Consumer Information for: AURO-TERBINAFINE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
AURO-TERBINAFINE is used to treat fungal infections of skin, fingernails and toenails:
AURO-TERBINAFINE is used to treat fungal infections of the nail (toes, fingers) and may be used for certain fungal skin infections that do not respond to topical treatment.
Consult your doctor to confirm which type of fungal skin infection you have. Your doctor can determine if AURO-TERBINAFINE is the right treatment for you.
The treatment should only be taken as prescribed by your doctor. Some evidence of infection may still be present at the end of treatment. This will gradually diminish.
What it does
Terbinafine interferes in the production of a substance (ergosterol) that the fungus needs to grow and causes a build-up of another substance in the cells (squalene). Both actions cause the death of the fungus and elimination of the infection.
When it should not be used
Do not use AURO-TERBINAFINE if you are allergic to terbinafine (the active antifungal ingredient) or any of the ingredients in the formulation (See What the nonmedicinal ingredients are). If you think you may be allergic, ask your doctor for advice.
Do not use AURO-TERBINAFINE if you have chronic or active liver disease.
What the medicinal ingredient is
Terbinafine hydrochloride
What the non-medicinal ingredients are
Non-medicinal Ingredients (in alphabetical order): Cellulose microcrystalline, hypromellose, magnesium stearate, silica colloidal anhydrous and sodium starch glycolate.
What dosage form it comes in
AURO-TERBINAFINE is available as 250 mg tablets.
Warnings and precautions
Serious Warnings and Precautions
AURO-TERBINAFINE (terbinafine hydrochloride) tablets must not be used if you have pre-existing chronic or active liver disease. Serious and life-threatening cases of liver failure, including death, or requiring liver transplant, have been reported in patients with or without pre-existing chronic or active liver disease receiving terbinafine tablets.
Stop taking AURO-TERBINAFINE tablets and consult your doctor immediately should you develop jaundice (yellowness of skin and/or eyes or other symptoms). See Table of Serious Side Effects.
Your doctor may order blood tests before you start AURO-TERBINAFINE and during AURO-TERBINAFINE treatment.
Before you use AURO-TERBINAFINE, talk to your doctor if you:
- have or have a history of any other medical problems such as liver or kidney problems, blood diseases (e.g. anemia), serious skin reactions, or alcohol abuse • if you have or have had liver problems, your doctor may require blood tests before and during AURO-TERBINAFINE treatment to test liver function
- are allergic to any other medicines (either prescription or non-prescription) or foods • are pregnant or intend to become pregnant while using AURO-TERBINAFINE. • are breast-feeding; oral AURO-TERBINAFINE is excreted in breast milk.
Contact your doctor immediately, while taking AURO-TERBINAFINE, if you develop conditions such as:
- liver problems with symptoms such as persistent nausea, vomiting, abdominal pain, dark urine, pale stools, fatigue, loss of appetite, yellowing of the skin and eyes • serious skin reactions such as blistering or peeling skin, blistering of the lips, eye or mouth, red/inflamed skin, hives, fever (due to skin reactions), rash (due to high white blood cell count-eosinophilia) • experience symptoms of lupus erythematosus such as thickened patches of red/silver skin (psoriasis), joint pain, muscle disorder/pain and fever • blood disorder with symptoms such as weakness, unusual bleeding, bruising, sore throat or frequent infections
Interactions with this medication
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including herbal medicines, oral contraceptives (birth control pills) and non-prescription medicines. Some other medicines may interact with AURO-TERBINAFINE. These include:
- some medicines used to treat infectious diseases called antibiotics (e.g. rifampicin), • some medicines used to treat mood disorders (some antidepressants (such as tricyclic antidepressants, selective serotonine reuptake inhibitors including class 1A, 1B and 1C, monoamine oxidase inhibitors Type B, desipramine), • some medicines used to treat irregular heart rhythm (antiarrhythmics (e.g. propafenone, amiodarone), • some medicines used to treat high blood pressure (e.g. beta-blockers such as metoprolol), • theophylline, a medicine used to relieve bronchospasm in asthma • some medicines used to treat cough (e.g. dextromethorphan), • cyclosporine, a medicine used to control your body’s immune system (e.g. in order to prevent rejection of transplanted organs). • St John’s wort [Hypericum perforatum]), a herbal medicine used to treat depression
Some cases of menstrual irregularities and pregnancies have been reported in patients taking AURO-TERBINAFINE concomitantly with oral contraceptives; however, the rate of occurrence appears to be within the background incidence for patients taking oral contraceptives alone.
Proper use of this medication
To help clear up your infection completely, it is very important that you keep taking this medicine for the prescribed treatment period, even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungal infections may be very slow to clear up, stopping your medication too soon can cause the symptoms and the fungal infection to flare up again.
