Patient Medication Information: uses, side effects, how to take - NTP-Temazepam
ABOUT THIS MEDICATION
What the medication is used for:
NTP-TEMAZEPAM is intended to help you sleep if you have transient and short-term insomnia. Symptoms of insomnia include difficulty falling asleep, and/or waking up often during the night or too early in the morning.
Treatment with NTP-TEMAZEPAM should usually not go on for more than 7-10 days and should be restricted for insomnia where disturbed sleep results in impaired daytime functioning. NTP-TEMAZEPAM does not treat the underlying cause of your insomnia.
What it does:
NTP-TEMAZEPAM is a benzodiazepine which acts on receptors in your brain to produce a calming effect.
NTP-TEMAZEPAM is one of several benzodiazepine sleeping pills that have generally similar properties. If you are prescribed one of these medications, you should consider both their benefits and risks.
Important risks you should consider when taking NTP-TEMAZEPAM are:
the longer you use NTP-TEMAZEPAM, the
less effective it may become,
You may become dependent on NTP- TEMAZEPAM,
- NTP-TEMAZEPAM may affect your mental alertness or memory, particularly when not taken as prescribed
(see “WARNINGS AND PRECAUTIONS”)
When it should not be used:
- Patients with a known allergy to temazepam or other benzodiazepines or to any of the ingredients NTP-TEMAZEPAM contains (see ‘What the nonmedicinal ingredients are’)
- Patients with a chronic disease characterized by weakness of the skeletal muscles (myasthenia gravis)
- Patients with a sleep disorder which causes pauses in breathing or shallow breathing while sleeping (sleep apnea)
- Patients with a past history of unexpected reactions to alcohol or sedative medications, such as irritability, aggression, hallucinations, etc.
What the medicinal ingredient is:
Temazepam
What the nonmedicinal ingredients are:
colloidal silicon dioxide, lactose, and magnesium stearate, in a hard gelatin capsule [which contains titanium dioxide, gelatin, FD&C Blue No. 1, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10 and FD&C Yellow No. 6 (15 mg capsules only). The agent used to polish the capsules is: Talc.
What dosage forms it comes in:
Capsules 15 mg and 30 mg
WARNINGS AND PRECAUTIONS
Complex sleep-related behaviours
There have been reports of people getting out of bed while not fully awake after taking NTP-TEMAZEPAM and doing activities that they did not know they were doing. The next morning they did not remember doing these activities. This unusual behaviour is more likely to occur if NTP-TEMAZEPAM is taken with alcohol or other drugs that make you sleepy such as treatments for depression or anxiety. The activities you may do in these situations can put you and people around you in danger. Reported activities included driving a car (“sleep-driving”), leaving the house, making and eating food, talking on the phone, etc.
Important:
- 1. Do not take more NTP-TEMAZEPAM than prescribed.
- 2. Do not take NTP-TEMAZEPAM if you drink alcohol.
- 3.
Talk to your doctor about all of your medicines, including over-the-counter medicines and herbal products. Your doctor will tell you if you can take NTP-
TEMAZEPAM with your other medicines.
- 4. You and people close to you should watch for the type of unusual behaviour described above. If you find out you have done any such activities for which you have no memory you should call your doctor immediately.
Mental Alertness
NTP-TEMAZEPAM may affect your ability to be alert. Do not operate a car or dangerous machinery while using NTP-TEMAZEPAM until you know how this drug affects you.
Memory problems
Sleeping pills can cause a special type of memory loss (amnesia). You may not recall events that occurred during a period of time, usually several hours after taking the drug. This lapse can be a problem if you take the medication to induce sleep while travelling, such as during an airplane flight, as you may wake up before the effect of the drug is gone. This has been called “traveler’s amnesia”. Do not take NTP-TEMAZEPAM when a full night’s sleep is not possible before you would again need to be active and functional, e.g., overnight flight of less than 8 hours. Memory lapses may occur in such situations. Your body needs time to eliminate the medication from your system.
