FLOVENT (Fluticasone Propionate) Rota Caps

About FORMOTEROL+FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE+FORMOTEROL is a combination medication primarily used to prevent and treat symptoms of asthma and chronic obstructive pulmonary diseases (COPD) such as shortness of breath or wheezing (whistling sound while breathing). Asthma is a chronic (long-term) respiratory condition in which airways narrow, swell, and produce extra mucus, leading to difficulty in breathing. COPD is a group of lung diseases with emphysema (shortness of breath) and chronic bronchitis (inflammation of the lining of bronchial tubes).

FLUTICASONE PROPIONATE+FORMOTEROL is a combination of two drugs, namely: Formoterol (bronchodilator) and Fluticasone propionate (corticosteroid). Formoterol belongs to the class of bronchodilators that works by relaxing muscles and widening the airways of the lungs. Thus, it makes breathing easier. Fluticasone propionate belongs to the class of corticosteroids that works by acting inside cells of the nasal lining and stops the release of certain chemicals in the body that cause inflammatory reactions. Thereby, provides relief from sneezing, runny or blocked nose and sinus discomfort.

FLUTICASONE PROPIONATE+FORMOTEROL is for inhalation only. Take FLUTICASONE PROPIONATE+FORMOTEROL by inhaling the number of puffs as advised by your doctor. Your doctor will recommend you how often you take FLUTICASONE PROPIONATE+FORMOTEROL based on your medical condition. Some people may experience headache, sore throat, sneezing, stuffy nose, hoarse voice, cough, low fever, chest tightness, a fungal infection in the mouth, sinus pain, nausea, stomach upset, dizziness, nervousness, vomiting or irregular heartbeat. Most of these side effects of FLUTICASONE PROPIONATE+FORMOTEROL do not require medical attention and gradually resolve over time. However, if the side effects persist or worsen, please consult your doctor.

If you are allergic to FLUTICASONE PROPIONATE+FORMOTEROL or any other ingredients, please tell your doctor. If you are pregnant or breastfeeding, please inform your doctor before using FLUTICASONE PROPIONATE+FORMOTEROL. FLUTICASONE PROPIONATE+FORMOTEROL is not recommended for children below 12 years of age. Use of FLUTICASONE PROPIONATE+FORMOTEROL may worsen asthma symptoms in some patients. If you experience severe difficulty in breathing, please consult a doctor immediately so that alternative medicine may be prescribed. Regular monitoring of potassium levels is recommended while taking FLUTICASONE PROPIONATE+FORMOTEROL as it may cause low potassium levels in the blood. If you have high blood pressure, diabetes, chest or lungs infection, hyperthyroidism (overactive thyroid), hypokalaemia (low potassium levels in the blood), glaucoma, cataracts, osteoporosis (weak bones), tuberculosis, heart, liver or adrenal gland problems, inform your doctor before taking FLUTICASONE PROPIONATE+FORMOTEROL.

Uses of FORMOTEROL+FLUTICASONE PROPIONATE

Asthma, Chronic obstructive pulmonary disease (COPD)

Medicinal Benefits

FLUTICASONE PROPIONATE+FORMOTEROL is a combination of two drugs, namely: Formoterol and Fluticasone propionate that is used to treat symptoms of asthma and chronic obstructive pulmonary diseases (COPD). Formoterol belongs to the class of bronchodilators that works by relaxing muscles and widening the airways of the lungs. Thus, it makes breathing easier. Fluticasone propionate belongs to the class of corticosteroids that works by acting inside cells of the nasal lining and stops the release of certain chemicals in the body that cause inflammatory reactions. Thereby, provides relief from sneezing, runny or blocked nose and sinus discomfort.

Directions for Use

Shake the inhaler well and check the label for directions before using FLUTICASONE PROPIONATE+FORMOTEROL. FLUTICASONE PROPIONATE+FORMOTEROL is for inhalation only. Take FLUTICASONE PROPIONATE+FORMOTEROL daily at the same time to maintain a consistent level of FLUTICASONE PROPIONATE+FORMOTEROL in the body. While you are breathing FLUTICASONE PROPIONATE+FORMOTEROL from the mouth, press down inhaler once to release the medicine and hold your breath for 10 seconds. Repeat until you have inhaled the number of puffs as advised by your doctor. Rinse your mouth with water and spit it out after using FLUTICASONE PROPIONATE+FORMOTEROL to avoid fungal infections in mouth and throat.

Storage

Store in a cool and dry place away from sunlight

Side Effects of FORMOTEROL+FLUTICASONE PROPIONATE

Like all medicines, FLUTICASONE PROPIONATE+FORMOTEROL can cause some common side effects such as headache, sore throat, sneezing, stuffy nose, hoarse voice, cough, low fever, chest tightness, a fungal infection in the mouth, sinus pain, nausea, stomach upset, dizziness, nervousness, vomiting or irregular heartbeat. Most of these side effects of FLUTICASONE PROPIONATE+FORMOTEROL do not require medical attention and gradually resolve over time. However, if the side effects persist or worsen, please consult your doctor.

