Patient leaflet - Famciclovir 500 mg film-coated tablets
1. What Famciclovir is and what it is used for
Famciclovir is an antiviral medicine. It stops the infecting virus from reproducing. Since the virus reproduces very early in the infection, you will benefit most from treatment if you take Famciclovir as soon as the first symptoms appear.
Famciclovir is used to treat two types of viral infections in adults:
- Shingles (herpes zoster), which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Famciclovir stops the virus from spreading in the body so that healing can occur faster.
- Famciclovir is also used for the treatment of shingles in the area around the eye or of the eye itself (ophthalmic zoster).
- Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is normally spread by sexual contact. It causes blisters and burning or itching around the genitals, which may be painful. Famciclovir is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes can also take Famciclovir to help to prevent the attacks.
2. What you need to know before you take Famciclovir
Do not take Famciclovir
- If you are allergic to famciclovir, to any of the other ingredients of this medicine (listed in section 6), or to penciclovir (the active metabolite of famciclovir and an ingredient of some other medicines).
Ask your doctor for advice, if you think you may be allergic.
Warnings and precautions
Talk to your doctor before taking Famciclovir
- If you have kidney problems (or have had them before). Your doctor may decide to give you a lower dose of Famciclovir.
- If you have problems with your body’s immune system.
- If you have liver problems.
If any of these applies to you, tell your doctor before you take Famciclovir
Children and adolescents (below the age of 18 years)
Famciclovir is not recommended for use in children and adolescents.
Prevent passing genital herpes to others
If you are taking Famciclovir to treat or to suppress genital herpes, or you have had genital herpes in the past, you should still practise safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.
Other medicines and Famciclovir
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:
- Raloxifen (used to prevent and treat osteoporosis).
- 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.
Famciclovir with food and drink
You can take Famciclovir with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Famciclovir is not to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks of taking
Famciclovir during pregnancy.
Famciclovir is not to be used during breast-feeding unless clearly necessary. Your doctor will discuss with you the possible risks of taking Famciclovir during breast-feeding.
Driving and using machines
Famciclovir can cause dizziness, drowsiness or confusion. Do not drive or use machines if you have any of these symptoms while taking Famciclovir.
Famciclovir contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.
3. How to take Famciclovir
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
- The daily dose and length of treatment will depend on the type of viral infection you have – see below. Your doctor will prescribe the correct dose for you.
- For the best results start the medicine as soon as possible after the first signs and symptoms appear.
- Do not have sexual contact with anyone if you have symptoms of genital herpes – even if you have started treatment with Famciclovir. This is because you could pass the herpes infection to your partner.
- If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir.
Dose for shingles
If you have a normal immune system, the recommended dose is:
- 500 mg three times a day, for seven days.
If you have a reduced immune system, the recommended dose is:
- 500 mg three times a day, for ten days.
Dose for genital herpes
The dose depends on the state of your immune system, and the stage of your infection.
If you have a normal immune system, the doses are as follows:
For the first outbreak, the recommended dose is:
- 250 mg three times a day, for five days.
To treat further outbreaks, the recommended dose is:
- 125 mg twice a day, for five days.
To prevent future outbreaks, the recommended dose is:
- 250 mg twice a day.
Your doctor will tell you how long you need to continue taking your tablets.
If you have a reduced immune system, the doses are as follows:
To treat the current outbreak, the recommended dose is:
- 500 mg twice a day, for seven days.
To prevent future outbreaks, the dose is:
- 500 mg twice a day.
Your doctor will tell you how long you need to continue taking your tablets. L-05-1835-01
If you take more Famciclovir than you should
If you have taken more tablets than you have been told to take, or if someone else accidentally takes your medicine, go to your doctor or hospital for advice immediately. Show them your pack of tablets.
Taking too much 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.
If you forget to take Famciclovir
If you forget to take a dose of Famciclovir, you should take it as soon as you remember. Then take your next dose as scheduled. However, do not take two doses within a time interval of less than 1 hour, in that case you should skip the missed dose. Furthermore, do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects of Famciclovir are:
Most of these side effects are rare or uncommon (they affect between 1 to 100 in every 10,000 patients)
- Severe blistering of the skin or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (these could be signs of a serious allergic skin reaction).
- Unexplained bruising, reddish or purplish patches on the skin or nosebleeds (these could be signs of a decrease in the number of blood platelets).
- Swelling below the surface of the skin (e.g. facial swelling, swelling around eye, eyelid swelling, throat swelling).
- Yellowing of the skin and/or eyes (signs of jaundice).
The frequency of the following side effects is not known (cannot be estimated from the available data):
- Purple skin patches, itching, burning (signs of inflamed blood vessels).
- Seizures or fits.
- Difficulty breathing or swallowing. Rash, itching, hives, wheezing or coughing, light-headedness, dizziness, changes in levels of consciousness. Hypotension, with or without generalised itching, skin reddening, facial/throat swelling, blue discoloration of the lips, tongue or skin (signs of severe allergic reaction).
Contact a doctor or go to the emergency department at your nearest hospital straight away if you get any of these effects.
Very common side effects (these side effects affect more than 1 in 10 people)
- Headache
Common side effects (these side effects affect up to 1 in 10 people)
- Feeling sick (nausea)
- Vomiting
- Abdominal pain
- Diarrhoea
- Dizziness
- Rash
- Itching
Liver function test giving abnormal results
Uncommon side effects (these side effects affect up to 1 in 100 people)
- Confusion
- Drowsiness (usually in the elderly)
- Itchy rash (urticaria)
Rare side effects (these side effects affect up to 1 in 1,000 people)
- Hallucinations (seeing or hearing things that are not really there)
Palpitations (signs of abnormal heart beat)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Famciclovir
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package in order to protect from moisture.
Do not use this medicine if you notice the pack is damaged or shows signs of tampering.
Do not use this medicine after the expiry date.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
If your medicine show’s any signs of deterioration or discolouration, consult your pharmacist for advice. If damaged please tell your doctor or pharmacist.
6. Contents of the pack and other information
What Famciclovir contains
The active substance is famciclovir.
Each film-coated tablet contains 500mg famciclovir.
The other ingredients are sodium starch glycolate (type A), hydroxypropyl cellulose and magnesium stearate.
The tablet coating is composed of hypromellose, titanium dioxide (E171), macrogol 4000 and macrogol 6000.
What Famciclovir looks like and contents of the pack
Famciclovir tablets are white, oval
film-coated tablets, biconvex, bevelled edges with ‘FV500’ engraved on one side only and plain on the reverse.
Famciclovir comes in blister packs of 14 and 21 tablets.
Not all pack sizes may be marketed.
PL 20774/1835 Famciclovir 500mg film-coated tablets
Manufactured by Novartis Farma S.p.A., Largo Umberto Boccioni, 1 21040 Origgio VA, Italy or Laboratori Fundació DAU, Pol. Ind. Consorci Zona Franca c/ C, 12-14 08040 Barcelona, Spain or Cosmo S.p.A Via Cristoforo Colombo, 1 20020 Lainate (Milan) Italy. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.
Leaflet revision date 26th May 2022
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Phone Quadrant Pharmaceuticals Ltd. Tel: 01204 471 269
L-05-1835-01
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