ase in the therapeutic effectiveness of DALIRESP. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with DALIRESP is not recommended [see Drugs That Induce Cytochrome P450 (CYP) Enzymes (7.1) and Clinical Pharmacology (12.3)].
Manufactured by:
Nycomed GmbH
Production Site Oranienburg
Lehnitzstrasse 70 – 98
16515 Oranienburg
Germany
Manufactured for:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045, USA
Component Code Number:
© 2010 Forest Laboratories, Inc.
MEDICATION GUIDE
DALIRESP™ (da'-li-resp)
(roflumilast)
Tablets
Read this Medication Guide before you start taking DALIRESP™ and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about DALIRESP?
DALIRESP can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking DALIRESP.
DALIRESP may cause mental health problems including suicidal thoughts and behavior. Some people taking DALIRESP may develop mood or behavior problems including:
thoughts of suicide or dying
attempt to commit suicide
trouble sleeping (insomnia)
new or worse anxiety
new or worse depression
acting on dangerous impulses
other unusual changes in your behavior or mood
Weight loss. DALIRESP can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking DALIRESP if you lose too much weight.
DALIRESP may affect the way other medicines work, and other medicines may affect how DALIRESP works. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
What is DALIRESP?
DALIRESP is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).
DALIRESP is not a bronchodilator and should not be used for treating sudden breathing problems. Your healthcare provider may give you other medicine to use for sudden breathing problems.
It is not known if DALIRESP is safe and effective in children.
Who should not take DALIRESP?
Do not take DALIRESP if you:
have certain liver problems. Talk with your healthcare provider before you take DALIRESP if you have liver problems.
What should I tell my healthcare provider before taking DALIRESP?
Before you take DALIRESP, tell your healthcare provider if you:
have or have had a history of mental health problems including depression and suicidal behavior.
have liver problems
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if DALIRESP will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if DALIRESP passes into your breast milk. You and your healthcare provider sho
