RATIOALLERG

RATIOALLERG Heuschnupfenspray

Important notes (mandatory information)

ratioAllerg Hay Fever Spray Active ingredient: Beclomethasone dipropionate. Areas of application: for the symptomatic short-term treatment of hay fever (seasonal allergic rhinitis) in adults, provided that the initial diagnosis of hay fever has been made by a doctor. Warning: Contains preservatives (benzalkonium chloride)!

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

ratioAllerg Hay Fever Spray 50 µg/spray Nasal spray, suspension for use in adults
Active ingredient: Beclomethasone dipropionate

Read the entire package leaflet carefully because it contains important information for you. 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 even worse after several days, contact your doctor.

What this leaflet contains

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

1. WHAT IS RATIOALLERG HAY FEVER SPRAY AND WHAT IS IT USED FOR?

ratioAllerg Hay Fever Spray is a rhinologic (medicine for use in the nose). ratioAllerg Hay Fever Spray is used for the symptomatic short-term treatment of hay fever (seasonal allergic rhinitis) in adults, provided that the initial diagnosis of hay fever has been made by a doctor. Note: ratioAllerg Hay Fever Spray is not suitable for the immediate relief of acute symptoms of allergic rhinitis.

2. WHAT SHOULD YOU CONSIDER BEFORE USING RATIOALLERG HAY FEVER SPRAY?

ratioAllerg Hay Fever Spray must not be used:

• if you are allergic to beclomethasone dipropionate or any of the other ingredients of this medicine listed in section 6,
• Patients with hypersensitivity to benzalkonium chloride should refrain from using ratioAllerg Hay Fever Spray.

Warnings and precautions

Please talk to your doctor or pharmacist before using ratioAllerg Hay Fever Spray. If you may have concomitant fungal infections or other infections in the nose and sinuses, these must be clarified by your doctor before using ratioAllerg Hay Fever Spray and treated specifically. Nasally applied glucocorticoids can cause side effects, especially when high doses are given over long periods of time. These effects occur much less frequently than with corticosteroids taken orally and can vary from patient to patient and between different corticosteroid preparations. Possible systemic effects include Cushing's syndrome (typical signs are full moon face, trunk obesity and facial flushing), hypofunction or atrophy of the adrenal cortex, growth retardation in children and adolescents, clouding of the lens (cataract), increased intraocular pressure (glaucoma) and, more rarely, a number of psychological effects or behavioral disorders including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children). Growth retardation has been reported in children receiving nasally applied glucocorticoids at the recommended dosage. It is recommended that the growth of children receiving long-term therapy with nasally applied glucocorticoids be monitored regularly. If the recommended dosage is exceeded, a clinically relevant impairment of adrenal cortex function may occur with reduced production or production that is no longer sufficiently increased in the event of increased demand (stress situations). In such cases, temporary additional systemic glucocorticoid administration should be considered in stress situations (e.g. before surgery) to compensate for the reduced natural glucocorticoid production. If you experience blurred vision or other visual disturbances, contact your doctor. Benzalkonium chloride can cause irritation of the mucous membranes and constriction of the airways.

Children and adolescents

ratioAllerg Hay Fever Spray is not indicated for the treatment of children and adolescents under 18 years of age.

Effects in case of misuse for doping purposes

The use of ratioAllerg Hay Fever Spray can lead to positive results in doping controls. The use of ratioAllerg Hay Fever Spray as a doping agent can be hazardous to health.

Use of ratioAllerg Hay Fever Spray together with other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may increase the effects of ratioAllerg Hay Fever Spray and your doctor may need to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

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

ratioAllerg Hay Fever Spray should not be used during pregnancy, especially during the first 3 months, as there is insufficient experience with its use in pregnant women.

breastfeeding

Glucocorticoids ("cortisone preparations"; this group of medicines includes, for example, beclomethasone dipropionate) pass into breast milk. If higher doses are used or if long-term treatment is necessary, breastfeeding should be discontinued.

Driving and operating machinery

The ability to drive a vehicle, operate machinery or work without a safe hold is not affected by the preparation.

ratioAllerg Hay Fever Spray contains benzalkonium chloride

The preservative (benzalkonium chloride) contained in ratioAllerg Hay Fever Spray can, especially with prolonged use, cause swelling of the nasal mucosa. If such a reaction is suspected (persistent nasal congestion), a nasal medication without preservatives should be used if possible. If such nasal medications without preservatives are not available, a different dosage form should be considered.

3. HOW TO USE RATIOALLERG HAY FEVER SPRAY?

Always use this medicine exactly as described in this 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: Spray 2 single doses (corresponding to 0.1 mg per application and 0.2 mg per day with a single dose of 0.05 mg beclomethasone dipropionate) into each nostril twice a day. In many cases, less frequent spraying into each nostril is sufficient. Once the symptoms (e.g. runny nose, stuffy nose) have improved, treatment should be continued with the lowest possible dose. The lowest dose with which effective control of symptoms is possible should be administered. A daily dose of 8 single doses (4 single doses, corresponding to 0.2 mg beclomethasone dipropionate, per nostril) should normally not be exceeded. ratioAllerg Hay Fever Spray is not suitable for the immediate relief of acute symptoms of allergic rhinitis. Treatment with ratioAllerg Hay Fever Spray improves the underlying disorders of these symptoms, and a pronounced effect is usually to be expected within a few days. It is therefore important to use ratioAllerg Hay Fever Spray regularly.

