Patient Medication Information: uses, side effects, how to take - Teva-Terbinafine (Teva Canada, PM 00036944)
What the medicinal ingredient is:
terbinafine hydrochloride
What the non-medicinal ingredients are:
Colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose.
What dosage forms it comes in:
250 mg Tablets
What the medication is used for:
TEVA-TERBINAFINE is used to treat fungal infections of skin, fingernails and toenails:
- TEVA-TERBINAFINE tablets are 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 TEVA- 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 TEVA-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.
Before you use TEVA-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 terbinafine hydrochloride 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 terbinafine hydrochloride.
- are breast-feeding; terbinafine hydrochloride is excreted in breast milk.
Contact your doctor immediately, while taking TEVA- 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
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
TEVA-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 hydrochloride tablets.
Stop taking TEVA-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 TEVA- TERBINAFINE and during TEVA-TERBINAFINE treatment.
IMPORTANT: PLEASE READ
- 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
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 TEVA-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 serotonin 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 our 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 terbinafine hydrochloride concomitantly with oral contraceptives; however, the rate of occurrence appears to be within the background incidence for patients taking oral contraceptives alone.
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 TEVA-TERBINAFINEis too strong or too weak, talk to your doctor or pharmacist.
Adults: 250 mg once daily.
Taking TEVA-TERBINAFINEat the same time each day will help you remember when to take your medicine. TEVA- TERBINAFINEtablets can be taken on an empty stomach or after a meal.
You can take TEVA-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:
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:
Symptoms caused by an overdose of TEVA-TERBINAFINE tablets include headache, nausea, stomach pain and dizziness.
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
TEVA-TERBINAFINE tablets
As with all medicines, some patients taking TEVA- TERBINAFINE tablets may experience some unwanted effects (side effects), although not everybody gets them.
The following side effects have been reported with terbinafine hydrochloride tablets:
Very common (likely to affect more than 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
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
PROPER USE OF THIS MEDICATION
INTERACTIONS WITH THIS MEDICATION
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
IMPORTANT: PLEASE READ
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 terbinafine hydrochloride 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).
This is not a complete list of side effects. For any unexpected effects while taking TEVA-TERBINAFINE, contact your doctor or pharmacist
Bottles should be stored between 15ºC and 30ºC. Protect tablets from light.
Blister packs should be stored between 15ºC and 25ºC. Protect blister packs from light and high humidity.
Keep out of reach of children.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||
| Symptom / effect | Talk with your | Stop taking |
HOW TO STORE IT
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| doctor or pharmacist | drug and seek immediate emergency medical attention | ||||
| 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, | √ | |||
| 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) | √ | ||||
IMPORTANT: PLEASE READ
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or Fax: 1-416-335-4472
30 Novopharm Court Toronto, Ontario M1B 2K9 Canada www.tevacanada.com
Last revised: October 26, 2016
MORE INFORMATION
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp- mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc- sc.gc.ca/dhp-mps/medeff/index-eng.php).
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.