Patient Medication Information: uses, side effects, how to take - Dom-Clonazepam-R - Tab 0.5mg
ABOUT THIS MEDICATION
What the medication is used for:
Dom-CLONAZEPAM-R is used for the treatment of certain types of seizures.
What it does:
Dom-CLONAZEPAM-R contains the active ingredient clonazepam, which belongs to a group of medicines known as
benzodiazepines. Dom-CLONAZEPAM-R 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 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 Yellow # 6 Lake, lactose, magnesium stearate and microcrystalline cellulose.
What dosage forms it comes in:
Tablets: 0.5 mg
WARNINGS AND PRECAUTIONS
Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R as this may provoke epileptic seizures.
- Always contact your doctor before stopping or reducing your dosage of Dom-CLONAZEPAM-R, as suddenly stopping treatment or a large decrease in dose can cause reappearance of seizures and withdrawal symptoms.
- Benzodiazepines such as Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R 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/
- Dom-CLONAZEPAM-R 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 anti-epileptics such as CLONAZEPAM-R have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.
BEFORE you use Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R. 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 Dom-CLONAZEPAM-R or may affect how well Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R.
You must not consume alcohol while taking Dom-CLONAZEPAM-R as its effects may worsen side effects that some patients experience with Dom-CLONAZEPAM-R.
Grapefruit juice may increase blood levels of Dom-CLONAZEPAM-R, therefore you should avoid drinking grapefruit juice while you are taking Dom-CLONAZEPAM-R.
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 Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R 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 Dom-CLONAZEPAM-R.
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 Dom-CLONAZEPAM-R 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 | Stop taking drug and seek medical help | |||
| Only if severe | In all cases | ||||
| 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), and thoughts of death or suicide. | √ | ||||
| Un-common | 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 Dom-CLONAZEPAM, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep Dom-CLONAZEPAM-R 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:
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, Dominion Pharmacal. at, 1-888-550-6060.
Dominion Pharmacal
Montreal Quebec
H4P 2T4