iMedi.co.uk

Famciclovir 500mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 00030-0448 change

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Famciclovir 500 mg film-coated tablets [To be completed nationally]

famciclovir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    Famciclovir has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

In this leaflet:

1.    What Famciclovir is and what it is used for

2.    Before you take Famciclovir

3.    How to take Famciclovir

4.    Possible side effects

5.    How to store Famciclovir

6.    Further information

1. What Famciclovir is and what 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.

How Famciclovir works

Famciclovir is used to treat cold sores (herpes labialis) of the lips in adults. Cold sores are an infection caused by a virus called herpes simplex type 1. Cold sores usually begin on or around the lips, as small red bumps that turn into fluid-filled blisters. Cold sores can be tender or painful. Many people who get cold sores know when one is coming by a tingling, burning, itchy or painful sensation or redness in the area.

2. What you need to know before you take Famciclovir Do not take Famciclovir

- If you are allergic (hypersensitive) to famciclovir, to any of the other ingredients of Famciclovir 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 or pharmacist before taking Afamcicvir:

-    If you have kidney problems (or have had them before), please refer to your doctor who may recommend you another treatment.

-    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.

Other medicines and Famciclovir

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Before taking Famciclovir, 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.

Taking Famciclovir with food and drink

You can take Famciclovir with or without food.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or think you may be, tell your doctor. 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.

If you are breast-feeding, tell your doctor. 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.

Important information about other ingredients of Famciclovir

Famciclovir film-coated tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Famciclovir

Always take this medicine exactly as described in this leaflet or as your doctor or

pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

-    For the best results start the medicine as soon as possible after the first signs and symptoms appear.

-    If you have or have had kidney problems, please refer to your doctor who may recommend you another treatment.

The tablets cannot be split in half. For dose recommendations that are not possible with this product, other medicinal products should be used.

Dose for cold sores

If you have a normal immune system, the recommended dose is

-    three tablets of 500 mg taken together as a single dose.

Clinical efficacy data have not been presented for Famciclovir when administered more than 1 hour after the first symptoms. Therefore Famciclovir tablets should be taken as soon as possible after the first symptoms (e.g. tingling, itching or burning) or signs (e.g. redness or swelling) of a cold sore appear. Do not take the tablets if a hard crust has already formed on the cold sore.

The minimum time interval between two treatments of recurrent cold sores has not been defined. Always take this medicine exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

Method of administration

Swallow each tablet whole with a glass of water. Famciclovir can be taken with or without food. It is not necessary to chew or crush the tablet.

If you take more Famciclovir than you should

If you have taken more than 3 tablets in a single dose, 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 have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Famciclovir can cause side effects, although not everybody gets them. The side effects caused by Famciclovir are usually mild to moderate in intensity.

Serious side effects of Famciclovir are:

Most of these side effects are rare (may affect up to 1 in every 1,000 people) or uncommon (may affect up to 1 in every 100 people)

•    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).

Purple skin patches, itching, burning (signs of inflamed blood vessels).

Contact a doctor or go to the emergency department at your nearest hospital straight away if you get any of these effects.

Some side effects are very common (may affect more than 1 in 10 people)

-    Headache

Some side effects are common (may affect up to 1 in 10 people)

-    Feeling sick (nausea)

-    Vomiting

-    Abdominal Pain

-    Diarrhoea

-    Dizziness

-    Rash

-    Itching

-    Liver function test giving abnormal results

Some side effects are uncommon (may affect up to 1 in 100 people)

-    Confusion

-    Drowsiness (usually in older people)

-    Itchy rash (urticaria)

Some side effects are rare (may affect up to 1 in 1,000 people)

-    Hallucinations (seeing or hearing things that are not really there)

-    Palpitations (signs of abnormal heart beat)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting 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 any side effects directly via the Yellow card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information onthe safety of this medicine.

5. How to store Famciclovir

•    Keep this medicine out of the sight and reach of children.

•    Do not use Famciclovir after the expiry date which is stated on the carton label and blister foil after EXP. The expiry date refers to the last day of that month. Do not store above 25°C.

•    Do not use Famciclovir if you notice the pack is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further Information

What Famciclovir contains

The active substance is famciclovir.

One film-coated tablet contains 500 mg famciclovir.

The other ingredients are

Tablet core:

Lactose anhydrous Hydroxypropylcellulose Sodium Starch Glycollate, type A Magnesium Stearate

Tablet coat:

Hypromellose Titanium Dioxide (E171)

Macrogol 4000 Macrogol 6000

What Famciclovir looks like and contents of the pack

Famciclovir 500 mg film-coated tablets are oval, white-tablets marked ‘FV 500’ on one side and plain on the reverse side.

They come in blister packs of 3-tablets.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health UK Limited Trading as Novatis Consumer Health Watchmoor Park Camberley, GU15 3YL UK

This leaflet was last revised in December 2015