Consumer Information for: CLONAZEPAM

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

CLONAZEPAM is used for the treatment of certain types of seizures.

What it does

CLONAZEPAM contains the active ingredient clonazepam, which belongs to a group of medicines known as benzodiazepines. CLONAZEPAM has anticonvulsant properties which help to manage seizures.

When it should not be used

  • If you are allergic to the group of medicines known as benzodiazepines (examples: diazepam, chlordiazepoxide, bromazepam, or flurazepam)
  • If you are allergic to the medicinal ingredient (clonazepam)
  • If you are allergic to any of the other non-medicinal ingredients it contains (see ‘What the non-medicinal ingredients are’)
  • If you suffer from lung disease.
  • If you have a liver condition.
  • If you have glaucoma.
  • If you have myasthenia gravis.
What the medicinal ingredient is

Clonazepam.

What the non-medicinal ingredients are

Corn starch, FD&C Blue # 1 Lake (0.25 mg), FD&C Red # 40 Lake (1 mg), lactose, magnesium stearate, microcrystalline cellulose and Yellow # 6 Lake (0.5 mg).

What dosage form it comes in

Tablets: 0.25 mg, 0.5 mg, 1 mg and 2 mg

Warnings and precautions

  • CLONAZEPAM may affect your ability to be alert. Driving, operating machinery and other hazardous activities should therefore be avoided altogether or at least during the first few days of treatment. This effect of CLONAZEPAM may be made worse if you take alcoholic drinks. If you increase your dose or change the timings of when you take your medication this may also modify your reactions.
  • You must not consume alcohol or other drugs that affect your central nervous system while taking CLONAZEPAM as this may provoke epileptic seizures.
  • Always contact your doctor before stopping or reducing your dosage of CLONAZEPAM, as suddenly stopping treatment or a large decrease in dose can cause reappearance of seizures and withdrawal symptoms.
  • Benzodiazepines such as CLONAZEPAM have produced dependence (addiction) and withdrawal symptoms can occur when treatment is stopped suddenly. The risk of dependence (addiction) increases with higher doses and longer duration of treatment. Symptoms of withdrawal may include shaking, sweating, sleep disturbances, agitation/restlessness, headache, muscle pain, anxiety, confusion, and irritability. In severe cases of withdrawal, symptoms may include numbness and tingling of the extremities, hallucinations (see or hear things that are not there), increased sensitivity to light, noise and physical contact.
  • There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those also taking other sedatives (including alcoholic beverages) and in the elderly.
  • Memory loss may occur when CLONAZEPAM is used at therapeutic doses.
  • Do not take this medicine if you are pregnant, or might become pregnant, unless advised by your doctor. Contact your doctor if you think you may be pregnant, or are intending to become pregnant. If you are pregnant or thinking about becoming pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling (1-888)233-2334 (toll free). Women who are pregnant and planning to take an antiepileptic drug should call the pregnancy registry to enable collection of valuable data about its use in pregnancy. Information on the registry can also be found at the website: http://www.aedpregnancyregistry.org/
  • CLONAZEPAM passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you.
  • A small number of people being treated with antiepileptics such as CLONAZEPAM have had thoughts of harming or killing hemselves. If at any time you have these thoughts, contact your doctor immediately.
BEFORE you use CLONAZEPAM talk to your doctor or pharmacist if you:
  • Have a lung, liver or kidney condition.
  • Have glaucoma.
  • Are taking or plan on taking ANY other drugs (including herbal preparations, drugs you purchase without prescriptions, and those not prescribed by your doctor).
  • Regularly drink alcohol or use recreational drugs.
  • Suffer from a form of incoordination of the muscles called spinal or cerebellar ataxia.
  • Have a history of depression and/or suicide attempts.
  • Have rare hereditary problems of galactose intolerance.
Interactions with this medication

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food store without a prescription.

