Patient Medication Information: uses, side effects, how to take - Floctafenine
Serious Warnings and Precautions
Heart and blood vessel problems:
Stomach and intestine (gastrointestinal) problems:
Pregnancy:
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What is FLOCTAFENINE used for?
FLOCTAFENINE is used in adults for a short time to relieve mild to moderate pain.
How does FLOCTAFENINE work?
FLOCTAFENINE belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It can reduce the chemicals produced by your body which causes pain and swelling.
FLOCTAFENINE only treats the symptoms and relieves pain and inflammation as long as you take it. FLOCTAFENINE does not cure the illness or stop it from getting worse.
What are the ingredients in FLOCTAFENINE?
Medicinal ingredient: Floctafenine
Non-medicinal ingredients: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid.
FLOCTAFENINE comes in the following dosage forms:
Tablets: 200 mg and 400 mg.
Do not use FLOCTAFENINE if:
- You have heart bypass surgery (planning to have or recently had).
- You have severe, uncontrolled heart failure.
- You have 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 floctafenine or any other ingredients in FLOCTAFENINE 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 intestinal 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 taking:
- other NSAIDs, used to treat pain, fever and inflammation.
- beta blockers, used to treat heart problems.
- You are under 18 years of age.
- You have coronary artery disease.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take FLOCTAFENINE. Talk about any health conditions or problems you may have, including if you:
- have a condition that makes you frail or weak.
- have or have had heart attacks, chest pain, heart disease, stroke or heart failure.
- have a history of ulcer or bleeding from the stomach or gut (small or large intestine).
- have a stomach infection.
- have liver or kidney problems, urine problems or are dehydrated.
- have asthma and have growths in your nose (nasal polyps).
- have poor blood flow to your extremities (like your hands and feet).
- smoke or used to smoke.
- drink a lot of alcohol.
- have high blood pressure, high cholesterol or diabetes.
- have other bleeding or blood problems.
- have immune system problems.
- are pregnant, planning on becoming or become pregnant while taking FLOCTAFENINE.
- are taking any other medicines.
- are on a low-sodium diet.
Other warnings you should know about:
FLOCTAFENINE may cause serious side effects, including:
Blood and bleeding problems:
- FLOCTAFENINE can cause blood problems, bleeding and prolonged bleeding.
Taking FLOCTAFENINE 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).
- Aseptic meningitis (inflammation of the protective lining of the brain that is not caused by an infection): Patients with autoimmune disorders are at a higher risk.
Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as FLOCTAFENINE.
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
- Stevens-Johnson syndrome (SJS),
- toxic epidermal necrolysis (TEN),
- exfoliative dermatitis and
- erythema multiforme
You may be at a greater risk of experiencing a serious skin reaction usually during the first month of treatment. See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Infection: FLOCTAFENINE may mask signs of an infection such as fever or muscle aches. If you notice other symptoms of infection (e.g., painful or frequent urination, sore throat, cough), tell your healthcare professional.
Surgery: Tell any healthcare professional that you see, that you are taking this medicine. This is especially important if you are planning to have heart surgery.
Fertility in women: FLOCTAFENINE 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 FLOCTAFENINE. Talk to your healthcare professional if you have any 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 FLOCTAFENINE. They will monitor your health during and after treatment.
Driving and using machinery: FLOCTAFENINE 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 FLOCTAFENINE, do NOT drive or operate machinery.
Check-ups and testing: You will have regular visits with your healthcare professional during treatment with FLOCTAFENINE to monitor your health. They will:
- Check your blood pressure.
- Check your eyes. FLOCTAFENINE can cause blurred or reduced vision.
- Do blood and urine tests to check your liver, kidney and blood health.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not take FLOCTAFENINE with:
Taking FLOCTAFENINE with these medicines may cause serious drug interactions. Ask your healthcare professional if you are unsure you are taking these medicines. |
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The following may interact with FLOCTAFENINE:
- Corticosteroids (including glucocorticoids such as prednisone), used to treat inflammation.
- Lithium, used to treat mental illness.
- Medicines used to treat depression called Selective Serotonin Reuptake Inhibitors (such as citalopram, fluoxetine, paroxetine, and sertraline).
- Medicines used to treat high blood pressure, like enalapril, lisinopril, perindopril, ramipril, candesartan, irbesartan, losartan, and valsartan.
- Medicines used to lower extra fluid levels (diuretics), like furosemide, and hydrochlorothiazide.
