This combination inhaler is indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Asthma: Indicated for regular maintenance therapy in patients where the use of a combination of an inhaled corticosteroid (ICS) and a long-acting β2-adrenergic agonist (LABA) is appropriate.

COPD: Indicated for the symptomatic treatment of patients with severe COPD who have a history of repeated exacerbations despite regular treatment with long-acting bronchodilators.

This preparation is a combination of Beclomethasone Dipropionate and Formoterol Fumarate Dihydrate in a hydrofluoroalkane (HFA)-based, environmentally friendly inhaler that does not contain chlorofluorocarbons (CFCs), which are known to contribute to ozone layer depletion. Beclomethasone Dipropionate is a synthetic corticosteroid with strong anti-inflammatory activity. When inhaled, it acts locally in the lungs to reduce inflammation without the systemic side effects commonly associated with oral corticosteroids. Formoterol Fumarate Dihydrate is a long-acting selective β2-adrenergic agonist with a rapid onset of action. It acts as a bronchodilator by relaxing bronchial smooth muscles, thereby improving airflow. As an inhaled therapy, the medication is delivered directly to the lungs, resulting in targeted action with minimal systemic exposure.

Asthma: Dosage should be adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose.

Maintenance Therapy: Adults & Adolescents (18 years & above): One or two inhalations twice daily.The maximum daily dose is 4 inhalations.

Maintenance and reliever therapy: Patients take a daily maintenance dose of this inhaler as needed in response to symptoms. Patients should be advised to always have this inhaler available for rescue use.

Adults & Adolescents (18 years & above): One inhalation twice daily. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations.

COPD: 2 Inhalations twice daily.

Administration

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations).
• Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

With medicines: Concurrent use with beta-adrenergic agents, quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants should be avoided due to the risk of enhanced cardiovascular effects.

With food & others: No significant interaction with food has been reported.

This inhaler is contraindicated in patients with known hypersensitivity to Beclomethasone Dipropionate, Formoterol Fumarate, or any of the formulation components.

Common side effects:

• Hypokalemia
• Headache
• Tremor
• Palpitations
• Cough
• Muscle cramps
• Prolongation of QT interval

Rare side effects:

• Rash
• Urticaria
• Itching (pruritus)
• Erythema
• Swelling of the eyes, face, lips, or throat

This inhaler should be used during pregnancy and breastfeeding only if the expected benefit to the mother outweighs any potential risk to the fetus or infant.

This combination should not be initiated for the management of acute severe asthma attacks or in patients with rapidly worsening asthma symptoms.

Respiratory corticosteroids.

Do not puncture, break, or incinerate the pressurized canister, even when empty. Store below 30°C in a dry place, protected from heat and direct sunlight. Keep away from eyes and out of reach of children.