Famciclovir (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Herpes zoster:

FAMCICLOVIR is an antiviral medicine and treats an infection, shingles, caused by a virus called varicella zoster.

FAMCICLOVIR stops the virus spreading, and reduces the blistering, pain, and rash.

Genital herpes:

FAMCICLOVIR is used to treat or prevent recurrence of the viral infections which cause genital herpes.

FAMCICLOVIR does not stop you from spreading herpes to another person. It is important to understand that the drug must be taken as early as possible as soon as you know that an attack is starting.

What it does:

FAMCICLOVIR helps stop the virus from multiplying and shortens the time the virus is released and spread, which helps healing.

When it should not be used:

Do not use FAMCICLOVIR if:

• you have a known hypersensitivity to famciclovir or any of the nonmedicinal ingredients in this product (See “What the important nonmedicinal ingredients are” section, below)

What the medicinal ingredient is:

Each FAMCICLOVIR tablet contains 125mg, 250 mg or 500 mg of famciclovir as the medicinal ingredient.

What the important nonmedicinal ingredients are:

Hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alchohol, sodium starch glycolate, talc, and titanium dioxide.

If you know you are allergic to any of these substances tell your doctor before you start taking these tablets.

The tablets are gluten-free.

The tablets do not contain sucrose, tartrazine or any other azo dyes.

What dosage form it comes in:

FAMCICLOVIR is available as 125 mg, 250 mg or 500 mg tablets with the following descriptions:

FAMCICLOVIR 125 mg tablets are white to off-white, film-coated, round biconvex tablet with “FC” on one side and “ ” on the other. 125

FAMCICLOVIR 250 mg tablets are white to off-white, film-coated, round biconvex tablet with “FC” on one side and “ ” on the other. 250

FAMCICLOVIR 500 mg tablets are white to off-white, film-coated, capsule-shaped, biconvex tablet with “FC500” on one side and “ ” on the other.

WARNINGS AND PRECAUTIONS

Before you take FAMCICLOVIR, talk to your doctor if:

• You have an allergy (including itching) or other unwanted

  (side) effects when previously taking famciclovir

• You are pregnant, planning to become pregnant or breastfeeding when using FAMCICLOVIR

• You have a past history of, or current kidney disease
• You have other medical conditions
• It is important to tell your doctor, dentist or pharmacist if you are taking other medication, as combining drugs can sometimes result in a change from the expected drug effects, or cause harmful effects.

INTERACTIONS WITH THIS MEDICATION

Always tell your doctor about other medical conditions you have or any medicines you are taking. This means medicines you bought for yourself as well as medicines on prescription. Your doctor or pharmacist will know if it is safe to take FAMCICLOVIR as well.

PROPER USE OF THIS MEDICATION

How do I use FAMCICLOVIR?

You should take FAMCICLOVIR only as directed by your doctor. Do not take more of it, do not take it more often and do not take it for a longer period of time than your doctor ordered.

Be sure to take FAMCICLOVIR regularly as prescribed. Try to take your tablets at the same time each day. You should continue to take your medicine even if you do not feel better, as it may take a few days for your medicine to work.

If your kidneys are not working very well, your doctor will probably have you take this medicine less often, check with your doctor if you have kidney problems.

FAMCICLOVIR will work whether or not you take it with food. You should swallow the tablets whole, with water. Do not chew them.

How long do I use FAMCICLOVIR?

The usual adult dose is one FAMCICLOVIR tablet three times a day for shingles.

Follow your doctor’s instructions about how and when to take your tablets. Start taking them as soon as you can for the best effect.

Most people take one tablet when they get up in the morning, one in the middle of the afternoon and one before going to bed at night.

Finish all the tablets you have been given even if you start to feel better. The treatment lasts for seven days.

Treating an outbreak of recurrent genital herpes:

If you have had herpes infections of the genitals before (called recurrent genital herpes), your doctor may decide to treat the outbreak. You will likely be told to take one 125 mg tablet twice a day for 5 days or if you are HIV-positive, one 500 mg tablet twice a day for 7 days. Most people with recurrent genital herpes take one tablet when waking, and one tablet just before going to bed. FAMCICLOVIR should be taken as soon as possible after the early symptoms (pain, burning, blisters) begin to appear.

Preventing outbreaks of recurrent genital herpes:

If you have had herpes infections of the genitals before (called recurrent genital herpes), then your doctor may decide to prevent future outbreaks. Your doctor will likely tell you that you should continually take one 250 mg tablet twice a day. Most people with recurrent genital herpes take one tablet when waking, and one tablet just before going to bed.

Missed Dose:

If you miss taking a FAMCICLOVIR tablet, don’t worry. Take it as soon as you remember. Take your next tablet at the normal time. Carry on as normal until you have finished all the tablets. It is important that you finish all the tablets you have been given, unless your doctor tells you to stop taking them. Do not double-dose.

Overdose

All tablets are risky if you take too many. If you take too many FAMCICLOVIR tablets at once, tell your doctor or hospital Emergency Department or poison control centre immediately Bring your pack of tablets with you. Taking too much of any type of medicine is risky.

