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Nighttime Pain Relief by Apotex
ibuprofen - diphenhydramine
How does this medication work? What will it do for me?
This combination product contains two medications: ibuprofen and diphenhydramine. Ibuprofen belongs to the class of medications called non-steroidal anti-inflammatory medications (NSAIDs). It is used to reduce fever and pain caused by inflammation. It is believed to work by stopping the body’s production of prostaglandins, which cause inflammation in response to injury. Diphenhydramine belongs to the class of medications called antihistamines. Antihistamines are used to treat symptoms caused by allergies, but they also cause drowsiness and are often used to help people sleep.
Together, these medications temporarily help to relieve pain caused by headaches, migraine, arthritis, menstrual pain, and toothache pain at night, and help people to sleep.
If you have trouble sleeping with pain, do not take this medication for more than five nights in a row. Talk to your doctor about other treatment options suitable for you if you have sleeplessness as a result of ongoing pain.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each transparent blue, one piece, oval softgel capsule, printed with the logo "IBU PM" in white ink contains 200 mg of ibuprofen (present as free acid and potassium salt) and 25 mg of diphenhydramine hydrochloride. Nonmedicinal ingredients: D&C Red No. 33, FD&C Blue No. 1, gelatin, mannitol, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol; capsule shell: shellac glaze, titanium dioxide, propylene glycol, ammonium hydroxide, and simethicone.
How should I use this medication?
The recommended adult dose of ibuprofen – diphenhydramine is 1 or 2 capsules taken at night if pain is causing difficulty getting to sleep or staying asleep. It should be taken at least 4 hours after the most recent dose of ibuprofen or diphenhydramine. Take this medication with food or milk if stomach upset occurs.
If you are taking other medications containing ibuprofen or diphenhydramine during the day, you should not take more than a total of 1200 mg of ibuprofen and 300 mg of diphenhydramine during a 24-hour period. Each capsule of this medication contains 200 mg of ibuprofen and 25 mg of diphenhydramine.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor.
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take ibuprofen – diphenhydramine if you:
- are allergic to ibuprofen, diphenhydramine or any ingredients of the medication
- are currently taking other NSAIDs
- have an active peptic ulcer, a history of recurring ulcers, or an active inflammatory disease of the digestive system (such as Crohn’s disease or ulcerative colitis)
- have nasal polyps, or have had asthma, an allergic reaction or allergic-type reaction (e.g., difficulty breathing, wheezing, itchy skin rash, swelling of the face, throat, or tongue) to ASA (acetylsalicylic acid) or any other NSAIDs (nonsteroidal anti-inflammatory drugs; e.g., ketorolac, indomethacin, naproxen)
- have reduced kidney function or kidney disease
- have reduced liver function or liver disease
- have high blood levels of potassium
- are dehydrated due to vomiting, diarrhea, or lack of fluid intake
- are going to have or have recently had heart surgery
- are pregnant or breast-feeding
- have systemic lupus erythematosus
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- ringing or buzzing in the ears
- trouble sleeping
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- fluid retention (swelling in hands and wrists, feet and ankles)
- shortness of breath
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- skin rash
- vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
October 30, 2020
Health Canada has issued new restrictions concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.
Aseptic meningitis: Rarely, ibuprofen can cause symptoms of aseptic meningitis (inflammation or swelling of the membranes around the brain and spinal cord that is not caused by bacteria). If you have an autoimmune condition (e.g., systemic lupus erythematosus, mixed connective tissue disease), you may be at increased risk for developing this. If you experience symptoms such as stiff neck, severe headache, nausea, vomiting, fever, or changes in consciousness, stop taking this medication can get immediate medical attention.
Bleeding: Ibuprofen – diphenhydramine may cause the platelets in the blood to not stick together as well as they should. This can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Breathing: Diphenhydramine can cause the secretions in the lungs to become dry and difficult to cough out. If you have breathing problems, such as asthma, emphysema, or chronic obstructive airway disease (COPD), talk to your doctor or pharmacist before using this medication.
Drowsiness/reduced alertness: This medication is intended to cause drowsiness and should only be taken at night. Ibuprofen – diphenhydramine may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.
Gastrointestinal problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during therapy with this medication. These complications can occur at any time and are sometimes severe enough to require immediate medical attention.
The risk of ulcers and bleeding increases for people taking higher doses of ibuprofen for longer periods of time. Stomach problems are also more likely to occur with alcohol use. Do not drink alcohol while taking this medication.
If you are prone to irritation of the stomach and intestines, particularly if you have had a stomach ulcer, bloody stools, diverticulosis, or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn’s disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time without warning during treatment.
Glaucoma: This medication may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking this medication.
Heart problems: As with other NSAIDs, ibuprofen can cause fluid to build up in the body. This may increase blood pressure and make it harder for the heart to pump the blood through the circulation. By doing to, it can make symptoms of heart disease worse. Long-term or continued use of this mediation may increase your risk of heart attack or stroke. If you have heart disease such as angina, high blood pressure, congestive heart failure, or arrhythmia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. Ibuprofen – diphenhydramine can also cause decreased kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Potassium levels: This medication may cause high blood potassium levels. If you are a senior; have diabetes or kidney failure; or are taking certain other medications that affect potassium levels, you may be at increased risk of high blood potassium.
Surgery: Ibuprofen – diphenhydramine may make it difficult for open wounds to clot and heal. If you have surgery planned, make sure the health care providers involved in your care know you are taking this medication.
Urinary tract problems: Medications such as ibuprofen can sometimes cause urinary tract symptoms. If you experience abdominal pain, pain when urinating, blood in the urine or increased need to urinate, contact your doctor as soon as possible.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if ibuprofen – diphenhydramine passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: This medication is not recommended for children less than 16 years of age unless directed by a doctor.
Seniors: Seniors have an increased risk of developing side effects of this medication, including stomach ulcers, bleeding, and dizziness. A lower dose of this medication should be considered.
What other drugs could interact with this medication?
There may be an interaction between ibuprofen – diphenhydramine and any of the following:
- acetylcholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine)
- acetylsalicylic acid (ASA)
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
- bisphosphonates (e.g., alendronate, etidronate)
- botulinum toxin-containing medications
- chloral hydrate
- corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- kava kava
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- nonsteroidal anti-inflammatory medications (e.g., diclofenac, ibuprofen, ketorolac, naproxen)
- potassium chloride
- prostaglandin eye drops (e.g., latanoprost, bimatoprost)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- seizure medications (e.g., clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- sodium phosphates
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib, sunitinib)
- Vitamin E
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Nighttime-Pain-Relief-by-Apotex