clobazam – oral, Onfi

Medication Uses: This medication is used to control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

HOW TO USE: Read the Medication Guide before you start taking clobazam 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 unable to swallow tablets, they may be crushed and mixed with applesauce. If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/syringe. Do not use a household spoon because you may not get the correct dose. Read the Instructions for Use on how to properly use the special measuring device/syringe. If you have any questions, ask your pharmacist. If you are taking this medication once daily, take it at bedtime. If you are taking this medication in divided doses, take the largest dose at bedtime. Dosage is based on your medical condition and response to treatment. In infants, the dosage may also be based on weight. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day. This medication may cause withdrawal reactions, especially if used regularly for a long time or in high doses. In such cases, withdrawal symptoms may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when directed. When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, tiredness, headache, constipation, weight gain, fever, cough, drooling, trouble sleeping, or nausea may occur. If any of these effects persist or worsen, 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 immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, mental/mood/behavior changes (e.g., agitation, nervousness, confusion, memory loss), muscle weakness, loss of coordination, shaking (tremor) of the fingers, vision changes (e.g., blurred vision, double vision), slurred speech, decrease in sexual interest, painful urination. A small number of people who take anticonvulsants for any condition may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. Clobazam may rarely cause very serious (possibly fatal) skin reactions, especially during the first 8 weeks of treatment or when restarting treatment with this medication. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or mouth sores. If you have a very serious skin reaction and your doctor says it was caused by clobazam, you should not take the medication again. Ask your doctor or pharmacist for more details. 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.

PRECAUTIONS: Before taking clobazam, tell your doctor or pharmacist if you are allergic to it or other benzodiazepines; 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: myasthenia gravis, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, glaucoma, mental/mood disorders (e.g., depression, psychosis), brain disorders (e.g., head injury, brain damage), breathing problems (e.g., asthma, COPD, sleep apnea), muscle disorders (e.g., weakness, loss of coordination). Before having surgery, tell your doctor or dentist that you are taking this medication. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages since they may increase dizziness/drowsiness and also may increase the drug levels. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects, especially drowsiness. Caution is advised when using this drug in children because they are more sensitive to the effects. This drug can often cause excitement in young children instead of drowsiness. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, so do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control methods may not work if taken with this medication, discuss reliable forms of birth control with your doctor. This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

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. A product that may interact with this drug is sodium oxybate. Other medications can affect the removal of clobazam from your body, which may affect how clobazam works. Examples include fluconazole, fluvoxamine, among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, certain antihistamines, certain herbal medications, medicine for sleep or anxiety, muscle relaxants, narcotic pain relievers, psychiatric medicines. 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 decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

QUESTION

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. 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: confusion, weakness, severe drowsiness/dizziness, slow/shallow breathing, loss of consciousness, slowed/decreased reflexes. NOTES: Do not share this medication with others. It is against the law. Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. 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 and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. If using the liquid form of this medication, store the bottle upright and throw away any unused medication after 90 days. 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 for more details about how to safely discard your product. 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). Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.