What GD Terbinafine is used for and how to use it
Россия
  • Россия
  • Украина

GD Terbinafine - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Cutaneous Candidiasis, Onychomycosis, Fingernail, Onychomycosis, Toenail, Skin and Structure Infection, Skin Infection, bacterial (Bacterial Skin Infection), Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis
Class: Antifungals, Miscellaneous antifungals
Form: Tablets
Ingredients: terbinafine hydrochloride, cellulose microcrystalline, hypromellose, magnesium stearate, silica colloidal anhydrous, sodium starch glycolate

(terbinafine hydrochloride)

125 mg and 250 mg tablets (as terbinafine base)

About This Medication

What the Medication is Used For

GD-terbinafine is used to treat fungal infections of skin, fingernails and toenails:

GD -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 GD-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 GD-terbinafine if you are allergic to terbinafine (the active antifungal ingredient) or any of the ingredients in the formulation (see What thenonmedicinal ingredients are).

If you think you may be allergic, ask your doctor for advice.

Do not take GD-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

GD-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 GD-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.
  • are pregnant or intend to become pregnant while using this medicine;
  • are breast-feeding; GD-terbinafine is excreted in breast milk.
  • are taking any other medicines, prescription or nonprescription (OTC), especially cimetidine or rifampicin (see Interactions with thismedicine).

Serious Warnings and Precautions

Rarely GD-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 GD-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 GD-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 GD-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 GD-terbinafine or may have had some liver disease in the past. These individuals are at risk of developing abnormal liver function. Stop taking GD-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 GD-terbinafine tablets:

  • Very occasionally some patients have developed blood abnormalities while being treated with GD-terbinafine. These reactions usually resolve on their own after stopping GD-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 GD-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 GD-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 our 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 GD-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

IndicationDuration 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, cruris2-4 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 GD-terbinafine tablets include headache, nausea, stomach pain and dizziness.

For management of a suspected overdose, contact your local Poison Control Centre.

Side Effects and What to Do About Them

In general, GD-terbinafine is well tolerated. Like all medicines, GD -terbinafine may cause some unwanted effects (side effects) in some people.

Side Effects

Very common (likely to affect more that 1 in every 10patients): 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 100patients): Headache.

Uncommon (likely to affect 1 to 10 in every 1,000patients): Loss of or altered sense of taste. This is uncommon and usually recovers within several weeks after stopping treatment with GD-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 10,000patients): 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 GD -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 / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
RareLiver 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 rareBlood 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

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 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 0701D
          Ottawa, Ontario
          K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect 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

This document plus the full product monograph, prepared for health professionals can be found at:

www.pfizer.ca

or by contacting the sponsor, GenMed, a division of Pfizer Canda Inc., at:

1-800-463-6001