Consumer Information for: APO-FAMCICLOVIR

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-FAMCICLOVIR is an antiviral medicine that is used to treat a number of viral infections described below. It stops the infecting virus from reproducing. Since the virus reproduces very early in the infection, the best results in the treatment are obtained if APO-FAMCICLOVIR is started as soon as possible after the first symptoms appear

Herpes zoster:

APO-FAMCICLOVIR is used to treat herpes zoster (Shingles). Herpes zoster is an infection caused by a virus called varicella zoster (the same virus that causes chickenpox). APO-FAMCICLOVIR stops the virus from spreading in the body so that healing can occur faster if taken within 72 hours of the first lesion, and reduces the blistering, pain, and rash.

Genital herpes:

APO-FAMCICLOVIR is used to treat or prevent recurrence of the viral infections which cause genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2, and is normally spread by sexual contact. It causes blisters and burning or itching around the genitals, which may be painful.

APO-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. Although APO-FAMCICLOVIR does not cure the viral infection, it helps to shorten the duration of symptoms and allows the infections to heal faster.

What it does

APO-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 APO-FAMCICLOVIR if:

  • you have a known hypersensitivity to APO-FAMCICLOVIR (famciclovir), to penciclovir (a compound formed from famciclovir by your body and an ingredient of some other medicines) (See: What the important nonmedicinal ingredients are) or to any ingredient of the formulation or packaging
What the medicinal ingredient is

APO-FAMCICLOVIR contains 125 mg, 250 mg or 500 mg of famciclovir.

What the non-medicinal ingredients are

APO-FAMCICLOVIR also contains the following nonmedicinal ingredients: butylated hydroxy toluene, hydroxypropyl methylcellulose, Poloxamer 407, polyethylene glycol, stearic acid and titanium dioxide.

What dosage form it comes in

HERPES ZOSTER

APO-FAMCICLOVIR 500 mg: each white, oval, biconvex, film-coated tablet, engraved “APO” on one side and “FAM 500” on the other side, contains 500 mg famciclovir. Check with your doctor or pharmacist if your tablets look different from this

GENITAL HERPES

APO-FAMCICLOVIR 125 mg: each white, round, biconvex, film-coated tablet, engraved “APO” on one side and “FAM” over “125” on the other side, contains 125 mg famciclovir.

APO-FAMCICLOVIR 250 mg: each white, round, biconvex, film-coated tablet, engraved “APO” on one side and “FAM” over “250” on the other side, contains 250 mg famciclovir.

Check with your doctor or pharmacist if the identifying markings or colour of your tablets are not the same as these.

Warnings and precautions

Before you take APO-FAMCICLOVIR, talk to your doctor if:

  • You have an allergy (including itching) or other unwanted (side) effects when previously taking APO-FAMCICLOVIR.
  • You are pregnant, planning to become pregnant, or if you are breastfeeding or planning to breastfeed
  • You have a past history or current kidney disease
  • You have severe liver problems
  • 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 APO-FAMCICLOVIR as well.

It is particularly important that you tell your doctor or pharmacist if you are taking any of the following medicines:

  • Probenecid (used to treat high blood levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics), or any other medicine that can affect your kidneys.

  • Raloxifene (used to prevent and treat osteoporosis).

You can take APO-FAMCICLOVIR with or without food.

Proper use of this medication

How do I use APO-FAMCICLOVIR?

You should take APO-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 APO-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.

APO-FAMCICLOVIR will work whether or not you take it with or without food. You should swallow the tablets whole, with water. Do not chew them.

How long do I use APO-FAMCICLOVIR?

The usual adult dose is one APO-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 125 mg twice a day for 5 days or if you are HIV-positive, 500 mg t 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. APO-FAMCICLOVIR should be taken as soon as possible after the early symptoms (pain, burning, blisters, itching, tingling) 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 250 mg twice a day. Most people with recurrent genital herpes take one tablet when waking, and one tablet just before going to bed

Overdose

In case of drug overdose, contact a healthcare practitioner (doctor), hospital emergency department or regional poison control centre, even if there are no symptoms. Bring your pack of tablets with you.

Taking too much of any type of medicine is risky.

Taking too much APO-FAMCICLOVIR may affect the kidneys. In people who already have kidney problems it may, rarely, lead to kidney failure if their dose is not correctly lowered.

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

Missed Dose

If you miss taking an APO-FAMCICLOVIR tablet, don’t worry. Take it as soon as you remember. Take your next tablet at the normal time. However, do not take two doses within a time interval of less than 1 hour, in that case you should skip the missed dose. 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

Side effects and what to do about them

Any medicine can cause side effects. With APO-FAMCICLOVIR, some people may feel sick or get a headache, or experience confusion or dizziness. Other side effects include drowsiness (usually in older people), hallucinations (seeing or hearing things that are not really there), vomiting, yellowing of the skin and/or eyes, abnormal liver function test results, palpitations (signs of abnormal heart beat), skin rash, itching or blistering, diarrhea, tiredness and abdominal pain.

If you get these or any other problems while you are taking APO-FAMCICLOVIR, tell your doctor or pharmacist.

Some effects could be serious:

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk to your doctor or pharmacist Only if severe Talk to your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Signs of serious skin reaction: pruritis (e.g. itching, erythema multiforme, Steven Johnson syndrome, toxic epidermal necrolysis), severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, angioedema (e.g. swelling of tissues such as face, mouth, eyes, throat, skin, hands and feet)     ✔
Serious allergic reaction with symptoms such as difficulty of breathing or swallowing, rash, itching, hives, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness, hypotension, with or without generalized itching, skin reddening, facial/throat swelling, blue discoloration of the lips, tongue or skin     ✔
Seizures or fits     ✔
Signs of decrease in the number of blood platelets: Unexplained bruising, reddish or purplish patches on the skin or nosebleeds     ✔
Purple skin patches, itching, burning (signs of inflamed blood vessels)     ✔

Tell your doctor immediately or go to the emergency department at your nearest hospital if any of the following side effects occur:

If you experience anything unusual, while you are receiving treatment with APO-FAMCICLOVIR, you should report it to your physican. A more complete listing of side effects reported to date, is contained in the Product Monograph supplied to your physician.

Driving and using machines

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

This is not a complete list of side effects. If you have any unexpected effects after receiving APO-FAMCICLOVIR, contact your doctor or pharmacist.

How to store
  • Store APO-FAMCICLOVIR in the bottle or package provided by the pharmacist, at room temperature (15°C -30°C).
  • Do not take any tablets after the expiry date.
  • Never let anyone else take your tablets, even if they have shingles as well.
  • Keep out of reach and sight of children.

More information about shingles.

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.
  • Shingles is caused by the same virus that causes chickenpox.
  • 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 APO-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.

If you are taking APO-FAMCICLOVIR to treat or to suppress genital herpes, or you have had genital herpes in the past, you should still practise “safer sex”, including the use of condoms. This is important to prevent you passing the infection on to others.

While taking this medication:

  • remember that your infection is contagious.
  • tell any other doctor, pharmacist or dentist you see, that you are taking APO-FAMCICLOVIR.
  • contact your doctor if you develop any unusual discomfort.
  • you should not take APO-FAMCICLOVIR when pregnant or breast-feeding unless your doctor tells you to.
  • do not give APO-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.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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.

More information

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet, plus the full product monograph, prepared for
healthcare professionals, can be obtained by contacting
DISpedia, Apotex’s Drug Information Service, at 1-800-667-
4708.

This leaflet can also be found at http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: May 24, 2017

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