Patient Medication Information: uses, side effects, how to take - Nighttime Pain Reliever
ABOUT THIS MEDICATION
What the medication is used for:
Nighttime Pain Reliever
For fast and effective relief of occasional mild to moderate nighttime pain and accompanying sleeplessness, due to minor aches and pains associated with joints, muscles, backache, headache and toothache as well as pain of migraine and arthritis.
For longer sleep, uninterrupted by temporary pain.
Only for temporary mild to moderate pain that causes sleeplessness. If this is not the case, do not use.
What it does:
Contains two drugs: ibuprofen (a pain reliever for short term use) and diphenhydramine hydrochloride (a sleep-aid for sleeplessness).
When it should not be used:
Do not use if:
You have active peptic ulcer, a history of recurrent
ulceration active inflammatory disease of the gastrointestinal system or gastrointestinal bleeding.
Nasal polyps (swelling of the inside of the nose), or allergic
manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), uticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms,
Taking, acetylsalicylic acid (ASA), acetaminophen, or other
Non-Steroidal Anti-inflammatory Drugs (NSAIDs), such as naproxen or other ibuprofen product.
Known or suspected hypersensitivity or allergy to
ibuprofen or other NSAIDs, ASA or other salicylates, diphenhydramine or to any ingredient in the formulation.
Dehydrated (significant fluid loss) due to vomiting,
diarrhea or lack of fluid intake.
- Diagnosed with severe high blood pressure or have severe coronary artery disease, serious liver or kidney disease, Systemic Lupus Erythematosus.
Pregnant or nursing.
- You have pain that does not keep you from sleeping.
- You have sleeplessness but are not in pain.
What the medicinal ingredients are:
Ibuprofen (present as free acid and potassium slat) and diphenhydramine hydrochloride.
What the nonmedicinal ingredients are:
Polyethylene glycol, Povidone K-30, Potassium hydroxide, Purified water, gelatine, special sorbitol sorbitan solution, FD& C Blue No. 1, D& C red No. 33, isopropyl alcohol and pharmaceutical ink.
What dosage forms it comes in:
Each soft gelatin capsule (gelatin capsule) contains ibuprofen 200 mg (as free acid and potassium salt) and diphenhydramine hydrochloride 25 mg.
WARNINGS AND PRECAUTIONS
Serious Warnings And Precautions
- Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.
Nighttime Pain Reliever causes sedation or sleepiness.
Not for daytime use.
BEFORE use, talk to your doctor or pharmacist if you have/are:
- Diabetes
- Chronic lung disease
- Glaucoma
- Difficulty in urination due to an enlarged prostate
- Autoimmune disease (e.g., lupus)
- High blood pressure
- Heart disease
- Heart failure or thyroid disease
- Peptic ulcers
- Asthma
- Blood clotting disorders (such as hemophilia)
- Kidney or liver disease
- Any other serious disease
- Taking any other prescription or over-the-counter drug
- Over 65 years of age
- Pregnant or nursing a baby
- Sleeplessness due to mild to moderate pain persists continually for more than 5 days.
Insomnia may be a symptom of a serious underlying medical condition other than pain.
While taking this product, do not drive motor vehicle or operate machinery.
INTERACTIONS WITH THIS MEDICATION
Do not use Nighttime Pain Reliever if you are taking:
Daily low dose ASA (81-325mg), without taking
to a doctor or pharmacist. Ibuprofen may interfere with the preventive benefits of ASA.
- ASA or other anti-inflammatory medication. Drugs that may interact with Nigttime Reliever include:
- Anticoagulants (blood thinners)
Antihistamines, tranquilizers, alcohol or other sedating
drugs
- Digoxin
- Diuretics (e.g., for bloating or heart conditions)
- Insulin
- Lithium
Medications for high blood pressure or depression,
including mononamine oxidase inhibitors (MAOIs)
- Methotrexate
- Oral antidiabetic agents
- Other NSAIDs
- Other pain relievers, sleep-aids or cold medicines
Protien-bound drugs including probenecid, thyroxine,
antibiotics, phenytoin, corticosteroids or benzodiazapenes.
Do not take this product at the same time as other medications containing pain relievers (e.g., ibuprofen, ASA, acetaminophen, naproxen, etc.) or diphenydramine (e.g., allergy medications, Sedating drugs, cough/cold/flu medications, antinausea drugs) etc.
Tell your doctor or pharmacist what prescription drugs you are taking or plan to take.
PROPER USE OF THIS MEDICATION
Usual dose:
Adults ≥ 16 to 65 years: Take 1 or 2 capsules at night, 4-6 hours after the last daytime ibuprofen or diphenhydramine dose. Do not take more than 5 consecutive days̷ nights unless directed by a doctor. Do not exceed a combined total of any 6 Nighttime Pain Relievers in 24 hours, unless directed by a doctor.
Do not give to children under 16 unless directed by a doctor.
Overdose:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and
skip the missed dose. Do not take twice the recommended dose after a missed dose.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
If heartburn, nausea or vomiting, bloating, diarrhea or constipation, ringing or buzzing in the ears, nervousness, dizziness, fluid retention, or any other side effect or unexplained symptoms develop while taking Nighttime Pain Reliever, discontinue use immediately and contact a doctor.
Talk to your doctor if the symptoms of pain or sleeplessness persist for more than 5 days.
Side effects may be minimized by using the smallest dose for the shortest duration of time.
| SERIOUS SIDE EFFECTS HOW OFTEN THEY HAPPEN | ||
| AND WHAT TO DO ABOUT THEM | ||
| STOP USE and consult your doctor immediately if you experience: abdominal pain, allergic reaction (itching, blisters, rashes, skin reddening, etc), any change in vision, blood in vomit, bloody or black stools, bladder pain, hallucinations, or difficulty speaking. | ||
This is not a complete list of side effects. For any unexpected effects while taking Nighttime Pain Reliever, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15°-30°C).
Keep out of reach of children. This package contains enough medicine to seriously harm a child.
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 0701E
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 obtained by contacting the sponsor, Marcan Pharmaceuticals Inc. at: 1-613-228-2600