Combihale Fb 200 Inhaler (120 Dose)

COMBIHALE FB 200 INHALER (120 DOSE) by MANKIND PHARMA LTD

Combihale FB 200 Inhaler is a combination medication designed for the long-term management of respiratory conditions. It is manufactured by Mankind Pharma Ltd.

Composition Each actuation of the inhaler contains two active ingredients:

• Budesonide: 200 mcg (an inhaled corticosteroid)
• Formoterol Fumarate: 6 mcg (a long-acting beta-2 adrenergic agonist or bronchodilator)

Budesonide works by reducing inflammation and swelling in the airways, while Formoterol relaxes the muscles in the airways and widens them, making breathing easier.

Uses Combihale FB 200 Inhaler is primarily prescribed for the regular treatment and long-term management of:

• Asthma: To reduce inflammation, prevent asthma attacks, and manage symptoms such as difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness.
• Chronic Obstructive Pulmonary Disease (COPD): Including conditions like emphysema and chronic bronchitis, to alleviate symptoms, improve airflow, and maintain respiratory function. This medicine is not intended for immediate relief during sudden, acute asthma attacks.

Dosage and Administration Combihale FB 200 Inhaler is administered by oral inhalation. The dosage and frequency should be strictly followed as prescribed by a doctor, typically twice daily.

• Shake the inhaler well for 5 seconds before each use.
• Breathe out fully, then place the mouthpiece in your mouth and seal your lips around it.
• Press down on the inhaler once to release the medication while breathing in slowly and deeply.
• Hold your breath for about 5 to 10 seconds before breathing out slowly.
• If multiple puffs are prescribed, repeat the process.
• Important: Rinse your mouth with water and spit it out after each use to help prevent fungal infections (oral candidiasis) in the mouth and throat.

Side Effects Common side effects may include:

• Fungal infection in the mouth (oral candidiasis)
• Headache
• Sore throat or throat irritation
• Hoarse voice
• Cough
• Upper respiratory tract infection or flu-like symptoms
• Back pain
• Increased heart rate, palpitations, or trembling
• Muscle pain or difficulty sleeping
• Nausea, vomiting, or stomach pain
• Dizziness

If side effects persist or worsen, consult your doctor.

Precautions

• Allergies: Do not use if allergic to budesonide, formoterol, or any other components of the inhaler.
• Acute Symptoms: Not for use during acute asthma attacks or severe breathlessness.
• Pregnancy and Breastfeeding: Consult a doctor before use if pregnant or breastfeeding, as it is generally not recommended unless the benefits outweigh the risks.
• Children: Not recommended for children under 6 years of age. For children above 6, growth and height may be monitored.
• Pre-existing Conditions: Inform your doctor if you have heart problems (e.g., high blood pressure, heart failure, irregular heartbeat), diabetes, thyroid problems (hyperthyroidism), glaucoma, cataracts, osteoporosis, fits/seizures, liver or kidney diseases, or immune system problems.
• Infections: Use with caution if you have or are exposed to viral, bacterial, fungal, parasitic infections, pulmonary tuberculosis, chickenpox, or measles, as it may weaken the immune system.
• Potassium Levels: Regular monitoring of potassium levels is recommended as it may cause low blood potassium.
• Alcohol: Alcohol consumption is generally not recommended while using this medication.
• Drug Interactions: Inform your doctor about all current medications, including antifungals (e.g., ketoconazole, itraconazole), beta-blockers (e.g., propranolol), antiretrovirals (e.g., ritonavir), certain antibiotics (e.g., clarithromycin), and some antidepressants.

Storage Store the Combihale FB 200 Inhaler in a cool and dry place, away from direct sunlight and moisture. Keep it out of sight and reach of children. Store at room temperature, ideally between 10ºC to 25ºC or below 30ºC. Always keep the inhaler in a closed condition.

What is Combihale FB 200 Inhaler used for?

Combihale FB 200 Inhaler is primarily used for the long-term management and treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). It helps to prevent and treat symptoms such as difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness. It is typically used when these conditions are not adequately controlled by other medications.

How does Combihale FB 200 Inhaler work?

This inhaler contains two active ingredients: Budesonide and Formoterol. Budesonide is a corticosteroid that reduces inflammation and swelling in the airways of the lungs, helping to prevent asthma attacks. Formoterol is a long-acting bronchodilator that relaxes the muscles around the airways, widening them and making it easier to breathe. Together, they provide both anti-inflammatory and bronchodilator actions.

What is the usual dosage for Combihale FB 200 Inhaler?

The typical dosage for Combihale FB 200 Inhaler is usually twice daily. For children aged 6 to 11 years, the dosage might be 1 puff twice a day (100 mcg Budesonide + 6 mcg Formoterol), while for those 12 years and above, it could be 1 puff twice a day (200 mcg Budesonide + 6 mcg Formoterol). However, the exact dosage depends on individual factors and the severity of the condition, so it should always be taken as prescribed by your doctor. It is not intended for immediate relief during sudden asthma attacks.

What are the possible side effects of Combihale FB 200 Inhaler?

Common side effects may include headache, dizziness, nausea, vomiting, stomach discomfort, body pain, sore throat, hoarseness of voice, cough, and respiratory tract infection. A fungal infection in the mouth (oral thrush) is also possible. To help prevent oral thrush, it is recommended to rinse your mouth with water and spit it out after each use of the inhaler.

Is Combihale FB 200 Inhaler safe during pregnancy or breastfeeding?

During pregnancy, there is limited information, but it is generally considered safe if prescribed by a doctor after assessing the potential benefits versus risks to the mother and fetus. The doctor may prescribe the lowest effective dose. If you are pregnant or planning to be, inform your doctor.

When breastfeeding, components of the inhaler can pass into breast milk. It should only be used if prescribed by a doctor who has assessed that the benefits to the mother outweigh any potential risk to the child. Inform your doctor if you are a nursing mother.

Can Combihale FB 200 Inhaler be taken with other medications?

Certain medications can interact with Combihale FB 200 Inhaler. You should avoid concomitant use with anti-fungal medicines like Ketoconazole, HIV medications like Ritonavir, and antibiotics like Clarithromycin, as they can alter the effects of this medicine. Blood pressure or heart-related medicines such as Propranolol and Atenolol may weaken its effects. There's an increased risk of cardiac side effects if taken with L-Dopa (for Parkinson's disease) or L-thyroxine (thyroid hormone). Inform your doctor about all medications you are taking, including over-the-counter drugs and supplements.

What precautions should be taken while using Combihale FB 200 Inhaler?

Do not stop or increase the dose of this medicine on your own, as sudden discontinuation can worsen your condition. It is crucial to rinse your mouth with water and spit it out after each dose to prevent oral fungal infections. This inhaler is for maintenance therapy and is not meant for immediate relief of acute asthma attacks; always carry a rescue inhaler for such episodes. Inform your doctor if you have liver problems, diabetes, heart conditions (e.g., high blood pressure, heart failure), thyroid problems, glaucoma, cataracts, osteoporosis, or a history of seizures. Growth monitoring is recommended for children using inhaled steroids.

What happens if a dose of Combihale FB 200 Inhaler is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should Combihale FB 200 Inhaler be stored?

Combihale FB 200 Inhaler should be stored in a cool and dry place, away from direct sunlight and moisture. Keep it out of the sight and reach of children. The inhaler should be kept in a closed condition when not in use and stored at room temperature, typically below 25°C or 30°C.