Roflumilast (Oral)

Roflumilast is used to prevent the symptoms (flare-ups) of chronic obstructive pulmonary disease (COPD).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress during regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

This medicine is used to prevent sudden flare-ups of COPD. It is not used to stop a flare-up that has already begun. You should use an inhaled medicine for sudden flare-ups that will work quickly to help you breathe better. If you do not have an inhaled medicine for sudden COPD flare-ups, or if you have any questions about this, talk to your doctor.

This medicine may cause some people to feel agitated or show other unusual behaviors, such as feeling sad or hopeless, getting upset easily, having trouble sleeping, or feeling nervous or hostile. It may also cause some people to have thoughts of suicide or to become more depressed. If you or someone taking care of you notices any of these side effects, tell your doctor right away.

This medicine may cause you to lose weight. Your doctor may need to check your weight regularly while you are taking this medicine.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, you should think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies on the effects of roflumilast in children have not been conducted. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of roflumilast.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions might happen. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following is usually not recommended, but may be necessary in some instances. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Ceritinib
• Clarithromycin
• Fosphenytoin
• Phenytoin
• Rifampin

Using this medicine with any of the following may increase the risk of certain side effects, but using both may be the best option for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Cimetidine
• Enoxacin
• Erythromycin
• Ethinyl Estradiol
• Fluvoxamine
• Gestodene
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with specific types of food due to potential interactions. Alcohol or tobacco may also lead to interactions with certain medicines. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Depression, history of or
• Mental illness, history of—Use with caution. May worsen these conditions.

• Liver disease, moderate to severe—Should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Unexplained weight loss

Less common

• Chills
• cough
• diarrhea
• discouragement
• fear or nervousness
• feeling sad or empty
• fever
• general feeling of discomfort or illness
• headache
• irritability
• joint pain
• loss of appetite
• loss of interest or pleasure
• muscle aches and pains
• nausea
• runny nose
• shivering
• sleeplessness
• sore throat
• sweating
• thoughts of killing oneself or changes in behavior
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Abdominal or stomach pain
• back pain
• bladder pain
• bloody or cloudy urine
• burning feeling in the chest or stomach
• decreased appetite
• difficult, burning, or painful urination
• dizziness
• frequent urge to urinate
• indigestion
• lower back or side pain
• muscle spasm
• pain or tenderness around the eyes and cheekbones
• shakiness in the legs, arms, hands, or feet
• shortness of breath or troubled breathing
• sneezing
• stomach upset
• stuffy or runny nose
• sweating
• tenderness in the stomach area
• tightness of the chest or wheezing
• trembling or shaking of the hands or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Daliresp

Available Dosage Forms:

• Tablet

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Phosphodiesterase Inhibitor

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For prevention of COPD: Adults—One 500 microgram (mcg) tablet per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.