This product's status changed to Approval withdrawn on 2025.12.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Summary
- Main use
- Maintenance therapy for relief of chronic obstructive pulmonary disease symptoms
- Who uses it
- Adults · Children
- Adult dosage
- Inhale one capsule of this medication using the Hanmi Haler (inhaler) once a day. Inhale at the same time every day, and if a dose is missed, take it as soon as possible on the same day. Do not exceed one dose per day.
- Children's dosage
- This medication is not administered to pediatric patients under 18 years of age.
Ingredients
- Indacaterol Maleate(Micronised)0.143mg / 1 capsule
- Glycopyrronium Bromide(Micronised)0.063mg / 1 capsule
- Manufacturer
- 한미약품(주)
Efficacy & effects
Maintenance therapy for relief of chronic obstructive pulmonary disease symptoms
- Symptoms of chronic obstructive pulmonary disease
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This medication helps patients with chronic obstructive pulmonary disease by widening the airways, making breathing easier, and alleviating symptoms such as cough or phlegm. Regular use can prevent symptom deterioration and contribute to maintaining lung function. Therefore, this medication is used for symptom relief and maintenance therapy for chronic obstructive pulmonary disease.
Dosage and Administration
Adult dosage
Inhale one capsule of this medication using the Hanmi Haler (inhaler) once a day. Inhale at the same time every day, and if a dose is missed, take it as soon as possible on the same day. Do not exceed one dose per day.
Children's dosage
This medication is not administered to pediatric patients under 18 years of age.
Precautions
This medication is a maintenance therapy that is inhaled once daily to dilate the airways and should not be used as an emergency medicine to relieve sudden bronchospasm. Rarely, there may be paradoxical bronchospasm with this medication, where the airways may constrict instead; if such symptoms occur, use should be stopped immediately and medical attention should be sought. This medication should not be used in asthma patients, as its safety and efficacy in asthma are not established. Patients with narrow-angle glaucoma or urinary retention should take special caution when using this medication, and care should be taken to avoid contact of the powder with the eyes. People allergic to this medication or its components, asthma patients, and those with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with heart disease, convulsive disorders, thyroid problems, hypokalemia, diabetes, glaucoma, urinary retention, or severe kidney disease should use this medication with greater caution. Common side effects may include headaches, cough, and rhinitis. Rarely, various adverse reactions such as heart abnormalities, eye problems, or digestive disturbances have been reported. Since this medication can affect the cardiovascular system, symptoms such as increased heart rate or elevated blood pressure may occur; if these symptoms manifest, consult a doctor. Potassium levels in the blood may drop, so patients with cardiovascular issues should be cautious. Diabetes patients should closely monitor blood sugar variations. It is advisable not to use this medication with other long-acting beta2-agonists or anticholinergic drugs. Pregnant or breastfeeding women should only use this medication after consulting a physician, and it should not be used in children under 18 years of age. In cases of overdose, symptoms such as increased heart rate, tremors, headaches, and vomiting may occur, and serious cases may require hospital treatment. This medication should be inhaled using the dedicated inhaler Hanmi Haler, and the capsule should not be swallowed. Be sure to learn the correct use of the inhaler and use it properly, and after use, keep the inhaler clean and be sure to remove the capsule. When storing, keep in a dry place below 25 degrees and out of reach of children.
Side effects and when to seek care immediately
Serious side effects
Angioedema, urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, angioedema (difficulty breathing or swallowing, swelling of the tongue, lips, and face), severe allergic reactions, paradoxical bronchospasm, severe swelling, urinary retention, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, pneumonia, pulmonary edema, pulmonary embolism, septic shock, severe cutaneous adverse reactions, severe neurological reactions
Mild side effects
- Headaches
- cough
- rhinitis
- upper respiratory tract infections
- urinary tract infections
- sinusitis
- allergic rhinitis
- insomnia
- dizziness
- paresthesia
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- glaucoma
- ischemic heart disease
- atrial fibrillation
- tachycardia
- palpitations
- throat irritation
- oropharyngeal pain
- nosebleed
- indigestion
- cavities
- dry mouth
- gastroenteritis
- itching
- rash
- musculoskeletal pain
- muscle cramps
- limb pain
- myalgia
- bladder obstruction
- fever
- chest pain
- peripheral edema
- fatigue
- angioedema
- voice disorders
Not everyone experiences these, and they can vary from person to person.
Storage
This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is advisable to maintain room temperature between 1 and 25 degrees.
Appearance and packaging
Appearance
Transparent inhalation capsules with a yellow upper part and a colorless lower part containing white powder (inhalation device included).
Package unit
30 capsules/box
Questions about this medicine
No questions yet.
For anything that needs medical judgment, consult a doctor or pharmacist.