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 Sandoz Nitrazepam.
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.
Alcohol and other medications that cause drowsiness: People taking Sandoz Nitrazepam should not combine it with alcohol and avoid combining it with other medications, such as narcotic pain relievers, or other sedatives that cause drowsiness. Doing so can cause additional drowsiness and reduced breathing as well as other side effects, which can be dangerous.
Asthma and other respiratory conditions: Nitrazepam may cause increased breathing difficulty for people having an acute asthma attack, or those with COPD (Chronic Obstructive Pulmonary Disease) (chronic Bronchitis, emphysema) or other conditions that affect breathing. If you have asthma or any other breathing disorder, discuss with your doctor how Sandoz Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Nitrazepam, and whether any special monitoring is needed.
Behavioural and mood changes: Sandoz Nitrazepam may cause mood and psychiatric changes, including aggressiveness, confusion, anxiety, restlessness, and memory lapses. Tell your doctor as soon as possible if you notice any unusual changes in your behaviour.
Complex sleep-related behaviours: There have been reports of complex sleep-related behaviours that have occurred while using nitrazepam and other similar medications to treat difficulty sleeping. People taking nitrazepam have been reported to talk, walk, cook, eat, and drive while they were not fully awake, and did not remember doing these things afterwards. If you experience similar events, or notice them in a family member who is taking Sandoz Nitrazepam, contact your doctor as soon as possible.
Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with benzodiazepines such as nitrazepam. Severe withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. These symptoms include seizures, irritability, nervousness, sleep problems, agitation, tremors, Diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.
A temporary condition called rebound insomnia, where the symptoms that led to treatment with nitrazepam come back worse than before, may occur on withdrawal of the medication. It may be accompanied by other reactions including mood changes or anxiety.
Depression: Sandoz Nitrazepam can make some symptoms of depression worse. If you have depression or a history of depression, discuss with your doctor how Sandoz Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Nitrazepam, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, contact your doctor as soon as possible. If you experience feelings of wanting to harm yourself, or notice this in a family member who is taking Sandoz Nitrazepam, seek medical help immediately.
Drowsiness/reduced alertness: Nitrazepam causes drowsiness and sedation. Avoid activities requiring mental alertness, judgment, and physical coordination such as driving or operating machinery until you have determined how Sandoz Nitrazepam affects you. Drinking alcohol can increase the drowsiness effects and should be avoided.
Kidney function: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Sandoz Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Nitrazepam, and whether any special monitoring is needed.
Liver function: People with reduced liver function or liver disease may experience a stronger effect from the medication than would normally occur. If you have reduced liver function or liver disease, discuss with your doctor how Sandoz Nitrazepam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Nitrazepam, and whether any special monitoring is needed.
Pregnancy: Nitrazepam, like other benzodiazepines, can cause harm to an unborn baby if the mother takes it while pregnant. Sandoz Nitrazepam should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Sandoz Nitrazepam, contact your doctor immediately.
Breast-feeding: Sandoz Nitrazepam passes into breast milk. If you are a breast-feeding mother and are taking nitrazepam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of nitrazepam for sleep difficulties have not been established for children and adolescents less than 18 years of age.
Seniors: Seniors are more likely to experience sedation and decreased coordination when taking nitrazepam. The lowest effective dose of Sandoz Nitrazepam should be used for the shortest possible length of time.