In-Depth Precautions and Warning

Drug Warnings

If you are allergic to FLUTICASONE PROPIONATE+FORMOTEROL or any other ingredients, please tell your doctor. If you are pregnant or breastfeeding, please inform your doctor before using FLUTICASONE PROPIONATE+FORMOTEROL. FLUTICASONE PROPIONATE+FORMOTEROL is not recommended for children below 12 years of age. Use of FLUTICASONE PROPIONATE+FORMOTEROL may worsen asthma symptoms in some patients. If you experience severe difficulty in breathing, please consult a doctor immediately so that alternative medicine may be prescribed. Contact your doctor if you have blurred vision or any other vision disturbances while taking FLUTICASONE PROPIONATE+FORMOTEROL. Regular monitoring of potassium levels is recommended while taking FLUTICASONE PROPIONATE+FORMOTEROL as it may cause low potassium levels in the blood. If you have high blood pressure, diabetes, chest or lungs infection, hyperthyroidism (overactive thyroid), hypokalaemia (low potassium levels in the blood), glaucoma, cataracts, osteoporosis (weak bones), tuberculosis, heart, liver or adrenal gland problems, inform your doctor before taking FLUTICASONE PROPIONATE+FORMOTEROL.

Drug Interactions

Drug-Drug Interaction: FLUTICASONE PROPIONATE+FORMOTEROL may interact with bronchodilators (salbutamol, aminophylline, theophylline), steroids (budesonide, prednisone, mometasone, beclomethasone), heart-related medicines (sotalol, digoxin, disopyramide, procainamide, quinidine), drugs used to treat Hodgkin’s disease (procarbazine), water pills (furosemide), antibiotics (telithromycin, furazolidone, clarithromycin), drugs used to lower high blood pressure (atenolol, metoprolol, propranolol), medicines to induce labour (oxytocin), antithyroid agent (levothyroxine), antidepressants (imipramine, amitriptyline, isocarboxazid, phenelzine), antifungals (itraconazole, ketoconazole), HIV medicines (atazanavir, ritonavir, nelfinavir, indinavir, cobicistat, saquinavir) and antiparkinson drug (levodopa).

Drug-Food Interaction: FLUTICASONE PROPIONATE+FORMOTEROL may interact with grapefruit and grapefruit juice. Therefore, avoid intake of grapefruit or its juice with FLUTICASONE PROPIONATE+FORMOTEROL as it may lead to severe adverse effects.

Drug-Disease Interaction: If you have high blood pressure, diabetes, chest or lungs infection, hyperthyroidism (overactive thyroid), hypokalaemia (low potassium levels in the blood), glaucoma, cataracts, osteoporosis (weak bones), tuberculosis, heart, liver or adrenal gland problems, inform your doctor before taking FLUTICASONE PROPIONATE+FORMOTEROL.

Safety Advice

• ALCOHOL
• The interaction of FLUTICASONE PROPIONATE+FORMOTEROL with alcohol is unknown. Please consult a doctor before consuming alcohol with FLUTICASONE PROPIONATE+FORMOTEROL.
• PREGNANCY
• The safety of FLUTICASONE PROPIONATE+FORMOTEROL in pregnant women is unknown. Therefore, it is given to pregnant women only if the doctor thinks benefits outweigh risks.
• BREAST FEEDING
• It is unknown whether FLUTICASONE PROPIONATE+FORMOTEROL is excreted in human milk. It is given to breastfeeding mothers only if the doctor thinks benefits are greater than risks.
• DRIVING
• FLUTICASONE PROPIONATE+FORMOTEROL usually does not affect your ability to drive or operate machinery.
• LIVER
• Use FLUTICASONE PROPIONATE+FORMOTEROL with caution, especially if you have a history of Liver diseases/conditions. The dose may be adjusted by your doctor as required.
• KIDNEY
• If you have any concerns regarding the use of FLUTICASONE PROPIONATE+FORMOTEROL in patients with Kidney problems, please consult a doctor.

Habit Forming

No

Diet & Lifestyle Advise

• Eat a healthy diet and exercise regularly to strengthen your breathing muscles and boost your immune system.
• Avoid foods such as cabbage, beans, garlic, onions, shrimp, pickled food, dried fruits, fried foods, carbonated drinks, wine, bottled lemon and lime juice as it may worsen asthma symptoms.
• Do meditation, deep breathing, regular exercise and try progressive muscle relaxation techniques to get relief from stress and reduce the risk of an asthma attack.
• Quit smoking as it may reduce the effectiveness of the FLUTICASONE PROPIONATE+FORMOTEROL and irritate the lungs worsening breathing problem.
• Learning breathing exercises will help you move more air in and out of your lungs.

Special Advise

Regular monitoring of blood sugar levels is recommended while taking FLUTICASONE PROPIONATE+FORMOTEROL especially if you have diabetes as it may increase blood sugar levels.

Patients Concern

Disease/Condition Glossary

Asthma: It is a chronic (long-term) respiratory condition in which airways narrow, swell, and produce extra mucus, leading to difficulty in breathing. The symptoms of asthma include wheezing (whistling sound while breathing), shortness of breath, chest tightness and cough, especially at night. The symptoms of mild persistent asthma may occur more than 2 times in a week and up to 4 nights in a month whereas, in case of severe persistent asthma, the symptoms occur several times every day and most nights. The treatment for asthma includes medication, breathing exercises and self-care.

Chronic obstructive pulmonary disease (COPD): It is a group of lung diseases with emphysema (shortness of breath) and chronic bronchitis (inflammation of the lining of bronchial tubes). The major cause of COPD is smoking tobacco. Also, long-term exposure to fumes and chemicals may lead to COPD. The symptoms include chronic cough, shortness of breath or wheezing (whistle sound while breathing).