Administer Asmalin ® Plus HFA Inhaler by oral inhalation only. 2 puffs as needed, with a maximum of 12 puffs in 24 hours.

This is contraindicated for patients showing hypersensitivity to salbutamol, budesonide, or to any of the excipients.

• If this inhaler produces paradoxical bronchospasm, it should be discontinued immediately, and alternative therapy should be instituted. • This inhaler can produce cardiovascular effects in some patients as measured by increases in pulse rate, blood pressure, and/or other symptoms. If such effects occur, this Inhaler may need to be discontinued. • This inhaler should not be used more than the maximum daily dose. • Hypersensitivity reactions can occur after administration of this inhaler such as anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash and urticaria. Discontinue this Inhaler if such reactions occur. • Beta-adrenergic agonist medicines may produce significant hypokalemia in some patients. • Inhaled corticosteroids should be used with caution in patients. It may produce active or quiescent tuberculosis infection of the respiratory tract, systemic fungal, bacterial, viral, or parasitic infections or ocular herpes simplex. • This inhaler contains budesonide, an inhaled corticosteroid (ICS) which can cause infections of the mouth and pharynx with Candida Albicans. When such an infection develops, it should be treated with appropriate local or systemic antifungal therapy while treatment with this inhaler continues. • Patients treated with this inhaler should be observed carefully for any evidence of systemic corticosteroid effects. • Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing ICS. • Glaucoma increased intraocular pressure, and cataracts have been reported following the long-term administration of ICS, including budesonide. These patients should consult with an ophthalmologist. • Caution should be exercised when considering the co-administration of this inhaler with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g.- ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin). • If the patient continues to experience symptoms after using this inhaler or requires more doses of this inhaler than usual and requires evaluation of the patient with their treatment regimen.

Common side effects: Headache, cough, thrush in mouth and throat, adrenal insufficiency, allergic reactions, low bone mineral density, eye problems including glaucoma, cataracts etc.

• Strong cytochrome P4503A4 inhibitors (e.g.- ritonavir) should be used with caution. • Other short-acting broncho dilators: Use judiciously with other short-acting beta agonists. • Beta blockers: May decrease effectiveness of this inhaler and produce severe bronchospasm. • Diuretics, or non-potassium-sparing diuretics: May potentiate hypokalemia or ECG changes consider monitoring potassium levels with concomitant use. • Monoamine oxidase inhibitors (MAOI) and tricyclic antidepressants: Use these types of medications alongside this inhaler with caution.

Use in pregnancy: There are no adequate and well-controlled studies with this preparation in pregnant women to inform a drug-associated risk. However, available data from epidemiological studies and post-marketing case reports of pregnancy outcomes following inhaled salbutamol use do not consistently demonstrate a risk of major birth defects or miscarriage. Reviews with budesonide use in pregnant women have not identified a drug-related risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Use in lactation: There are no available data on the effects of this preparation on the breastfed child or on milk production.

Asmalin® Plus HFA Inhaler: Each canister contains 120 puffs.