AIRTEC FB 400 MCG INSTACAP (30 CAP) by GLENMARK PHARMACEUTICALS LTD.

Name

• Brand Name: AIRTEC FB 400 INSTACAP
• Common Name: Budesonide and Formoterol Fumarate Inhalation Capsule

Composition

Each Instacap contains:

• Budesonide: 400 mcg
• Formoterol Fumarate: 6 mcg

Uses

AIRTEC FB 400 INSTACAP is a combination medicine used for the long-term management and treatment of:

• Asthma: It helps to reduce inflammation, prevent asthma attacks, and relieve symptoms such as coughing, wheezing, shortness of breath, and chest tightness.
• Chronic Obstructive Pulmonary Disease (COPD): It is effective in managing symptoms like breathlessness, wheezing, coughing, and chest tightness, thereby improving respiratory function. It is also indicated for moderate to severe COPD with frequent symptoms and a history of exacerbations.

This medicine is for maintenance treatment and is not for immediate relief of sudden breathing difficulties.

Dosage and Administration

AIRTEC FB 400 INSTACAP is for inhalational use only and should be used exactly as prescribed by a doctor. The capsule should not be swallowed. It is typically administered by placing the capsule in an inhaler device, twisting the mouthpiece until a click is heard, and then inhaling deeply. After use, it is recommended to rinse the mouth with water and spit it out to prevent fungal infections. The dose and duration depend on the patient's age, body weight, and severity of the condition. Do not exceed the prescribed dose or frequency.

Side Effects

Common side effects may include:

• Fungal infection in the mouth/oral candidiasis
• Headache
• Sore throat/throat irritation
• Hoarse voice/voice change
• Upper respiratory tract infection, flu, cough, nasopharyngitis
• Back pain
• Increased heart rate, palpitations
• Trembling/tremors
• Nausea, vomiting, stomach discomfort
• Muscle pain and cramps
• Difficulty sleeping
• Increased blood sugar levels
• Decreased potassium levels in the blood (hypokalaemia)

Consult a doctor if side effects persist or worsen.

Precautions

• Allergies: Do not use if allergic to Budesonide, Formoterol, or any other components of the medicine.
• Pregnancy and Breastfeeding: Generally not recommended during pregnancy or breastfeeding unless deemed necessary by a doctor, as safety data is limited and it passes into breast milk.
• Pre-existing Conditions: Inform your doctor if you have heart problems (e.g., high blood pressure, heart failure, increased heart rate), diabetes, hypokalaemia, glaucoma, cataracts, osteoporosis, fits/seizures, immune system problems, thyroid problems, liver problems, or a history of viral, bacterial, or fungal infections (e.g., chickenpox, measles).
• Children: Not recommended for children below 6 years of age. For children above 6, growth monitoring may be recommended.
• Interactions: Inform your doctor about all medications you are taking, including antifungals (e.g., Ketoconazole), antibiotics (e.g., Clarithromycin), HIV protease inhibitors (e.g., Ritonavir), antidepressants (e.g., Isocarboxazid), blood pressure medications (e.g., Propranolol), and certain anaesthetic agents.
• Immune System: May weaken the immune system, increasing the risk of infections.
• Dosage: Do not stop taking the medicine suddenly without consulting a doctor, as it can worsen the condition.

Storage

Store in a cool and dry place, away from direct sunlight, at a temperature between 10ºC to 25ºC or below 30ºC. Keep out of the sight and reach of children. Keep the inhaler in a closed condition. Do not use after the expiry date.

AIRTEC FB 400 MCG INSTACAP by GLENMARK PHARMACEUTICALS LTD. is a combination medication containing Budesonide (400 mcg) and Formoterol (6 mcg). It is used for the management of certain respiratory conditions.

Here are some frequently asked questions about AIRTEC FB 400 MCG INSTACAP:

What is AIRTEC FB 400 MCG INSTACAP used for?