  • Some medicines may interfere with CLONAZEPAM.
    These medicines include:
  • medicines to control seizures
  • narcotics and narcotic pain relievers
  • muscle relaxants
  • sleeping medication
  • medicines to treat your mood, such as monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazines
  • phenytoin, phenobarbital, carbamazepine, and valproate.
These medicines may be affected by CLONAZEPAM or may affect how well CLONAZEPAM works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of the above, tell him/her before you start taking CLONAZEPAM.

You must not consume alcohol while taking CLONAZEPAM as its effects may worsen side effects that some patients experience with CLONAZEPAM.

Grapefruit juice may increase blood levels of CLONAZEPAM, therefore you should avoid drinking grapefruit juice while you are taking CLONAZEPAM.
Proper use of this medication

Usual dose

Always take the tablets exactly as your doctor tells you to. Your doctor will prescribe a suitable dose for you. The dose your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and body weight. The table below shows the different doses that your doctor may prescribe according to your age. Your doctor will start you on an initial low dose and gradually increase it until the desired effect is achieved.

Initial Dose Maintenance Dose
Adults 1.5 mg/day or less in divided doses 8-10 mg/day in divided doses
Children (up to 10 years or 30kg) 0.01-0.03 mg/kg/day in divided doses 0.1-0.2 mg/kg/day in divided doses

The total daily dose should be taken as advised by your doctor.

Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor.

Your doctor will advise you when to stop taking the medicine. Your doctor will slowly decrease the dosage as sudden discontinuation of treatment can cause the appearance of withdrawal symptoms. Overdose:

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Take the missed dose of CLONAZEPAM as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take 2 doses at the same time.

Side effects and what to do about them

Like all medications CLONAZEPAM can cause some side effects.

For most patients these side effects are likely to be minor and temporary as your body adjusts to the medicine. However, some may be serious. Consult your doctor or pharmacist as soon as you can if you do not feel well while taking CLONAZEPAM.

The most common side effects are:

  • Feeling drowsy or tired, especially at the start of treatment.
  • Some muscle weakness and dizziness.
  • Increased salivation.
Less common possible side effects are:
  • Increased secretion from the lungs may occur. Children should therefore be watched carefully as this might cause difficulties in breathing and/or severe choking and coughing.
  • In rare cases changes in your blood and liver may occur and your doctor will monitor for these.
  • Falls and fractures: The risk is increased in those also taking other sedatives (including alcoholic beverages) and in the elderly.
Withdrawal-related side effects:
  • With long-term CLONAZEPAM treatment development of physical and psychological dependence may occur. If treatment is stopped suddenly symptoms of withdrawal may occur, including: shaking, sweating, agitation/restlessness, sleep disturbances, anxiety (possibly extreme), headaches, muscle pain, tension, restlessness, confusion and irritability. In severe cases of withdrawal, symptoms may include numbness and tingling of the extremities, hallucinations (see or hear things that are not there), increased sensitivity to light, noise and physical contact.
Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention
Rare
Unusual behavioural problems (aggression, rage), sudden anxiety or excitation; restlessness, agitation, irritability; hallucinations (see or hear things that are not there) or delusions; severe sleep disturbances, nightmares, inappropriate behaviour   ✔  
Allergic reactions (red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes)     ✔
immediately
Depression. Symptoms may include: difficulty sleeping, changes in weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family gatherings and activities with friends, reduced libido (sex drive)   ✔  
Uncommon
Suicidal Thoughts or Actions: Thoughts, plans and actions taken for the purpose of killing or harming yourself.   ✔  

This is not a complete list of side effects. For any unexpected effects while taking CLONAZEPAM, contact your doctor or pharmacist.
How to store

  • Keep CLONAZEPAM in a cool dry place stored at room temperature (15-30°C).
  • Keep this medicine out of sight and reach of children
Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

Reminder: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Sivem Pharmaceuticals ULC, at 1-855-788-3153 or

by written request at:
4705 Dobrin Street
Saint-Laurent, QC, Canada
H4R 2P7

or at :
www.sivem.ca

This leaflet was prepared by Sivem Pharmaceuticals ULC.

Last revised: June 4, 2015

Date modified: