Patient Medication Information: uses, side effects, how to take - Teva-Naproxen

Serious warnings and precautions box

Heart and blood vessel problems:

TEVA-NAPROXEN can cause heart and blood vessel problems like heart attacks, stroke, blood clots, high blood pressure and heart failure. These can lead to death.
The risk of having heart problems is higher if you take TEVA-NAPROXEN for long periods of time and/or at higher doses and/or in people who have heart disease.
Tell your healthcare professional if you have or had heart problems, high blood pressure or diabetes.

Stomach and intestine (gastrointestinal) problems:

TEVA-NAPROXEN can cause stomach and intestine problems like ulcers, inflammation, bleeding, holes/perforation, blockage or pain.

Talk to your healthcare professional about any medical conditions you have and drugs you are taking.

Pregnancy:

DO NOT take TEVA-NAPROXEN if you are pregnant and in a later stage of pregnancy (28 weeks or later).
If you are pregnant and in an earlier stage of pregnancy (less than 28 weeks) only take TEVA-NAPROXEN if you are told to do so by your healthcare professional.
Medicines like TEVA-NAPROXEN may cause harm to you and your baby. Your healthcare professional will need to closely monitor your health and that of your baby (including your amniotic fluid levels) if they prescribe TEVA-NAPROXEN during this time.
Tell your healthcare professional right away if you become pregnant, think you may be pregnant or want to get pregnant during your treatment with TEVA-NAPROXEN.

What TEVA-NAPROXEN is used for:

TEVA-NAPROXEN is used in adults to:

Treat the signs and symptoms of arthritis disorder such as:
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis
help relieve:
- minor aches and pains in muscles, bones and joints
- mild to moderate pain with inflammation in sprains and strains and period cramps (primary dysmenorrhea).

How TEVA-NAPROXEN work:

TEVA-NAPROXEN (naproxen) belongs to a group of medicines called non-steroidal anti-inflammatory drug (NSAID). It can reduce the chemicals produced by your body which cause pain and swelling.

TEVA-NAPROXEN only treats the symptoms and relieves pain and inflammation as long as you take it. TEVA-NAPROXEN does not cure the illness or stop it from getting worse.

The ingredients in TEVA-NAPROXEN are:

Medicinal ingredient: naproxen

Non-medicinal ingredients:

TEVA-NAPROXEN Tablets contain the following nonmedicinal ingredients: Colloidal silicon dioxide, FD&C yellow #6 lake 15-18% (HT), magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate and sodium starch glycolate. In addition, 250 mg & 500 mg Tablets have D&C yellow #10 lake 15-20% (HT).
TEVA-NAPROXEN EC Tablets contain the following nonmedicinal ingredients: Chromateric White Deb 5018 WE, Colloidal Silicon Dioxide, Croscarmellose Sodium (Ac-Di-Sol), Dri Klear 042, Eudragit L30D, Magnesium Stearate, Povidone and Sodium Lauryl Sulphate.

TEVA-NAPROXEN comes in the following dosage forms:

immediate release tablets, 250 mg, 375 mg and 500 mg
enteric coated tablets, 250 mg, 375 mg and 500 mg

Do not use TEVA-NAPROXEN if:

you have heart bypass surgery (planning to have or recently had).
you have severe, uncontrolled heart failure.
you are bleeding in the brain or other bleeding disorders.
you are pregnant and in a later stage of pregnancy (28 weeks or later).
you are currently breastfeeding (or planning to breastfeed).
you are allergic to naproxen or any of the other ingredients in this medicine or the container.
you have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an allergic reaction after taking acetylsalicylic acid (ASA) or other NSAIDs.
you have active stomach or intestine ulcers.
you have active bleeding from the stomach or gut.
you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
you have liver disease (active or severe).
you have kidney disease (severe or worsening).
you have high potassium in the blood.
you are under 18 years old.

