Summit Ultra: Uses, Side Effects and Dosage

What is SUMMIT ULTRA used for?

SUMMIT ULTRA is used for effective relief of pain associated with muscle spasms, such as back pain, tense neck muscles, strains and sprains.

How does SUMMIT ULTRA work?

Ibuprofen reduces pain, fever and inflammation. Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work within the body by decreasing the production of substances, called prostaglandins which are involved in the development of pain and inflammation.

Methocarbamol is a muscle relaxant. Methocarbamol is thought to act on the central nervous system.

Serious Warnings and Precautions

What are the ingredients in SUMMIT ULTRA?

Medicinal ingredients: Methocarbamol and Ibuprofen

Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Iron Oxide Red, Sodium Lauryl Sulfate, and Sodium Starch Glycolate.

SUMMIT ULTRA comes in the following dosage forms:

Tablet, Methocarbamol 500mg and Ibuprofen 400 mg

Do not use SUMMIT ULTRA if:

• You have stomach distress, stomach or gastric ulcers
• You are bleeding from the stomach or gut
• You have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
• You are taking acetylsalicylic acid (ASA) or any other Non-Steroidal Anti-Inflammatory Drugs (NSAID) including any other ibuprofen product.
• You recently had or are about to have heart surgery.
• You have severe heart failure
• You have bleeding in the brain or other bleeding disorders

• You are in your third trimester (after 28 weeks) of pregnancy

• You are allergic to methocarbamol, ibuprofen, ASA (Acetylsalicylic Acid) or other salicylates or other NSAIDs, or any of the non-medicinal ingredients in SUMMIT ULTRA (see the heading “What the non-medicinal ingredients are”). Allergic reactions may appear as hives, difficulty breathing, shock, skin reddening, rash or blisters, swelling of the face or throat, or sudden collapse.
• You have nasal polyps (swelling of the inside of the nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life threatening allergic reaction), urticaria/hives, rhinitis (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.
• You are dehydrated (significant fluid loss) due to vomiting, diarrhea or lack of fluid intake.
• You have Systemic Lupus Erythematosus.
• You have serious liver disease or kidney disease
• You have high potassium in the blood

Patients who took a drug in the same class as SUMMIT ULTRA after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SUMMIT ULTRA. Talk about any health conditions or problems you may have, including if you:

have or are:

• pregnant or breastfeeding
• High blood pressure
• Diabetes mellitus or on a low sugar diet
• Heart or thyroid disease
• Poor circulation to your extremities
• A current or past habit of smoking
• Kidney disease or urine problems
• Previous ulcer or bleeding from the stomach or gut
• Previous bleeding in the brain
• Liver disease
• Taking drugs for depression, sedatives or any other medication
• Asthma, glaucoma, blood clotting disorder (such as hemophilia), any other serious disease, are under doctor’s care for any serious condition

Other warnings you should know about:

• The use of NSAIDs, like SUMMIT ULTRA, in the second trimester of pregnancy should be restricted to the lowest dose necessary for shortest possible duration.
• At 20 weeks or later in pregnancy, your use of NSAIDs may need to be monitored by a health care practitioner due to the rare risk of kidney problems in the unborn baby which may result in decreased amniotic fluid volume and other complications.

While taking this medication:

• fertility may be decreased. The use of SUMMIT ULTRA is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping treatment with SUMMIT ULTRA should be considered.

• exercise caution when operating machinery or motor vehicles as SUMMIT ULTRA may cause drowsiness or dizziness.

• Avoid consuming alcohol.
• Use with caution in the elderly.
• Long-term continuous use may increase the risk of heart attack or stroke.

Stop use and ask a doctor if:

• You show signs of stomach bleeding
• Pain worsens or lasts for more than 5 days
• Any new or unusual symptoms appear
• You get a rash or itchy skin

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SUMMIT ULTRA:

Do not use this product if you are taking ASA.

• Acetylsalicylic Acid (ASA) or other NSAIDs

  e.g., ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen

• Antacids
• Antidepressants

• Blood pressure medications

  • ACE (angiotensin converting enzyme) inhibitors

    e.g., enalapril, lisinopril, perindopril, ramipril

  • ARBs (angiotensin II receptor blockers)

    e.g., candesartan, irbesartan, losartan, valsartan

• Blood thinners e.g., warfarin, ASA, clopidogrel

• Corticosteroids (including glucocorticoids)

  • e.g., prednisone
• Cyclosporin or Tacrolimus
• Digoxin

• Diuretics

  • e.g., furosemide, hydrochlorothiazide
• Lithium
• Methotrexate
• Oral hypoglycemics (diabetes medications)

• Selective Serotonin Reuptake Inhibitors (SSRIs)

  • e.g., citalopram, fluoxetine, paroxetine, sertraline

How to take SUMMIT ULTRA:

Preferably, take on an empty stomach, but if stomach upset occurs, take with food or milk.

Usual dose:

Take SUMMIT ULTRA only as directed by your health care provider. Do not take more than recommended or longer than five days. Use the lowest effective dose for the shortest duration.

SUMMIT ULTRA should NOT be used in children 12 years of age and under since safety and effectiveness have NOT been established.

Overdose:

Missed Dose:

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

What are possible side effects from using SUMMIT ULTRA?

These are not all the possible side effects you may have when taking SUMMIT ULTRA. If you experience any side effects not listed here, tell your healthcare professional.

SUMMIT ULTRA may cause some side effects, such as heartburn, constipation, nausea, bloating, nervousness or sleeplessness especially when used for a long time or in large doses. The risk of having side effects may be decreased by using the smallest dose for the shortest duration of time. Stop use and contact a doctor or pharmacist if these symptoms worsen or persist.

SUMMIT ULTRA may cause you to become drowsy or tired. Be careful when driving or participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking SUMMIT ULTRA, do NOT drive or operate machinery.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15-30°C).

Keep out of reach and sight of children.

If you want more information about SUMMIT ULTRA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.pendopharm.com, or by calling 1-888-550-6060

Date of Authorization: OCT 31, 2024