Document: leaflet MAH GENERIC_PL 30306-0537 change

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• leaflet MAH GENERIC_PL 30306-0537

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T00074-01 Malta Zejtun 190x345 PIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Famciclovir 125mg, 250mg or 500mg Film-coated Tablets

(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.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

1. WHAT FAMCICLOVIR TABLETS ARE AND WHATTHEY ARE 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 Tablets as soon as the first symptoms appear.

Famciclovir Tablets are 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.

Do not take Famciclovir Tablets:

•    If you are allergic to famciclovir or 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 or pharmacist before taking Famciclovir Tablets.

This is especially important if any of the following apply to you:

•    If you have kidney problems (or have had them before). Your doctor may decide to give you a lower dose of Famciclovir Tablets.

•    If you have problems with your body's immune system.

•    If you have liver problems.

Children and adolescents

Famciclovir Tablets are not recommended for use in children and adolescents.

Prevent passing genital herpes to others

If you are taking Famciclovir Tablets to treat or to suppress genital herpes, or you have had genital herpes in the past, you should still practice 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 Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 Tablets with food

You can take Famciclovir Tablets with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Famciclovir Tablets are not to be used during pregnancy or breast-feeding unless clearly necessary. Your doctor will discuss with you the potential risks of taking famciclovir during pregnancy or during breast-feeding.

Driving and using machines

Famciclovir Tablets can cause dizziness, drowsiness or confusion. Do not drive or use machines if you have any of these symptoms while taking famciclovir.

| 3. HOWTO TAKE FAMCICLOVIR TABLETS_

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 one tablet of 500 mg, three times a day, for seven days

If you have a reduced immune system, the recommended dose is one tablet of 500 mg three times a day, for ten days.

Famciclovir 125mg, 250mg & 500mg film-coated tablets PIL - UK (Arrow)			colours/plates:
			1. Black
^actavis creating value In pharmaceuticals t 0044 1271 311400 f 00441271311449	item no: AAAI0432	dimensions: 190x345	2.
	print proof no: 2	pharmacode:	3.
			4.
	origination date: 16.06.15	min pt size: 9pts	5.
@ artworkstudio@actavis.co.uk	originated by: dje		6.
approved for print/date	revision date: 29.06.15	Technical Approval	Non Printing Colours
			1.
	revised by: dje	date sent: N/A
			2.
	supplier: Actavis Malta Zejtun	technically app. date:	3.

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:

-    one tablet of 250 mg three times a day, for five days.

To treat further outbreaks, the recommended dose is:

-    one tablet of 125 mg twice a day, for five days.

To prevent future outbreaks, the recommended dose is:

-    one tablet of 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:

-    one tablet of 500 mg twice a day, for seven days.

To prevent future outbreaks, the dose is

-    one tablet of 500 mg twice a day.

Your doctor will tell you how long you need to continue taking your tablets.

If you take more Famciclovir Tablets 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 many Famciclovir Tablets 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 Tablets

If you forget to take a dose of Famciclovir Tablets, 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. 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. The side effects cased by famciclovir are usually mild to moderate in intensity.

The frequency of possible side effects listed below is defined using the following convention:

-    very common: may affect more than 1 in 10 people

-    common: may affect up to 1 in 10 people

-    uncommon: may affect up to 1 in 100 people

-    rare: may affect up to 1 in 1,000 people

-    very rare: may affect up to 1 in 10,000 people

Serious side effects of famciclovir are:

•    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, for frequency see below).

•    Swelling of the face, eyes, lips and/or throat which make it difficult to swallow or breathe (these could be signs of a severe allergic reaction called angioedema).

•    Unexplained bruising, reddish or purplish patches on the skin or nosebleeds (these could be signs of a decrease in the number of blood platelets, for frequency see below).

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

•    Headache.

Uncommon side effects

•    Confusion

•    Severe skin reactions

Rare side effects

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOWTO STORE FAMCICLOVIR TABLETS

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

Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP:. The expiry date refers to the last day of that month.

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

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 protect the environment.

6. FURTHER INFORMATION

What Famciclovir Tablets contain:

•    The active substance is famciclovir. Each film-coated tablet contains 125mg, 250mg or 500mg of famciclovir.

•    The other ingredients in the tablet core are microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl cellulose and magnesium stearate. The tablet coat is Opadry II 85F18378 White which contains polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350 and talc.

What Famciclovir Tablets look like and contents of the pack:

Your medicine is in the form of film-coated tablets.

The 125mg tablets are white, round, film-coated tablets with 'FC' over "125" on one side and '>' on the other.

The 250mg tablets are white, round, film-coated tablets with 'FC' over "250" on one side and '>' on the other.

The 500mg tablets are white, capsule-shaped, film-coated tablets with 'FC 500' on one side and '>' on the other.

Famciclovir 125mg tablets are available in blisters containing 10, 30 or 56 film-coated tablets.

Famciclovir 250mg tablets are available in blisters containing 15,

21.30    or 56 film-coated tablets.

Famciclovir 500mg tablets are available in blisters containing 14,

21.30    or 56 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Actavis Group PTC ehf., Reykjavfkurvegi 76-78 220 Hafnarfjordur, Iceland

Manufacturer:

Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta.

This leaflet was last revised in June 2015.

Common side effects

•    Feeling sick (nausea)

•    Vomiting

•    Dizziness

•    Drowsiness

•    Rash

•    Pruritus

•    Liver function test giving abnormal results.

Famciclovir 125mg, 250mg & 500mg film-coated tablets PIL - UK (Arrow)			colours/plates:
			1. Black
^actavis creating value In pharmaceuticals t 0044 1271 311400 f 00441271311449	item no: AAAI0432	dimensions: 190x345	2.
	print proof no: 2	pharmacode:	3.
			4.
	origination date: 16.06.15	min pt size: 9pts	5.
@ artworkstudio@actavis.co.uk	originated by: dje		6.
approved for print/date	revision date: 29.06.15	Technical Approval	Non Printing Colours
			1.
	revised by: dje	date sent: N/A
			2.
	supplier: Actavis Malta Zejtun	technically app. date:	3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated.

Any technical changes madeby the supplier after approval are not the responsibility of the Artwork Studio.