Famciclovir Teva 250 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

2.- What you need to know before taking 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 replication of the infecting virus. Since the virus replicates at a very early stage of infection, you will benefit most from treatment if you start taking Famciclovir Teva as soon as the first symptoms appear.

Famciclovir Teva 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 Teva stops the spread of the virus in the body, allowing faster healing.
• Famciclovir Teva is also used to treat shingles affecting the area around the eye or even the eye itself (ophthalmic zoster).
• Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is usually transmitted through sexual contact. It causes blisters and a burning or itching sensation around the genitals, which may be painful. Famciclovir Teva is used to treat episodes of genital herpes in adults. People who experience frequent episodes of genital herpes may also take Famciclovir Teva to help prevent recurrences.

2. What you need to know before taking Famciclovir Teva

Do not take Famciclovir Teva

• 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 in some other medicines)

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

Warnings and precautions

Talk to your doctor before starting to take Famciclovir Teva

• If you have or have had any kidney disease. 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 of age)

The use of Famciclovir Teva is not recommended in children and adolescents.

Preventing the spread of genital herpes to other people

If you are taking Famciclovir Teva to treat or suppress genital herpes, or if you have had genital herpes in the past, you should practice safe sex by using condoms. This is important to help prevent spreading the infection to others. You should avoid sexual activity if you have pain or blisters in the genital area.

Taking Famciclovir Teva with other medicines

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

It is especially important to inform 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 may 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 become pregnant, consult your doctor before using this medicine.

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

Driving and using machines

Rarely, Famciclovir Teva may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms while being treated with Famciclovir Teva, do not drive or operate machinery.

Famciclovir Teva contains sodium

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

3. How to take Famciclovir Teva

Follow exactly the instructions for using this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

• The daily dose and duration of treatment will depend on the type of viral infection you have – see below. Your doctor will prescribe the correct dose for you.
• To achieve the best results, start taking the medicine as soon as the first signs and symptoms appear.
• Do not have sexual intercourse with anyone if you have symptoms of genital herpes—even if you have started treatment with Famciclovir Teva. This is because you may transmit 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 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 status 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 episodes, the recommended dose is:

• 125 mg twice a day for five days

For preventing new episodes, the recommended dose is:

• 250 mg twice a day

Your doctor will inform you 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 episodes, the dose is:

• 500 mg twice a day

Your doctor will inform you 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 anyone else has accidentally taken your medicine, go immediately to your doctor or hospital. Show them your tablet pack. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Taking too much Famciclovir Teva may damage your kidneys. People with kidney problems may rarely develop renal failure if their dose is not appropriately reduced.

If you forget to take Famciclovir Teva

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects of famciclovir include:

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

• Severe blisters on the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (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 beneath the skin surface (e.g., swelling of the face, around the eyes, eyelids, and throat).
• Yellowing of the skin and/or eyes (signs of jaundice).

The frequency of the following adverse effects is unknown (cannot be estimated from the available data):

• Purple spots on the skin, itching, burning sensation (signs of inflamed blood vessels).
• Seizures or epileptic attacks.
• Difficulty breathing or swallowing. Rash, itching, hives, wheezing, or cough, feeling faint, dizziness, changes in consciousness level. Hypotension, with or without generalized itching, skin redness, facial/throat swelling, bluish discoloration of lips, tongue, or skin (signs of a severe allergic reaction).

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

Very common adverse effects (these may affect more than 1 in 10 patients)

• Headache

Common adverse effects (these may affect up to 1 in 10 patients)

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

Uncommon adverse effects (these may affect up to 1 in 100 patients)

• Confusion
• Drowsiness (usually in elderly patients)
• Itchy rash (urticaria)

Rare adverse effects (these may affect up to 1 in 1,000 patients)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Famciclovir Teva

• Keep this medicine out of the reach and sight of children.
• Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
• Keep the blister in the outer packaging to protect it from light.
• Do not use Famciclovir Teva if you notice that the packaging is damaged or shows signs of deterioration.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Famciclovir Teva

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

The other components are microcrystalline cellulose E460, sodium starch glycolate (Type A) from potato, anhydrous colloidal silica E551, low-substituted hydroxypropyl cellulose, sodium croscarmellose, sodium stearyl fumarate, titanium dioxide E171, polydextrose, hypromellose, triacetin and macrogol.

Appearance of the product and contents of the pack

Film-coated tablets, white to off-white, round, engraved with "8118" on one side and "93" on the other.

Pack sizes of: 1, 10, 14, 15, 20, 21, 30, 56 and 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11,

Edificio Albatros B, 1st floor

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

This patient information leaflet was approved in June 2015

Detailed information about this medicinal product is available on the website of the {Spanish Agency of Medicines and Health Products (AEMPS)} (http://www.aemps.gob.es/)

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

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