Jamp-Terbinafine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Jamp-Terbinafine is used to treat fungal infections of the skin, fingernails and toenails.

What it does:

Jamp-Terbinafine works by blocking squalene epoxidase, an enzyme responsible for the creation of a component of the fugnal cell membrane called ergosterol. The lack of ergosterol result in fungal cell death. .

When it should not be used:

Do not use Jamp-Terbinafine if you are allergic to terbinafine hydrochloride or any of the ingredients in the medication (see What the non-medicinal ingredients are).

What the medicinal ingredient is:

Terbinafine Hydrochloride

What the nonmedicinal ingredients are:

Colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

What dosage forms it comes in:

Tablets: 250 mg

WARNINGS AND PRECAUTIONS

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.

Discuss with your doctor the possible side effects that may be caused by this medicine. Tell your doctor if you:

• are allergic to any medicines, either prescription or nonprescription (OTC), or foods;

• are pregnant or intend to become pregnant while using this medicine;

• are breast-feeding; Jamp-Terbinafine is excreted in breast milk;
• are taking any other medicine, prescription or nonprescription (OTC), especially cirnetidine or rifampicin;

• have a history of other medical problems, especially liver diseases such as jaundice (yellowness to skin and/or eyes), kidney disease, alcohol abuse, serious skin reactions, or blood diseases such as anemia. If you have or ever had a problem with your liver, do not take Jamp-Terbinafine tablets until you have discussed this problem with your doctor. He/she will check your liver function.

INTERACTIONS WITH THIS MEDICATION

Taking other medication together with Jamp-Terbinafine:

Before you start taking Jamp-Terbinafine, be sure to tell your doctor about all medicines you are taking or have taken recently including any that you bought without a prescription or any natural products. This is because the effects of Jamp-Terbinafine or the other medicines may be changed or you might get side effects. Furthermore, do not start any new medicine, whether prescription, non-prescription or natural products without first checking with your doctor.

Examples of drugs that may interact with Jamp-Terbinafine are:

• Drugs used to treat depression (i.e.

  Desipramine, Fluvoxamine, Selegiline)

• Drugs used to treat high blood pressure (i.e.

  Metoprolol, Propanolol)

• Birth Control

• Drugs used to treat arrhythmic abnormalities

  (i.e. Flecainide, Propafenone)

• Drugs used to treat mental disorders (i.e

  Chloprornazine, Haloperidol)

• Rifampin
• Cimetidine
• Fluconazole

PROPER USE OF THIS MEDICATION

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.

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.

Keep your regular appointments with your doctor.

Adult Dose

250 mg once daily

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, 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.

Overdose

If you think you have taken an overdose of this medicine, check with your doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The common side effects associated with taking Jamp-Terbinafine is gastrointestinal discomfort (diarrhea, cramps, nausea, vomiting, feeling of fullness or bloating). These possible side effects may go away during treatment; however, if they continue or are bothersome, contact your doctor.

Less common side effects associated with taking Jamp-Terbinafine include dry mouth, loss of or altered sense of taste (this is uncommon and usually recovers within several weeks after stopping treatment with Jamp-Terbinafine tablets; this 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); tiredness, lack of concentration, non-serious skin disorders (red, itchy skin), headache, pain (back, knee, legs, feet, kidney). These side effects should be reported to your doctor as soon as possible.

Rare and serious side effects associated with taking Jamp-Terbinafine include severe skin problems including allergic reactions, hives. *Sore throat and fever, jaundice (yellowness to skin and/or eyes), unusual fatigue, lack of appetite, dark urine, pale stools. *These signs may indicate blood or liver disorders. Stop taking Jamp-Terbinafine and notify your doctor immediately.

If you have any questions, 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.

This is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.

Ask your doctor if you do not understand these instructions or want more information.

HOW TO STORE IT

Store at temperatures between 15 °C and 30° C. Protect tablets from light. Remember, keep this and all other medicines out of reach of children and never share this medicine with others.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting JAMP Pharma Corporation, at 1-866-399-9091

JAMP Pharma Corporation

Boucherville, Quebec J4B 5H2

Last revised: September 16, 2010

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll free telephone: 866-234-2345

Toll free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectivness Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.