Method of administration

ratioAllerg Hay Fever Spray is intended for spraying into the nose. Please follow all points of the instructions for use carefully so that ratioAllerg Hay Fever Spray can develop its full effect. Clear the nostrils by gently blowing your nose before each use.

Instructions for use

Before using for the first time, shake the contents of the bottle briefly and then remove the protective cap from the nasal tube. Hold the bottle between your thumb, index finger and middle finger: your thumb under the bottom of the bottle, your index finger and middle finger on the round handle. Pressing down on the round handle activates the atomizer pump. Before using for the first time, press the pump 2-3 times as described above to fill the atomizer chamber. The spray bottle is then ready for use.

Using ratioAllerg Hay Fever Spray

1. Shake the container before each use.
2. Remove the protective cap.
3. Close one nostril, tilt your head slightly forward and then carefully insert the nasal tube into the other nostril; the bottle must be held upright.
4. Press the round handle down firmly once, as described above. This releases a precisely measured single dose. Inhale slowly and evenly through your nose.
5. Then exhale through your mouth and remove the nasal tube from your nose.
6. Then spray another single dose into the other nostril in the same way.
7. Then carefully wipe the nasal tube with a clean tissue or similar to remove any remaining liquid and replace the protective cap.

Duration of use

If the symptoms persist despite the use of ratioAllerg Hay Fever Spray for several days, you should consult a doctor who will check whether further treatment with ratioAllerg Hay Fever Spray is indicated or whether other measures should be taken. Please talk to your doctor or pharmacist if you have the impression that the effect of ratioAllerg Hay Fever Spray is too strong or too weak.

If you have used more ratioAllerg Hay Fever Spray than you should

As a result of an overdose, undesirable glucocorticoid-like effects may occur, which may manifest themselves, for example, in increased susceptibility to infection. If the specified maximum dose is exceeded for a short period of time, the hormonal control circuit (suppression of the hypothalamus-pituitary-adrenal cortex function) may be impaired, which can be detected by lowered plasma cortisol levels. Special emergency treatment is usually not necessary. Treatment should be continued at the prescribed dosage; the hormonal control circuit is generally restored after 1-2 days. It is important that you always use the dosage as stated on the outer carton by your pharmacy or follow the instructions of your doctor. You should only use the dose recommended by your doctor; your symptoms may worsen if you use a lower or higher dose.

If you forget to use ratioAllerg Hay Fever Spray

Do not use twice the amount if you have forgotten the previous application. Continue treatment as before without making up for the missed application.

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.

Complaints at the site of administration:

• Common: dry and irritated nasal or throat mucosa, nosebleeds, unpleasant odor or taste sensations
• Very rare: damage to the nasal septum (nasal septum perforation)

Infections:

• Very rare: fungal infections (candidiasis)

Immune system disorders:

• Very rare: hypersensitivity reactions* including rash (exanthema), hives (urticaria), itching (pruritus), swelling (edema) and redness (erythema) of the face, eyes, lips and throat, bronchial spasm (bronchospasm).

*anaphylactic/anaphylactoid reactions

Eyes:

• Very rare: increased intraocular pressure up to glaucoma (glaucoma)
• Not known: blurred vision

Side effects whose frequency is not known (see above), but which may also occur are: restlessness, sleep disorders, anxiety, depression, aggression, behavioral changes (especially in children). Nasally applied glucocorticoids can cause side effects, especially when high doses are given over long periods of time (see also 2. under "Warnings and precautions"). Growth impairments in children cannot be ruled out.

Countermeasures

Please discuss this question with your doctor. He can give you binding information and, if necessary, initiate the necessary countermeasures.

Reporting side effects

If you experience 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 about the safety of this medicine.

5. HOW TO STORE RATIOALLERG HAY FEVER SPRAY?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the outer carton and the bottle label after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you are no longer using it. You help to protect the environment.

6. Contents of the pack and further information

What ratioAllerg Hay Fever Spray contains

The active ingredient is: Beclomethasone dipropionate 1 ml nasal spray, suspension contains 0.555 mg beclomethasone dipropionate. Each spray of 0.09 ml nasal spray, suspension contains 0.05 mg beclomethasone dipropionate. The other ingredients are: benzalkonium chloride (0.1 mg/ml), polysorbate 80, D-glucose, microcrystalline cellulose, carmellose sodium, purified water, sodium hydroxide and hydrochloric acid for pH adjustment.

What ratioAllerg Hay Fever Spray looks like and contents of the pack

ratioAllerg Hay Fever Spray is available in packs of 10 ml nasal spray, suspension (equivalent to at least 80 single doses).

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This leaflet was last revised in May 2017.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Beclomethasone dipropionate. Areas of application: for the symptomatic short-term treatment of hay fever (seasonal allergic rhinitis) in adults, provided that the initial diagnosis of hay fever has been made by a doctor. Warning: Contains preservatives (benzalkonium chloride)!