Rofaday Tablet 10?S Allschoolabs -

Specification

INTRODUCTION
ROFADAY contains Roflumilast which belongs to theroup of medicines called Phosphodiesterase-4 inhibitors. It is used for the maintenance treatment 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 treatment 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 side effects of taking ROFADAY are diarrhoea, nausea, stomach pain, decreased appetite, headache and sleeplessness. Consult your doctor if any of the side effect worsens.
USES OF ROFADAY
Used in adult patients:
For the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis

HOW ROFADAY 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 alass 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 ROFADAY

COMMON

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 theullet (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)

HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take ROFADAY with or just after meals. Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Diarrhoea:
Drink lot of fluids such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Do not take any medicine on your own to treat diarrhoea without consulting your doctor.
Headache:
Drink ample amount of water.et adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.
Stomach Pain:
Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.
Decreased appetite:
Eat when you are hungry. Try to eat smaller meals more often than usual. Snack only when you?re hungry. Always try to have a nutritious snack which is high in calories and protein, such as dried fruit and nuts.
WARNING & PRECAUTIONS

PREGNANCY
ROFADAY is not recommended for use in pregnant women. Consult your doctor before taking it.
BREASTFEEDING
Inform your doctor if you are a breast-feeding woman before taking this medicine.
DRIVING AND USING MACHINES
ROFADAY has no influence on the ability to drive and use machines.
LIVER
ROFADAY 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.
ALLERGY
Do not take ROFADAY if you are allergic to Roflumilast or any of the other ingredients of this medicine.
LUNGS
ROFADAY is not recommended for use in patients who have sudden attack of breathlessness. Consult your doctor before taking ROFADAY.
HEART DISEASE
ROFADAY is not recommended for use in patients with severely impaired heart function. Consult your doctor before taking ROFADAY.
OTHERS
ROFADAY 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 ineriatrics:
ROFADAY should be used with caution in elderly patients (aged 65 years and above). Consult your doctor before taking it.
INTERACTIONS
A. Drug ? Drug interactions:
Before taking ROFADAY, inform your doctor if you are taking any of the following medicines:
Theophylline (used to treat respiratory diseases)

Methotrexate, azathioprine, infliximab, etanercept or oral corticosteroids (Ex. prednisolone) (used to treat immunological diseases)

Fluvoxamine (used to treat anxiety disorders and depression)

Cimetidine (used to treat stomach ulcers or heartburn)

Antibiotics such as rifampicin, enoxacin (used to treat bacterial infections)

Phenobarbital, carbamazepine or phenytoin (used to treat epilepsy)

Inhaler or bronchodilators (Ex. salmeterol, formoterol) (used to treat 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

FAQs ABOUT ROFADAY
Can ROFADAY be used in sudden breathlessness attack?
ROFADAY should not be used to treat sudden attacks of breathlessness as it will not help you in this situation. Your doctor will provide you with another medicine that will be always available to you to cope with such an attack.
Can ROFADAY cause weight loss?
Yes, decrease in weight is observed commonly in patients taking ROFADAY. You should check your body weight regularly and inform your doctor if you observe a loss of body weight which is not related to a diet or exercise programme, while taking this medicine.
Can ROFADAY be taken during pregnancy?
If you are pregnant, think you may be pregnant or planning toet pregnant, consult your doctor before taking this medicine. You should not become pregnant during treatment with ROFADAY and use an effective method of contraception during treatment, as it may cause harm to the unborn baby.
What if I forget to take a dose of ROFADAY?
If you forget to take a dose of ROFADAY, take it as soon as you remember. However, omit the missed dose if it is almost time for the next dose. Do not take the medicine twice to make up for a forgotten dose.
Can I stop taking ROFADAY on my own?
Continue taking ROFADAY until your doctor tells you to stop, unless you experience any unwanted effects, worsening of your condition or any new symptoms. In such case, contact your doctor right away. Taking ROFADAY for as long as prescribed by your doctor, even when you have no symptoms, is important to maintain control of your lung function.
Is ROFADAY safe to use in patients with liver problems?
ROFADAY 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.
REFERENCES
1. Barbara. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Chronic Obstructive Pulmonary Disease. Pharmacotherapy Handbook. Ninth edition. Page ? 841.
2. Jadwiga A Wedzicha, Peter MA Calverley and Klaus F Rabe. Roflumilast: a review of its use in the treatment of COPD. NIH: National Library of Medicine, National center for biotechnology information. PMC PubMed Central. January 2016. [Accessed on 1st July 2022]?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4708192/#:~:text=Roflumilast is a PDE4 inhibitor,exacerbators and also of hospitalization.
3. AstraZeneca. Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated with Fixed Combinations of Long-acting ?2-agonists (LABA) and Inhaledlucocorticosteroid (ICS) (REACT). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in December 2016] [Accessed on 1st July 2022]?https://clinicaltrials.gov/ct2/show/NCT01329029
4. TakedambH. Electronic Medicines Compendium (EMC). [Revised in March 2021] [Accessed on 1st July 2022] https://www.medicines.org.uk/emc/files/pil.5650.pdf
5. Central Drugs Standard Control Organization (CDSCO). Roflumilast. [Accessed on 1st July 2022] https://cdscoonline.gov.in/CDSCO/Drugs
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