"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Cesamet 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. Some people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur: fainting, mental/mood changes (e.g., depression, anxiety, panic, paranoia, hallucinations, psychosis), unusual weakness, vision changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: fast heartbeat, seizures.
Because nabilone can cause mental, mood, or behavior changes, you should be under the close supervision of a responsible adult or caretaker while you are taking this medication. If you experience any such effects, remain calm and tell your doctor immediately. Do not take any more nabilone until after you consult with your doctor.
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, 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 Cesamet (nabilone capsules) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking nabilone, tell your doctor or pharmacist if you are allergic to it; or to marijuana or related products; 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: liver disease, high blood pressure, heart disease, mental/mood conditions (e.g., mania, depression, schizophrenia), personal or family history of regular use/abuse of drugs/alcohol/other substances.
This drug may make you dizzy or drowsy or affect your judgment. Do not drive, use machinery, or do any activity that requires alertness and clear thinking until you know how this medication affects you and until you are sure you can perform such activities safely. Alcohol can worsen these side effects. Avoid alcoholic beverages.
To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially the effects on blood pressure and mental/mood changes.
Caution is advised when using this drug in children because they may be more sensitive to its effects, especially the mental/mood changes.
This medication is not recommended for use during pregnancy because of possible unborn baby/infant harm reported with marijuana exposure (nabilone is similar to a substance found in marijuana). Consult your doctor for more details.
It is not known whether this drug passes into breast milk. Because other cannabinoids pass into breast milk, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
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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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