Maxiflo 100 Rotacaps (30 Cap)

MAXIFLO 100 ROTACAPS (30 CAP) by CIPLA LTD

Name

• Brand Name: MAXIFLO 100 ROTACAPS
• Common Name: Fluticasone Propionate and Formoterol Fumarate Rotacaps

Composition

Each MAXIFLO 100 ROTACAP contains two active ingredients:

• Fluticasone Propionate: 100 mcg (a corticosteroid)
• Formoterol Fumarate: 6 mcg (a long-acting beta2-adrenergic receptor agonist/bronchodilator)

Uses

MAXIFLO 100 ROTACAPS are primarily used for the regular maintenance treatment and management of chronic respiratory conditions:

• Asthma: A chronic condition where airways narrow, swell, and produce extra mucus, causing difficulty breathing, wheezing, shortness of breath, chest tightness, and cough. It is used for persistent asthma in adults.
• Chronic Obstructive Pulmonary Disease (COPD): This includes conditions like emphysema and chronic bronchitis, which make breathing difficult. It helps to keep the airways open, relieving symptoms such as chest tightness, shortness of breath, wheezing, and persistent coughing.

This medicine is not for the relief of sudden breathing problems or acute asthma attacks; a quick-relief inhaler should be used for such situations.

Dosage and Administration

MAXIFLO 100 ROTACAPS are for oral inhalation only and should not be swallowed.

• Typical Dosage: The recommended dosage varies, but typically it is one rotacap inhaled twice daily, approximately 12 hours apart, or as advised by a physician.
• Administration:
  • Use only with the supplied inhalation device (Rotahaler).
  • Place the capsule at the base of the rotahaler, not in the mouthpiece.
  • Twist the mouthpiece completely until a click is heard, then breathe in deeply through the mouthpiece.
  • Hold your breath for up to 10 seconds. If powder remains, repeat the process to ensure the full dose is received.
  • It should be taken at the same time each day to maintain a consistent level in the body.
  • After using, rinse your mouth with water and spit it out to help prevent fungal infections in the mouth and throat.

Side Effects

Common Side Effects:

• Headache
• Sore throat / throat irritation
• Hoarseness of voice / alteration in voice
• Nausea, vomiting, stomach upset
• Dizziness
• Dry mouth
• Sneezing, stuffy nose, sinus inflammation
• Cough, chest tightness
• Fungal infections in the mouth and throat (oral candidiasis)
• Tremors, shaking
• Palpitations / irregular heartbeat / fast heartbeat
• Muscle spasms/cramps
• Rash

Serious Side Effects (consult a healthcare provider immediately if experienced):

• Sudden swelling of the face, tongue, eyelids, or throat
• Difficulty breathing or sudden changes in breathing pattern (e.g., increased wheezing or worsening asthma symptoms)
• Blurred vision or other visual disturbances
• Severe or persistent side effects.

Precautions

• Allergies: Inform your doctor if you are allergic to fluticasone, formoterol, or any of its components.
• Pre-existing Conditions: Exercise caution and inform your doctor if you have conditions such as heart disease (e.g., irregular heartbeat, high blood pressure, heart failure), diabetes, an aneurysm, an overactive thyroid gland (hyperthyroidism), low potassium levels (hypokalemia), liver or kidney problems, or if you are undergoing surgery.
• Pregnancy and Breastfeeding: Not generally recommended unless clearly necessary and advised by a doctor after assessing risks and benefits. Close monitoring of the infant is advised if used during breastfeeding.
• Children: Not recommended for use in children under 12 years of age.
• Immunosuppression: Long-term use of the steroid component may slightly lower immune response, potentially increasing the risk of infections.
• Drug Interactions: Inform your doctor about all medications, supplements, and herbal products you are taking. Interactions can occur with strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir), beta-blockers (e.g., Propranolol, Metoprolol), and tricyclic antidepressants (e.g., Amitriptyline, Imipramine).
• Monitoring: Regular monitoring of blood potassium levels may be recommended.
• Alcohol: Avoid alcohol consumption as it may cause unwanted side effects.

