Clonazepam (kloe naz' e pam) Tablets, USP
for oral use
|What is the most important information I should know about clonazepam tablets?
Do not drive or operate heavy machinery until you know how taking clonazepam tablets and opioids affect you.
Clonazepam tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens:
- shallow or slowed breathing
- breathing stops (which may lead to the heart stopping)
- excessive sleepiness (sedation)
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam tablets, which can lead to overdose and serious side effects including coma and death.
Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including clonazepam tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects.
You can develop an addiction even if you take clonazepam tablets as prescribed by your healthcare provider.
Take clonazepam tablets exactly as your healthcare provider prescribed.
- Do not share your clonazepam tablets with other people.
- Keep clonazepam tablets in a safe place and away from children.
Physical dependence and withdrawal reactions. Clonazepam tablets can cause physical dependence and withdrawal reactions.
Do not suddenly stop taking clonazepam tablets. Stopping clonazepam tablets suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
- Do not take more clonazepam tablets than prescribed or take clonazepam tablets for longer than prescribed.
Clonazepam tablets can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.
- Clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse.
Like other antiepileptic medicines, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- acting on dangerous impulses
- new or worse irritability
- an extreme increase in activity and talking (mania)
- acting aggressive, being angry, or violent
- other unusual changes in behavior or mood
|How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Do not stop clonazepam tablets without first talking to a healthcare provider.
- Stopping clonazepam tablets suddenly can cause serious problems. Stopping clonazepam tablets suddenly can cause seizures that will not stop (status epilepticus).
|What are clonazepam tablets?
It is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old.
- Clonazepam tablets are a prescription medicine used alone or with other medicines to treat:
- certain types of seizure disorders (epilepsy) in adults and children
- panic disorder with or without fear of open spaces (agoraphobia) in adults
Clonazepam tablets are a federally controlled substance (C-IV) because it contains clonazepam that can be abused or lead to dependence. Keep clonazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away clonazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
|Who should not take clonazepam tablets?
Do not take clonazepam tablets if you:
Ask your healthcare provider if you are not sure if you have any of the problems listed above.
- are allergic to benzodiazepines
- have significant liver disease
- have an eye disease called acute narrow angle glaucoma
|Before you take clonazepam tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- have liver or kidney problems
- have lung problems (respiratory disease)
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have any other medical problems
- are pregnant or plan to become pregnant.
- Taking clonazepam tablets late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with clonazepam tablets.
- If you become pregnant while taking clonazepam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
- are breastfeeding or plan to breastfeed. Clonazepam can pass into breast milk.
- Breastfeeding during treatment with clonazepam tablets may cause your baby to have sleepiness, feeding problems, and decreased weight gain.
- Talk to your healthcare provider about the best way to feed your baby while you take clonazepam tablets.
Taking clonazepam tablets with certain other medicines can cause side effects or affect how well clonazepam tablets or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.
|How should I take clonazepam tablets?
- Take clonazepam tablets exactly as your healthcare provider tells you. If you take clonazepam tablets for seizures, your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms.
- Clonazepam is available as a tablet.
- Do not stop taking clonazepam tablets without first talking to your healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems.
- Clonazepam tablets should be taken with water and swallowed whole.
- If you take too many clonazepam tablets, call your healthcare provider or local Poison Control Center right away.
|What should I avoid while taking clonazepam tablets?
- Clonazepam tablets can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.
- Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness much worse.
|What are the possible side effects of clonazepam tablets?
See “What is the most important information I should know about clonazepam tablets?”
Clonazepam tablets can also make your seizures happen more often or make them worse. Call your healthcare provider right away if your seizures get worse while taking clonazepam tablets.
The most common side effects of clonazepam tablets include:
These are not all the possible side effects of clonazepam tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Aurobindo Pharma USA, Inc. at 1-866-850-2876.
- problems with walking and coordination
- problems with memory
|How should I store clonazepam tablets?
- Store clonazepam tablets between 20° to 25°C (68° to 77°F).
Keep clonazepam tablets and all medicines out of the reach of children
|General Information about the safe and effective use of clonazepam tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam tablets for a condition for which they were not prescribed. Do not give clonazepam tablets to other people, even if they have the same symptoms that you have. They may harm them.
You can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals.
|What are the ingredients in clonazepam tablets?
Active ingredient: clonazepam
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The 0.5 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and the 1 mg tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides.
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 032, India
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.