Analgesic and Muscle Relaxant by Pharmascience

The recommended dose for adults and children over 12 years of age is 1 caplet every 4 to 6 hours. Do not take more than 3 caplets in 24 hours unless directed by your doctor. If your symptoms last longer than 5 days, you should consult your doctor. The lowest effective dose of this medication should be used for the shortest length of time possible.

This medication should preferably be taken on an empty stomach, but if you experience stomach upset, you can take it with food or milk.

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 to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and 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 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.

Each capsule-shaped, coated, bilayer tablet, debossed with "P" on one side (white) and "E" and "S" separated by a score on the other side (purple), contains 500 mg of methocarbamol and 400 mg of ibuprofen. Nonmedicinal 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.

Do not take methocarbamol - ibuprofen if you:

• are allergic to methocarbamol, ibuprofen, or any ingredients of the medication
• are allergic to other carbamates, or nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ketoprofen, diclofenac)
• are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ketoprofen, diclofenac)
• are breast-feeding
• are going to or have just had heart surgery
• are or may be pregnant
• are 12 years of age or older and have kidney disease with significant fluid loss (dehydration) due to vomiting, diarrhea, or the lack of fluid intake
• have an active stomach ulcer or duodenal ulcer, or a history of recurrent stomach or duodenal ulcers
• have active inflammatory gastrointestinal (stomach and intestine) disease (e.g., diverticulosis, ulcerative colitis, Crohn's disease)
• have active liver disease or poor liver function
• have asthma, anaphylaxis, hives, rhinitis, or other allergic reactions that are caused by acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ketoprofen, diclofenac)
• have high potassium levels
• have nasal polyps
• have poor or worsening kidney function
• have systemic lupus erythematosus (SLE)

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.

• bloating or gas
• constipation
• diarrhea
• difficulty sleeping
• drowsiness
• heartburn or indigestion
• nausea
• nervousness
• stomach pain or cramps
• tiredness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• appetite changes

• blurred vision

• confusion

• dizziness or lightheadedness

• fluid retention (e.g., swollen ankles)

• hearing problems

• new or worsening signs of depression (such as feeling sad, losing interest in things you used to enjoy, weight changes, changes in sleep habits, feelings of guilt or worthlessness, thoughts of suicide)

• ringing in the ears

• signs of bleeding (e.g., unusual bleeding or bruising, bleeding gums, unexplained nosebleeds)

• signs of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, feet)

• signs of urinary tract problems, e.g.:

  • bladder pain

  • bloody or cloudy urine

  • difficult, burning, or painful urination

  • change in urine colour or odour

  • frequent urge to urinate

  • sudden, large increase or decrease in the amount of urine

  • loss of bladder control

• signs of liver problems, e.g.:

  • dark urine

  • nausea

  • pale stools

  • stomach pain

  • vomiting

  • yellowing of the skin or eyes

• worsening asthma symptoms

• vision changes

• vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

• 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)

• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, difficulty breathing)

• signs of meningitis not caused by infection (e.g., headache (severe), throbbing, or with stiff neck or back, decreased level of consciousness)

• signs of a serious allergic reaction, e.g.:

  • abdominal cramps

  • difficulty breathing

  • nausea and vomiting

  • swelling of the face and throat

• signs of a severe skin reaction, e.g.:

  • a rash combined with fever or discomfort

  • a rash covering a large area of the body

  • a rash that spreads quickly

  • blistering

  • peeling

• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

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.

Before you begin taking 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 take this medication.

Allergy: Some people who are allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs) or ASA also experience allergic reactions to ibuprofen. Before you take methocarbamol - ibuprofen, inform your doctor about any previous adverse reactions you have had to medications, especially NSAIDs. People who have experienced difficulty breathing after taking ASA or other NSAIDs should not take methocarbamol - ibuprofen.

Aseptic meningitis: Some NSAIDs such as ibuprofen can cause symptoms of aseptic meningitis (e.g., stiff neck, severe headache, nausea, vomiting, fever, decreased level of consciousness). If you experience these symptoms, contact your doctor immediately.

People with an autoimmune disorder, such as lupus or mixed connective tissue disease, are also at higher risk of developing symptoms of aseptic meningitis. If you have an autoimmune disorder, 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.

