Novo-Profen: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Since everyone’s pain is different, NOVO-PROFEN offers 3 levels of pain relief to suit your needs. So you can choose your relief, NOVO-PROFEN products are available in three strengths; NOVO-PROFEN 200 mg, 300 mg, and 400 mg strengths).

NOVO-PROFEN products provide fast and effective relief of PAIN from:

• headache, including mild to moderate migraine and tension headache
• menstrual cramps
• toothache (dental pain), including dental extraction

• inflammation from arthritis, muscle strain, and sprains,

  muscles, bones and joints, including back pain

NOVO-PROFEN is also an effective fever reducer and will provide relief from the aches and pain due to the common cold and flu.

Clinical studies show long lasting relief for up to 8 hours for fever and up to 6 hours for pain.

What it does:

NOVO-PROFEN (ibuprofen) starts to work fast and treats pain where it starts.

Ibuprofen is a member of a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs work within the body by blocking the production of substances, called prostaglandins, which are involved in the development of pain and inflammation.

When it should not be used:

NOVO-PROFEN should not be used if you:

• are taking acetylsalicylic acid (ASA) or any

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

• are allergic or have had a reaction to ibuprofen, acetylsalicylic acid (ASA), other non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates, or 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 nasal polyps (swelling of the inside of the

  nose), or allergic manifestations such as asthma, anaphylaxis (sudden severe life-threatening anaphylactic reactions), urticaria/hives, rhinitis

  (stuffed or runny nose that may be due to allergies), skin rash or other allergic symptoms.

• have been diagnosed with severe high blood pressure

  or have severe coronary artery disease.

• are dehydrated (significant fluid loss) due to vomiting,

  diarrhea or lack of fluid intake.

• have active or recurrent stomach ulcer, gastrointestinal (GI) bleeding, or active inflammatory bowel disease (e.g. Crohn’s, colitis)
• have liver or kidney disease.
• have systemic lupus erythematosus.

• are pregnant or nursing, unless advised otherwise by a doctor.

• Right before or after heart surgery

What the medicinal ingredient is:

Ibuprofen

What the nonmedicinal ingredients are:

NOVO-PROFEN (ibuprofen) 200 mg tablets/caplets contain ibuprofen 200 mg and the following non-medicinal ingredients in alphabetic order: carnauba wax, colloidal silicon dioxide, D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake, hydroxypropyl methyl cellulose, magnesium staerate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.

NOVO-PROFEN (ibuprofen) 300 mg tablets contain ibuprofen 300 mg and the following non-medicinal ingredients in alphabetic order: colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium staerate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide and triacetin.

NOVO-PROFEN (ibuprofen) 400 mg tablets contain ibuprofen 400 mg and the following non-medicinal ingredients in alphabetic order: carnauba wax, colloidal silicon dioxide, FD&C yellow # 6 aluminum lake, hydroxypropyl methyl cellulose, magnesium staerate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.

What dosage forms it comes in:

Tablets: 200mg, 300mg, 400mg

Caplets: 200mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer.

Keep this medication out of the reach of children.

BEFORE you use NOVO-PROFEN talk to your doctor or pharmacist if you:

• have stomach ulcers, high blood pressure, asthma, heart failure, kidney or liver disease, diabetes, alcoholism, a history of stomach bleeding, systemic lupus erythematosus, or any other serious disease or condition.
• are taking an anticoagulant (blood thinning medication),oral corticosteroid or any other drug.
• are nursing an infant.
• are over 65 years of age.
• are taking low-dose ASA.
• suffer from asthma or have nasal polyps (a swelling inside the nose)
• are dehydrated (severe fluid loss)
• have a blood-clotting disorder (e.g. hemophilia, sickle cell anemia, etc.)
• have a heart disease
• have any unusual urinary symptoms (e.g. bladder problems)
• are on a special diet (e.g. low-sodium)
• suffer from hyperkalemia (high levels of potassium in your blood)

They may recommend an alternative analgesic such as acetaminophen.

Novo-Profen is not recommended for children under 12 years of age. Suitable ibuprofen formulations are available to treat children under 12 years of age.

INTERACTIONS WITH THIS MEDICATION

Always tell any doctor, dentist, or pharmacist you consult that you are taking this medicine.

Drugs that may interact with NOVO-PROFEN include: acetylsalicylic acid (ASA) or other NSAIDs, blood thinning medications (anticoagulants), blood pressure medication (anti-hypertensives), diuretics (water pills), oral steroids (glucocorticoids), lithium, , diabetes medications (hypoglycemics), methotrexate, phenytoin, acetaminophen and digoxin.

Do not use this product if you are taking daily

low dose ASA (81-325 mg) without talking to a

doctor or pharmacist. Ibuprofen may interfere

with the preventative benefits of ASA.

PROPER USE OF THIS MEDICATION

Usual dose:

For accurate dosing of each product strength, refer to the dosage table and follow the instructions carefully.

The single oral dose may be taken every 4-6 hours as needed. Do not take more than the maximum daily dose (1200 mg in 24 hours) unless advised by a doctor. Take with food or milk if mild stomach upset occurs with use. NOVO-PROFEN should not be taken for pain for more than 5 consecutive days or for fever for more than 3 days without first talking to your doctor or dentist.

Use the lowest effective dose for the shortest duration.

Do not take this product while taking ASA, other ibuprofen containing products or any other pain or fever medicine.

For effective use of this medicine, unless recommended by your doctor or dentist, DO NOT take:

• more than the recommended number of tablets or caplets in each single dose
• a dose more often than every 4-6 hours
• this product longer than the recommended period of time

Overdose:

In case of overdose, even if there are no symptoms, call a doctor or Poison Control Centre at once.

Missed Dose:

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take your medicine and skip the missed dose. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If unusual symptoms or any of the following reactions develop during treatment, stop use and see a doctor immediately: nausea, vomiting, abdominal pain or diarrhea; heartburn, bloating or constipation; fluid retention; skin rash or itching; dizziness; any change in vision; ringing or buzzing in the ears, vomiting any blood or have tarry stools, jaundice (yellowing of the eyes or skin due to liver problems).

If you experience dizziness, blurred vision, or hearing problems while taking NOVO-PROFEN, please use caution when carrying out activities requiring alertness.

Ibuprofen may cause a severe allergic reaction that could include wheezing, facial swelling, hives, shortness of breath, shock or a fast, irregular heartbeat. Any of these reactions could be serious. Stop using the product and get emergency medical help immediately.

This is not a complete list of side effects. For any unexpected effects while taking NOVO-PROFEN, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C. Unit dose strips should be stored between 15°C and 25 °C and protected from high humidity.

Keep Out of the Reach of Children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:

1-800-268-4127 ext. 1255005 (English);

1-877-777-9117 (French)

or druginfo@tevacanada.com

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: November 26, 2015