Beclosone Forte 100 mcg Solution for Inhalation 200 Metered Inhalations

Beclosone Forte 100 mcg Solution for Inhalation 200 Metered Inhalations 

Composition:

Each dose contains:
Beclometasone dipropionate — 100 mcg.
Excipients: Absolute ethanol, tetrafluoroethane (HFA 134a).

Product Description:

• Beclozone Forte is a topical glucocorticosteroid used as a baseline anti-inflammatory therapy for bronchial asthma.
• It reduces airway edema, bronchial hyperresponsiveness, and mucus production in the lungs, facilitating breathing and preventing asthma attacks.
• It is intended for regular continuous use.
• The medication does not exert an immediate effect and should not be used to relieve acute asthma attacks (a quick-acting inhaler should be used for this purpose).

Indications for Use:

Prevention and baseline therapy of bronchial asthma of any severity level in adults and children (for controlling symptoms of shortness of breath and wheezing).

Method of Administration and Dosage:

• Method of Administration: Inhalation use, inhaled through the mouth into the lungs. Dosage is adjusted individually depending on the severity of the disease.
• Adults and Elderly Patients: Initial dose — 100 mcg (1 inhalation) twice daily. In severe cases, the dose may range from 400 to 600 mcg per day (divided into 2–3 doses).
• Children: Initial dose — 100 mcg twice daily. Depending on the severity of bronchial asthma, the daily dose may be increased up to 400 mcg per day (divided into 2–4 doses).
• Hygiene: After each inhalation, it is recommended to rinse the mouth with water (without swallowing) to reduce the risk of oral candidiasis.

Contraindications:

• Hypersensitivity to beclometasone or any of the excipients.
• Active or inactive pulmonary tuberculosis.
• Ophthalmic herpes (herpes simplex eye infection).
• Fungal infections of the nasopharynx and respiratory tract (including those caused by Candida).
• Untreated parasitic and systemic infections.
• Severe reduction of adrenal function.
• Increased intraocular pressure, open-angle glaucoma, cataracts (clouding of the eye lens).
• Presence of nasal septum ulcers or respiratory tract injuries.

Precautions:

• Relief of Attacks: Do not use the medication for quick relief of bronchospasm attacks. Always keep a short-acting (rescue) inhaler with you.
• Paradoxical Bronchospasm: If severe wheezing and breathing difficulty occur immediately after inhalation, use a quick-acting inhaler right away, discontinue beclometasone, and consult a physician.
• Systemic Effects and Withdrawal Syndrome: Prolonged use at high doses or transitioning from systemic oral corticosteroids to inhaled ones may cause adrenal insufficiency.
• Symptoms Requiring Medical Attention: Severe fatigue, muscle weakness or pain, sudden abdominal or leg pain, loss of appetite, weight loss, nausea, vomiting, diarrhea, dizziness, fainting spells, depression, irritability, hyperpigmentation of the skin.
• Infections: Avoid contact with patients who have chickenpox or measles if you have not previously had these infections or have not been vaccinated.
• Medical Monitoring: Regularly inform your physician about any history of tuberculosis, glaucoma, cataracts, or changes in the effectiveness of your usual dose.

Adverse Reactions / Side Effects:

Local Reactions: Dryness and irritation of the throat mucous membrane, hoarseness (dysphonia), cough, unpleasant taste in the mouth, oral and pharyngeal candidiasis (thrush).
Allergic Reactions: In rare cases, rash, itching, urticaria, angioedema (face, tongue, throat), severe dizziness, and difficulty breathing may occur.

Pregnancy and Lactation:

Use during pregnancy is permitted only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
If pregnancy occurs during treatment, consult a physician immediately.
Administration during lactation requires caution and evaluation of the benefit-to-risk ratio under medical supervision.

Storage Conditions:

• Store at a temperature not exceeding 30 °C.
• Protect from freezing and direct sunlight.
• Keep out of reach of children.
• The canister is pressurized: do not disassemble, puncture, or burn even when empty.

Packaging:

An aluminum canister with a metering valve, actuator, and protective cap, containing 200 doses of the product, placed in a cardboard box with a patient instruction leaflet.