- Medicines used as blood thinners or to prevent blood clots, like warfarin, clopidogrel, heparin, and dextrans.
- Medicines used to control certain types of seizures, like phenytoin.
- Methotrexate, used to treat different cancers.
- Medicines used to treat diabetes, like sulfonylureas or other oral hypoglycaemics like glibenclamide, metformin, chlorpropamide or phenformin, tolbutamide.
- Medicines used to treat bacterial infections (antibiotics), like sulphonamide.
- Vitamin K Antagonists used to prevent blood clotting.
How to take FLOCTAFENINE:
- Take FLOCTAFENINE exactly as your healthcare professional has told you. They should recommend the lowest dose possible for your treatment for the shortest time needed.
To lessen stomach upset, take this medicine immediately after a meal or food. Swallow the tablets with a glass of water. If stomach upset (indigestion, nausea, vomiting, stomach pain or diarrhea) occurs and continues, contact your healthcare professional.
- You should remain standing or sitting upright for about 15 to 30 minutes after taking this medicine. This helps to prevent irritation that may lead to trouble swallowing.
- This medicine has been prescribed specifically for you. Do not give it to anyone else. It may harm them, even if their symptoms seem similar to yours.
Usual dose:
Adults (18 years of age and older):
- Your healthcare professional will decide on the best dosage for you based on your condition, age and health of your kidneys.
Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop your 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 FLOCTAFENINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
- If you miss a dose of FLOCTAFENINE, take the dose as soon as you remember. Take your next dose at the usual time.
- If it is almost time for your next dose, skip the missed dose. Take your next dose at the usual time.
- Do NOT double your dose to make up the missed dose.
What are possible side effects from using FLOCTAFENINE?
These are not all the possible side effects you may have when taking FLOCTAFENINE. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, diarrhea, vomiting, stomach upset, heartburn, constipation, indigestion, feeling gassy
- feeling of burning of the face and extremities
- drowsiness, dizziness, headache
- trouble sleeping, nervousness, irritability
- thirst, dry mouth, changes in tastes
- skin rash, itching, hives
- redness and itching of the face and neck
- feeling discomfort
- hot flushes and increased sweating
- weakness, tiredness
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 | |||
| Allergic Reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat | √ | ||
| 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 sensation when passing urine | √ | ||
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 | √ | ||
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 | ||
| diarrhea, chills or fever | |||
| Kidney problems: 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, abnormal blood test results, mental status changes (drowsiness, confusion, coma) | √ | ||
| Lung problems (asthma): increased shortness of breath, wheezing, difficulty breathing, cough and chest tight ness, irregular heartbeat | √ | ||
| UNCOMMON | |||
| Anorexia (an eating disorder): fear of gaining weight, unusual eating behaviours, altered body image | √ | ||
| 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 | √ | ||
| Blurred vision | √ | ||
| Tachycardia (abnormally fast heartbeat): dizziness, light headedness, shortness of breath, racing heart | √ | ||
| Tinnitus: ringing, buzzing, clicking or hissing in the ears | √ | ||
| RARE | |||
| Aseptic meningitis (inflammation of the protective lining of the brain that is not | √ | ||
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 | ||
| caused by infection): headaches, stiff neck, nausea and vomiting, fever or clouding of consciousness | |||
| 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 | √ | ||
| Depression (sad mood that won’t go away): difficulty sleeping or sleeping too much, changes in appetite or weight, feelings of worthlessness, guilt, regret, helplessness or hopelessness, withdrawal from social situations, family, gatherings and activities with friends, reduced libido (sex drive) and thoughts of death or suicide. If you have a history of depression, your depression may become worse | √ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | √ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain in the chest, jaw, left arm, between the shoulder blades 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 | ||
| upper abdomen, shortness of breath, dizziness, fatigue, light-headedness, clammy skin, sweating, indigestion, anxiety, feeling faint and possible irregular heartbeat | |||
| 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 | √ | ||
| Stroke: sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body; sudden confusion, difficulty speaking or understanding others; sudden difficulty in walking or loss of balance or coordination; suddenly feeling dizzy or sudden severe headache with no known cause | √ | ||
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 FLOCTAFENINE at room temperature (15°C to 30°C) and protected from light.
Keep out of reach and sight of children.
Do NOT keep outdated medicine or medicine no longer needed. Return any outdated or unused medicine to your healthcare professional.
If you want more information about FLOCTAFENINE:
- 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 (https://www.aapharma.ca/en/), or by calling 1-877-998-9097.