Patient Medication Information: uses, side effects, how to take - Diflunisal
Serious Warnings and Precautions
Heart and blood vessel problems:
Stomach and intestine (gastrointestinal) problems:
Talk to your healthcare professional about any medical conditions you have and drugs you are taking. Pregnancy:
|
|---|
What is DIFLUNISAL used for?
DIFLUNISAL is used in adults and children 12 years of age and older to:
Treat the signs and symptoms of arthritis disorders such as:
- Osteoarthritis
- Rheumatoid arthritis
Help relieve mild to moderate pain with inflammation:
- in muscle and bone injuries (sprains and strains)
- after surgery (including dental surgery)
- after giving birth (postpartum pain)
How does DIFLUNISAL work?
DIFLUNISAL belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It can reduce the chemicals produced by your body which cause pain and swelling.
DIFLUNISAL does NOT cure your illness or prevent it from getting worse. It can only treat the symptoms and relieves pain and inflammation as long as you take it.
What are the ingredients in DIFLUNISAL?
Medicinal ingredients: Diflunisal
Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 (250 mg tablet only), FD&C yellow #6, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch and titanium dioxide.
DIFLUNISAL comes in the following dosage forms:
Tablets: 250 mg and 500 mg
Do not use DIFLUNISAL if you:
- have heart bypass surgery (planning to have or recently had).
- have severe, uncontrolled heart failure.
- have bleeding in the brain or other bleeding disorders.
- are pregnant and in a later stage of pregnancy (28 weeks or later).
- are currently breastfeeding (or planning to breastfeed).
- are allergic to diflunisal or any other ingredients in this medicine or the container.
- 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.
- have active stomach or intestine ulcers.
- have active bleeding from the stomach or gut.
- have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
- have liver disease (active or severe).
- have kidney disease (severe or worsening).
- have high potassium in the blood.
- are under 12 years old.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DIFLUNISAL. 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 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
- have immune system problems
Other warnings you should know about:
Serious Side Effects: DIFLUNISAL may cause serious side effects, including:
- Allergic Reactions: In rare cases, serious or life-threatening allergic reactions have been reported with some NSAIDs, such as DIFLUNISAL. See the Serious Side Effects section below for more information on the symptoms.
- Reye’s Syndrome (disorder of swelling in the brain and liver): Reye’s syndrome has been associated with the use of Acetylsalicylic acid (ASA). Since DIFLUNISAL is a byproduct of ASA, its use may also be associated with Reye’s syndrome.
- The use of DIFLUNISAL may hide symptoms of a fever.
Blood and bleeding problems:
- DIFLUNISAL can cause blood problems, bleeding and prolonged bleeding.
Taking DIFLUNISAL with the following medicines 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 or life-threatening skin reactions (see the Serious side effects and what to do about them table below) have been reported with some NSAIDs, such as DIFLUNISAL. 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. DIFLUNISAL 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 DIFLUNISAL to monitor your health. They will:
- Check your blood pressure.
- Check your eyes. DIFLUNISAL can cause blurred or reduced vision.
- Do blood and urine tests to check your liver, kidney and blood health.
Surgery: Tell any doctor, 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 machinery: DIFLUNISAL 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 participating in activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking DIFLUNISAL, do NOT drive or operate machinery.
Fertility in Women: DIFLUNISAL 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 DIFLUNISAL. 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 DIFLUNISAL. 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 interact with DIFLUNISAL:
Acetylsalicylic Acid (ASA) or other NSAIDs, used to treat pain, fever, or inflammation, like:
- celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen, sulindac, acetaminophen
- Antacids, used to treat ulcers
- 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
- Corticosteroids (including glucocorticoids), used to treat inflammation, like prednisone
- Medicines used to treat diabetes like oral sulphonylurea hypoglycemics (e.g., tolbutamide), or other oral hypoglycemics
- Medicines used to treat bacteria infections (antibiotics) like quinolone or sulphonamide
- Medicines used to lower the risk of organ transplant rejection, like cyclosporine and tacrolimus
- Digoxin, used to treat heart disorders
- Medicines used to treat different cancers, like methotrexate
- Alcohol
How to take DIFLUNISAL:
- Take exactly as your healthcare professional has told you. They should recommend the lowest dose possible for your treatment for the shortest time needed.
- If you will be taking this medicine for more than 7 days, see your healthcare professional regularly. They will check if it is working for you and if it is causing you any side 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.
Take right after a meal or with food to avoid an upset stomach.
- Swallow your tablets whole. Do NOT break, crush, or chew them.
Usual dose:
Adults and Children 12 years and older:
- Your healthcare professional will decide on the best dosage for you based on your condition.
Your healthcare professional may change 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 DIFLUNISAL, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
- If you miss a dose, 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.
What are possible side effects from using DIFLUNISAL?
These are not all the possible side effects you may have when taking DIFLUNISAL. 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
- Lack of energy, tired
- Headache, dizziness, light-headedness
- Feeling of burning/prickliness/numbing
Confusion, hard to concentrate or think, nervousness, hallucinations
- Bruises, skin rash, swelling, hives or itching
- Taste disorder, thirst, dry mouth
- Muscle pain
- Mouth sores/swelling
- Hair loss
- Increased sweating
- Eating disorder, anorexia
- Temporary vision problems, blurred vision
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||||
|---|---|---|---|---|---|---|---|
| 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, fever, chills, 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 (breakdown of red blood cells, low white and/or red blood cell or platelet count): feeling tired or weak, pale skin, dizziness, fainting, thirst, rapid breathing, 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 | ✓ | ||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| 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 | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| 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, purple or red spots on skin | ✓ | ||
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:
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:
Store at room temperature 15°C to 30°C.
Protect from light and moisture.
Keep out of reach and sight of children.
If you want more information about DIFLUNISAL:
- 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). Find the Patient Medication Information on the manufacturer’s website (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.