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DALIRESP- roflumilast tablet


  1. Do Not Take Daliresp If You:
  2. Before You Take Daliresp, Tell Your Healthcare Provider If You:
  3. How Should I Take Daliresp?
  4. Daliresp Can Cause Serious Side Effects, Including:
  5. Active Ingredient:
  6. Inactive Ingredients:
  7. Patient Information

Do Not Take Daliresp If You: 

have certain liver problems. Talk with your healthcare provider before you take DALIRESP if you have liver problems.

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 should decide if you will take DALIRESP or breastfeed. You should not do both.

How Should I Take Daliresp? 

Take DALIRESP exactly as your healthcare provider tells you to take it.
DALIRESP can be taken with or without food.
If you take more than your prescribed dose of DALIRESP, call your healthcare provider or go to the nearest hospital emergency room right away.

Daliresp Can Cause Serious Side Effects, Including: 

Store DALIRESP at 68 F to 77 F (20 C to 25 C); excursions permitted to 15 - 30 C (59 - 86 F). [

Active Ingredient: 

roflumilast

Inactive Ingredients: 

lactose monohydrate, corn starch, povidone and magnesium stearate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rev. 08/2013

Manufactured by:
Takeda GmbH
Production Site Oranienburg
Lehnitzstrasse 70 98
16515 Oranienburg
Germany

Manufactured for:
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, LLC
St. Louis, MO 63045, USA

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Bronchospasm

DALIRESP is not a bronchodilator and should not be used for immediate relief of breathing problems (i.e., as a rescue medication).

Psychiatric Events including Suicidality

Treatment with DALIRESP is associated with an increase in psychiatric adverse reactions. Cases of suicidal ideation and behavior, including completed suicide, have been observed in the post-marketing setting in patients with or without a history of depression.

The risks and benefits of treatment with DALIRESP in patients with a history of depression and/or suicidal thoughts or behavior should be carefully considered. Advise patients, caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider so that the risks and benefits of continuing treatment with DALIRESP may be considered[

DALIRESP can cause serious side effects.Tell your healthcare provider right away if you have any of the symptoms listed below while taking DALIRESP.

1.
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
2.
Weight loss.DALIRESP can cause weight loss. You should check your weight on a regular basis. You will also need to

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.



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