Tolerance/Withdrawal Symptoms
After nightly use for more than a few weeks, this drug may lose some of its effectiveness to help you sleep (tolerance).
Withdrawal effects can occur when patients stop taking sleeping pills suddenly. The effects may occur following use for only a week or two but may be more common and more severe after long periods of continuous use. Symptoms may range from unpleasant feelings to a major withdrawal syndrome that may include stomach/muscle cramps, vomiting, sweating, tremors or, rarely, convulsions. The severe symptoms are uncommon.
You may develop an increase in sleep difficulties (rebound insomnia) and/or increased daytime anxiety (rebound anxiety) for one or two days after
discontinuing NTP-TEMAZEPAM. This effect does not occur in everyone.
Also, although not common, it is possible that your body may eliminate NTP-TEMAZEPAM too quickly and the level of drug in your body may be too low at some point during each night’s use to maintain sleep for the full night. This can lead to being awake during the last third of the night and/or increased daytime anxiety or nervousness. If this happens to you, talk to your doctor.
Dependence/Abuse
Sleeping pills can cause dependence (addiction) especially when used regularly for more than a few weeks or at higher doses. Some people develop a need to continue taking these drugs, either at the prescribed dose or higher doses – not only for continued therapeutic effect, but also to avoid withdrawal symptoms or to achieve non-therapeutic effects. Patients who depend on or have depended on alcohol or other drugs in the past may be at particular risk but ALL PEOPLE ARE AT SOME RISK. Consider this matter before you take these medications beyond a few weeks.
Mental and Behavioural Changes
A variety of abnormal thinking and behaviour changes may occur when you use benzodiazepine sleeping pills, including aggressiveness, extroversion, confusion, strange behaviour, restlessness, illusions, hallucinations, feeling like you are not yourself, worsening of insomnia or worsening of depression including suicidal thinking. It is rarely clear whether such symptoms are caused by the medication, by an illness that was present before the medication was used or are simply spontaneous happenings. If you develop any unusual disturbing thoughts or behaviour discuss the matter with your doctor immediately.
Worsening of Side Effects
Do not consume alcohol while taking NTP-TEMAZEPAM . Some medicines may also worsen side effects that some patients experience with NTP-TEMAZEPAM (see “INTERACTIONS WITH THIS MEDICATION”).
Elderly
An increased risk of falls and fractures has been reported in elderly people who take
Benzodiazepines such as NTP-TEMAZEPAM.
Effects on Pregnancy
Certain benzodiazepine sleeping pills have been linked to birth defects when taken during the early months of pregnancy. In addition, benzodiazepine sleeping pills taken during the last weeks of pregnancy have been known to sedate the baby and may also cause withdrawal symptoms after birth. Do not take NTP-TEMAZEPAM at any time during pregnancy.
BEFORE you use NTP-TEMAZEPAM talk to your doctor or pharmacist if:
- You have a lung disease or breathing problems
- You have liver or kidney conditions.
- You have a history of depression and/or suicide thoughts or attempts.
- You have a history of drug or alcohol abuse or addiction.
- You are pregnant, if you are planning to become pregnant, or if you become pregnant while taking this medication.
- You are breastfeeding.
- You consume alcohol.
- You are taking other medications, including drugs you can buy without a prescription and herbal products.
- You have lactose intolerance.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription and herbal products.
Drugs that may interact with NTP-TEMAZEPAM include: alcohol, barbiturates, hypnotics (sleeping pills), antihistamines, narcotics, antipsychotics, antidepressants and anticonvulsants.
Do not take NTP-TEMAZEPAM if you drink alcohol.
Do not use NTP-TEMAZEPAM along with other medications without first discussing this with your doctor.
