What is this medicine?
ROFLUMILAST decreases inflammation in the lungs. This medicine is used to prevent COPD flare-ups. Do not use this medicine to treat sudden breathing problems.
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What should I tell my health care provider before I take this medicine?
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They need to know if you have any of these conditions:
-liver disease
-mental illness
-an unusual or allergic reaction to roflumilast, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
-breast-feeding
How should I use this medicine?
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Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
What if I miss a dose?
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If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
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-carbamazepine
-cimetidine
-enoxacin
-erythromycin
-fluvoxamine
-ketoconazole
-phenobarbital
-phenytoin
-rifampicin
-St. John's wort
What should I watch for while using this medicine?
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Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.
What side effects may I notice from receiving this medicine?
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Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-anxious
-breathing problems
-suicidal thoughts or other mood changes
-trouble sleeping
-weight loss
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
-back pain
-diarrhea
-dizziness
-general ill feeling or flu-like symptoms
-headache
-loss of appetite
-nausea, vomiting
Where should I keep my medicine?
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Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
Information on use before, during and after pregnancy.
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FIRST Trimester
Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
SECOND Trimester
Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
THIRD Trimester
Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.
Lactation
Avoid - This drug is known to cause harm to infants when taken by nursing mothers.
