BICLO

Nasal Spray

– Each actuation delivers 42 mcg of beclomethasone dipropionate.

– BECLO Nasal Spray provides 120 actuations (sprays).

Properties:

– Beclomethasone dipropionate, the active componant of BECLO Nasal Spray, is an anti-inflammatory steroid.

– BECLO Nasal Spray reduces the swelling and irritation in the nose, so it helps to relieve the uncomfortable symptoms.

Indications:

– BECLO Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and non- allergic rhinitis.

– BECLO Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. The treatment should be continued for several weeks or more before a therapeutic result can be fully assessed.

Contraindications:

Hypersensitivity to any of the ingredients of BECLO Nasal Spray. Warnings:

– The replacement of a systemic corticosteroid with BECLO Nasal Spray can be accompanied by signs of adrenal insufficiency in addition to some symptoms e.g.,joint and/ or muscular pain, lassitude and depression. – Patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

– Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids.

Side effects:

– Most people do not have any problems after using BECLO Nasal Spray.

– The most common side effect is irritation of the nasal mucous membranes.

– Rare cases of urticaria, rash, bronchospasm, sneezing, headache, nausea, nosebleeds and tearing eyes. Overdosage:

When BECLO Nasal Spray is used at excessive doses, it should be discontinued slowly under physician supervision.

Information for Patients:

– Patient should use BECLO Nasal Spray at regular intervals.

– Patient should take the medication as directed and should not exceed the prescribed dosage.

– Patient should contact the physician if symptoms do not improve after 3 weeks, if the condition worsen, or if sneezing or nasal irritation occurs.

Pregnancy:

– There are no adequate studies in pregnant women.

– BECLO Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to fetus.

Nursing Mothers:

It is not known whether beclomethasone dipropionate is excreted in human milk, because other steroids are excreted in human milk, caution should be exercised when BECLO Nasal Spray is administered to a nursing mother.

Pediatric Use:

Corticosteriods may cause a reduction in growth velocity in children and teenagers with extended use. Dosage & Administration:

– Adults and children 12 years of age and older: 1 – 2 inhalations in each nostril twice a day.

– Children 6-12 years of age: 1 inhalation in each nostril twice a day, patients not adequately responding to this dose may use 2 inhalations in each nostril.

– Not recommended for children less than 6 years of age.

– The effect of BECLO Nasal Spray is not immediate; this should be explained to the patient in order to ensure continuation of treatment.

– In the presence of excessive nasal secretion or edema of the nasal mucosa, BECLO Nasal Spray may fail

to reach the site of action; so nasal vasoconstrictor may be used during the first 3 days of BECLO Nasal Spray therapy.

Storage:

– Store between 15-30°C.

– Protect from light.

– Store away from low temperature, Do not put in refrigerator.

– Patient must cease to use this medication, 3 months after initial use of the nasal spray.

Presentation:

Plastic Bottle contains 8 g of BECLO Nasal Spray.