IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DRONABINOL - ORAL

(dro-NAB-in-all)

COMMON BRAND NAME(S): Marinol

USES: Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is usually used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients with HIV infection. Dronabinol (also called THC) is a man-made form of the active natural substance in marijuana (cannabis).

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking dronabinol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually up to 4 to 6 times daily if you are taking it to control nausea and vomiting or twice daily (before lunch and before dinner) if you are taking it to treat appetite loss. Follow your doctor\'s instructions carefully. The dosage is based on your medical condition and response to treatment. If you are taking this medication to control nausea and vomiting, your dosage may also be based on your body size. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase. If you suddenly stop using this medication, you may have withdrawal symptoms (such as irritability, trouble sleeping, restlessness, hot flashes, diarrhea). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used dronabinol for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Dizziness, drowsiness, confusion, feeling \"high\", an exaggerated sense of well-being, lightheadedness, nausea, vomiting, or stomach/abdominal pain may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. 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 right away if you have any serious side effects, including: fainting, fast/pounding heartbeat, mental/mood changes (such as anxiety, nervousness, hallucinations, abnormal thoughts, paranoia). A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana (cannabis); or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), 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: personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), heart disease, high blood pressure, mental/mood disorders (such as mania, depression, schizophrenia), seizures. This drug may make you dizzy or drowsy or affect your judgment. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and mental/mood changes. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast heartbeat, mental/mood changes, seizures.

NOTES: Do not share this medication with others. Sharing it is against the law. Keep all medical appointments so your doctor can monitor your response to treatment (such as your weight) and check for side effects.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store this medication according to the directions on the product package, away from light and moisture. Some brands must be refrigerated, and others may be stored at room temperature. Consult your pharmacist for more details. Do not freeze this medication or store it in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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