• 0.05 mg beclometasone dipropionate

• 0.02 mg benzalkonium chloride
• Polysorbate 80
• cellulose, microcrystalline
• carmellose sodium
• glucose
• Sodium hydroxide for pH adjustment
• water, purified
• disodium edetat-2 water

Indication/ seasonal allergic rhinitis Application

• The medicine is a nasal spray.
• field of use
  • For the short-term symptomatic treatment of hay fever (seasonal allergic rhinitis).
  • Notice:
    • The drug is not suitable for the immediate treatment of acute symptoms of allergic rhinitis.
    • Treatment should only be started after an initial diagnosis by a doctor.

seasonal allergic rhinitis dosage

• Always use this preparation exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• The usual dose is:
  • The lowest dose at which symptoms are effectively controlled should be used.
  • Adults:
    • Spray 2 single doses twice daily (equivalent to 0.2 mg per application and 0.4 mg per day for a single dose of 0.05 mg beclometasone dipropionate) in each nostril. In many cases, a less frequent spraying into each nostril is sufficient.
    • Once the symptoms (e.g. runny nose, stuffy nose) have improved, treatment should be continued at the lowest possible dose. A daily dose of 8 single doses (4 single doses per nostril) should normally not be exceeded.
  • Notice:
    • The medicinal product is not suitable for the immediate treatment of acute symptoms of allergic rhinitis. Treatment with this preparation improves the disorders underlying these symptoms, and a pronounced effect can usually be expected within a few days. Therefore, it is important to use this preparation regularly in the specified dose.

• duration of use
  • Do not use the medicine for more than 7 days without medical advice.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you use more than you should
  • As a result of an overdose, undesirable effects that are typical of glucocorticoids can occur, which can manifest themselves, for example, in an increased susceptibility to infections. If the specified maximum dose is exceeded for a short time, the side effect can be an impairment of the hormonal control circuit (suppression of the hypothalamus-pituitary-adrenal cortex function), which can be determined by reduced plasma cortisol levels.
  • Special emergency treatment is usually not required.
  • Treatment should be continued at the indicated dosage; the functionality of the hormonal control circuit is generally restored after 1 - 2 days.

• If you forgot the application
  • Skip the missed application, continue further application as indicated in the dosing instructions.

• If you cancel the application
  • You could jeopardize the success of the treatment.
  • Please talk to your doctor or pharmacist before stopping treatment.

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

seasonal allergic rhinitis way

• The medicine is intended for spraying into the nose. Please carefully observe all points in the operating instructions so that the medicinal product can develop its full effect. Before each application, clear your nostrils by gently blowing your nose.
• Operation manual:
  • Before using for the first time, shake the contents of the bottle briefly and then pull off the protective cap from the nasal tube. Hold the bottle between thumb, index and middle finger; thumb under the bottom of the bottle, index and middle finger on the handle. The atomizer pump is actuated by depressing the handle. Before the first use, operate the pump 2 - 3 times in the manner described so that the atomizer chamber is filled. After that, the spray bottle is ready for use.
• Application:
  • 1. Shake the container before each use.
  • 2. Pull off the protective cap.
  • 3. Cover one nostril, tilt your head slightly forward, and then gently insert the nasal tube into the other nostril; the bottle must be held upright.
  • 4. Firmly press the grip down once as described above. This releases a precisely measured single dose. Breathe in slowly and evenly through your nose.
  • 5. Then exhale through your mouth and take the nasal tube out of your nose.
  • 6. Then spray another single dose into the other nostril in the same way. Put the protective cap back on.
• Cleaning after use:
  • Always keep the nose tube clean and cover it with the protective cap after use.

side seasonal allergic rhinitis effects

• Like all medicines, this medicine can have side effects, although not everyone gets them. The evaluation of side effects is based on the following frequency information:
  • Very common: may affect more than 1 in 10 people
  • Common: may affect up to 1 in 10 people
  • Uncommon: may affect up to 1 in 100 people
  • Rare: may affect up to 1 in 1,000 people
  • Very rare: may affect up to 1 in 10,000 people
  • Not known: frequency cannot be estimated from the available data
• possible side effects
  • diseases of the immune system
    • Very rare: Hypersensitivity reactions* including skin rash (exanthema), hives (urticaria), itching (pruritus), redness (erythema) and swelling (oedema) of the face, eyes, lips and throat, sudden narrowing of the airways (bronchospasm)
    • *anaphylactic/anaphylactoid reactions
  • Diseases of the nervous system
    • Common: Unpleasant taste or smell
    • Rare: headache
  • eye diseases
    • Very rare: increase in intraocular pressure, glaucoma, cloudy lens (cataract)
  • Respiratory, thoracic and mediastinal disorders
    • Common: Nosebleeds, dryness and irritation of the lining of the nose and throat
    • Very rare: perforation of the nasal septum
  • When switching from oral or parenteral corticosteroid therapy to this drug, concomitant diseases outside
    the nasal area such as e.g. B. allergic conjunctivitis and allergic skin symptoms reappear, which were suppressed under oral or parenteral corticosteroid treatment. These may require additional treatment.
  • Nasal glucocorticoids can cause systemic side effects, particularly when high doses are given for long periods of time.
  • Systemic effects, including growth retardation in children and adolescents or increased susceptibility to infections, may occur when the recommended dose is exceeded or in patients with particular sensitivity or in predisposed patients who have recently received systemic corticosteroid treatment.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

seasonal allergic rhinitis interactions

• Use together with other medicines
  • Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines that can be obtained without a prescription.
  • Some medicines can increase the effects of this medicine and your doctor may want to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).

seasonal allergic rhinitis Contraindications

• The drug must not be used
  • if you have known hypersensitivity to beclometasone dipropionate or any of the other ingredients of this medicine.

pregnancy seasonal allergic rhinitis and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
• pregnancy
  • The drug should not be used during pregnancy, especially in the first three months, as there is insufficient experience with its use in pregnant women.
• lactation
  • Glucocorticoids pass into breast milk. Breast-feeding should be discontinued if higher doses are used or during long-term treatment.

patient seasonal allergic rhinitis notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before using this product.
  • If you have any concomitant fungal diseases or other infections in the area of ​​the nose and sinuses, these must be clarified and specifically treated by your doctor before using this medicine.
  • If you have a recent nose injury or surgery, or have problems with ulcer formation, you should seek medical advice before using this medicine.
  • Nasal glucocorticoids can cause side effects, particularly when high doses are given for long periods of time.
  • Growth retardation has been reported in children receiving nasal glucocorticoids at recommended doses.
  • It is recommended that the growth of children receiving long-term therapy with nasal glucocorticoids be monitored regularly.
  • If the recommended dosage is exceeded, a clinically relevant reduction in the function of the adrenal cortex can occur with reduced production of endogenous glucocorticoids, or production of endogenous glucocorticoids that can no longer be increased sufficiently in the event of increased demand (stressful situations).
  • In such cases, temporary additional glucocorticoid administration should be considered in stressful situations (e.g. before operations) to compensate for the reduced natural glucocorticoid production.
• children and young people
  • The medicine is not indicated for the treatment of children and adolescents under 18 years of age.

• Ability to drive and use machines
  • There is no experience of impairment of the ability to drive and use machines.