Sandoz Nitrazepam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• Sandoz Nitrazepam is intended to help you sleep if you

  have transient and short-term insomnia. Symptoms of insomnia include difficulty in falling asleep, waking up often during the night, or too early in the morning. Treatment with Sandoz Nitrazepam 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. Sandoz Nitrazepam does not treat the underlying cause of your insomnia.

• Sandoz Nitrazepam is also useful for the management of

  myoclonic seizures.

What it does:

Sandoz Nitrazepam is one of several benzodiazepine sleeping pills that have generally similar properties such as a calming effect.

If you are prescribed one of these medications, you should consider both their benefits and risks. Important risks and limitations include the following:

• the longer you use the medication, the less effective it may

  become;

• you may become dependent on the medication;

• the medication may affect your mental alertness or

  memory, particularly when not taken as prescribed (see WARNINGS AND PRECAUTIONS).

When it should not be used:

Do not take Sandoz Nitrazepam if you have:

• known allergy to nitrazepam or other benzodiazepines, or

  to any of the ingredients Sandoz Nitrazepam contains (see What the nonmedicinal ingredients are);

• severe lung or respiratory disease, including sleep apnea;

• myasthenia gravis, a chronic disease characterized by

  weakness of the skeletal muscles;

  • a severe liver condition.

Sandoz Nitrazepam is not to be used for insomnia in children under 18 years of age.

What the medicinal ingredient is:

The medicinal ingredient in Sandoz Nitrazepam is nitrazepam.

What the non-medicinal ingredients are:

Sandoz Nitrazepam tablets contain the following non-medicinal ingredients: cellulose microcrystalline, lactose, magnesium stearate, and croscarmellose sodium.

What dosage forms it comes in:

Sandoz Nitrazepam is available in tablets of 5 mg and 10 mg strengths for oral administration.

WARNINGS AND PRECAUTIONS

Complex sleep-related behaviours:

There have been reports of people getting out of bed while not fully awake after taking Sandoz Nitrazepam and doing activities that they did not know they were doing. The next morning, they did not remember doing those activities. This unusual behaviour is more likely to occur when Sandoz Nitrazepam is taken with alcohol or other drugs that can make you sleepy such as those for the treatment of 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:

• Do not take more Sandoz Nitrazepam than prescribed.
• Do not take Sandoz Nitrazepam if you drink alcohol.
• 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 Sandoz Nitrazepam with your other medicines.
• You and people close to you should watch for the type of unusual behaviour described above. If you find out that you have done any such activities for which you have no memory you should call your doctor immediately.

Mental Alertness:

Sandoz Nitrazepam may affect your ability to be alert. DO NOT DRIVE A CAR or operate potentially dangerous machinery until you experience how this drug will affect you.

Memory Problems:

All benzodiazepine sleeping pills can cause a special type of memory loss (amnesia); you may not recall events that occurred during some period of time, usually several hours, after taking the drug. This lapse is usually not a problem, because the person taking the sleeping pill intends to be asleep during this critical period of time. But it can be a problem if

you take the medication to induce sleep while travelling, such as during an airplane flight, because you may wake up before the effect of the drug is gone. This has been called “traveler’s amnesia”. DO NOT TAKE Sandoz Nitrazepam when a full night's sleep is not possible before you would again need to be active and functional; e.g., an 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 benzodiazepines may lose some of their effectiveness. You may also develop a degree of dependence.

“Withdrawal” effects can occur when patients stop taking benzodiazepine sleeping pills. The effects may occur following use for only a week or two but may be more common and severe after long periods of continuous use. For example, you may experience an increase in sleep difficulties (rebound insomnia) and/or increased daytime anxiety (rebound anxiety) for one or two days after discontinuing Sandoz Nitrazepam.

Other withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, dysphoria, perceptual disturbances, insomnia, headache, extreme anxiety, tension, restlessness, confusion and irritability) have occurred following abrupt discontinuation of benzodiazepines, and may follow the discontinuation of Sandoz Nitrazepam. In severe cases, the following symptoms may occur: sense of detachment from one’s surroundings, unreal feeling with a sensation that the extremities have changed in size, abnormal sensitivity to sound, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations and epileptic seizures. The more severe symptoms are usually associated with higher dosages and longer usage.

Dependence/Abuse:

All benzodiazepine 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 at higher doses - not only for continued therapeutic effect, but also to avoid withdrawal symptoms or to achieve non-therapeutic effects.

Individuals who depend, or have depended at any time in the past, on alcohol or other drugs may be at particular risk of becoming dependent on drugs of this class. 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. Some of these changes include aggressiveness and extroversion which seem out of character. Other changes, although rare, can be more unusual and extreme such as confusion, strange behaviour, restlessness, illusions, hallucinations, feeling like you are not yourself, worsening insomnia and worsening depression, including suicidal thinking.

It is rarely clear whether such symptoms are caused by the medication, or 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 while using Sandoz Nitrazepam, discuss the matter immediately with your doctor.

