FAMCICLOVIR TEVA 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Famciclovir Teva 250 mg Film-Coated Tablets EFG

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.

Contents of the pack:

1. What is Famciclovir Teva and what is it used for

2. What you need to know before you take Famciclovir Teva

3. How to take Famciclovir Teva

4. Possible side effects

5. How to store Famciclovir Teva

6. Contents of the pack and other information

1. What is Famciclovir Teva and what is it used for

Famciclovir Teva is an antiviral medicine. It stops the multiplying of the infecting virus. Since the virus reproduces in a very early stage of the infection, you will benefit more from the treatment if you start taking Famciclovir Teva after the first symptoms appear.

Famciclovir Teva is used to treat two types of viral infections in adults:

• Herpes zoster, which is a viral infection caused by a virus called varicella-zoster (the same virus that causes chickenpox). Famciclovir Teva stops the spread of the virus in the body, so healing occurs more quickly.
• Famciclovir Teva is also used to treat herpes zoster in the area around the eye or even in the eye itself (herpes zoster ophthalmicus).
• Genital herpes. Genital herpes is a viral infection caused by the herpes simplex virus type 1 or 2. It is usually spread by sexual contact. It causes blisters and a burning or itching sensation around the genitals, which can be painful. Famciclovir Teva is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes can also take Famciclovir Teva to help prevent their recurrence.

2. What you need to know before you take Famciclovir Teva

Do not take Famciclovir Teva

• 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 in some other medicines)

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take Famciclovir Teva

• If you have any kidney disease (or have had it before). Your doctor may decide to give you a lower dose of Famciclovir Teva.
• If you have problems with your immune system.
• If you have liver problems.

If any of these apply to you, consult your doctor before taking Famciclovir Teva.

Children and adolescents (under 18 years)

Famciclovir Teva is not recommended for use in children and adolescents.

Prevention of transmission of genital herpes to others

If you are taking Famciclovir Teva to treat or suppress genital herpes, or if you have had genital herpes in the past, you can practice safe sex by using condoms. This is important to prevent infecting others. You should not have sex if you have pain or blisters on your genitals.

Taking Famciclovir Teva with other medicines

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:

• Raloxifene (used to prevent and treat osteoporosis).
• Probenecid (used to treat high levels of uric acid associated with gout and to increase blood levels of penicillin-type antibiotics) or other medicines that may affect your kidneys.

Taking Famciclovir Teva with food

You can take Famciclovir Teva with or without food.

Pregnancy and breastfeeding

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

Famciclovir Teva should not be used during pregnancy or breastfeeding unless it is clearly necessary. Your doctor will discuss with you the potential risks of taking Famciclovir Teva during pregnancy and breastfeeding.

Driving and using machines

On rare occasions, Famciclovir Teva can cause dizziness, drowsiness, or confusion. If you experience any of these symptoms during treatment with Famciclovir Teva, do not drive or use machines.

Famciclovir Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Famciclovir Teva

Follow exactly the instructions of administration of this medicine given to you by your doctor.

In case of doubt, consult your doctor or pharmacist again.

• The daily dose and duration of treatment will depend on the type of viral infection you are suffering from - see below. Your doctor will prescribe the correct dose for you.
• To get the best results, start taking the medicine as soon as the first signs and symptoms appear.
• Do not have sex with anyone if you have symptoms of genital herpes - even if you have started treatment with Famciclovir Teva. This is because you can infect your partner with the herpes infection.
• If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir Teva.

Dose for herpes zoster

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

• 500 mg, three times a day, for seven days

If you have a weakened 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 dose is as follows:

For the first episode,the recommended dose is:

• 250 mg three times a day, for five days.

For treating new episodesthe recommended dose is:

• 125 mg twice a day, for five days.

For preventing new episodesthe recommended dose is:

• 250 mg twice a day

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

If you have a weakened immune system, the dose is as follows:

For treating the current episode,the recommended dose is:

• 500 mg twice a day, for seven days.

For preventing new episodesthe dose is:

• 500 mg twice a day

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

If you take more Famciclovir Teva than you should

If you have taken more tablets than you should, or if someone else has taken your medicine by mistake, go to your doctor or hospital immediately. Show them your tablet pack. You can also call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

Taking too much Famciclovir Teva can harm your kidneys. People with kidney problems may, rarely, suffer from kidney failure if their dose is not lowered correctly.

If you forget to take Famciclovir Teva

If you forget to take a dose of Famciclovir Teva, you should take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses in a period of less than 1 hour, in that case skip the missed dose. Also, do not take a double dose to make up for a missed dose.

If you have any other questions about 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.

Severe side effects of famciclovir are:

Many of these effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).

• Severe skin and/or mucous membrane blisters(these could be signs of severe allergic skin reactions).
• Unexplained bruising, redness, or purple areas on the skin or nosebleeds(these may be signs of a decrease in the number of platelets in the blood).
• Swelling under the skin surface (e.g., swelling in the face, around the eye, on the eyelids, and in the throat).
• 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 spots on the skin, itching, burning (signs of inflamed blood vessels).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Rash, itching, hives, wheezing, cough, feeling of fainting, dizziness, changes in levels of consciousness. Low blood pressure, with or without generalized itching, flushing of the skin, swelling of the face/throat, blue discoloration of the lips, tongue, or skin (signs of severe allergic reaction).

If you notice any of these side effects, contact a doctor immediately or go to the nearest emergency department.

Very common side effects(these side effects may affect more than 1 in 10 people)

• Headache

Common side effects(these side effects may affect up to 1 in 10 people)

• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Dizziness
• Rash
• Itching
• Abnormal liver function test results

Uncommon side effects(these side effects may affect up to 1 in 100 people)

• Confusion
• Drowsiness (usually in elderly people)
• Itchy rash (hives)

Rare side effects(these side effects may affect up to 1 in 1,000 people)

• Hallucinations (seeing or hearing things that are not real)
• Palpitations (signs of abnormal heartbeats)

Reporting of side effects

If you experience 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 Spanish Medicines Agency website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Famciclovir Teva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
• Store the blister in the outer carton to protect from light.
• Do not use Famciclovir Teva if you notice that the packaging is damaged or shows signs of deterioration.
• 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. Contents of the pack and other information

Composition of Famciclovir Teva

The active substance is famciclovir. One film-coated tablet contains 250 mg of famciclovir.

The other ingredients are microcrystalline cellulose E460, sodium starch glycolate (Type A) potato, colloidal anhydrous silica E551, low-substituted hydroxypropyl cellulose, sodium croscarmellose, sodium stearyl fumarate, titanium dioxide E 171, polydextrose, hypromellose, triacetin, and macrogol.

Appearance and packaging

White to off-white, round, film-coated tablets, engraved with 8118 on one face and 93 on the other face.

They are available in packs of: 1, 10, 14, 15, 20, 21, 30, 56, and 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11,

Edificio Albatros B, 1ª planta

Alcobendas (Madrid)

Spain

Manufacturer:

Pharmachemie B.V.

Swensweg 5, Haarlem, 2031 GA

Netherlands

Or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Merckle GmbH,

Graf-Arco-Str. 3, Ulm, 89079,

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

This leaflet was approved in June 2015

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69341/P_69341.html

QR code + URL