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Daliresp (Generic Roflumilast)

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Why is this medication prescribed?

Patients with severe chronic obstructive pulmonary disease (COPD; a set of illnesses that affect the lungs and airways) can take roflumilast to lessen the frequency of episodes or worsening of COPD symptoms. A group of drugs known as phosphodiesterase inhibitors includes roflumilast. It reduces pulmonary edoema to have its desired effects.

How should this medicine be used?

Roflumilast is available as an oral tablet. It is typically taken once day, with or without food. Take roflumilast every day at roughly the same time. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Roflumilast should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

To treat abrupt bouts of respiratory issues, do not take roflumilast. Ask your doctor whether there are any other medications that can be used to address the signs of an emergency respiratory condition.

Roflumilast may be able to manage COPD, but it cannot heal it. Roflumilast should be taken even if you feel fine. Without consulting your doctor, do not discontinue taking roflumilast.

Whenever you refill your prescription for roflumilast, your doctor or chemist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and ask your doctor or chemist. To obtain the Medication Guide, go to the manufacturer’s website.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking roflumilast,

  • If you have an allergy to roflumilast, any other medications, or any of the chemicals in roflumilast tablets, inform your doctor and chemist right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention any of the following: rifampicin, carbamazepine (Tegretol), cimetidine (Tagamet), enoxacin (not sold in the United States), erythromycin (E.E.S., E-Mycin), fluvoxamine, ketoconazole (Nizoral), phenobarbital, phenytoin (Dilantin), carbamazepine (E.E.S. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • In case you have liver problems, let your doctor know. Your physician might advise against taking roflumilast.
  • Inform your doctor if you have or have ever experienced any mental health issues, such as depression, thoughts of self-harm or suicide or plans or attempts to do so, severe worry, or any unexpected changes in behaviour or mood. Describe the dangers of taking roflumilast to your doctor.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you get pregnant while taking Roflumilast.
  • You should be aware that while using roflumilast, your mental health could change in unforeseen ways. If you notice any of the following new symptoms or a worsening of current symptoms, you, your family, or your carer should contact your doctor straight soon. Inability to fall or remain asleep; depression; suicidal thoughts; intending to injure or kill oneself; excessive concern; agitation; or changes in mood. To call the doctor if you are unable to seek treatment on your own, let your family or caretaker know that these symptoms may be significant.
  • Roflumilast can lead to weight loss, which you should be aware of. While receiving therapy with roflumilast, your doctor should regularly monitor your weight and you should do the same. Make an appointment with your doctor if you start to lose weight.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Roflumilast might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Nausea
  • Dizziness
  • Headache
  • Back ache
  • Tense muscles
  • Reduction in hunger
  • Uncontrolled trembling in a bodily component

Certain adverse effects can be very harmful. Call your doctor right away if you encounter any of the signs and symptoms detailed in the SPECIAL PRECAUTIONS section.

Further adverse effects of roflumilast are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Headache
  • Dizziness
  • Lightheadedness
  • Clammy, frigid skin
  • Rapid heart rate

What other information should I know?

Keep all of your doctor’s appointments.

No one else should take your medication. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Daliresp®
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