Missed Dose
Try not to miss any doses. If you do miss a dose, take it as soon as possible. However, if it is almost time for your next dose (up to 4 hours), skip the missed dose and go back to your regular schedule. Do not double the doses and never make dose changes on your own. Take as prescribed by your doctor.
Usual Adult Dose
Follow your doctor’s instructions carefully. Do not exceed the recommended dosage. If you have the impression that the effect of AURO-TERBINAFINE is too strong or too weak, talk to your doctor or pharmacist.
Adults: 250 mg once daily.
Taking AURO-TERBINAFINE at the same time each day will help you remember when to take your medicine. AURO-TERBINAFINE tablets can be taken on an empty stomach or after a meal.
You can take AURO-TERBINAFINE tablets if you are aged 65 years and over at the same dose as younger adults.
The duration of treatment varies according to the indication and the severity of infection:
| Indication | Duration of Treatment |
| Onychomycosis (of fingers and toes) | 6 weeks to 3 months |
| Skin Infections Tinea pedis interdigital & plantar/moccasin type) | 2-6 weeks |
| Tinea corporis, cruris | 2-4 weeks |
Overdose
Symptoms caused by an overdose of AURO-TERBINAFINE tablets include headache, nausea, stomach pain and dizziness.
Side effects and what to do about them
As with all medicines, some patients taking AURO-TERBINAFINE tablets may experience some unwanted effects (side effects), although not everybody gets them.
The following side effects have been reported with Terbinafine tablets:
Very common (likely to affect more that 1 in every 10 patients): headache, nausea, mild abdominal pain, stomach discomfort after meal (heartburn), diarrhea, swelling or bloating (a feeling of fullness) of the abdomen, loss of appetite, skin rashes (itchy), joint pain and muscle pain.
Common (likely to affect 1 to 10 in every 100 patients): Mood disorder (depression), disturbance or loss of sense of taste, dizziness, eye disorder and tiredness. If you suffer dizziness, do not drive or operate machinery.
Uncommon (likely to affect 1 to 10 in every 1,000 patients): If you notice abnormal pale skin, mucosal lining or nail beds, unusual tiredness or weakness or breathlessness on exertion (possible signs of a disease that affects the level of red blood cells), anxiety, tingling or numbness and decreased skin sensitivity, increased sensitivity of the skin to sun, noises (e.g. hissing) in ears, fever and weight loss.
Rare (likely to affect less than 1 to 10 in every 10,000 patients): Yellow eyes or skin (liver problems) and abnormal liver function test results.
Very rare (likely to affect less than 1 in every 10,000 patients): Decrease in certain types of blood cells, lupus (an autoimmune disease), serious skin reactions, allergic reactions, psoriasis-like skin eruptions (rash with silver coloured appearance), worsening of psoriasis, skin rash with flaking or peeling and hair loss.
If you experience smell, taste, visual or hearing disorders or symptoms of depression, then stop using AURO-TERBINAFINE and call your doctor.
If any of the listed side effects affect you severely, discuss this with your doctor.
Other side effects not listed above may also occur in some patients. If you notice any other side effects not mentioned in this leaflet, inform your doctor or pharmacist.
Some side effects could be serious:
- if you develop fever, shivering, a sore throat or mouth ulcers due to infections and weakness or if you get infections more frequently or
- if you experience difficulty in breathing, dizziness, swelling mainly of the face and throat, flushing, crampy abdominal pain and loss of consciousness or if you experience symptoms such as joint pain, stiffness, rash, fever or swollen/enlarged lymph nodes (possible signs of severe allergic reactions).
- If you develop any skin problems such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever.
- If you experience severe upper stomach pain with radiation to the back (possible signs of pancreas inflammation).
- If you experience unexplained muscle weakness and pain or dark (red-brown) urine (possible signs of muscle necrosis).
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Rare | |||
| Liver problems, sometimes fatal with symptoms such as persistent nausea and vomiting, abdominal pain, fatigue, loss of appetite, dark urine, pale stools or jaundice (yellowing of the skin and eyes). | ✔ | ||
| Very rare | |||
| Blood abnormalities with symptoms of sore throat, fever, mouth sore, unusual bleeding or bruising | ✔ | ||
| Inflammation of the blood vessels (vasculitis) or the Pancreas (pancreatitis) | ✔ | ||
| Serious allergic reactions (anaphylactic or serum sickness reactions) or infections | ✔ | ||
| Muscle breakdown (rhabdomyolysis) | ✔ | ||
| Immune system disorders (lupus) | ✔ | ||
| Serious skin reactions (blistering, peeling skin) | ✔ | ||
How to store
Store at room temperature between 15 and 30°C.
Protect from light.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about AURO-TERBINAFINE:
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: July 27, 2016
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| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ARIDOL | 02489562 | PHARMAXIS EUROPE LIMITED | MANNITOL 5 MG / CAP MANNITOL 10 MG / CAP MANNITOL 20 MG / CAP MANNITOL 40 MG / CAP |