AIRTEC FB 400 MCG INSTACAP is primarily used for the regular management and long-term control of symptoms associated with asthma and Chronic Obstructive Pulmonary Disease (COPD) in adults and children over 6 years of age. It helps relieve symptoms such as coughing, wheezing, breathing difficulty, chest tightness, and shortness of breath. It is not intended for the immediate relief of sudden, acute breathing problems.

How does AIRTEC FB 400 MCG INSTACAP work?

This medicine works due to the combined action of its two active ingredients: Budesonide and Formoterol. Budesonide is a corticosteroid that reduces inflammation in the airways in a dose-dependent manner, thereby decreasing swelling and preventing the worsening of asthma. Formoterol is a long-acting bronchodilator that relaxes the muscles around the airways, widening the air passages and making breathing easier.

What is the usual dosage for AIRTEC FB 400 MCG INSTACAP?

The exact dose and duration of treatment for AIRTEC FB 400 MCG INSTACAP will be determined by your doctor based on your age, body weight, and the severity of your condition. It is for inhalational use only and should be used exactly as advised by your healthcare provider. Do not increase the dose or frequency without consulting your doctor.

What are the possible side effects of AIRTEC FB 400 MCG INSTACAP?

Common side effects may include headache, dizziness, nausea, vomiting, stomach discomfort, body pain, coughing, sore throat, hoarseness of voice, and fungal infection in the mouth (oral thrush). Other reported side effects include upper respiratory tract infections, back pain, increased heart rate, and trembling (palpitations). If you experience any persistent or worsening side effects, consult your doctor. Serious side effects, though less common, can include severe allergic reactions, worsening breathing problems immediately after use (paradoxical bronchospasm), infections (like pneumonia), adrenal insufficiency, eye problems (glaucoma or cataracts), decreased bone mineral density (osteoporosis), and low blood potassium levels (hypokalemia).

Is AIRTEC FB 400 MCG INSTACAP safe during pregnancy or breastfeeding?

There is limited information about the safety of AIRTEC FB 400 MCG INSTACAP during pregnancy. It is generally not recommended unless the potential benefits to the mother outweigh the risks to the fetus, and a doctor's consultation is essential. Similarly, for breastfeeding mothers, this medicine passes into breast milk, so it should only be used if prescribed by a doctor who has weighed the benefits against any possible risks to the child.

Can AIRTEC FB 400 MCG INSTACAP be taken with other medications?

Concomitant use of AIRTEC FB 400 MCG INSTACAP with certain medications should be avoided or used with caution as it may alter its effects or increase the risk of side effects. These include certain anti-fungal medicines (e.g., Ketoconazole, Itraconazole), antibiotics (e.g., Clarithromycin), medicines for HIV infection (e.g., Ritonavir), some antidepressants (e.g., Monoamine oxidase inhibitors, Tricyclic antidepressants), and certain medicines for blood pressure or heart-related illnesses (e.g., Propranolol, Atenolol). Always inform your doctor about all medicines and supplements you are taking.

What precautions should be taken while using AIRTEC FB 400 MCG INSTACAP?

Rinse your mouth with water after each use of the inhaler to help prevent fungal infections (thrush) in the mouth and throat. Do not stop using this medicine suddenly, as it can worsen your condition. This medicine is not for sudden breathing problems; always carry a rescue inhaler for acute attacks. Inform your doctor if you have conditions such as severe liver problems, diabetes, heart problems (including high blood pressure or heart failure), an overactive thyroid gland, low blood potassium levels, or if your asthma is suddenly worsening. Avoid contact with people who have infections as this medicine may weaken the immune system.

What happens if a dose of AIRTEC FB 400 MCG INSTACAP is missed?

If you miss a dose of AIRTEC FB 400 MCG INSTACAP, take the missed dose 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 the missed one.

How should AIRTEC FB 400 MCG INSTACAP be stored?

Store AIRTEC FB 400 MCG INSTACAP in a cool and dry place, away from direct sunlight and moisture. Keep it out of the sight and reach of children. Always keep the inhaler in a closed condition and do not use the medicine after its expiry date.