Incruse Ellipta

Incruse Ellipta is a prescription medication used for long-term control of symptoms of chronic obstructive pulmonary disease (COPD).

Incruse Ellipta belongs to a group of drugs called anticholinergic agents. These work by relaxing and opening airways in the lungs.

This medication is available as a powder for inhalation and used taken once daily. The ingredient in Incruse Ellipta is also an ingredient in a combination prescription product.

Common side effects of Incruse Ellipta include inflammation in the nose and throat, upper respiratory tract infection, cough, and joint pain.

Incruse Ellipta can also cause dizziness. It can cause blurred vision in patients with narrow angle glaucoma. Do not drive or operate heavy machinery until you know how Incruse Ellipta affects you.

Incruse Ellipta is a prescription medication used as long-term control of symptoms of chronic obstructive pulmonary disease such as wheezing, shortness of breath, coughing, and chest tightness.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Glaxo SmithKline Pharmaceuticals

Serious side effects have been reported with Incruse Ellipta. See the “Incruse Ellipta Precautions” section.

Common side effects of Incruse Ellipta include the following:

• Runny nose
• Sore throat
• Cough
• Joint or muscle pain

This is not a complete list of Incruse Ellipta side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antihistamines such as diphenhydramine (Benadryl, Sominex, in Advil PM, in Tylenol PM), chlorpheniramine (Chlor-Trimeton), or doxylamine (Unisom)
• Atropine
• Other medications for COPD including aclidinium (Tudorza Pressair), ipratropium (Atrovent HFA), and tiotropium (Spiriva)
• Medications for irritable bowel disease such as dicyclomine (Bentyl) or hyoscyamine (Anaspaz, Cystospaz, Levsin)
• Medications for motion sickness such as dimenhydrinate (Dramamine) or scopolamine
• Medications for Parkinson's disease such as benztropine (Cogentin) or trihexyphenidyl (Artane, Parkin, Pacitane)
• Medications for urinary problems such as oxybutynin (Ditropan, Driptane, Lyrinel XL), tolterodine (Detrol, Detrusitol), or solifenacin (Vesicare)

This is not a complete list of Incruse Ellipta drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Incruse Ellipta including the following:

• Rash
• Hives
• Itching
• Swelling or the face, mouth, or tongue
• Coughing, wheezing, or chest tightness that begins after you inhale umeclidinium
• Eye pain, redness, or discomfort, blurred vision, or seeing halos or bright colors around lights
• Difficulty urinating
• Frequent or painful urination
• Fast or irregular heartbeat

Incruse Ellipta can cause dizziness and blurred vision. Do not drive or operate heavy machinery until you know how Incruse Ellipta affects you.

Do not take Incruse Ellipta if you:

• are allergic to Incruse Ellipta or to any of its ingredients
• have a hypersensitivity to milk proteins

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Incruse Ellipta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Incruse Ellipta, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Incruse Ellipta or to any of its ingredients
• have prostate or bladder problems
• have heart problems
• have glaucoma
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Incruse Ellipta falls into category C. In animal studies, pregnant animals were given this medication and there was no evidence of problems for the mother or offspring. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Incruse Ellipta crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Incruse Ellipta.

Use Incruse Ellipta exactly as prescribed.

Incruse Ellipta is available as a powder for inhalation. It is used once daily.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not use more than 1 inhalation of Incruse Ellipta each day. Do not take two doses of Incruse Ellipta at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose/dose range of Incruse Ellipta (umeclidinium) for the long-term control of symptoms of chronic obstructive pulmonary disease is 1 oral inhalation (62.5 mcg) daily. The dose should be taken at the same time each day.

If you take too much Incruse Ellipta, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Incruse Ellipta is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Incruse Ellipta at room temperature.

Store this medication in the foil tray in which it is dispensed.

Keep this and all medicines out of the reach of children.