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

Have high blood pressure, high cholesterol or diabetes
Have or had heart attacks, chest pain, heart disease, stroke or heart failure
Have poor blood flow to your extremities (like your hands and feet)
Smoke or used to smoke
Drink a lot of alcohol
Have a stomach infection
Have liver or kidney problems, urine problems or are dehydrated
Have a history of ulcer or bleeding from the stomach or gut (small or large intestine)
Have other bleeding or blood problems
Have asthma
Are pregnant, planning on becoming or become pregnant while taking TEVA-NAPROXEN.
Have immune system problems

Other warnings you should know about:

Serious Side Effects: TEVA-NAPROXEN can cause serious side effects, including:
- Blood and bleeding problems:
  - TEVA-NAPROXEN can cause blood problems, bleeding and prolonged bleeding.
  - Taking TEVA-NAPROXEN with the following drugs can increase the risk of bleeding:
    - anticoagulants (prevents blood clots), corticosteroids (anti-inflammatory) or antidepressants like selective serotonin reuptake inhibitors (SSRIs).
- Serious skin reactions: In rare cases, serious, life-threatening allergic and skin reactions have been reported with some NSAIDs, such as TEVA-NAPROXEN. These skin problems most often happen during the first month of treatment. Tell your healthcare professional immediately if you notice any changes in your skin both during and after treatment.
  TEVA-NAPROXEN might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, talk to your healthcare professional.
Check-ups and testing: You will have regular visits with your healthcare professional during treatment with TEVA-NAPROXEN to monitor your health. They will:
- Check your blood pressure.
- Check your eyes. TEVA-NAPROXEN can cause blurred or reduced vision.
- Do blood and urine tests to check your liver, kidney and blood health.
Surgery: Tell any dentist, pharmacist or healthcare professional that you see, that you are taking this medicine. This is especially important if you are planning to have heart surgery.
Driving and Using Machines: TEVA-NAPROXEN may cause eye or nervous system problems. This includes tiredness, trouble sleeping, blurred vision, spinning or dizziness (vertigo), hearing problems or depression. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking TEVA-NAPROXEN, do NOT drive or operate machinery.
Fertility in Women: TEVA-NAPROXEN may affect your fertility. This means that it may be difficult for you to have a child. If you have trouble having a child, you might need to stop taking TEVA-NAPROXEN. Talk to your healthcare professional if you have questions about this.
Adults (65 years or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of TEVA-NAPROXEN. They will monitor your health during and after treatment.

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

The following may also interact with TEVA-NAPROXEN:

Acetylsalicylic Acid (ASA) or other NSAIDs, used to treat pain, fever and inflammation, like:
o celecoxib, diclofenac, ibuprofen, naproxen
Antacids, used to treat symptoms of excess stomach acid
Medicines used to treat depression (antidepressants) like citalopram, fluoxetine, paroxetine, sertraline, and lithium
Medicines used to treat high blood pressure like enalapril, ramipril, candesartan, irbesartan, propranolol
Medicines used as blood thinners or to prevent blood clots, like warfarin, ASA, clopidogrel
Medicines used to lower extra fluid levels (diuretics), like furosemide, hydrochlorothiazide
Medicines used to treat diabetes, like sulphonylurea or other oral hypoglycemics
Medicines used to treat bacteria infections (antibiotics) like quinolone or sulphonamide
Medicines used to lower the risk of organ rejection, like tacrolimus and cyclosporin
Corticosteroids (including glucocorticoids such as prednisone), used as an anti-inflammatory
Cholestyramine, used to lower cholesterol levels
Digoxin, used to treat heart disorders
Hydantoin, used to treat seizures
Medicines used to treat different cancers, like methotrexate and pemetrexed
Oral birth control, used to prevent pregnancy
Probenecid, used to prevent gout
Alcohol

How to take TEVA-NAPROXEN:

Take exactly as your healthcare professional has told you. They should recommend the lowest dose possible for your treatment for the shortest time needed.
Swallow tablets whole. Swallow TEVA-NAPROXEN EC whole with food or milk. Do NOT split, chew or crush the tablets.
This medicine 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.
If you will be taking TEVA-NAPROXEN for more than 7 days, see your healthcare professional regularly. They will check if TEVA-NAPROXEN is working for you and if it is causing any side effects.