Important: Your doctor may give you different instructions better suited to your specific needs. If you need more information on how to take FAMCICLOVIR properly, double-check with your doctor or pharmacist.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Any medicine can cause side effects. With FAMCICLOVIR, side effects are usually mild and you usually don’t have to stop taking your tablets. Some people may feel sick or get a mild headache. Other side effects include diarrhea, constipation, tiredness, sleepiness, vomiting, dizziness, somnolence (predominantly in the elderly), abdominal pain, itching, rash, urticaria [i.e., hives], hallucinations, jaundice [i.e., yellowing of the skin or the whites of the eyes], or fever. If you get these or any other problems while you are taking FAMCICLOVIR, tell your doctor or pharmacist.

Driving and using machines

FAMCICLOVIR can cause dizziness, drowsiness or confusion in very rare cases. If you have any of these symptoms while taking FAMCICLOVIR, you should take special care when driving or using machines.

Some effects could be serious:

This is not a complete list of side effects. For any unexpected effects while taking FAMCICLOVIR, contact your doctor or pharmacist. A more complete listing of side effects reported to date, is contained in the Product Monograph supplied to your physician.

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 0701C

  Ottawa, ON 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.

HOW TO STORE IT

• Keep FAMCICLOVIR in the bottle or package provided by the pharmacist.
• Store at room temperature.
• Protect from light.
• FAMCICLOVIR must be kept out of the reach of children.
• Don’t take your tablets if they are past their expiry date.
• Never let anyone else take your tablets, even if they have shingles as well.
• Finish all the tablets in the way you have been told.

What is shingles like?

• At first you might feel burning and tingly where the rash is coming. You may get pain for a few days before you see the rash.
• Most people with shingles get a blistery rash down one side of their body or face. This can be painful.
• New blisters will keep coming for about five days. After this, the blisters will dry to form scabs.
• You may feel weak and tired.
• The rash usually lasts for two to three weeks. Afterwards, people can have pain where the rash was, sometimes for several months.

Who gets shingles?

People of any age can get shingles. Most people who get it are middle-aged or older.

You can only get shingles if you have had chickenpox. 50% of people have had shingles by the age of 85.

What causes shingles?

• Shingles is caused by the same virus that causes chickenpox.
• After you have had chickenpox, the inactive virus stays in your body.
• Many years later the virus can start to work again. This may happen when you are run down or tired.

How is shingles treated?

Tablets for shingles, such as FAMCICLOVIR, stop the virus spreading. They cut down blistering and pain of the rash. They help you get better quicker if you take them early in your illness.

What else can you do?

• To stop the rash itching, have cool baths - do not use perfumed soap or bath oils. You can also put ice cubes wrapped in a washcloth on the rash, or cover it with a soothing lotion like calamine for the first three days.
• Keep the rash clean and dry.
• Wear loose clothes.

• Do not scratch the rash. It could get infected and take longer

  to get better.

• Rest when you feel tired.
• Try to eat well and drink plenty of fluids.

• Tell your doctor right away if you start to have trouble with

  your eyes. Shingles can sometimes cause eye problems which can be treated.

Can other people catch your shingles?

Shingles is caused by the same virus that causes chickenpox. Most doctors agree that people do not catch shingles from each other. When you have shingles, you can give chickenpox to someone who has never had chickenpox before - but this is unlikely.

What is Genital Herpes?

Genital Herpes is a viral infection of the genital (sex organ) area which is caused by the Herpes Simplex Virus. You might suspect the onset of this infection if you see the appearance of sores or blisters or feel a burning sensation in your genital region.

Type II herpes simplex virus is the main cause of the sores and blisters that develop in your genital area, but you can also catch genital herpes from herpes simplex Type I which can be the cause of cold sores which occur around your mouth.

Genital Herpes can occur as a first-episode attack or recurrent infection. Unlike many other viruses, recovery from the first attack does not leave you with lifelong protection from re-infection. The virus is able to remain hidden in the nerves after the initial infection and stays there until reactivated. Since your body still carries the highly infectious virus, you can easily infect someone else, even if you feel fine and you have no symptoms of genital herpes. This explains why genital herpes is one of the most common sexually transmitted diseases (STD).

The risk is higher for people who are more sexually active and have more sexual partners. It is therefore recommended that you avoid sexual activity if you or your partner have any symptoms of herpes, even if you have started your treatment.

While taking this medication:

• remember that your infection is contagious.

• tell any other doctor, pharmacist or dentist you see, that you

  are taking FAMCICLOVIR.

• contact your doctor if you develop any unusual discomfort.

• you should not take FAMCICLOVIR when pregnant or

  breast-feeding unless your doctor tells you to.

• do not give FAMCICLOVIR to others because it may not be

  suitable for them.

• store your tablets in a dry place at room temperature in the

  original container provided by the pharmacy.

• keep this medication out of reach of children.

• read your prescription label carefully; consult your doctor or

  pharmacist if you have any questions or require further information.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals, at: 1-866-254-6111.

Cobalt Pharmaceuticals Inc.

Mississauga, ON

Canada, L58 2B8

Last revised: February 22, 2010