This inhaler is used for the treatment of asthma as follows:

• It is a prescription medicine used to control asthma symptoms and prevent wheezing in patients 12 years of age and older.
• This inhaler contains Formoterol, a Long Acting β2 Agonist (LABA). When LABA is used alone, it increases the risk of asthma-related hospitalizations and death. This product contains both an Inhaled Corticosteroid (ICS) and a LABA. When ICS and LABA are used together, there is no significant increased risk of asthma-related hospitalization or death.
• This inhaler is not intended for patients whose asthma is well controlled with a low to medium dose ICS alone. It is indicated for patients who require both an ICS and a LABA for adequate asthma control.

100 HFA inhaler: Each actuation delivers Mometasone Furoate EP 100 microgram and Formoterol Fumarate Dihydrate EP 5 microgram from the actuator, and Mometasone Furoate EP 115 microgram and Formoterol Fumarate Dihydrate EP 5.5 microgram from the valve.

200 HFA inhaler: Each actuation delivers Mometasone Furoate EP 200 microgram and Formoterol Fumarate Dihydrate EP 5 microgram from the actuator, and Mometasone Furoate EP 225 microgram and Formoterol Fumarate Dihydrate EP 5.5 microgram from the valve.

Mometasone Furoate is an inhaled corticosteroid (ICS) that reduces inflammation in the lungs. Airway inflammation can lead to breathing difficulty. Formoterol Fumarate is a long-acting β2 agonist (LABA) that relaxes airway smooth muscles, improving airflow and preventing symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms occur when airway muscles become tight, making breathing difficult.

Adult and adolescent patients aged 12 years and older: The dosage is either 2 inhalations twice daily of 200 HFA inhaler or 100 HFA inhaler. When choosing the starting dosage strength of this inhaler, consider the patient’s disease severity, based on their previous asthma therapy including inhaled corticosteroid dosage, as well as the patient’s current control of asthma symptoms and risk of future exacerbation. The maximum recommended dosage is two inhalations of 200 HFA inhaler twice daily (maximum daily dosage 800 mcg/20 mcg). After each dose of 2 puffs, rinse your mouth with water. Spit out the water. Do not swallow it. This will help prevent thrush in your mouth or throat.

• Remove the cap and shake the inhaler vigorously before each use.
• Holding the inhaler well away from your mouth, breathe out gently (but not fully).
• Place the mouthpiece in your mouth and close your lips around it.
• Start breathing in slowly and deeply through your mouth, then press the metal canister firmly to release the dose, and continue inhaling.
• Remove the inhaler from your mouth and hold your breath for 10 seconds, or as long as comfortable, then breathe out slowly.
• If a second inhalation is required, wait at least one minute before repeating steps 2, 3, and 4. Replace the cap after use.
• Check your technique in front of a mirror. If you see a white mist during inhalation, it may indicate improper technique such as not sealing lips properly or not inhaling while pressing the canister. Repeat the steps carefully if this occurs.
• It is very important to clean the plastic mouthpiece regularly to prevent powder build-up. Remove the metal canister and wash the plastic mouthpiece in warm water at least twice a week. Allow it to dry overnight in a warm place. Daily washing is also safe. For further assistance, consult your physician.

• Strong CYP3A4 inhibitors should be used with caution, as they may increase systemic corticosteroid exposure.
• Adrenergic agents should be used cautiously, as additional sympathomimetic drugs may enhance adrenergic effects.
• Xanthine derivatives and diuretics may potentiate ECG changes and/or hypokalemia and should be used with caution.
• MAO inhibitors, tricyclic antidepressants, macrolide antibiotics, and drugs that prolong the QTc interval should be used with extreme caution due to possible cardiovascular effects.
• Beta-blockers should be used only when clearly necessary, as they may reduce bronchodilator efficacy and may precipitate severe bronchospasm.
• Concomitant use with halogenated hydrocarbons may increase the risk of cardiac arrhythmias during anesthesia.

This combination is contraindicated for the primary treatment of status asthmaticus or other acute asthma attacks requiring intensive management. It is contraindicated in patients with known hypersensitivity to Mometasone Furoate, Formoterol Fumarate, or any component of the product.

Common side effects include nasopharyngitis, sinusitis, headache, influenza, and upper respiratory tract infections. Less common side effects include serious allergic reactions, oral and throat candidiasis (thrush), adrenal suppression, increased wheezing, reduced bone mineral density in osteoporosis patients, growth suppression in children, glaucoma, blurred vision, and hypokalemia.

Use during pregnancy and lactation should be limited to cases where the potential benefit outweighs the potential risk to the mother and fetus/infant.

Hepatic/Renal impairment: No specific data are available for use in patients with hepatic or renal impairment.
Geriatrics: Pharmacokinetic studies in elderly patients are limited.

Combined bronchodilators

Keep out of reach of children. Store below 30°C, protected from direct sunlight and heat. Avoid eye contact. Do not puncture, burn, or break the container even when empty.