Usual dose:

Adults 18 years and older:

Your healthcare professional will decide on the best dosage for you based on your condition.
Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:
- experience serious side effects, or
- your disease gets worse.

Overdose:

If you think you, or a person you are caring for, have taken too much TEVA-NAPROXEN, contact a healthcare professional, hospital emergency department or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose of TEVA-NAPROXEN, take the dose as soon as possible. Take your next dose at the usual time.
If it is close to the time of your next dose, skip the missed dose. Take your next dose at the usual time.
Do not take two doses at the same time to make up for a forgotten dose.

Possible side effects from using TEVA-NAPROXEN:

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

Nausea, vomiting, diarrhea, constipation, stomach upset/abdominal pain, heartburn, indigestion, feeling gassy
Headache, dizziness, light-headedness
Feeling of burning/prickliness/numbing
Confusion, hard to concentrate or think, short-term memory loss, nervousness
Bruises
Skin rash
Taste disorder, thirst, dry mouth
Muscle pain
Mouth sores
Hair loss
Increased sweating
Problems with your period (women)

Serious side effects and what to do about them

Frequency/Side Effect/ Symptom	Talk to your healthcare professional
Frequency/Side Effect/ Symptom	Only if severe		In all cases
Common
Gastrointestinal (GI) problems (bleeding, blockage, holes, ulcers or inflammation in your GI tract): blood in vomit, black tarry or bloody stool, dizziness, stomach pain, bloating, loss of appetite, weight loss, nausea, vomiting, constipation or diarrhea, chills or fever			√
Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain		√
Uncommon
Anaphylaxis/hypersensitivity (severe allergic reactions): sudden wheeziness and chest pain or tightness; or swelling of eyelids, face, lips, tongue or throat, swelling or anaphylactic reaction/shock					√
Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by infection): Headaches, stiff neck, nausea and vomiting, fever or clouding of consciousness			√
Blood problems (low white and/or red blood cell or platelet count): feeling tired or weak, pale skin, bruising or bleeding for longer than usual if you hurt yourself, fever, chills			√
Congestive heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise					√
Cystitis (bladder infection): increased need to urinate, pain in the pelvis or lower back, frequent urination during the night, cloudy urine that may contain blood, burning or pain urinating			√
Depression (sad mood that will not go away): difficulty sleeping or sleeping too much, changes in			√
appetite or weight, reduced sex drive and thoughts of death or suicide.
Kidney disorder/problems (including kidney failure): nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, mental status changes (drowsiness, confusion, coma)			√
Liver problems (including hepatitis, liver failure, cholestasis): yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness			√
Lung problems, asthma: increased shortness of breath, wheezing, difficulty breathing, cough and chest tightness, irregular heartbeat					√
Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat.				√
Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, or lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking and loss of balance					√
Tinnitus (hearing problems): includes ringing, buzzing, clicking or hissing in ears, loss of hearing			√
Vertigo (a sense of severe spinning dizziness, lightheadedness)			√
Rare
Serious Skin Reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in
and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine, hives, red or dry itchy skin, red or purple patch appearing on the skin which may be itchy or painful and reappear in the same spot if you take this medicine again.					√

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.

Storage:

TEVA-NAPROXEN tablets and TEVA-NAPROXEN EC tablets: Store at room temperature (15 to 30°C). Store in a dry place.

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

Keep out of reach and sight of children.

If you want more information about TEVA-NAPROXEN:

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 http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Teva-Naproxen: Uses, Side Effects and Dosage