Clonazepam (Meliapharm): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 any of the ingredients it contains(see

  ‘What the nonmedicinal 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 nonmedicinal ingredients are:

Corn starch, FD&C Red # 40 Lake (1 mg) lactose, magnesium stearate, and microcrystalline cellulose

What dosage forms it comes in:

Tablets: 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.
  • An increased risk of falls and fractures have been reported in elderly people who take benzodiazepines such as CLONAZEPAM.
  • 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.

  • CLONAZEPAM passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you.

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:

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:

• Increase 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.
• Increased falls and fractures may occur in elderly patients.

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.

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

HOW TO STORE IT

• Keep CLONAZEPAM in a cool dry place stored at room

  temperature (15-30°C).

• Keep this medicine out of the reach of children

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect .

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, MELIAPHARM INC. at, 1-888-550-6060.

MELIAPHARM INC.

Montreal Quebec

H4P 2T4

Last revised: May 31, 2011