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.

DIAZEPAM - ORAL

(dye-AZ-e-pam)

COMMON BRAND NAME(S): Valium

WARNING: Taking diazepam with opioid medications (such as codeine, hydrocodone) may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of diazepam that works, and take it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

USES: Diazepam is used to treat anxiety, alcohol withdrawal, and seizures. It is also used to relieve muscle spasms and to provide sedation before medical procedures. This medication works by calming the brain and nerves. Diazepam belongs to a class of drugs known as benzodiazepines.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking diazepam and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you are using the concentrated solution, use the medicine dropper provided and mix the measured dose with a small amount of liquid or soft food (such as applesauce, pudding). Take all of the mixture right away. Do not store the mixture for later use. The dosage is based on your medical condition, age, and response to treatment. 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 side effects will increase. Properly stop the medication when so directed. If you suddenly stop using this medication, you may have withdrawal symptoms (such as shaking, abdominal/muscle cramps, vomiting, sweating, anxiety, restlessness, seizures). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used diazepam for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well. 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. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. If directed by your doctor, take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: See also Warning section. Drowsiness, dizziness, tiredness, blurred vision, or unsteadiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 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: mental/mood changes (such as memory problems, agitation, hallucinations, confusion, restlessness, depression), trouble speaking, trouble walking, muscle weakness, shaking (tremors), trouble urinating, yellowing eyes/skin, signs of infection (such as sore throat that doesn\'t go away, fever, chills). Get medical help right away if you have any very serious side effects, including: slow/shallow breathing. 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 diazepam, tell your doctor or pharmacist if you are allergic to it; or to oxazepam or temazepam; 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 muscle disease (myasthenia gravis), lung/breathing problems (such as COPD, sleep apnea), mental/mood disorders (such as depression, thoughts of suicide, psychosis), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), glaucoma, liver disease, kidney disease. This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Some liquid products may contain alcohol. Ask your doctor or pharmacist about using this product safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). For some children, instead of having a calming effect, diazepam may have the opposite effect, causing mental/mood changes (such as agitation, hallucinations, restlessness). Older adults may be more sensitive to the side effects of this drug, especially drowsiness and loss of coordination. These side effects can increase the risk of falling. For some older adults, instead of having a calming effect, diazepam may have the opposite effect, causing mental/mood changes (such as agitation, hallucinations, restlessness). This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. Consult your doctor for more details. This drug passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning and How to Use sections. 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. Some products that may interact with this drug include: clozapine, fluvoxamine, orlistat, sodium oxybate. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other 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. This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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, slow reflexes, slow/shallow breathing, fainting, loss of consciousness.

NOTES: Do not share this medication with others. Sharing it is against the law. If this drug is used for a long period of time, lab and/or medical tests (such as liver function tests, complete blood count) may be done while you are taking this medication. Keep all medical and lab appointments.

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 at room temperature away from light and moisture. Do not store in the bathroom. If you are using the concentrated solution, discard the opened bottle after 90 days. 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

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