Excessive Salivation:

On rare occasions in infants and young children, as well as elderly, bed-ridden patients, there may be excessive secretion of saliva and fluid in the lungs which may lead to chest infections.

Worsening of Side Effects:

DO NOT CONSUME ALCOHOL WHILE TAKING Sandoz Nitrazepam. Some medicines may also worsen side effects that some patients experience with Sandoz Nitrazepam (see INTERACTIONS WITH THIS MEDICATION).

Elderly:

An increased risk of falls and fractures has been reported in elderly people who take benzodiazepines such as Sandoz Nitrazepam.

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 Sandoz Nitrazepam at any time during pregnancy.

BEFORE you use Sandoz Nitrazepam talk to your doctor or pharmacist if:

• You have a lung disease or breathing problems.
• You have liver or kidney condition.
• You have a history of depression and/or suicide thoughts or attempts.
• You have had unexpected reactions to alcohol or sedative medications in the past, such as irritability, aggression, hallucinations, etc.
• You have a history of drug or alcohol abuse or addiction.
• You are planning to become pregnant, you are pregnant, or you become pregnant while taking this medication.
• You are breastfeeding.
• You consume alcohol.

• You are taking other medicines, including drugs you

  can buy without a prescription.

• You have lactose intolerance.

INTERACTIONS WITH THIS MEDICATION

Sandoz Nitrazepam may produce more pronounced side effects when coadministered with alcohol, other tranquilizers or sleeping pills, sedative antihistamines, narcotic analgesics, anticonvulsants, antipsychotics (neuroleptics), anesthetics, or antidepressant agents or psychotropic medications which themselves can make you sleepy.

Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents. Examples include cimetidine or erythromycin.

Do not take Sandoz Nitrazepam if you drink alcohol. DO NOT USE Sandoz Nitrazepam along with other medications without first discussing this with your doctor.

PROPER USE OF THIS MEDICATION

Benzodiazepine sleeping pills 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 in Insomnia:

Sandoz Nitrazepam is a prescription medication intended to help you sleep. Follow your doctor's advice about how to take Sandoz Nitrazepam, when to take it, and how long to take it.

Adults: The usual adult dose is 5 or 10 mg before retiring.

Elderly and/or Debilitated Patients: It is recommended that in these patients therapy be initiated with 2.5 mg until individual responses are determined. Doses higher than 5 mg are usually not recommended in the elderly.

DO NOT TAKE Sandoz Nitrazepam if it is not prescribed for you.

DO NOT TAKE Sandoz Nitrazepam for more than 7-10 days without first consulting your doctor. If you still have problems sleeping after you finish your tablets, contact your doctor again.

The lowest effective dose should be used.

DO NOT INCREASE THE PRESCRIBED DOSE.

Do not take Sandoz Nitrazepam if you drink alcohol.

Do not take Sandoz Nitrazepam 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 Sandoz Nitrazepam will affect you the next day.

Sandoz Nitrazepam is not for use for insomnia in children under 18 years of age.

Overdose:

The principal manifestations of overdosage are drowsiness, confusion, reduced reflexes, increasing sedation, and coma. Effects on respiration, pulse and blood pressure are noticed with large overdoses. Patients exhibit some jitteriness and over stimulation usually when the effects of the drug begin to wear off.

Contact your doctor, regional Poison Control Centre or pharmacist immediately if you suspect you have taken an overdose or someone else accidentally takes your Sandoz Nitrazepam. 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 tablets.

In case of drug overdose, contact a health care practitioner, hospital emergency departement or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take Sandoz Nitrazepam tablets, do not take a double dose to make up for the forgotten individual dose. Take the next dose at the usual time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Common Side Effects:

Benzodiazepine sleeping pills may cause drowsiness, dizziness, light-headedness, and difficulty with coordination. Users must be cautious about engaging in hazardous activities requiring complete mental alertness, e.g., operating machinery or driving a motor vehicle.

DO NOT drink alcohol while using Sandoz Nitrazepam. DO NOT USE Sandoz Nitrazepam along with other medications without first discussing this with your doctor.

How sleepy you are the day after you use one of these sleeping pills depends on your individual response and on how quickly your body gets rid of the medication. 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. Benzodiazepines which are eliminated rapidly tend to cause

less drowsiness the next day, but may cause withdrawal problems the day after use.

Elderly patients are especially susceptible to side effects. Excessive drowsiness in the elderly may result in falls and fractures.

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 get these symptoms after taking Sandoz Nitrazepam.

Withdrawal-related side effects:

See WARNINGS AND PRECAUTIONS,

Tolerance/Withdrawal Symptoms.

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

HOW TO STORE IT

Store at controlled room temperature (15-30°C). Protect from light. The medicine should not be used after the expiry date (EXP) shown on the pack.

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 0701D Ottawa, Ontario

    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 obtained by contacting Sandoz Canada Inc., at:

1-800-361-3062

Or by written request at:

145 Jules-Léger

Boucherville Qc

J4B 7K8

Or by e-mail at:

medinfo@sandoz.com

Last revised: August 5, 2011.