Famciclovir: Package Insert and Label Information (Page 4 of 4)

17.3 Herpes Zoster (Shingles)

There are no data on treatment initiated more than 72 hours after onset of zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

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

Manufactured In Canada By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. E 2/2011

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PATIENT INFORMATION

Famciclovir Tablets

Read this Patient Information before you start taking famciclovir tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What are famciclovir tablets?

Famciclovir tablets are a prescription antiviral medicine used to:

  • treat outbreaks of cold sores (fever blisters) in healthy adults
  • treat outbreaks of genital herpes in healthy adults
  • decrease the number of outbreaks of genital herpes in healthy adults
  • treat outbreaks of herpes simplex lesions in or around the mouth, genitals, and anal area in people infected with HIV
  • treat shingles (herpes zoster) in adults with normal immune system

It is not known if famciclovir tablets are safe and effective in children younger than 18 years of age.

Famciclovir tablets are not a cure for 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 transmitted 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. Use a condom made of latex or polyurethane when you have a sexual contact. Ask your healthcare provider for more information about safer sex practices.

Who should not take famciclovir tablets?

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

What should I tell my healthcare provider before taking famciclovir tablets?

Before you start taking famciclovir tablets, tell your healthcare provider if you:

  • have kidney or liver problems
  • are pregnant or planning to become pregnant. It is not known if famciclovir tablets will harm your unborn baby
  • are breast-feeding or plan to breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

  • any other medicines and products you use to treat herpes outbreaks
  • probenecid (Probalan)

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist every time you get a new medicine.

How should I take famciclovir tablets?

  • Take famciclovir tablets exactly as prescribed
  • 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 can be taken with or without food
  • It is important for you to finish all of the medicine as prescribed, even if you begin to feel better
  • Your symptoms may continue even after you finish all of your famciclovir tablets. This does not mean that you need more medicine, since you have already finished a full course of famciclovir tablets and it will continue to work in your body. Talk to your healthcare provider if you have any questions about your condition and your treatment

What are the possible side effects of famciclovir tablets?

The most common side effects of famciclovir tablets include:

  • headache
  • nausea

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of famciclovir tablets. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider 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° and 77°F (20° to 25°C).

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

General information about famciclovir tablets

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use famciclovir tablets for a condition for which they were not prescribed. Do not give famciclovir tablets to other people, even if they have the same symptoms you have. They may harm them.

This leaflet summarizes the most important information about famciclovir tablets. If you would like more information, talk with your healthcare provider. Your healthcare provider or pharmacist can give you information about famciclovir tablets that is written for health professionals. For more information, call 1-888-838-2872, MEDICAL AFFAIRS.

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

Manufactured In Canada By:

TEVA CANADA LIMITED

Toronto, Canada M1B 2K9

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 2/2011

PRINCIPAL DISPLAY PANEL

Famciclovir Tablets 500 mg label
(click image for full-size original)

Famciclovir Tablets 500 mg Label Text

FAMCICLOVIR

Tablets

500 mg

PHARMACIST: PLEASE DISPENSE

WITH ATTACHED PATIENT

INFORMATION LEAFLET

Rx only

FAMCICLOVIR famciclovir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5905(NDC:0093-8119)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR (FAMCICLOVIR) FAMCICLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
POLYDEXTROSE
POLYETHYLENE GLYCOL
SILICON DIOXIDE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule-shaped) Size 18mm
Flavor Imprint Code 8119;93
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5905-0 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5905-1 21 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:54868-5905-2 03 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:54868-5905-3 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:54868-5905-4 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077487 06/16/2008
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 12/2011 Physicians Total Care, Inc.

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