"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
Uniphyl Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: confusion, dizziness, mental/mood changes, muscle twitching/pain/tenderness, weakness, rapid breathing.
Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, fast/slow/irregular heartbeat, vomit that looks like coffee grounds, dark/tarry stools, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, red/scaly skin, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Uniphyl (theophylline anhydrous tablet) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using theophylline, tell your doctor or pharmacist if you are allergic to it; or to theobromine or caffeine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain breathing disorder (cystic fibrosis), glaucoma, diabetes, heart problems (e.g., congestive heart failure, irregular heartbeat), high blood pressure, kidney disease, liver disease (e.g., cirrhosis), seizures, stomach/intestinal ulcer, thyroid disease.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
If you develop a fever/flu-like symptoms while taking this medication, tell your doctor promptly. The dose of your medicine may need to be adjusted.
Before having surgery, tell your doctor or dentist that you are using this medication.
Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, or trouble sleeping. Careful monitoring of side effects and drug blood levels is recommended.
Caution is advised when using this drug in children because they may be more sensitive to its effects. Careful monitoring of side effects, drug blood levels, and dose adjustment is recommended.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Changes in your body during the last 3 months of pregnancy may affect the amount of this drug in your blood. Your doctor should carefully monitor the amount of drug in your blood, as well as any side effects, so that your dose may be changed if needed.
This drug passes into breast milk and may have undesirable effects on a nursing infant (e.g., irritability). Consult your doctor before breast-feeding.
Additional Uniphyl Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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