PROPER USE OF THIS MEDICATION
Benzodiazepines are effective medications and are relatively free of serious problems when used for the short term management of insomnia. Insomnia may last only for a short time and may respond to brief treatment. The risks and benefits of prolonged use should be discussed with your doctor.
Usual dose:
Follow your doctor’s advice about how to take NTP-TEMAZEPAM, when to take it, and how long to take it.
Adults: The recommended dose is 30 mg right before bedtime, 15 mg may be sufficient for some patients.
Elderly and debilitated patients should start with 15 mg before bedtime.
The lowest effective dose should be used. Treatment with NTP-TEMAZEPAM should usually not exceed 7-10 consecutive days.
If you still have problems sleeping after you finish your capsules, contact your doctor again.
Do not take more NTP-TEMAZEPAM than prescribed.
Do not take NTP-TEMAZEPAM if you drink alcohol.
Do not take NTP-TEMAZEPAM if it is not prescribed for you.
Do not take NTP-TEMAZEPAM when a full night’s sleep is not possible before you would again need to be active and functional.
Do not drive a car or operate potentially dangerous machinery until you experience how NTP-TEMAZEPAM will affect you the next day.
NTP-TEMAZEPAM is not for use in children under 18 years of age.
Overdose:
Contact your doctor, regional Poison Control Centre or pharmacist immediately if you suspect you have taken an overdose or someone else accidentally takes your NTP-TEMAZEPAM . If you are unable to contact them, go to a hospital emergency department for medical help, even though you may not feel sick. Show your doctor your bottle of capsules.
Missed Dose:
If you miss a dose, take your usual dose the next evening. Do not double your dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Common Side Effects
The most common side effects include: drowsiness, dizziness, lightheadedness and difficulty with coordination. Patients should be cautious about performing hazardous activities requiring complete mental alertness (i.e: operating machinery or driving a car).
How sleepy you are the day after you use NTP-TEMAZEPAM depends on your individual response and how quickly your body gets rid of the medication. Benzodiazepines, which are eliminated rapidly,
tend to cause less drowsiness the next day but may cause withdrawal problems the day after use.
The larger the dose, the more likely that you will experience drowsiness, etc. the next day. For this reason, it is important that you use the lowest dose possible that will still help you sleep at night.
Elderly patients are especially susceptible to side effects.Excessive drowsiness in the elderly may result in falls and fractures.
Do not drink alcohol while using NTP-TEMAZEPAM. Do not use sleeping pills along with other medications without first discussing this with your doctor.
Rare cases of severe allergic reactions have been reported. Symptoms may include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you have any of these symptoms after taking NTP-TEMAZEPAM.
Withdrawal-related side effects: See ‘WARNINGS AND PRECAUTIONS, Tolerance/Withdrawal Symptoms’.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom/ effect | Talk with your doctor or pharmacist | Seek Urgent Medical attention | ||||
| Only if Severe | In all Ca ses | |||||
| Common | Depressed mood | U | ||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom/ effect | Talk with your doctor or pharmacist | Seek Urgent Medical attention | ||||
| Rare | Severe allergic reaction (swelling of tongue or throat, trouble breathing, nauseau & vomiting) | U | ||||
| Rare | Unexpected reactions such as excitement, agitation, hyperactivity, hallucination, worsened insomnia, aggressiveness, irritability, rages, psychoses, and violent behaviour | U | ||||
| Rare | Somnambulis m (sleepwalking)
activities you do not remember the day after | U | ||||
| Rare | Thoughts of death or suicide | U | ||||
This is not a complete list of side effects. For any unexpected effects while taking NTP- TEMAZEPAM , contact your doctor or pharmacist.
HOW TO STORE IT
Store at controlled room temperature (15-30°C). Protect from moisture and light. Keep out of 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 0701C 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.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting NT Pharma Canada Limited at:
1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)
or druginfo@novopharm.com
NT Pharma Canada Limited 5691 Main Street Stouffville, Ontario
Canada, L4A 1H5