Glycohale FB Inhaler

Description

Product Description

Glycohale FB Inhaler combines three respiratory medicines with different actions in a single metered-dose device. Each delivered dose contains Budesonide 200 mcg, Formoterol Fumarate 6 mcg and Glycopyrronium Bromide 12.5 mcg. Cipla Ltd. markets the 120-dose inhaler.

Budesonide is an inhaled corticosteroid that reduces inflammation in the airways. Formoterol is a long-acting bronchodilator that relaxes airway muscles, while Glycopyrronium is a long-acting muscarinic antagonist that helps prevent airway narrowing. The three-way approach is intended for regular maintenance treatment rather than immediate relief of a sudden breathing attack.

Uses

• Maintenance treatment of chronic obstructive pulmonary disease (COPD).
• Helps reduce persistent airway obstruction associated with COPD.
• Helps control symptoms such as breathlessness, wheezing and chest tightness over the course of regular treatment.
• Used when inhaled corticosteroid, long-acting beta-2 agonist and long-acting muscarinic antagonist therapy are considered appropriate together.

Key Benefits

• Combines anti-inflammatory and two different bronchodilator mechanisms in one inhaler.
• Budesonide helps reduce airway inflammation.
• Formoterol provides prolonged relaxation of airway smooth muscle.
• Glycopyrronium helps limit bronchoconstriction through muscarinic receptor blockade.
• Single-inhaler triple therapy can simplify a prescribed COPD maintenance regimen.

How to Use

• Use Glycohale FB Inhaler exactly as prescribed by your doctor.
• Follow the inhaler’s specific priming and inhalation instructions before the first use.
• Exhale fully away from the mouthpiece, place the mouthpiece correctly and inhale as instructed so the medicine reaches the lungs.
• Hold your breath for a few seconds after inhaling if your device instructions permit, then breathe out slowly.
• Rinse your mouth with water after use and spit it out to reduce the risk of oral fungal infection from Budesonide.
• Keep the inhaler clean and follow the device instructions for storage and handling.
• Do not use extra doses to relieve sudden breathlessness unless your doctor has specifically included them in your treatment plan.
• This inhaler is not intended to replace a prescribed rescue inhaler for an acute breathing attack.

How It Works

Glycohale FB combines three complementary respiratory actions. Budesonide reduces inflammatory activity within the airways. Formoterol stimulates beta-2 receptors on airway smooth muscle, producing prolonged bronchodilation. Glycopyrronium blocks muscarinic receptors that contribute to bronchial constriction, helping keep the airways more open. Together, these effects can improve airflow and support regular symptom control in COPD.

Side Effects

• Oral thrush or fungal infection in the mouth.
• Throat irritation.
• Hoarseness or voice changes.
• Headache.
• Tremor or shakiness.
• Dry mouth.
• Cough.
• Nausea.
• Palpitations or faster heartbeat.
• Muscle cramps may occur in some patients.

Contact your doctor if side effects persist, become severe or interfere with normal activities.

Precautions & Warnings

• Budesonide can increase the risk of pneumonia and other respiratory infections in patients with COPD. Seek medical advice for worsening cough, increased sputum, fever, chills or other signs of infection, particularly if breathing symptoms change suddenly.
• This inhaler is for regular maintenance treatment and should not be relied upon for rapid relief of an acute, severe breathing attack. Use your prescribed rescue medicine when appropriate and seek urgent care if severe breathlessness does not improve.
• Formoterol should be used as part of an inhaled corticosteroid-containing combination such as Glycohale FB rather than as a long-acting beta-2 agonist alone in patients for whom an inhaled corticosteroid is indicated.
• Rinse your mouth after each use to reduce the likelihood of oral thrush and other local corticosteroid effects.
• Tell your doctor if you have glaucoma, cataracts, difficulty passing urine or prostate enlargement because Glycopyrronium may worsen these conditions.
• Inform your doctor if you have heart disease, an abnormal heart rhythm, high blood pressure or other cardiovascular conditions because Formoterol may affect heart rate and rhythm.
• Tell your doctor if you have diabetes or thyroid disease, as Formoterol can influence blood glucose and other metabolic responses.
• Inform your doctor if you have osteoporosis or other conditions associated with reduced bone density, particularly during prolonged corticosteroid exposure.
• Tell your doctor about kidney or liver problems and all medicines you use, including other inhalers.
• Avoid allowing the inhaled medicine to enter the eyes, especially when using a mask or if the inhaler is used incorrectly.
• Do not discontinue regular COPD maintenance treatment without speaking with your doctor.
• Consult your doctor before using Glycohale FB during pregnancy or breastfeeding.
• Seek urgent medical attention for severe breathing difficulty, chest pain, fainting, a rapid or irregular heartbeat, serious allergic swelling or sudden worsening of symptoms.

Storage Instructions

• Store below 30°C.
• Keep the inhaler in its original packaging until use.
• Protect it from excessive heat and direct sunlight.
• Do not expose the inhaler to freezing temperatures.
• Keep the mouthpiece clean and dry.
• Keep out of reach and sight of children.
• Do not use the inhaler after the expiry date printed on the package.
• Follow the device-specific instructions for cleaning and disposal when the inhaler is empty.

FAQs

Q: What is Glycohale FB Inhaler used for?
A: Glycohale FB Inhaler is prescribed for regular maintenance treatment of chronic obstructive pulmonary disease (COPD).

Q: What does Glycohale FB Inhaler contain?
A: Each metered dose contains Budesonide 200 mcg, Formoterol Fumarate 6 mcg and Glycopyrronium Bromide 12.5 mcg.

Q: Is Glycohale FB Inhaler a prescription medicine?
A: Yes. It is a prescription inhaled medicine and should be used according to your doctor’s treatment plan.

Q: Is Glycohale FB a rescue inhaler?
A: No. It is intended for regular maintenance treatment and is not designed to provide immediate relief during a sudden severe breathing attack.

Q: Why should I rinse my mouth after using Glycohale FB?
A: Budesonide can increase the risk of oral fungal infection and throat irritation. Rinsing and spitting out the water after inhalation can help reduce these local effects.

Q: Who manufactures Glycohale FB Inhaler?
A: Glycohale FB Inhaler is marketed by Cipla Ltd. The commonly listed device contains 120 metered doses.