Rofaday Tablet 10'S
Key Information
Generic Name
Generic Name Roflumilast 500 mcg
Manufacturer
Lupin Ltd
Variant
10 Tablet(s) in a Strip
Country of Origin
India
Detailed Information
Introduction
INTRODUCTIONROFADAY contains Roflumilast which belongs to the group of medicines called Phosphodiesterase-4 inhibitors. It is used for the maintenance management of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis (long-term inflammation of the breathing tubes (bronchi)) in adult patients with a history of frequent worsening of their COPD symptoms (so-called exacerbations) as add on to bronchodilators. Chronic obstructive pulmonary disease (COPD) is a chronic disease of the lungs that results in tightening of the airways (obstruction) and swelling and irritation of the walls of the small air passages (inflammation). It is characterized by symptoms such as coughing, wheezing, chest tightness or difficulty in breathing. It is to be used in addition with bronchodilators. ROFADAY is not recommended for use in patients who have sudden attack of breathlessness, with moderate to severe liver problems, acute hepatitis and severely impaired heart function. It should be used with caution in patients with viral hepatitis. Prior to management with ROFADAY, your doctor might want you to take several tests to understand your existing condition. Before taking ROFADAY inform your doctor if you had or have tuberculosis, viral hepatitis, herpes viral infection or herpes zoster. Before taking ROFADAY inform your doctor if you are pregnant or breast-feeding women. ROFADAY is not recommended for use in children and adolescents (under 18 years of age). ROFADAY should be used with caution in elderly patients (aged 65 years and above). The most common
Uses
OF ROFADAYUsed in adult patients: For the maintenance management of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis
How It Works
ROFADAY works by reducing the activity of phosphodiesterase 4, a protein occurring naturally in body cells. When the activity of this protein is reduced, there is less inflammation in the lungs. This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD). Thereby eases breathing problems.
Directions for Use
Take ROFADAY as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking ROFADAY unless your doctor advises you to stop.
Side Effects
taking ROFADAY are diarrhoea, nausea, stomach pain, decreased appetite, headache and sleeplessness. Consult your doctor if any of the side effect worsens. USES OF ROFADAYUsed in adult patients: For the maintenance management of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis HOW ROFADAY WORKSROFADAY works by reducing the activity of phosphodiesterase 4, a protein occurring naturally in body cells. When the activity of this protein is reduced, there is less inflammation in the lungs. This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD). Thereby eases breathing problems. DIRECTIONS FOR USETake ROFADAY as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking ROFADAY unless your doctor advises you to stop. SIDE EFFECTS OF ROFADAYCOMMON diarrhea, nausea, stomach pain weight loss, decreased appetite headache sleeplessness UNCOMMON trembling, sensation of head spinning (vertigo), dizziness sensation of rapid or irregular heartbeat (palpitation) gastritis, vomiting reflux of stomach acid to the gullet (acid regurgitations), indigestion rash muscle pain, muscle weakness or cramps back pain feeling of weakness or tiredness, feeling unwell anxiety RARE male breast enlargement (gynecomastia) decreased sense of taste respiratory tract infections (excluding pneumonia) bloody stools, constipation elevation of liver or muscle enzymes nervousness, panic attack depressive mood Stop taking ROFADAY and contact your doctor immediately if you experience any of the following side effects: suicidal thinking and behavior (including suicide) allergic reactions (symptoms include swelling of the eyelids, face, lips and tongue, difficulties in breathing, drop in blood pressure and rapid heartbeat)
Warnings & Precautions
& PRECAUTIONSPREGNANCYROFADAY is not recommended for use in pregnant women. Consult your doctor before taking it. BREASTFEEDINGInform your doctor if you are a breast-feeding woman before taking this medicine. DRIVING AND USING MACHINESROFADAY has no influence on the ability to drive and use machines. LIVERROFADAY is not recommended for use in patients with moderate to severe liver problems, acute hepatitis and should be used with caution in patients with viral hepatitis. Consult your doctor before taking ROFADAY. ALLERGYDo not take ROFADAY if you are allergic to Roflumilast or any of the other ingredients of this medicine. LUNGSROFADAY is not recommended for use in patients who have sudden attack of breathlessness. Consult your doctor before taking ROFADAY. HEART DISEASEROFADAY is not recommended for use in patients with severely impaired heart function. Consult your doctor before taking ROFADAY. OTHERSROFADAY is not recommended for use if you have: severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML) cancer (except basal-cell carcinoma, slow-growing type of skin cancer) Before taking ROFADAY inform your doctor if you: had or have tuberculosis, herpes viral infection or herpes zoster Use in pediatrics: ROFADAY is not recommended for use in children and adolescents (under 18 years of age). Consult child’s doctor for advice. Use in geriatrics: ROFADAY should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking it.
Drug Interactions
SA. Drug - Drug interactions: Before taking ROFADAY, inform your doctor if you are taking any of the following medicines: theophylline (used to manage respiratory diseases) methotrexate, azathioprine, infliximab, etanercept or oral corticosteroids (Ex. prednisolone) (used to manage immunological diseases) fluvoxamine (used to manage anxiety disorders and depression) cimetidine (used to manage stomach ulcers or heartburn) antibiotics such as rifampicin, enoxacin (used to manage bacterial infections) phenobarbital, carbamazepine or phenytoin (used to manage epilepsy) inhaler or bronchodilators (Ex. salmeterol, formoterol) (used to manage chronic obstructive pulmonary disease (COPD)) Overdosage: If you or anyone else accidentally takes too much of ROFADAY consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are headache, nausea, diarrhoea, dizziness, throbbing of your heart (palpitation), light-headedness, clamminess and low blood pressure. SYNOPSIS Drug : Roflumilast Pharmacological Category : Phosphodiesterase-4 inhibitor Therapeutic Indication : Chronic obstructive pulmonary disease (COPD) Dosage Forms : Tablet MORE INFORMATION Keep ROFADAY out of reach of children Store at room temperature