COMBIHALE FF 250 DPI Capsule 30’s

INTRODUCTION

COMBIHALE FF 250 DPI CAPSULE is a combination of Fluticasone and Formoterol which belongs to the group of medicines called Steroids and Anti-asthmatic agents. It is indicated for regular treatment of patients with asthma and severe COPD (Chronic obstructive pulmonary disease). It refers to a group of disease that cause blockage of airflow and breathing problems. It includes emphysema and chronic bronchitis.

Prior to the treatment with COMBIHALE FF 250 DPI CAPSULE, your doctor might ask you to take several blood tests to understand the existing condition.

Before using COMBIHALE FF 250 DPI CAPSULE, inform your doctor if you have lungs, heart or liver disease, aneurysm (abnormal bulging of a blood vessel), diabetes, overactive thyroid gland, a planned surgery, stress, low levels of potassium, pheochromocytoma (tumour of adrenal gland) or poor adrenal gland function.

COMBIHALE FF 250 DPI CAPSULE should be used with caution in pregnant and breast-feeding women only if advised by the doctor. It is not recommended for use in children below 12 years of age. Side effects of using COMBIHALE FF 250 DPI CAPSULE are dry mouth, sore or irritated throat, alteration in voice, headache and dizziness. Talk to your doctor if any of these worsen or doesn’t improve.

USES OF COMBIHALE FF 250 DPI CAPSULE

Treats:

• Asthma
• Severe chronic obstructive pulmonary diseases (COPD)

HOW COMBIHALE FF 250 DPI CAPSULE WORKS

COMBIHALE FF 250 DPI CAPSULE helps in treating asthma and COPD, where fluticasone is a corticosteroid which inhibits the agents that cause inflammation and results in reduced swelling and inflammation in the lungs. Formoterol is a beta-2 receptor agonist which acts on certain receptors and stimulates the release of an enzyme called cAMP. The rise in the levels of cAMP cause the muscles of the airways to relax and dilate. It also inhibits the release of chemicals that cause hypersensitivity such as histamine and leukotrienes. Together they help in improving and easy breathing.

DIRECTIONS FOR USE

Use COMBIHALE FF 250 DPI CAPSULE as advised by your physician. It is for oral inhalational use only. Do not exceed the recommended dose of COMBIHALE FF 250 DPI CAPSULE. Your doctor will decide the correct dose and duration of COMBIHALE FF 250 DPI CAPSULE for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF COMBIHALE FF 250 DPI CAPSULE

HOW TO MANAGE SIDE EFFECTS

Diarrhea

Drink lot of fluids, such as water, squash or fruit juice to keep yourself hydrated. Do not consume any medicine by yourself without consulting your doctor. Consult your doctor if the symptom doesn’t improve.

Dry Mouth

Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.

Headache

Try to take rest and don’t involve yourself in exertive activities. Apply a pain-relieving balm on your forehead if necessary. Consult your doctor if the symptom doesn’t improve.

WARNING & PRECAUTIONS

PREGNANCY

MONITORING REQUIRED

COMBIHALE FF 250 DPI CAPSULE is not recommended for use in pregnant women unless it is considered clearly necessary. Consult your doctor before using it.

BREASTFEEDING

MONITORING REQUIRED

COMBIHALE FF 250 DPI CAPSULE is not recommended for use in breast-feeding women unless it is considered clearly necessary. Consult your doctor before using it.

DRIVING AND USING MACHINES

USE WITH CAUTION

COMBIHALE FF 250 DPI CAPSULE is unlikely to affect your ability to drive or use machines.

ALCOHOL

CONSULT YOUR DOCTOR

Avoid consumption of alcohol while using COMBIHALE FF 250 DPI CAPSULE as it may cause unwanted side effects.

 

LIVER

USE WITH CAUTION

COMBIHALE FF 250 DPI CAPSULE should be used with caution in patients having impaired liver function. Consult your doctor before using COMBIHALE FF 250 DPI CAPSULE.

ALLERGY

CONTRAINDICATED

Do not use COMBIHALE FF 250 DPI CAPSULE if you are allergic to Fluticasone or Formoterol.

LUNGS

USE WITH CAUTION

COMBIHALE FF 250 DPI CAPSULE should be used with caution in patients with pulmonary tuberculosis, quiescent tuberculosis or patients with fungal, viral or other infections of the airway, unstable asthma. Consult your doctor before using COMBIHALE FF 250 DPI CAPSULE.

HEART DISEASE

USE WITH CAUTION

COMBIHALE FF 250 DPI CAPSULE should be used with caution in patients with heart diseases such as problems with the blood flow to the heart, narrowing of one of the heart valves (aortic valve), heart failure, hypertrophic obstructive cardiomyopathy (enlarged heart muscle), irregular heartbeat or prolongation of the QTc interval (ECG changes). Consult your doctor before using COMBIHALE FF 250 DPI CAPSULE.

INTERACTIONS

A. Drug – Drug Interactions:

Before using COMBIHALE FF 250 DPI CAPSULE, inform your doctor if you are taking any of the following medicines:

• Beta-agonists such as salbutamol (used to treat asthma)
• Beta-antagonists such as atenolol, metoprolol, propranolol, timolol (used to treat heart problems), digoxin (used to treat heart failure), quinidine, disopyramide, procainamide (used to treat abnormal heart rhythms)
• Antihistamines such as cetirizine, levocetirizine (used to treat allergic reaction)
• Diuretics such as spironolactone, furosemide (used to get rid of extra fluid in the body)
• Monoamine oxidase inhibitors such as phenelzine and isocarboxazid, tricyclic antidepressants such as amitriptyline and imipramine, phenothiazines such as chlorpromazine, antipsychotics such as risperidone, clozapine (used to treat mental disorders and depression)
• Steroids such as prednisolone (used to treat inflammation)
• Antifungal medicines such as ketaconazole, itraconazole (used to treat fungal infections)
• Ritonavir, atazanavir, indinavir, nelfinavir, saquinavir, cobicistat (used to treat HIV)
• Antibiotics such as clarithromycin, telithromycin, furazolidone (used to treat certain bacterial infections)
• Levodopa (used to treat parkinson’s disease)
• Levothyroxine (used to treat an underactive thyroid gland)
• Procarbazine (used to treat Hodgkin’s disease)
• Oxytocin (used to induce labour)
• General anaesthesia (used to induce sleep before a surgery or other medical procedure)

Overdosage:

If you or anyone else accidentally use too much of COMBIHALE FF 250 DPI CAPSULE, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of COMBIHALE FF 250 DPI CAPSULE includes angina (specific type of chest pain), high or low blood pressure, palpitations, fast or irregular heartbeat, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, low levels of potassium, high or low blood sugar, nausea and vomiting, loss of consciousness, suppression of hypothalamic pituitary adrenocortical (HPA) axis function (anorexia, poor weight gain, growth suppression).

SYNOPSIS

MORE INFORMATION

• Keep COMBIHALE FF 250 DPI CAPSULE out of reach of children
• Store below at room temperature 30°C

FAQs ABOUT COMBIHALE FF 250 DPI CAPSULE

Q: What is COMBIHALE FF 250 DPI CAPSULE and why is it prescribed?

A: COMBIHALE FF 250 DPI CAPSULE is a combination of fluticasone and formoterol which belongs to the group of medicines called steroids and anti-asthmatic agents. It is indicated for regular treatment of patients with asthma and severe COPD (chronic obstructive pulmonary disease).

Q: Can COMBIHALE FF 250 DPI CAPSULE be used in diabetic patients?

A: Before using COMBIHALE FF 250 DPI CAPSULE you must tell your doctor if you have diabetes. Your doctor might monitor your blood sugar levels regularly while treating you with COMBIHALE FF 250 DPI CAPSULE.

Q: What are the precautions to be taken while using COMBIHALE FF 250 DPI CAPSULE if I have to undergo a surgery?

A: Before using COMBIHALE FF 250 DPI CAPSULE inform your doctor if you have to undergo any planned surgery. If you are using COMBIHALE FF 250 DPI CAPSULE and you have to undergo an operation which requires the use of general anaesthesia, you should inform your doctor that you are using this medicine.

Q: Is COMBIHALE FF 250 DPI CAPSULE safe to use in patients having heart diseases?

A: Since COMBIHALE FF 250 DPI CAPSULE can cause some side effects such as irregular heartbeat or palpitations, it must be used with caution in patients having heart diseases such as problems with the blood flow to the heart, narrowing of one of the heart valves (aortic valve), heart failure, hypertrophic obstructive cardiomyopathy (enlarged heart muscle), irregular heartbeat or prolongation of the QTc interval (ECG changes). Consult your doctor before using COMBIHALE FF 250 DPI CAPSULE.

Q: Can I stop using COMBIHALE FF 250 DPI CAPSULE on my own?

A: You must keep using COMBIHALE FF 250 DPI CAPSULE for as long as your doctor has advised you to. Stopping its use may result in unwanted side effects. If you wish to discontinue using COMBIHALE FF 250 DPI CAPSULE, consult with your doctor. Your doctor will tell you how to proceed with this, usually by decreasing the dose slowly so that there is no triggered asthma attack.

Q: How to manage if I forget to use a dose of COMBIHALE FF 250 DPI CAPSULE?

A: If at all you forget to use a dose of COMBIHALE FF 250 DPI CAPSULE, use it as soon as you remember. However, if it is nearly time for your next dose then skip the missed dose. Do not use a double dose of COMBIHALE FF 250 DPI CAPSULE to make up for a forgotten dose.

REFERENCES

1. K.D. Tripathi. Drugs for Cough and Bronchial Asthma. Essentials of medical pharmacology. Seventh edition. 2013. Page – 224 & 231.

2. Theresa R Prosser, Suzanne G Bollmeier. Fluticasone-formoterol: a systematic review of its potential role in the treatment of asthma. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. June 2015. [Accessed on 20th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4459636/

3. John L. Faul, Sandra R. Wilson, James W. Chu, James Canfield, Ware G. Kuschner. The Effect of an Inhaled Corticosteroid on Glucose Control in Type 2 Diabetes. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. June 2009. [Accessed on 20th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2705276/

4. Fluticasone. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Accessed on 20th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Fluticasone

5. Formoterol. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Accessed on 20th July 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Formoterol

6. Cipla Ltd. Maxiflo Forte Rotacaps (Formoterol fumarate + Fluticasone propionate). Ciplamed. [Revised in August 2021]. [Accessed on 20th July 2022] https://www.ciplamed.com/content/maxiflo-forte-rotacaps

7. Cipla Ltd. Maxiflo Rotacaps (Formoterol fumarate + Fluticasone propionate). Ciplamed. [Revised in February 2019]. [Accessed on 20th July 2022] https://www.ciplamed.com/content/maxiflo-rotacaps

8. Cipla Ltd. Maxiflo Synchobreathe. Ciplamed (Formoterol fumarate + Fluticasone propionate). [Revised in February 2022]. [Accessed on 20th July 2022] https://www.ciplamed.com/content/maxiflo-synchrobreathe

USEFUL DIAGNOSTIC TESTS

• Chest X-ray
• Pulmonary function tests

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 28 Jan 2023 | 09:52 AM(IST)