Details for: ALEVE NIGHTTIME
Company: BAYER INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02444593 | ALEVE NIGHTTIME | NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE | 220 MG; 25 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
Trust ALEVE Nighttime for providing fast and effective relief of occasional, night time, minor pain and accompanying sleeplessness due to aches and pain associated with joints, muscles, backache, headaches, toothaches, as well as pain of migraine, dental extractions, inflammation and arthritis. Helps you to fall asleep and stay asleep.
For use only if you have short-term night time sleeplessness caused by pain. If this is not the case, do not use.
What it does
ALEVE Nighttime is a pain reliever and sleep-aid.
The pain relief from naproxen sodium helps to fall asleep and diphenhydramine hydrochloride helps to stay asleep.
When it should not be used
Do not take ALEVE Nighttime if you:
- You have pain that does not keep you from sleeping
- You have sleeplessness but are not in pain
- are allergic to naproxen, naproxen sodium, diphenhydramine hydrochloride or any ingredient in the product
- are allergic to acetylsalicylic acid (ASA), other salicylates or other non-steroidal anti-inflammatory drugs (NSAIDs)
- have an active peptic ulcer, a history of recurrent ulceration, or active gastrointestinal bleeding
- have inflammatory bowel disease
- have liver disease (active or severe)
- have kidney disease (severe or worsening)
- right before or after heart surgery
- are in your third trimester of pregnancy because it may cause problems in the unborn child or complications during delivery
- do not have time for a full night’s sleep
- if you are elderly, as this drug may cause excitation rather than sedation
- with any other product containing diphenhydramine, even one used on skin
What the medicinal ingredient is
Naproxen sodium 220 mg
Diphenhydramine hydrochloride 25mg
What the non-medicinal ingredients are
carnauba wax, FD&C Blue # 2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc and titanium dioxide
What dosage form it comes in
Each caplet contains naproxen sodium 220mg and diphenhydramine hydrochloride 25mg.
Warnings and precautions
Drowsiness will occur, avoid alcohol and do not drive or operate machinery. Not for daytime use.
BEFORE you use ALEVE Nighttime talk to your doctor or pharmacist if you have or have had:
- asthma or a similar respiratory illness such as emphysema or chronic bronchitis
- diabetes
- nasal polyps
- itchy skin and hives
- history of gastrointestinal disease
- high blood pressure or heart disease
- a blood clotting disorder
- heart disease/failure
- difficulty urinating due to enlarged prostate gland
- glaucoma
- any other serious condition
- sleeplessness due to mild to moderate pain persists continually for more than 5 days
OR if you are:
- trying to conceive
- in your first or second trimester of pregnancy
- are breastfeeding
- older than age 65
- taking sedatives or tranquilizers
- taking any other drug
When using this product:
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
- avoid drinking alcohol
- Fever lasts more than 3 days
- Pain and sleeplessness lasts longer than 5 days or if your symptoms change.
- Symptoms get worse or new ones appear
Sleeplessness may be a symptom of a serious underlying medical condition other than pain
Interactions with this medication
Do not use this product if you are taking acetylsalicylic acid (ASA) for preventative therapy without talking to a doctor or pharmacist. Naproxen sodium may interfere with the preventative benefits of ASA.
BEFORE you use ALEVE Nighttime talk to your doctor or pharmacist if are taking any other drug especially (NOT a complete list):
- Anticoagulants (to decrease blood clotting)
- Antihypertensive drugs for your heart (including ACE inhibitors and beta-blockers)
- Antihistamines, tranquilizers, alcohol or other sedating drugs
- Diuretics (“water pills”)
- Cyclosporine
- Glucocorticoids
- Lithium
- Methotrexate
- low dose ASA for doctor supervised daily preventative therapy (e.g. ASPIRIN® 81mg)
- NSAIDs or other pain medications (e.g. ibuprofen, acetaminophen)
Taking ALEVE Nighttime with a meal may slightly delay its absorption.
Proper use of this medication
Usual Dose
Adults and children ≥ 12 years and older: 2 tablets at bedtime. Do not take more than 2 tablets in a 24 hour period. Drink a full glass of water with each dose. The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Overdose
Side effects and what to do about them
Like all medicines, ALEVE Nighttime may occasionally produce unwanted side effects. Stop use and contact a doctor or pharmacist if you experience: heartburn, nausea, vomiting, ringing or buzzing in the ears, bloating, redness or swelling is present in the painful area, choking sensation, diarrhea or constipation.
This is not a complete list of side effects. For any unexpected effects while taking ALEVE® Nighttime, contact your doctor or pharmacist
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Allergy alert Naproxen sodium may cause a severe allergic reaction, especially in people allergic to ASA. Symptoms may include hives, swelling of the eyes and mouth, wheezing, shock, skin reddening, blisters, or rash.
Stop use and get emergency medical attention IMMEDIATELY if you experience: difficulty breathing, facial swelling, skin reddening, shock, hives, rash or itching.
This product may cause stomach bleeding. Symptoms may include: feeling faint, vomiting blood, bloody or black stools. The chance of stomach bleeding is higher if you are:
- age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinner or steroid drug
- take with other drugs containing an NSAID like acetylsalicylic acid (ASA), ibuprofen, naproxen, or prescription anti-inflammatory drugs
- have 3 or more alcoholic drinks every day while using this product
Stop use and contact a doctor or pharmacist if you experience: black stools, feel faint, severe abdominal pain that does not get better, vomiting blood, any change in vision or fluid retention.
If you become drowsy, dizzy or lightheaded do not drive or operate machinery.
How to store
CAUTION: Contains enough drug to seriously harm a child, KEEP OUT OF THEIR REACH.
Store between 15-30oC.
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.Bayer.ca.
This leaflet was prepared by Bayer Inc.
Last revised: March 8th
, 2019
® TM see www.bayer.ca/tm-mc
Bayer Inc., Mississauga, ON L4W 5R6.
www.aleve.ca
© 2019, Bayer Inc.