What are famciclovir tablets?

Famciclovir tablets are a prescription antiviral medicine used:

in adults with a normal immune system to:
- treat outbreaks of cold sores
- treat outbreaks of genital herpes
- decrease the number of outbreaks of genital herpes
- treat shingles (herpes zoster)
in adults with human immunodeficiency virus (HIV) to treat outbreaks of herpes in or around the mouth, genitals or anal area

It is not known if famciclovir tablets are safe and effective for:

the first outbreak of genital herpes
shingles in the eye(s)
people with weakened immune systems, other than for the treatment of outbreaks of herpes in people with HIV
black and African American people with genital herpes outbreaks

It is not known if famciclovir tablets are effective in children.

Do not take famciclovir tablets if you are allergic to any of its ingredients or to Denavir ® (penciclovir cream). See the end of this Patient Information leaflet for a complete list of ingredients in famciclovir tablets.

Before you take famciclovir tablets, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems
are pregnant or plan to become pregnant. It is not known if famciclovir tablets will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if famciclovir passes into your breastmilk or how it may affect your breast fed baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take famciclovir tablets?

Take famciclovir tablets exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how many famciclovir tablets to take and when to take them. Your dose of famciclovir tablets and how often you take it may be different depending on your condition.
Famciclovir tablets may be taken with or without food.
If you are taking famciclovir tablets for outbreaks of cold sores or genital herpes, take famciclovir tablets as soon as you have the first symptoms of the infection such as itching, redness, pain, burning or tingling, or when the sore appears.
If you take too many famciclovir tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking famciclovir tablets?

You should avoid driving or operating machinery if you get dizziness, sleepiness or confusion during treatment with famciclovir tablets.

What are the possible side effects of famciclovir tablets?

The most common side effects of famciclovir tablets are headache and nausea.

These are not all the possible side effects of famciclovir tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store famciclovir tablets?

Store famciclovir tablets at room temperature between 68° to 77°F (20° to 25°C).

Keep famciclovir tablets and all medicines out of reach from children.

General information about the safe and effective use of famciclovir tablets

Famciclovir tablets are not a cure for cold sores or genital herpes. It is not known if famciclovir tablets can stop the spread of herpes to others.

If you are sexually active, you can pass herpes to your partner even if you are taking famciclovir tablets. Herpes can be passed to your partner even if you do not have active symptoms. You should continue to practice safer sex to lower the chances of spreading genital herpes to others. Do not have sexual contact with your partner during an outbreak of genital herpes or if you have any symptoms of genital herpes. Ask your healthcare provider for more information about safer sex practices.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use famciclovir tablets for a condition for which it was not prescribed. Do not give famciclovir tablets to other people, even if they have the same symptoms you have. They may harm them. You can ask your healthcare provider or pharmacist for information about famciclovir tablets that is written for health professionals.

What are the ingredients in famciclovir tablets?

Active ingredient: famciclovir

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, and triacetin

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Rev. 12/18

AV 05/21 (P)

For more information about famciclovir tablets, call 1-855-361-3993.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Medication Guide — Famvir