Teva Announces Its Launch of the First Generic PERFOROMIST, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML, Used to Treat Chronic Obstructive Pulmonary Disease (COPD), in the United States - Seite 2

IMPORTANT SAFETY INFORMATION

Do not use formoterol fumarate inhalation solution if you have asthma.

Before using formoterol fumarate inhalation solution tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have high blood pressure
• have diabetes
• have seizures
• have thyroid problems
• have liver problems
• are pregnant or plan to become pregnant. It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.
• are breastfeeding or plan to breastfeed. It is not known if the medicine formoterol in formoterol fumarate inhalation solution passes into breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Formoterol fumarate inhalation solution and certain other medicines may interact with each other. This may cause serious side effects.

What are the possible side effects of formoterol fumarate inhalation solution?

Formoterol fumarate inhalation solution can cause serious side effects, including:

• people with asthma who take long-acting LABA medicines, such as formoterol fumarate inhalation solution, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
  • Call your healthcare provider if breathing problems worsen over time while using formoterol fumarate inhalation solution. You may need a different treatment.
  • Get emergency medical care if:
    • breathing problems worsen quickly
    • you use your rescue inhaler medicine, but it does not relieve your breathing problems
• COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of formoterol fumarate inhalation solution, instead call your healthcare provider.
• using too much of a LABA medicine may cause: chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache, or nervousness.
• sudden shortness of breath immediately after use of formoterol fumarate inhalation solution. Sudden shortness of breath may be life-threatening. If you have sudden breathing problems immediately after inhaling your medicine, call your healthcare provider or go to nearest hospital emergency room right away.
• effects on your heart, including fast or irregular heartbeat, chest pain or increased blood pressure.
• changes in laboratory levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm.
• serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

Common side effects of formoterol fumarate inhalation solution include: headache, muscle cramps, dizziness, tremor, nausea, tiredness, nervousness, vomiting, trouble sleeping, dry mouth, or diarrhea.