Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ratio Temazepam.
HEALTH CANADA ADVISORY
October 30, 2020
Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Addiction potential: Temazepam can become habit-forming. Withdrawal symptoms similar to those occurring with other benzodiazepines and alcohol, have been observed after stopping the medication suddenly after having taken it regularly over as little as 2 to 3 weeks. These symptoms of withdrawal include:
- abdominal cramps
- agitation
- confusion
- Diarrhea
- extreme anxiety
- headache
- irritability
- memory impairment
- muscle pain
- nervousness
- restlessness
- sleep problems
- tension
- tremors
- vomiting
If you have been taking Ratio Temazepam for a while, it should be stopped gradually as directed by your doctor.
Anxiety or restlessness: An increase in daytime anxiety or restlessness has been observed during treatment with temazepam.
Complex sleep-related behaviours: Occasionally, people taking Ratio Temazepam have experienced instances of driving, preparing food and eating, making phone calls and other activities while "sleeping". These events are generally not remembered. Taking temazepam along with other medications that cause drowsiness, including alcohol, appears to increase the risk for these behaviours. If you observe these behaviours in a family member who is taking Ratio Temazepam, or become aware of them yourself, contact your doctor as soon as possible.
Confusion: Ratio Temazepam may affect mental efficiency (e.g., concentration, attention, and vigilance). The risk of confusion is greater for seniors and those with brain injury.
Depression or psychosis: Abnormal thinking and psychotic behavioral changes have been reported with benzodiazepines (e.g., aggressiveness). Particular caution is warranted in patients with a history of violent behaviour.
If you have a history of depression or other mental illness, this may be more likely to occur. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Ratio Temazepam, contact your doctor as soon as possible. You should be closely monitored by your doctor for emotional and behaviour changes while taking Ratio Temazepam.
Drowsiness/reduced alertness: You should not engage in hazardous activities requiring complete mental alertness such as driving or operating machinery until the effects of Ratio Temazepam have worn off. Using alcohol or other drugs that cause drowsiness or sedation is not recommended.
Kidney function: Kidney Disease or reduced kidney function may cause Ratio Temazepam to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Ratio Temazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ratio Temazepam, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Ratio Temazepam to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Ratio Temazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ratio Temazepam, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Ratio Temazepam.
Memory disturbance: Amnesia of varying severity has been reported following normal doses Ratio Temazepam. Seniors are at particular risk.
Pregnancy: Ratio Temazepam may cause harm to a developing baby and should not be used during pregnancy. If you become pregnant while taking Ratio Temazepam, contact your doctor immediately.
Breast-feeding: It is not known if temazepam passes into breast milk. If you are a breast-feeding mother and are taking Ratio Temazepam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of temazepam have not been established for children below the age of 18 years.
Seniors: The sedative effects of temazepam may affect seniors more than others. Extra caution is needed, for example, when getting up during the night.
