Budison FG Inhaler

✔️ Each puff contains:

• Formoterol fumarate: 5.5 mcg, as formoterol fumarate dihydrate
• Glycopyrronium bromide: 10.4 mcg
• Budesonide: 182 mcg

✔️ Side Effects

Possible side effects and risks include:

• Oral or throat fungal infection (oral thrush)
• Cough or throat irritation
• Increased risk of pneumonia in patients with COPD
• Palpitations, increased heart rate, or other cardiovascular effects
• Muscle cramps or low potassium levels
• Allergic reactions
• Blurred vision or worsening of narrow-angle glaucoma
• Difficulty passing urine or worsening urinary retention
• Adrenal suppression or other systemic corticosteroid effects, particularly with excessive exposure or certain drug interactions
• Reduced bone mineral density with prolonged corticosteroid exposure

✔️ Side Effect

Hepatic impairment: Patients with severe liver impairment may have increased systemic exposure to some components. Medical supervision and monitoring may be required.

Renal impairment: Use in severe kidney impairment should be assessed carefully by the prescribing physician.

Children: The supplied product information does not establish safety and efficacy in children. Use only in the population approved by the current product label.

Older adults: Routine dose adjustment may not be necessary in all older patients, but kidney function, cardiovascular health, and individual tolerability should be considered.

✔️ Drug Interaction

Tell your doctor about all medicines and supplements you take. Important potential interactions include:

• Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, and clarithromycin, may increase systemic exposure to budesonide.
• Other adrenergic medicines may increase cardiovascular effects.
• Diuretics, xanthine derivatives, and corticosteroids may increase the risk of low potassium levels or changes in heart rhythm.
• Monoamine oxidase inhibitors and tricyclic antidepressants may increase the cardiovascular effects of formoterol.
• Beta-blockers may reduce the bronchodilating effect of formoterol and, in some cases, trigger bronchospasm.
• Other anticholinergic medicines may increase adverse effects such as urinary retention or glaucoma-related symptoms.

Do not start or stop any medicine without consulting your healthcare professional.

✔️ Precautions and Warnings

• Budison-FG is intended for maintenance treatment of COPD, not for immediate relief of acute bronchospasm.
• Do not use another LABA-containing medicine alongside this inhaler unless specifically directed by your doctor.
• Increased use of a rescue inhaler or worsening breathing symptoms may indicate deteriorating COPD and require prompt medical assessment.
• Inhaled corticosteroids can increase the risk of oral thrush and pneumonia. Rinse your mouth after every dose and report symptoms such as fever, worsening cough, or increased sputum.
• Use cautiously if you have heart disease, high blood pressure, cardiac rhythm disorders, diabetes, thyroid disorders, glaucoma, urinary retention, osteoporosis, or kidney or liver impairment.
• Do not stop long-term oral corticosteroids abruptly when changing treatment. Any transition must be supervised by a healthcare professional.

If sudden breathing difficulty occurs and the inhaler does not provide relief, follow your prescribed rescue plan and seek urgent medical help when necessary.

✔️ Contraindications

Budison-FG should not be used by patients with known hypersensitivity to budesonide, glycopyrronium, formoterol, or any of the product's other ingredients.

✔️ Pregnancy and Breastfeeding

There are limited data on the safety of this combination inhaler during pregnancy and breastfeeding. Budesonide can pass into breast milk, while information about glycopyrronium and formoterol transfer into human milk is limited.

Pregnant or breastfeeding patients should consult their doctor to assess the benefits of treatment against potential risks. Do not discontinue prescribed COPD treatment without medical advice.

✔️ Storage:

• Store below 30°C, protected from direct sunlight, heat, and moisture.
• Do not puncture, burn, or incinerate the pressurized canister, even when empty.
• Keep out of reach of children and avoid spraying into the eyes.
• Shake well before use if directed by the product instructions.
• Follow the manufacturer's instructions for cleaning and disposal.