Budetrol 100 Mcg Capsule ( 30 Cap )

BUDETROL 100 MCG CAPSULE by MACLEODS PHARMACEUTICALS LTD.

Name

• Brand Name: Budetrol 100mcg Capsule
• Common Name: Budesonide and Formoterol Fumarate Capsules

Composition

Each capsule contains a fixed-dose combination of:

• Budesonide: 100 mcg
• Formoterol Fumarate: 6 mcg

Uses

BUDETROL 100mcg Capsule is prescribed for the long-term management and maintenance treatment of chronic respiratory conditions. It is used for:

• Asthma (a condition with swollen and narrow airways in the lungs, resulting in breathing difficulties).
• Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and/or emphysema, to improve breathing and reduce symptoms such as wheezing, shortness of breath, and coughing.
• Enhancing airflow in patients suffering from chronic bronchitis and helping manage symptoms in patients with emphysema.

Dosage and Administration

BUDETROL 100mcg Capsule should be taken orally as directed by your doctor. It is important not to crush or chew the capsules. The dosage and frequency depend on your condition and response to treatment. Administer it at the same time every day to maintain a constant level of this medicine in your body. Do not stop the medication suddenly, even if symptoms improve, as it may worsen your condition. This medication is not recommended as a rescue inhaler for acute breathlessness.

Side Effects

Common Side Effects:

• Headache
• Nervousness
• Cough
• Tremor
• Sore throat, throat irritation
• Oral thrush (fungal infection in the mouth)
• Hoarseness and changes in voice
• Nausea and vomiting
• Upper respiratory tract infection, bronchitis

Serious Side Effects:

• Increased risk of infections due to weakened immune system
• Hypokalaemia (low blood potassium levels)
• Increased blood glucose levels in diabetic patients

Precautions

• Pregnancy and Breastfeeding: Consult your doctor before using this medicine during pregnancy or while breastfeeding to evaluate potential benefits and risks.
• Interactions: Inform your doctor about all current medications, including over-the-counter drugs, supplements, and herbal products, as some may interact with BUDETROL 100mcg.
• Disease Interactions: Use with caution in patients with heart conditions (e.g., high blood pressure, arrhythmias), diabetes, convulsive disorders (seizures), tuberculosis, severe liver problems, glaucoma, cataracts, or osteoporosis.
• Children: Not recommended for use in children below six years of age due to lack of safety and efficacy studies. Growth monitoring is recommended for children using inhaled steroidal medicines.
• Alcohol: It is advisable to limit alcohol consumption while on this medicine.

Storage

Store at room temperature (20-25°C) or below 30°C. Protect from moisture and light. Keep out of the sight and reach of children.

Here are frequently asked questions about BUDETROL 100 MCG CAPSULE:

What is BUDETROL 100 MCG CAPSULE used for?

BUDETROL 100 MCG CAPSULE is used for the long-term management of asthma and moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It helps to relieve symptoms such as coughing, wheezing, breathing difficulty, and chest tightness. It is important to note that this medicine is a maintenance treatment and is not intended for immediate relief of acute asthma attacks or sudden worsening of COPD symptoms.

How does BUDETROL 100 MCG CAPSULE work?

This medicine contains a combination of two active ingredients: Budesonide and Formoterol. Budesonide is a corticosteroid that works by reducing inflammation and swelling in the airways of your lungs. Formoterol is a long-acting bronchodilator that relaxes the muscles around the airways, widening them and making it easier to breathe. Together, these components help improve airflow and manage respiratory symptoms.

What is the usual dosage for BUDETROL 100 MCG CAPSULE?

The dosage of BUDETROL 100 MCG CAPSULE should be strictly followed as prescribed by your doctor. For adults and adolescents (12 years and older) with asthma, a common maintenance dose is 1 puff twice daily or 2 puffs once daily. In some cases, 2 puffs twice daily may be appropriate. You may take an additional puff as needed for symptoms, but generally, no more than 6 puffs should be taken on any single occasion. For children (4 years and older) with asthma, the usual maintenance dose is 1 inhalation capsule once daily, with an additional capsule as needed for symptoms, not exceeding 4 capsules on any single occasion. This medicine is for inhalation only and should not be swallowed. It is used with a specific inhaler device (such as a Revolizer or Rotahaler), and it's crucial to rinse your mouth with water and spit it out after each use to help prevent fungal infections.

What are the possible side effects of BUDETROL 100 MCG CAPSULE?

Common side effects may include headache, dizziness, nausea, vomiting, stomach discomfort, coughing, sore throat, hoarseness of voice, and respiratory tract infections like nasopharyngitis or sinusitis. Some individuals might experience fungal infection in the mouth (oral thrush), palpitations, tremors, muscle pain, difficulty sleeping, increased heart rate, increased blood sugar levels, or decreased potassium levels. Rinsing your mouth thoroughly with water after each inhalation can help prevent oral thrush. If any side effects persist or worsen, or if you experience severe symptoms like chest pain or blurred vision, consult your doctor.

Is BUDETROL 100 MCG CAPSULE safe during pregnancy or breastfeeding?

There is limited information regarding the safety of BUDETROL 100 MCG CAPSULE during pregnancy. It is generally not recommended for use by pregnant women or those planning a pregnancy unless considered essential by a doctor and the potential benefits outweigh the risks. This medicine is known to pass into breast milk, so it is also generally not recommended for breastfeeding mothers unless the expected benefit to the mother is greater than any possible risk to the child. Always consult your doctor before using this medicine if you are pregnant or breastfeeding.

Can BUDETROL 100 MCG CAPSULE be taken with other medications?

BUDETROL 100 MCG CAPSULE can interact with other medications, so it is important to inform your doctor about all prescription, over-the-counter, and herbal medicines and supplements you are currently taking. Concomitant use with certain antifungal medications (like ketoconazole, itraconazole), some HIV medicines (e.g., ritonavir, indinavir), and certain antibiotics (such as clarithromycin) should be avoided as they can increase the levels of Budesonide in your body, potentially leading to increased side effects. Beta-blockers (e.g., propranolol, atenolol) may reduce the effectiveness of Formoterol. Diuretics (water pills) can increase the risk of low potassium levels when taken with Budetrol.

What precautions should be taken while using BUDETROL 100 MCG CAPSULE?

Do not use this medicine for sudden breathing difficulties; always have a separate rescue inhaler for such situations. It is crucial not to stop treatment abruptly, even if your symptoms improve, as this can worsen your condition. Inform your doctor if you have pre-existing conditions such as severe liver problems, diabetes, heart problems (including high blood pressure, heart failure, or irregular heartbeat), an overactive thyroid gland, low blood potassium levels, seizures, eye problems like glaucoma or cataracts, osteoporosis, immune system diseases, or current/recent viral, bacterial, or fungal infections. Regular monitoring of growth is recommended for children using this inhaled steroid, and it is generally not recommended for children under 6 years of age. It's also advisable to avoid alcohol as it may worsen your condition, and to exercise caution when driving or operating machinery if you experience dizziness.

What happens if a dose of BUDETROL 100 MCG CAPSULE is missed?

If you miss a dose of BUDETROL 100 MCG CAPSULE, 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 compensate for the missed one.

How should BUDETROL 100 MCG CAPSULE be stored?

BUDETROL 100 MCG CAPSULE should be stored below 30°C in a cool and dry place. Keep it protected from direct sunlight, moisture, and heat. Always keep the medicine out of the sight and reach of children and pets. Do not use expired or damaged medicine. It should be kept in its original container, tightly closed.