Bladder problems: NSAIDs such as ibuprofen can cause bladder problems. Stop taking this medication and contact your doctor if you experience bladder pain, difficulty urinating, frequent urination, or blood in the urine.

**Bleeding disorders: **NSAIDs such as ibuprofen may increase bruising, and bleeding from cuts may take longer to stop. If you have bleeding disorders, a history of bleeding problems, or  are taking medications to prevent clotting, 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.

Blood pressure: Ibuprofen may cause an increase in blood pressure, even when there have been no blood pressure problems in the past. If you have high blood pressure, 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 ongoing increase in blood pressure to your doctor as soon as possible.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Blurred vision: If you experience blurred vision while taking this medication, stop taking it and contact your doctor.

Fluid retention and high potassium levels: NSAIDs such as ibuprofen can cause fluid retention and high blood potassium levels. If you have a history of heart failure, high blood pressure, diabetes, or kidney failure, are a senior, or are also taking beta-blockers (e.g., atenolol, metoprolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril, enalapril, lisinopril), 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.

Heart attack and stroke: High doses of ibuprofen taken for prolonged periods of time have been linked to increased risk of heart attack and stroke. If you have had a heart attack or stroke, or are at risk of a heart attack or stroke, 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.

Infection: This medication may mask the signs of an infection. If you experience symptoms of an infection (e.g., fever, sore throat), contact your doctor as soon as possible.

**Kidney function: **Long-term use of products that contain ibuprofen may increase the risk of developing reduced kidney function. This risk is increased for people who already have kidney disease, liver disease, or heart failure; for people who are taking certain medications (e.g., beta-adrenergic blockers, angiotensin converting enzyme [ACE] inhibitors, angiotensin-II receptor antagonists, cyclosporine, or some diuretics [water pills]); and for seniors. Your doctor will monitor your kidney function with blood tests during long-term therapy with ibuprofen.

Liver function: NSAIDs such as ibuprofen can cause reduced liver function or make existing liver problems worse. If you have reduced liver function or liver 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.

If you experience symptoms of liver problems such as fatigue, nausea, vomiting, stomach pain, yellowing of the skin or eyes, pale stools, dark urine, stop taking this medication and contact your doctor. If you are taking this medication for a long period of time, your doctor will monitor your liver function.

Stomach and intestines: Ibuprofen can cause stomach and duodenal ulcers and bleeding. You may have an increased risk for these problems if you have a history of stomach or duodenal ulcer, if you smoke, drink excessive amounts of alcohol, are a senior, are a woman, or are also taking oral steroids (e.g., prednisone) or anticoagulants (e.g., warfarin). Stop taking this medication and contact your doctor immediately if you experience persistent heartburn; stomach pain; vomit that looks like coffee grinds; or black, tarry, or bloody stools.

Systemic lupus erythematosus (SLE): People with SLE appear to be at a greater risk of experiencing severe adverse reactions to ibuprofen, including anaphylaxis. This medication is not recommended for people with SLE.

**Pregnancy: **There is not enough information to determine whether using methocarbamol - ibuprofen is safe during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks, and it should be avoided during the last trimester of pregnancy (after 28 weeks of pregnancy). If you become pregnant while taking this medication, contact your doctor as soon as possible.

If ibuprofen is taken during the earlier stages of pregnancy, there is an increased risk of miscarriage. Use of methocarbamol - ibuprofen at 20 weeks or later in pregnancy may increase the risk of kidney damage and complications due to low amniotic fluid in the developing baby. Using ibuprofen, as with any NSAID, late in pregnancy may cause labour to be prolonged.

Breast-feeding: Methocarbamol passes into breast milk. It is not known if ibuprofen passes into breast milk. If you are breast-feeding and taking methocarbamol - ibuprofen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 12 years old.

**Seniors: **Seniors are more likely to experience side effects with this medication and may require lower doses.

For a full list of interactions, use the** Drug Interaction Checker **available on the Drugs.com website.

If you are taking other 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.

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 – 2024. 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/Analgesic-and-Muscle-Relaxant-by-Pharmascience