Ibuprofen+Methocarbamol Caplets: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

For effective relief of pain associated with muscle spasm such as back pain, tense neck, muscles, strains and sprains.

What it does:

Pain reliever and Muscle Relaxant.

When it should not be used:

Do not take Ibuprofen+Methocarbamol Caplets if you have or are:

• peptic ulcer disease or gastrointestinal bleeding or

  any other active inflammatory disease of the gastrointestinal tract (e.g. colitis, Crohn’s disease),

• taking acetylsalicylic acid (ASA) or any other

  non- steroidal anti-inflammatory medication including any other ibuprofen product,

• allergic/hypersensitive to ibuprofen or other non-

  steroidal anti-inflammatory drugs (NSAIDs), ASA or other salicylates, methocarbamol or to any ingredient in the formulation or component of the container, or any of

  Ibuprofen+Methocabramol Caplets ingredients (Refer to the nonmedicinal ingredients on outer carton or composition section),

• 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,

  • dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake,
  • right before or after heart surgery,
  • serious liver or kidney disease,

  • Systemic Lupus Erythematosus, in your third trimester of pregnancy

What the medicinal ingredient is:

Methocarbamol and ibuprofen.

What the important nonmedicinal ingredients are:

pregelatinized starch, maize starch, sodium starch glycolate, microcrystalline cellulose, povidone, sodium lauryl sulphate, FD&C Blue No.2, ferric oxide (red), stearic acid, magnesium stearate, colloidal silicon dioxide, and aquarius BP 19008 (Contains: hypromellose and polyethylene glycol).

What dosage forms it comes in:

Each caplet contains methocarbamol 500 mg and ibuprofen 200 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Caution in those with heart failure, high blood pressure or other conditions predisposing to fluid retention.
• Caution in those prone to gastrointestinal tract irritation, diverticulosis, or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis or Crohn’s disease.
• Caution in those at risk of kidney or liver problems, those taking diuretics and the elderly.
• Stop use immediately if you have difficulty or pain when urinating.
• The chance of stomach bleeding higher if you are: age 60 or older, have had stomach ulcer 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.

BEFORE you use Ibuprofen+Methocarbamol Caplets talk to your doctor or pharmacist if:

• you have diabetes, high blood pressure, heart or

  thyroid disease, asthma, kidney or liver disease, glaucoma, blood clotting disorder (such as hemophilia), any other serious disease, are under doctor’s care for any serious condition, you are trying to conceive, in your first or second trimester of pregnancy or if you are breastfeeding, or are taking any other drug including over the counter drugs.

May cause drowsiness or dizziness. Exercise caution in operating machinery or motor vehicles. Avoid alcohol. Use with caution in the elderly.

INTERACTIONS WITH THIS MEDICATION

Do not use this product if you are taking ASA.

Drugs that may interact with

Ibuprofen+Methocarbamol Caplets include: acetaminophen, anticoagulants (blood thinners), digoxin, oral antidiabetic agents and insulin, diuretics, methotrexate, lithium, protein-bound drugs including probenecid, thyroxine, antibiotics (e.g. cyclosporine), phenytoin, corticosteroids or benzodiazapenes, other NSAIDs, or medications for high blood pressure. Tell your doctor or pharmacist what prescription drugs you are taking or plan to take.

PROPER USE OF THIS MEDICATION

Usual dose:

Adults and children over 12: Take 1 or 2 caplets every four to six hours as needed. Do not exceed 6 caplets in 24 hours, unless directed by a physician. Consult your physician if symptoms persist for more than 5 days.

Overdose:

In case of drug overdose, contact a doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

Continue to take 1-2 tablets every 4-6 hours as needed after a missed dose. Do not take twice the recommended dose following a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Take with food or milk if upset stomach occurs Ibuprofen+Methocarbamol Caplets may occasionally produce unwanted side effects, such as heartburn, constipation, nausea, bloating, nervousness or sleeplessness.

Stop use and contact a doctor or pharmacist if these symptoms worsen or persist.

The risk of having side effects may be decreased by using the smallest dose for the shortest duration of time.

This is not a complete list of side effects. For any unexpected effects while taking Ibuprofen+ Methocarbamol contact your doctor or pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to Health Canada

• Visiting the Web page on Adverse Reaction

  Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

Note: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

HOW TO STORE IT

Store at room temperature (15-30^oC). Protect from light.

Keep out of reach of children. This package contains enough medicine to seriously harm a child.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Marcan Pharmaceuticals Inc., 2 Gurdwara Road, Suite 112 Ottawa, Ontario K2E 1A2, Canada Toll Free: +1-855-627-2261. or www.marcanpharma.com

Date of Authorization: February 21, 2025