Storage

Store below 25°C or at room temperature (below 30°C). Keep out of reach and sight of children.

MAXIFLO 100 ROTACAPS: Frequently Asked Questions

MAXIFLO 100 ROTACAPS is a medication prescribed for respiratory conditions. Here are some frequently asked questions about this medicine.

What is MAXIFLO 100 ROTACAPS used for?

MAXIFLO 100 ROTACAPS is primarily used for the regular management of asthma and chronic obstructive pulmonary disease (COPD), which includes conditions like emphysema and chronic bronchitis. It helps to prevent symptoms such as wheezing, shortness of breath, and chest tightness, and improves overall lung function.

How does MAXIFLO 100 ROTACAPS work?

This medicine is a combination of two active ingredients: Formoterol and Fluticasone Propionate. Formoterol is a long-acting bronchodilator that relaxes the muscles in the airways, causing them to widen and making breathing easier. Fluticasone Propionate is a corticosteroid that reduces inflammation (swelling) in the airways by stopping the release of certain chemical messengers that cause this inflammation.

What is the usual dosage for MAXIFLO 100 ROTACAPS?

Typically, the recommended dosage is one rotacap inhaled twice daily, usually in the morning and evening, approximately 12 hours apart. It is crucial to follow your doctor's prescribed dosage and not to exceed it. The rotacaps are designed for inhalation only and should not be swallowed. This medication is for maintenance treatment and should not be used to relieve sudden breathing problems; a rescue inhaler should be used for such instances.

What are the possible side effects of MAXIFLO 100 ROTACAPS?

Common side effects can include headache, sore throat, hoarseness of voice, cough, nausea, vomiting, respiratory tract infection, dizziness, tremors, palpitations, muscle cramps, and dry mouth. To help prevent fungal infections in the mouth and throat (oral candidiasis), it is recommended to rinse your mouth with water and spit it out after each inhalation. If you experience severe side effects such as sudden swelling of the face or throat, difficulty breathing, or blurred vision, seek immediate medical attention.

Is MAXIFLO 100 ROTACAPS safe during pregnancy or breastfeeding?

MAXIFLO 100 ROTACAPS is generally not recommended for use during pregnancy unless your doctor determines that the potential benefits outweigh the risks, as there is limited information on its effects in pregnant women. Similarly, for breastfeeding mothers, it is advised only if considered clearly necessary by a doctor, as it is unknown if the medicine passes into breast milk.

Can MAXIFLO 100 ROTACAPS be taken with other medications?

MAXIFLO 100 ROTACAPS may interact with certain medications. It is important to inform your doctor about all prescription, over-the-counter, and herbal supplements you are taking. Some medications that may interact include certain blood pressure-lowering medicines (like beta-blockers such as propranolol and metoprolol), strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir), and tricyclic antidepressants (e.g., amitriptyline, imipramine). These interactions could affect how MAXIFLO works or increase the risk of side effects.

What precautions should be taken while using MAXIFLO 100 ROTACAPS?

Before using this medicine, inform your doctor if you have any allergies to its components or if you have pre-existing conditions such as heart disease (e.g., irregular heartbeat, high blood pressure), liver or kidney impairment, diabetes, an overactive thyroid gland, aneurysm, low potassium levels, or certain eye conditions like glaucoma or cataracts. It is not recommended for children under 12 years of age. Avoid alcohol consumption while on this medication. Due to the possibility of dizziness, exercise caution when driving or operating machinery. Long-term use of the steroid component may slightly weaken the immune system.

What happens if a dose of MAXIFLO 100 ROTACAPS 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 MAXIFLO 100 ROTACAPS be stored?

MAXIFLO 100 ROTACAPS should be stored below 25°C or at room temperature, ideally below 30°C. Keep the medicine out of reach and sight of children.