Details for: SILENOR
Company: PALADIN LABS INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02398257 | SILENOR | DOXEPIN (DOXEPIN HYDROCHLORIDE) | 3.00 MG | TABLET | ORAL |
| 02398265 | SILENOR | DOXEPIN (DOXEPIN HYDROCHLORIDE) | 6.00 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
SILENOR is a hypnotic (sleep) medicine that is used to treat people who have trouble staying asleep.SILENOR is not for use in children under 18 years of age.
What it does
If you are prescribed sleep medications, you should consider both their benefits and risks. One important risk and limitation of Silenor is that it may affect your mental alertness particularly when not taken as prescribed. (see Warnings and Precautions)
When it should not be used
Do not use SILENOR if you:
- have an eye problem called narrow angle glaucoma that is not being treated
- have difficulty urinating
- take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MOAI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is a MAOI.
- are allergic (hypersensitive) to doxepin or any of the ingredients SILENOR contains (see What the nonmedicinal ingredients are)
Talk to your healthcare provider before taking this medicine if you have any of these conditions.
What the medicinal ingredient is
Doxepin hydrochloride
What the non-medicinal ingredients are
Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, D&C lake yellow and FD&C lake blue.
What dosage form it comes in
SILENOR tablets are available in two strengths, 3 mg and 6 mg.
Warnings and precautions
Need to diagnose other existing conditions
Sleep problems can be a symptom of many physical and psychiatric disorders. Your physician will need to evaluate your medical history before initiating treatment with SILENOR. Call your physician if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
Complex sleep-related behaviours
There have been reports of people getting out of bed while not fully awake after taking sleeping pills and doing activities that they did not know they were doing. The next morning, they did not remember doing those activities. The unusual behaviour is more likely to occur when sleeping pills are taken with alcohol or other drugs that can make you sleepy such as those for the treatment of depression or anxiety. These activities you may do in these situations can put you and people around you in danger. Reported activities included driving a car (“sleep-driving”), making and eating food, talking on the phone, having sex, sleepwalking, etc.
Important:
- Do not take more SILENOR than prescribed.
- Do not take SILENOR if you drink alcohol.
- Talk to your physician about all the medicines, including overthe- counter medicines and herbal products. Your physician will tell you if you can take SILENOR 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 physician immediately (see Complex sleeprelated behaviours).
Mental Alertness:
SILENOR 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.
Worsening of Side Effects:
DO NOT CONSUME ALCOHOL WHILE TAKING SILENOR. Some medicines may also worsen side effects that some patients experience with SILENOR (see Interactions with this medication).
BEFORE you use SILENOR talk to your physician or pharmacist if you:
- suffer from depression or have a history of depression and/or suicidal thoughts
- have breathing problems at night (sleep apnea)
- have a liver disease
- have a history of drug or alcohol abuse or addiction
- have an eye problem called narrow angle glaucoma that is not being treated
- have difficulty urinating
- are taking any other medicines, including over-the-counter medicines and herbal products. have any other medical conditions
- are pregnant, planning to become pregnant or you become pregnant while taking this medication. It is not known if SILENOR will harm your unborn baby.
- are breastfeeding or plan to breastfeed. SILENOR may pass into your milk and may harm your baby. You should not breast-feed while taking SILENOR.
- have any allergies to SILENOR or its ingredients or components of the container.
Interactions with this medication
Do not use SILENOR if you drink alcohol.
Do not use SILENOR along with other medications, over-the counter medicines or herbal products without first discussing this with your physician or pharmacist.
SILENOR may produce more pronounced side effects when coadministered with:
- alcohol
- other sleeping pills
- certain allergy medicines (antihistamines)
- other medicines that can make you sleepy or affect your breathing (narcotic analgesics)
- medicines used to control or prevent convulsions (anticonvulsants)
- mood altering drugs, which themselves can make you sleepy (antipsychotics, antidepressants and other psychotropic medications)
SILENOR may affect the way other medicines work, and other medicines may affects how SILENOR works. Especially tell your healthcare provider if you take:
- monoamine oxidase inhibitor (MAOI)
- cimetidine (an anti-acid medication)
Proper use of this medication
How should I take SILENOR?
- Follow your physician’s advice about how to take SILENOR, when to take it, and how long to take it. Do not take more SILENOR than prescribed for you.
- Take SILENOR not more than 30 minutes before you get into bed. After taking SILENOR, you should confine your activities to those necessary to prepare for bed.
- Do not take SILENOR within 3 hours of a meal. SILENOR may not work as well, or may make you sleepy the next day when taken with or right after a meal.
- Do not take SILENOR unless you are able to get a full night of sleep (7-8 hours) before you must be active and functional again.
- Do not take SILENOR if you drink alcohol.
- Do not drive a car or operate potentially dangerous machinery until you experience how SILENOR will affect you the next day.
- Call your physician if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
- SILENOR is not indicated for patients under 18 years of age. Do not take SILENOR if you are under 18 years of age.
- Do not take SILENOR if it is not prescribed for you.
Usual Dose
Adults
The recommended dose of SILENOR for adults is 6 mg once daily. The daily dose can be decresed to 3 mg if recommended by your physician.
Elderly
The recommended starting dose of SILENOR in elderly patients (≥ 65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if recommended by your physician.
The daily dose prescribed by your physician should be of a maximum of 6 mg.
Overdose
Missed Dose
You should only take SILENOR at bedtime. If you miss a dose, wait and take your next dose at your regular time the next night. Do not take 2 doses at the same time. Do not make up for a missed dose.
Side effects and what to do about them
Serious side effects of SILENOR include getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See Warnings and Precautions, Complex Sleep-related behaviours)
Call your physician right away if you have the above serious side effect or any other side effects that worry you while using SILENOR.
The most common side effects of SILENOR are tiredness, dizziness, nausea, headache and dry mouth.
How sleepy you are the day after you use one of sleeping pills depends on your individual response and on how quickly your body gets rid of the medication.
Do not drive or do any dangerous activities after taking SILENOR until you feel fully awake.
These are not all the side effects of SILENOR. Ask your physician or pharmacist for more information.
Call your physician for medical advice about side effects.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Tiredness, dizziness, feeling “drugged” | ✔ | ||
| Rare | |||
| Somnambulism (sleepwalking) – getting out of bed while not fully awake and doing activities you do not remember the day after | ✔ | ||
| Very rare | |||
| Thoughts of death or suicide | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking SILENOR, contact your physician or pharmacist.
How to store
- Store at room temperature between 15° and 30°C and protect from light.
- Keep SILENOR in a safe place away from children.
Reporting 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 three 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 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 at: http://www.paladinlabs.com or by contacting the sponsor, Paladin Labs Inc., at: 1-888-550-6060
This leaflet was prepared by:
Paladin Labs Inc.
Montreal QC H4P 2T4
Last revised: December 7, 2012