INTRODUCTION

ROFADAY 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 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 management 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 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 ROFADAY

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 manage diarrhoea without consulting your doctor.

Headache:

Drink ample amount of water. Get 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

INTERACTIONS

A. 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

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 manage 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 to get pregnant, consult your doctor before taking this medicine. You should not become pregnant during management with ROFADAY and use an effective method of contraception during management, 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 G. 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 management 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%20is%20a%20PDE4%20inhibitor,exacerbators%20and%20also%20of%20hospitalization.

3. AstraZeneca. Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Manageed with Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (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. Takeda GmbH. 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