ROFLUMILAST

Do not use roflumilast if:

• You are allergic to any ingredient in Roflumilast
• You have moderate to severe liver problems
• You are taking Carbamazepine, Hydantoins (eg, Phenytoin), Phenobarbital, Primidone, Rifamycins (eg, Rifampin), or St. John’s Wort

If any of these apply to you, contact your doctor or healthcare provider right away.

Common side effects may include:

• Diarrhea
• Weight Loss
• Stomach or Abdominal Pain
• Nausea
• Loss of Appetite
• Headache
• Dizziness

Tell your doctor or pharmacist promptly if any of these effects persist or worsen.

Serious side effects may include:

• Mental or Mood Changes (such as Nervousness, Depression, Thoughts of Suicide)
• Trouble Sleeping
• Shaking (Tremors)
• Fast or Irregular Heartbeat

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• Rash
• Itching or Swelling (especially of the Face, Tongue, Throat)
• Severe Dizziness
• Trouble Breathing

Precautions

Before taking Roflumilast, tell your doctor and pharmacist if you are/have:

• Allergic to Roflumilast, any other medications, or any of the ingredients in Roflumilast tablets.
• Taking other medications, vitamins, nutritional supplements, and herbal products. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Liver disease. Your doctor may tell you not to take Roflumilast.
• Ever had a history of mental health conditions, including depression; thoughts about harming or killing yourself, or planning or trying to do so; extreme worry; or other unusual changes in your behavior or mood.
• Pregnant, planning to become pregnant, or are breast-feeding. If you become pregnant while taking Roflumilast, call your doctor.

Your mental health may change in unexpected ways during treatment with Roflumilast. Call your doctor right away if you experience worsening symptoms like:

• Difficulty Falling Asleep or Staying Asleep
• Depression
• Thinking or Planning to Harm or Kill Yourself
• Extreme Worry
• Agitation
• Changes in Mood

This medication can also cause weight loss. Your weight should be checked regularly by your doctor and you should also check your weight on a regular basis during treatment with Roflumilast.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. Tell your doctor all the products you are using including prescription and nonprescription drugs and herbal products.

Some medications can affect the removal of roflumilast from your body, which may affect how this product works. Examples include:

• Rifamycins (such as Rifampicin)
• Drugs Used to Treat Seizures (such as Carbamazepine, Phenytoin)

Call emergency hotline if someone has overdosed and has serious symptoms such as passing out or trouble breathing.

Symptoms of overdose may include:

• Headache
• Dizziness
• Lightheadedness
• Cold, Clammy Skin
• Fast Heart Beat

Available brand/s:

• Daxas