Famciclovir (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Famciclovir tablets are supplied as film-coated tablets as follows: 125 mg in bottles of 30; 250 mg in bottles of 30; and 500 mg in bottles of 30.

Famciclovir 125 mg tablet:

White coloured, circular, film-coated, biconvex tablet debossed with ‘C’ and’269′ on one side and plain on other side.

125 mg 30’s…………………………………………………………..NDC 16714-614-01

Famciclovir 250 mg tablet:

White coloured, circular, film-coated, biconvex tablet debossed with ‘C’ and ‘271’ on one side and plain on other side.

250 mg 30’s……………………………………………………………NDC 16714-615-01

Famciclovir 500 mg tablet:

White coloured, capsule shaped, film-coated, biconvex tablets debossed with ‘C272’ on one side and plain on other side.

500 mg 30’s……………………………………………………………NDC 16714-616-01

Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

There is no evidence that famciclovir tablets will affect the ability of a patient to drive or to use machines. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking famciclovir tablets should refrain from driving or operating machinery.

Because famciclovir tablets contains lactose (famciclovir 125 mg, 250 mg and 500 mg tablets contain lactose 11 mg, 22 mg and 44 mg, respectively), patients with rare hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption should be advised to discuss with their healthcare provider before taking famciclovir tablets.

Herpes Labialis (Cold Sores)

Patients should be advised to initiate treatment at the earliest sign or symptom of a recurrence of cold sores (e.g., tingling, itching, burning, pain, or lesion). Patients should be instructed that treatment for cold sores should not exceed 1 dose. Patients should be informed that famciclovir tablets is not a cure for cold sores.

Genital Herpes

Patients should be informed that famciclovir tablets are not a cure for genital herpes. There are no data evaluating whether famciclovir tablets will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices.

If episodic therapy for recurrent genital herpes is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.

There are no data on safety or effectiveness of chronic suppressive therapy of longer than 1-year duration.

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.

Pregnancy

Healthcare providers are encouraged to report pregnancies and pregnancy outcomes to Northstar Rx LLC, at 1-800-206-7821.

Disclaimer: Other Brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured for:

Northstar Rx LLC, Memphis, TN 38141.

Manufactured by:

Cipla Ltd., Verna Goa, India.

Issued: 02/2019

PATIENT INFORMATION

Famciclovir (fam sye’ kloe vir) Tablets

What are famciclovir tablets?

Famciclovir tablets are a prescription antiviral medicine used to:

  • 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 is 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
  • have a rare genetic problem with galactose intolerance, a severe lactase deficiency or you do not absorb glucose-galactose (malabsorption)
  • are pregnant or plan to become pregnant. It is not known if famciclovir tablets will harm your unborn baby.
  • Pregnancy exposure reporting: There is a pregnancy reporting system for women who take famciclovir tablets during pregnancy. The purpose of this reporting system is to collect information about the health of you and your baby. Talk to your healthcare provider about how to report your pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if famciclovir tablets 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 can 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 much 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 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

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. It 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, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, polyethylene glycols 6000 and titanium dioxide.

Disclaimer: Other Brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured for:

Northstar Rx LLC, Memphis, TN 38141.

Manufactured by:

Cipla Ltd.

Verna Goa, INDIA

Revised: 02/2019

Principal Display Panel – Bottle Label

NDC -16714-614-01 Rx Only

Famciclovir

Tablets

125 mg

30 Tablets

NORTHSTAR

Image
(click image for full-size original)

Principal Display Panel – Bottle Label

NDC -16714-615-01 Rx Only

Famciclovir

Tablets

250 mg

30 Tablets

NORTHSTAR

image
(click image for full-size original)

NDC -16714-616-01 Rx Only

Famciclovir

Tablets

500 mg

30 Tablets

NORTHSTAR

image
(click image for full-size original)
FAMCICLOVIR famciclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-614
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR (penciclovir) FAMCICLOVIR 125 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C;269
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-614-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078278 02/01/2017
FAMCICLOVIR famciclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-615
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR (penciclovir) FAMCICLOVIR 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C;271
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-615-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078278 02/01/2017
FAMCICLOVIR famciclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR (penciclovir) FAMCICLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code C;272
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-616-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078278 02/01/2017
Labeler — NorthStar RxLLC (830546433)
Registrant — Cipla Ltd.- Goa (650072015)
Establishment
Name Address ID/FEI Operations
Cipla Kurkumbh 917066446 API MANUFACTURE (16714-614), API MANUFACTURE (16714-615), API MANUFACTURE (16714-616)
Establishment
Name Address ID/FEI Operations
Cipla Ltd.- Goa 650072015 MANUFACTURE (16714-614), MANUFACTURE (16714-615), MANUFACTURE (16714-616)

Revised: 02/2019 NorthStar RxLLC

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