Medication Guide

Medication Guide
Clonazepam Tablets, USP
(kloe-NA-za-pam)
CIV

What is the most important information I should know about clonazepam tablets?

• Clonazepam tablets is a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.

•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 affects 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 may make your sleepiness or dizziness worse.

• Like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempt to commit suicide
• new or worse depression
• new or worse anxiety
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• 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.
  

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.

•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).

•Clonazepam tablets can cause abuse and dependence.

• Do not stop taking clonazepam all of a sudden. Stopping clonazepam tablets suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
• Talk to your healthcare provider about slowly stopping clonazepam tablets to avoid withdrawal symptoms.
• 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.

Clonazepam tablets is a federal controlled substance (C-IV) because it 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.

What is Clonazepam tablets?

Clonazepam tablets is 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
  It is not known if clonazepam tablets is safe or effective in treating panic disorder in children younger than 18 years old.

Who should not take Clonazepam tablets?

Do not take clonazepam tablets if you:

• are allergic to benzodiazepines
• have significant liver disease
• have an eye disease called acute narrow angle glaucoma

Ask your healthcare provider if you are not sure if you have any of the problems listed above.

Before you take clonazepam tablets, tell your healthcare provider if you:

• 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. It is not known if clonazepam tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. You and your healthcare provider will decide if you should take clonazepam tablets while you are pregnant.

• Studies in pregnant animals have shown harmful effects of benzodiazepine medications (including the active ingredient in clonazepam tablets on the developing fetus.
• Children born to mothers receiving benzodiazepine medications including clonazepam tablets late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms.
• 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. You and your healthcare provider should decide how you will feed your baby while you take clonazepam.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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 much 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:

• Drowsiness
• Problems with walking and coordination
• Dizziness
• Depression
• Fatigue
• Problems with memory

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.

How should I store clonazepam tablets?

• Store clonazepam tablets between 59ºF to 86ºF (15ºC to 30ºC).

Keep clonazepam tablets and all medicines out of the reach of children.

General Information about 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 it was not prescribed. Do not give clonazepam tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals.

For more information, go to www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.

What are the ingredients in clonazepam tablets?

Active Ingredient: clonazepam

Inactive Ingredients:

Tablets:

• 0.5 mg tablets contain anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, starch (corn) and FD&C Yellow No. 6 Lake.
• 1 mg tablets contain anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, starch (corn) and FD&C Blue No. 2 Lake.
• 2 mg tablets contain anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn)

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication guide available at https://www.accordhealthcare.us/medication-guides

Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad -380 009, India.

10 0533 2 682353

Issued April 2018