Patient Medication Information: uses, side effects, how to take - Auro-Terbinafine (Auro Pharma, 125 mg)
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 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 belongs to the group of medicines called antifungal agents and is used to treat fungal infections of the skin, hair and nails. When taken by mouth, it reaches the site of infection in
concentrations strong enough to kill the fungus or stop it growing.
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 take AURO-TERBINAFINE:
- If you have or had any liver problems.
- If you have any kidney problems.
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 forms it comes in:
AURO-TERBINAFINE comes as a tablet containing 125 mg & 250 mg of Terbinafine.
WARNINGS AND PRECAUTIONS
General:
Discuss with your doctor the possible side effects that may be caused by this medicine. Before you use AURO-TERBINAFINE tablets, talk to your doctor if you:
- have liver or kidney problems
- are allergic to any medicines, either prescription or non prescription (OTC), or foods;
- are allergic to terbinafine or to any of the ingredients listed in this leaflet.
ABOUT THIS MEDICATION
are pregnant or intend to become pregnant
while using this medicine;
are breast-feeding; AURO-TERBINAFINE is
excreted in breast milk.
are taking any other medicines, prescription or
nonprescription (OTC), especially cimetidine or rifampicin (see Interactions with this medicine).
Serious Warnings and Precautions
Rarely AURO-TERBINAFINE tablets can cause liver problems, in very rare cases the liver problems can be serious such as liver failure, some leading to death or liver transplant.
Stop taking AURO-TERBINAFINE tablets and consult your doctor immediately should you develop jaundice (yellowness of skin and/or eyes). See Table of Serious Side Effects.
Before you use AURO-TERBINAFINE, talk to your doctor if you:
have a history of other medical problems,
especially liver diseases such as jaundice (yellowness of skin and/or eyes), kidney disease, alcohol abuse, serious skin reactions, or blood diseases such as anemia.
experience symptoms such as unexplained
persistent nausea, vomiting, stomach pain, loss of appetite, unusual tiredness, if your skin or the whites of your eyes look yellow, that your urine is unusually dark or your bowel motions are unusually light in colour (signs of liver problems). Do not take AURO-TERBINAFINE tablets until you have discussed this problem with your doctor, who will check your liver function. Some individuals may be either very sensitive to AURO-TERBINAFINE or may have had some liver disease in the past. These individuals are at risk of developing abnormal liver function. Stop taking AURO-TERBINAFINE and consult your doctor immediately should you develop jaundice (yellowness of skin and/or eyes).
experience any skin problem such as rash, red
skin, blistering of the lips, eyes or mouth, skin peeling (signs of serious skin reactions).
experience weakness, unusual bleeding, bruising
or frequent infections (signs of blood disorders).
Talk to your doctor if the following occurs while taking AURO-TERBINAFINE tablets:
- Very occasionally some patients have developed blood abnormalities while being treated with AURO-TERBINAFINE. These reactions usually resolve on their own after stopping AURO-TERBINAFINE treatment. However, contact your doctor if you develop symptoms such as fever, sore throat, mouth sores, unusual bleeding or bruising.
If you have any questions about this, check with your doctor. Always remember to follow your doctor’s instructions and have any medical tests done that your doctor may request. Keep your appointments for follow-up visits.
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 antibiotics (e.g. rifampicin),
- caffeine
- some antidepressants (e.g. desipramine),
some medicines used to treat heart problems (e.g.
propafenone),
some medicines used to treat high blood pressure
(e.g. metoprolol),
some medicines used to treat stomach ulcers (e.g.
cimetidine),
- monoamine oxidase inhibitors (medicines used to treat depression).
- cyclosporine, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs.
Be sure to tell your doctor about these, or any other medicines you take.
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.
If any of the information in this leaflet causes you special concern or if you want additional information about your medicine and its use, contact your doctor or pharmacist. Remember, keep this and all other medicines out of the reach of children and never share your medicines with others.
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: 125 mg twice daily or 250 mg once daily.
The duration of treatment varies according to the indication and the severity of infection:
TABLE I
| 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:
If you think you have taken an overdose of this medicine, check with your doctor. If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Symptoms caused by an overdose of AURO-TERBINAFINE tablets include headache, nausea, stomach pain and dizziness.
For the management of suspected overdose, contact your local Poison Control Centre.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
In general, AURO-TERBINAFINE is well tolerated. Like all medicines, AURO-TERBINAFINE may cause some unwanted effects (side effects) in some people.
Side effects:
Very common (likely to affect more that 1 in every 10 patients): Nausea, mild stomach pain, heartburn, diarrhea, a feeling of fullness in the stomach, loss of appetite, skin rashes, aching joints and muscles.
Common (likely to affect 1 to 10 in every 100 patients): Headache.
Uncommon (likely to affect 1 to 10 in every 1,000 patients): Loss of or altered sense of taste. This is uncommon and usually recovers within several weeks after stopping treatment with AURO-TERBINAFINE tablets. It may lead to a reduction of appetite and significant weight loss in very few patients. You should tell your doctor if the altered sense of taste lasts for several days.
Very rare (likely to affect less than 1 in every 10,000 patients): Hair loss, fatigue, psoriasis-like skin eruptions, worsening of psoriasis, dizziness, decreased physical sensitivity, numbness and tingling. If you suffer dizziness, do not drive or operate machinery.
If any of these affects 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 rare or very rare effects could be serious:
Rarely AURO-TERBINAFINE tablets can cause liver problems; in very rare cases the liver problems can be serious. Very rare side effects include a decrease in certain types of blood cells, lupus (an autoimmune disease) or serious skin problems, including allergic reactions. Tell your doctor immediately:
- If you experience symptoms such as unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness.
- If you notice that your skin or the whites of your eyes look yellow, that your urine is unusually
dark or your bowel motions are unusually light in colour.
If you develop a sore throat with fever and
shivering.
- If you experience unusual bleeding or bruising.
If you experience difficulty breathing, dizziness,
swelling mainly of the face and throat.
- If you develop any skin problems.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
Only if severe | In all cases | ||||
| 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 | √ | |||
| Serious skin reactions (blistering, peeling skin) | √ | ||||
HOW TO STORE IT
Store at room temperature between 15 and 30°C.
Protect from light.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect By email: Canada Vigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and
Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your healthcare provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor:
Auro Pharma Inc,
1170 Sheppard Ave. west, Unit #16
Toronto, Ontario
M3K 2A3, Canada