be expected. However, if large amounts (e.g. the entire contents of a bottle of nasal spray by a child) are accidentally swallowed, a doctor should be consulted in any case. There is no experience in humans after the use of toxic (very high, poisonous) doses of azelastine hydrochloride. However, based on animal experiments, central nervous system 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 Duo

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

If you stop using Allergodil akut Duo

Treatment with Allergodil akut Duo should be continued regularly until the symptoms have subsided. If you interrupt the use of Allergodil akut Duo, you must expect that the typical symptoms of your eye and nose condition will soon reappear.

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 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.

Eye drops

• Common: Mild eye irritation (e.g. burning, itching, tearing).
• Uncommon: Slightly bitter, substance-specific taste.
• Very rare: Allergic reactions.

Nasal spray:

• 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, skin rash, itching, hives, fatigue (lassitude, exhaustion), somnolence (drowsiness, sleepiness), dizziness or a feeling of weakness, which may also be caused by the disease process itself.

Measures to be taken if you are affected by side effects

The side effects mentioned usually subside quickly. Therefore, no special countermeasures are necessary. If you experience a bitter taste after using Allergodil akut Duo, you can counteract this with a non-alcoholic drink (e.g. juice, milk). If any of the side effects listed significantly affect you, stop using Allergodil akut Duo and see your doctor as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this 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: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALLERGODIL AKUT DUO?

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

Storage conditions:

• Eye drops

  No special storage conditions required.
• Nasal spray: Do not store below +8°C (i.e. not in the refrigerator). If the nasal spray is accidentally stored below +8°C for an extended period of time, the active ingredient will begin to crystallise out. However, by storing the solution at room temperature for a longer period of time (several hours), the crystals will dissolve completely again. This clear solution can then be used further.

Note on shelf life after opening:

• Use the eye drops within 4 weeks of opening.
• The nasal spray should not be used for more than 6 months after opening.

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 Duo contains

The active ingredient is: Azelastine hydrochloride.

• Eye drops

  1 ml solution contains 0.5 mg azelastine hydrochloride. One drop (solution) contains 0.015 mg azelastine hydrochloride. The other ingredients are: benzalkonium chloride (preservative), sodium edetate (Ph.Eur.), hypromellose, sorbitol solution 70% (crystallising) (Ph.Eur.), sodium hydroxide solution 4% and water for injections.
• Nasal spray: 1 ml solution contains 1 mg azelastine hydrochloride. 1 spray (0.14 ml solution) contains 0.14 mg azelastine hydrochloride. The other ingredients are: sodium edetate (Ph.Eur.), hypromellose, sodium monohydrogen phosphate dodecahydrate (Ph. Eur.), citric acid (Ph.Eur.), sodium chloride, purified water.

What Allergodil akut Duo looks like and contents of the pack

An original pack of Allergodil akut Duo contains 4 ml eye drops (solution) in a polyethylene dropper bottle and 10 ml nasal spray (solution) in a glass bottle with a screw-on pump. Both the eye drops and the nasal spray are clear, colourless solutions.

Pharmaceutical entrepreneur and manufacturer

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

This leaflet was last revised in March 2015.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Azelastine hydrochloride. Areas of application: for the symptomatic treatment of seasonal allergic rhinoconjunctivitis (e.g. hay fever in combination with allergic conjunctivitis) in adults, adolescents and children aged 6 and over.