PMS-Ibuprofen (Pharmascience, 600 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Your healthcare provider has prescribed pms-IBUPROFEN for you for one or more of the following medical conditions:

pms-IBUPROFEN is indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

High doses (2400 mg/day) of ibuprofen may increase the risk of serious heart and blood vessel side effects. Patients with an increased risk of heart and blood vessel disease should talk to their healthcare provider about other treatment options first.

What it does:

pms-IBUPROFEN is a nonsteroidal anti-inflammatory drug (NSAID) which can reduce the production of substances, called prostaglandins, which are involved in the development of pain and inflammation, pms-IBUPROFEN does not cure your illness or prevent it from getting worse, it can only relieve the pain and reduce swelling as long as you continue to take it.

When it should not be used:

DO NOT TAKE pms-IBUPROFEN if you have any of the following medical conditions:

• Heart bypass surgery (planning to have or recently had)
• Severe, uncontrolled heart failure
• Bleeding in the brain or other bleeding disorders

• Current pregnancy (after 28 weeks of pregnancy)

• Currently breastfeeding (or planning to breastfeed)
• Allergy to ASA (Acetylsalicylic Acid) or other NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
• Ulcer (active)
• Bleeding from the stomach or gut (active)
• Inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis)
• Liver disease (active or severe)
• Kidney disease (severe or worsening)

• High potassium in the blood

  pms-IBUPROFEN should not be used if you:

  • are allergic to any ingredient in the formulation (see non-medicinal ingredients below). Allergic reactions may appear as hives, difficulty breathing, rash, swelling of the face or throat or sudden collapse.
  • have had asthma, hives or any allergic-type reactions after taking ASA or other NSAIDs (complete or partial syndrome of ASA intolerance).
  • have systemic lupus erythematosus.

Patients who took a drug in the same class as pms-IBUPROFEN 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.

pms-IBUPROFEN should NOT be used in patients under 12 years of age since the safety and effectiveness have NOT been established.

What the medicinal ingredient is:

ibuprofen

What the non-medicinal ingredients are:

Colloidal silicon dioxide, FD&C yellow # 6 aluminum lake, lactose, povidone, pregelatinized starch, sodium starch glycolate, starch, stearic acid, titanium dioxide, triacetin and yellow iron oxide

What dosage forms it comes in:

Tablets: 600 mg

WARNINGS AND PRECAUTIONS

Before taking pms-IBUPROFEN, tell your healthcare provider if you have any of the following:

• High blood pressure
• High cholesterol
• Diabetes mellitus or on a low sugar diet
• Atherosclerosis (hardening of the arteries)
• Poor circulation to your extremities
• Blood-clotting disorder (e.g., hemophilia, sickle cell anemia, etc.)
• Hyperkalemia (high levels of potassium in your blood)
• Kidney disease or urine problems (bladder pain, any change in the amount and colour of urine)
• Liver disease, alcoholism, systemic lupus erythematous, or any other serious disease or condition.
• Previous ulcer or bleeding from the stomach or gut
• Previous bleeding in the brain
• Bleeding problems (dark urine, easy bruising, bloody or black tarry stools)
• Heart disease
• Family history of asthma, nasal polyps, long-term swelling of the sinus (chronic sinusitis) or hives
• Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
• You are taking an anticoagulant (blood thinning medication), oral corticosteroid (used to treat joint pain and swelling) or any other drug
• You are taking low dose ASA
• You are dehydrated (severe fluid loss)
• You are smoker or ex-smoker
• You are over 65 years of age
• You are on a special diet (e.g., low sodium)

They may recommend an alternative analgesic such as acetaminophen.

Before taking pms-IBUPROFEN, tell your healthcare provider if you are planning to get pregnant.

While taking pms-IBUPROFEN:

• Tell any other doctor, dentist, pharmacist or other healthcare professional that you see, that you are taking pms-IBUPROFEN, especially if you are planning to have heart surgery;
• Do NOT drink alcoholic beverages while taking pms-IBUPROFEN because you are more likely to develop stomach problems;
• Fertility may be decreased. The use of pms-IBUPROFEN is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping pms-IBUPROFEN should be considered.

INTERACTIONS WITH THIS MEDICATION

Talk to your healthcare provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):

• Acetylsalicylic Acid (ASA) or other NSAIDs

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

  • Antidepressants

    • Selective Serotonin Reuptake Inhibitors (SSRIs)

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

  • 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
  • Digoxin

  • Diuretics

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

Your healthcare provider may prescribe low dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking pms-IBUPROFEN. Take only the amount of ASA prescribed by your healthcare provider. You are more likely to upset or damage your stomach if you take both pms-IBUPROFEN and ASA than if you took pms-IBUPROFEN alone.

PROPER USE OF THIS MEDICATION

Usual adult dose:

• Starting dose: 600 mg twice daily
• Maintenance dosage: 600 to 1200 mg daily (1 to 2 tablets daily)
• Maximum dosage: 1800 mg daily

Take pms-IBUPROFEN only as directed by your healthcare provider. Do NOT take more of it, do NOT take it more often and do NOT take it for a longer period of time than your healthcare provider recommended. You should take the lowest dose of pms-IBUPROFEN for the shortest time period. Taking too much pms-IBUPROFEN may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

If you will be using pms-IBUPROFEN for more than 7 days, see your healthcare provider regularly to discuss whether this medicine is working for you and if it is causing you any unwanted effects.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

pms-IBUPROFEN is NOT recommended for use in patients under 12 years of age since safety and effectiveness have NOT been established.

pms-IBUPROFEN must be taken with food.

Overdose:

Missed Dose:

If you missed a dose, just resume your usual schedule the following day. Do not take an extra dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

pms-IBUPROFEN may cause some side effects, especially when used for a long time or in large doses. When these side effects occur, you may require medical attention. Report all symptoms or side effects to your healthcare provider.

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

Check with your healthcare provider IMMEDIATELY if you develop chills, fever, muscle aches or pains, or other flu-like symptoms, especially if they occur before or together with a skin rash. These symptoms may be the first signs of a SERIOUS ALLERGIC REACTION to this medication.

Side effects may include:

• Rash, itching
• Trouble sleeping (insomnia)
• Nausea, vomiting, stomach pain and/or cramps, heartburn, diarrhea, indigestion, constipation, bloating, gas

This is not a complete list of side effects. For any unexpected effects while taking pms-IBUPROFEN contact your healthcare provider or pharmacist.

HOW TO STORE IT

Store away from heat and direct light at room temperature (15°C - 30°C).

Do NOT keep outdated medicine or medicine no longer needed. Any outdated or unused medicine should be returned to your pharmacist.

Keep out of reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Pharmascience Inc., at: 1-888-550-6060.

www.pharmascience.com

Last revised: August 21, 2015