Glycohale FB Rotacap

Description

Product Description

Glycohale FB Rotacap is designed for use with a compatible Rotahaler or prescribed dry-powder inhalation device. Each capsule contains Budesonide 400 mcg, Formoterol Fumarate 12 mcg and Glycopyrronium Bromide 25 mcg. Cipla Ltd. markets the product, and the commonly listed presentation contains 30 Rotacaps.

The three ingredients have distinct roles in maintenance respiratory therapy. Budesonide reduces inflammation within the airways, Formoterol provides prolonged bronchodilation, and Glycopyrronium limits airway tightening through anticholinergic action. The combination is intended for regular COPD control and is not a substitute for a fast-acting rescue medicine during a sudden severe breathing episode.

Uses

• Maintenance treatment of chronic obstructive pulmonary disease (COPD).
• Helps control persistent breathlessness and wheezing associated with COPD.
• Supports regular management of airflow limitation.
• May be prescribed when triple inhaled therapy is appropriate for a patient’s COPD treatment plan.

Key Benefits

• Brings an inhaled corticosteroid together with two long-acting bronchodilators.
• Budesonide targets airway inflammation.
• Formoterol helps keep bronchial smooth muscle relaxed.
• Glycopyrronium reduces cholinergic bronchoconstriction.
• One inhaled formulation can simplify a prescribed triple-therapy regimen.

How to Use

• Use Glycohale FB Rotacap exactly as prescribed by your doctor.
• Use each Rotacap only with the inhalation device recommended for the product.
• Do not swallow the capsule.
• Place the capsule in the device according to its instructions, pierce it only as directed, and inhale the powder deeply through the mouthpiece.
• Do not open the capsule and mix the powder with food or water.
• Rinse your mouth after inhalation and spit out the water.
• Keep the inhalation device clean and use it according to the manufacturer’s instructions.
• Do not use additional doses for sudden breathlessness unless your doctor has specifically included them in your treatment plan.

How It Works

Budesonide suppresses inflammatory activity in the airways, helping reduce swelling and irritation over time. Formoterol stimulates beta-2 receptors on airway smooth muscle and produces prolonged bronchodilation. Glycopyrronium blocks muscarinic receptors involved in bronchial constriction, helping reduce narrowing of the airways. Working through these separate pathways, the three medicines can improve airflow and support sustained symptom control in COPD.

Side Effects

• Cough.
• Throat irritation.
• Hoarseness or voice changes.
• Oral fungal infection such as thrush.
• Headache.
• Dry mouth.
• Tremor.
• Palpitations or increased heart rate.
• Muscle cramps.
• Urinary difficulty may occur in susceptible patients.

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

Precautions & Warnings

• Inhaled corticosteroids such as Budesonide can increase the risk of pneumonia in patients with COPD. Seek medical advice for new or worsening cough, changes in sputum, fever, chills or other signs of respiratory infection.
• Glycohale FB is a maintenance treatment and should not be relied upon for immediate relief of an acute, severe breathing attack. Use your prescribed rescue medicine and seek urgent medical attention when necessary.
• Rinse your mouth after each dose to reduce the risk of oral candidiasis and throat irritation.
• Tell your doctor if you have glaucoma, cataracts, urinary retention or prostate enlargement because Glycopyrronium may aggravate these problems.
• Inform your doctor if you have heart disease, high blood pressure, an abnormal heart rhythm or other cardiovascular conditions because Formoterol can affect heart rate and rhythm.
• Tell your doctor if you have diabetes or thyroid disease.
• Inform your doctor if you have osteoporosis or other risk factors for reduced bone density, especially during prolonged corticosteroid exposure.
• Tell your doctor about kidney or liver disease and all other medicines or inhalers you use.
• Avoid getting the inhaled powder into the eyes.
• Do not stop regular maintenance therapy without discussing the change 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, serious allergic swelling or a rapid or irregular heartbeat.

Storage Instructions

• Store below 30°C.
• Keep the Rotacaps in their original blister until use.
• Protect from moisture, excessive heat and direct sunlight.
• Do not remove capsules from the blister until immediately before use.
• Keep the medicine in its original packaging.
• Keep out of reach and sight of children.
• Do not use the Rotacaps after the expiry date printed on the package.

FAQs

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

Q: What does Glycohale FB Rotacap contain?
A: Each Rotacap contains Budesonide 400 mcg, Formoterol Fumarate 12 mcg and Glycopyrronium Bromide 25 mcg.

Q: Is Glycohale FB Rotacap a prescription medicine?
A: Yes. It is a prescription inhalation medicine and should be used under medical supervision.

Q: Can I swallow Glycohale FB Rotacap?
A: No. The capsule is intended to be used with the appropriate inhalation device. It should not be swallowed.

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

Q: Who manufactures Glycohale FB Rotacap?
A: Glycohale FB Rotacap is marketed by Cipla Ltd. The commonly listed presentation contains 30 Rotacaps.