Formosone 250

Formosone 250 Respicap is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: Concomitant therapy with an inhaled corticosteroid in treatment of asthma Maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease Prevention of exercise-induced bronchospasm Seasonal and year-round allergic Stuffy/runny nose Itching and sneezing Itchy and watery eyes

Do not stop taking this medicine of your own unless advised by your doctor. Please do not use Formosone 250 Respicaps to treat sudden severe symptoms of asthma or as a rescue inhaler. Before taking Formosone 250 Respicaps, let your doctor know if have a history of heart, liver, kidney diseases, high blood pressure, hypokalaemia (low potassium levels in the blood), aneurysm (swelling of an artery), pheochromocytoma (adrenal gland tumor), hyperadrenocorticism (high levels of cortisol), eye disorders like cataract and glaucoma, chickenpox or measles, immune system problem, seizure (fits), osteoporosis (weak and brittle bones) and diabetes. Like Formoterol, bronchodilators can cause hypokalemia (low potassium levels in the blood), therefore should be used with caution in patients with hypokalaemia to prevent any cardiovascular effects. Special precautions should be taken in patients with a fungal, bacterial, parasitic, or viral infection and tuberculosis since nasal or inhaled corticosteroids like Fluticasone can cause secondary infections. Formosone 250 Respicaps can cause a rise in blood glucose levels. Hence monitor your blood glucose levels regularly and inform your doctor if you already have diabetes before using Formosone 250 Respicaps. Formosone 250 Respicaps may affect the unborn baby during pregnancy. Please let your doctor know if you plan to become pregnant or already pregnant and a lactating mother. Formosone 250 Respicaps is not recommended for children below five years of age.

Adverse effects which have been associated with Formosone inhaler during clinical development are given in as follows, listed by system organ class. The following frequency categories form the basis for classification of the adverse effects as: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse effects are presented in order of decreasing seriousness. Infections and Infestations: Rare: Oral candidiasis, acute sinusitis. Metabolism and Nutrition Disorders: Uncommon: Hyperglycaemia. Psychiatric Disorders: Rare: Abnormal dreams, agitation, insomnia. Not Known: Psychomotor hyperactivity, anxiety, depression, aggression, behavioural changes (predominantly in children). Nervous System Disorders: Uncommon: Headache, tremor, dizziness, dysgeusia. Ear and Labyrinth Disorders: Rare: Vertigo. Cardiac Disorders: Uncommon: Palpitations, ventricular, extrasystoles. Rare: Angina pectoris, tachycardia. Vascular Disorders: Rare: Hypertension. Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Exacerbation of asthma, dysphonia, throat irritation. Rare: Dyspnoea, cough. Gastrointestinal Disorders: Uncommon: Dry mouth. Rare: Diarrhoea, dyspepsia. Skin and Subcutaneous Tissue Disorders: Rare: Rash. Musculoskeletal and Connective Tissue Disorders: Rare: Muscle spasms. General Disorders and Administration Site Conditions: Uncommon: Peripheral oedema. Rare: Asthenia. As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straight away. Formosone inhaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Since Formosone inhaler contains both Fluticasone (Formosone) propionate and Formoterol (Formosone) fumarate, the same pattern of adverse effects as reported for these substances may occur. The following adverse effects are associated with Fluticasone (Formosone) propionate and Formoterol (Formosone) fumarate, but have not been seen during the clinical development of Formosone inhaler: Fluticasone (Formosone) Propionate: Hypersensitivity reactions including, urticaria, pruritus, angiooedema (mainly facial and oropharyngeal), anaphylactic reactions. Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These may include Cushing's syndrome, cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, sleep disorders, contusion, skin atrophy and susceptibility to infections. The ability to adapt to stress may be impaired. The systemic effects described, however, are much less likely to occur with inhaled corticosteroids than with oral corticosteroids. Prolonged treatment with high doses of inhaled corticosteroids may result in clinically significant adrenal suppression and acute adrenal crisis. Additional systemic corticosteroid cover may be required during periods of stress (trauma, surgery, infection). Formoterol (Formosone) Fumarate: Hypersensitivity reactions (including hypotension, urticaria, angioneurotic oedema, pruritus, exanthema), QTc interval prolongation, hypokalaemia, nausea, myalgia, increased blood lactate levels. Treatment with β2-agonists eg, Formoterol (Formosone) may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies. Hypersensitivity reactions have been reported in patients using inhaled sodium cromoglicate as an active ingredient. Whilst Formosone inhaler contains only a low concentration of sodium cromoglicate as an excipient, it is unknown if hypersensitivity reactions are dose-dependent. In the unlikely event of a hypersensitivity reaction to Formosone inhaler, treatment should be initiated in accordance with standard treatment for any other hypersensitivity reaction, which may include the use of antihistamines and other treatment as required. Formosone inhaler may need to be discontinued immediately and an alternative asthma therapy may need to be initiated if necessary. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using the product. Symptomatic candidiasis can be treated with topical antifungal therapy whilst continuing the treatment with Formosone inhaler.

Formosone 250 Respicaps may interact with fluid retention drugs (furosemide), corticosteroids (budesonide, mometasone, beclomethasone), bronchodilators (vilanterol, salmeterol, albuterol), respiratory drugs (ipratropium), drugs treating irregular heartbeat (sotalol) and blood pressure medicines (metoprolol).

Schedule H Prescription Drug

Store below 25C Protect from heat and Moisture.

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.

Before using Formosone 250 Respicap, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below. Breathing problem Chest or lung infection Do not expose the drug to moisture Do not to increase the dose or frequency unless consulted by doctor Do not use anti-inflammatory agents to replace corticosteroids in the treatment of asthma Handle capsules with dry hands It is not indicated to relieve acute asthma symptoms Learn to use the inhaler appropriately Liver disease Patients who are unusually responsive to sympathomimetic amines

In case you miss a dose, use it as soon as you notice. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule. Do not use extra dose to make up for a missed dose. If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently.