Roflumilast - oral

Patient Medicine Information
Why do I need this medicine?
Roflumilast is used on its own or together with other medicines to treat severe chronic obstructive pulmonary disease or COPD (a lung disease that causes difficulty in breathing) in patients with chronic bronchitis and history of worsening of COPD symptoms.
How do I take this medicine?
Take Roflumilast exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

It may be necessary for you to take Roflumilast for a long time, such as for a few years. Your doctor will advise you on the treatment timeframe.
What should I do if I have forgotten to take this medicine?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.
When should I not use this medicine?
Alert your doctor if you have liver disease as Roflumilast may not be suitable for you.
What should I take note of while taking this medicine?
Inform your doctor if you have the following conditions:
  • cancer
  • history of depression associated with suicidal thoughts and behaviour
  • heart disease
  • severe infection
  • severe immune system disorder
  • low body weight
Let your doctor know if you are pregnant or breastfeeding.

Roflumilast helps control COPD but is not meant to be used if you suddenly feel is it difficult to breathe. This medicine will not help you in this situation. Your doctor may give you another medicine to be available to you at all times for this problem.

For as long as you are taking Roflumilast, you may need to have regular monitoring of your body weight and liver function to check your body’s response to this medicine. Your doctor will advise you how often you need to have them.
What side effects could I experience?
Roflumilast may cause dizziness. If affected, do not drive or take part in any activity in which you need to be alert.

Other side effects include any of the following: headache, difficulty in sleeping, nervousness, depressed mood, nausea, diarrhoea, stomach pain, appetite loss, back pain and weight loss.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:
  • serious weight loss
  • thoughts of self-harm
Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.
Can I take this with other medicines?
Inform your doctor or pharmacist if you are taking any of these medicines:
  • certain antibiotics e.g. enoxacin, erythromycin
  • birth control pills e.g. gestodene, ethinylestradiol
  • medicines for epilepsy (fits or seizures) e.g. carbamazepine, phenobarbital, phenytoin
  • medicines for tuberculosis or TB e.g. rifampicin
  • stomach medicine e.g. cimetidine
  • medicine for mood disorders e.g. fluvoxamine
  • medicine for fungal infection e.g. ketoconazole
This list does not include all medicines that may interact with Roflumilast.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicine, supplements and medicines that you buy without a prescription.
What special dietary instructions should I follow?
Avoid alcohol.
How should I store this medicine?
Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.
This information is independently developed by MIMS based on roflumilast - oral and is provided for your reference only. It is not a replacement for and should only be used in conjunction with full consultation with a licensed healthcare professional, the information provided by your pharmacist and/or the manufacturer of the medication. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, we shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by
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