Leaflet: information for the user

Famciclovir Teva 250 mg film-coated tablets EFG

famciclovir

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• - If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.- How to take Famciclovir Teva

4.- Possible side effects

5.- Storage of Famciclovir Teva

6.- Contents of the pack and additional information

Famciclovir Teva is an antiviral medication. It stops the multiplication of the infecting virus. Since the virus reproduces at an early stage of the infection, you may benefit more from the treatment if you start taking Famciclovir Teva after the appearance of the first symptoms.

Famciclovir Teva is used for the treatment of two types of viral infections in adults:

• Herpes zoster, a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Famciclovir Teva stops the expansion of the virus in the body, resulting in faster healing.
• Famciclovir Teva is also used for the treatment of herpes zoster in the area around the eye or even in 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 can be painful. Famciclovir Teva is used to treat genital herpes infections in adults. People who have frequent episodes of genital herpes may also take Famciclovir Teva to help prevent its recurrence.

Do not take Famciclovir Teva

• if you are allergic to famciclovir, any of the other components of this medication described in section 6, or penciclovir (active metabolite of famciclovir and ingredient of some other medication)

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 in the past). Your doctor may decide to give you a lower dose of Famciclovir Teva.
• If you have problems with your body's immune system.
• If you have liver problems.

If any of these affect 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 genital herpes transmission 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, using condoms. This is important to avoid infecting others. You should not have sex if you have genital pain or blisters.

Taking Famciclovir Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently ormay have to take anyother medication.

It is especially important to inform your doctor or pharmacist if you are taking any of the following medications:

• Raloxifeno (used to prevent and treat osteoporosis).
• Probenecid (used to treat high levels of uric acid associated with gout and to increase levels of penicillin-type antibiotics in the blood) or other medications 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, or think you may be pregnant, consult your doctor before using this medication.

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

Driving and operating machines

In rare cases, Famciclovir Teva may cause dizziness, drowsiness, or confusion. If you experience any of these symptoms during treatment with Famciclovir Tevado not drive or operate machines.

Famciclovir Teva contains sodium

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor.

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

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

Dosage 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 weakened immune system, the recommended dose is

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

Dosage for genital herpes

• The dose depends on the state of your immune system and the phase of your infection.

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

For thefirst episode,the recommended dose is:

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

Fortreatment of new episodesthe recommended dose is:

• 125 mg twice a day, for five days.

Forprevention of 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:

Fortreatment of the current episode,the recommended dose is:

• 500 mg twice a day, for seven days.

Forprevention of 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 anyone else has taken your medication by mistake, go immediately to your doctor or hospital. Show them your tablet packaging. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

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

If you forgot to take Famciclovir Teva

If you forgot to take the dose of Famciclovir Teva, you should take it as soon as you remember. Then take the next dose at the scheduled 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 compensate for the missed dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects of famciclovir are:

Many of these side effects are rare (can affect up to 1 in 100 patients) or very rare (can affect up to 1 in 1,000 patients).

• Severe blisterson the skin and/or mucous membranes of the lips, eyes, mouth, nostrils, or genitals (these could be signs of severe allergic skin reactions).
• Unexplained appearance of bruises, redness, or purple areas on the skin ornosebleeds(these may be signs of a decrease in platelet count in the blood).
• Swelling under the skin's surface (for example, swelling in the face, around the eye, on the eyelids, and in the throat).
• Yellowish discoloration on the skin and/or eyes (signs of jaundice).

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

• Blue spots on the skin, itching, burning (signs of inflamed blood vessels).
• Convulsions or epileptic seizures.
• Difficulty breathing or swallowing. Rash, itching, urticaria, wheezing, or cough, feeling of fainting, dizziness, changes in levels of consciousness. Hypotension, with or without generalized itching, skin redness, facial swelling/throat swelling, 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 service.

Very common side effects(these side effects can affect more than 1 in 10 patients)

• Headache

Common side effects(these side effects can affect up to 1 in 10 patients)

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

Rare side effects(these side effects can affect up to 1 in 100 patients)

• Confusion
• Drowsiness (usually in older people)
• Rash with itching (urticaria)

Very rare side effects(these side effects can affect up to 1 in 1,000 patients)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the reach and sight of children.
• Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.
• Store the blister in the outer packaging to protect it from light.
• Do not use Famciclovir Teva if you observe that the packaging is damaged or shows signs of deterioration.
• Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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Famciclovir Teva Composition

The active ingredient is famciclovir. A tablet contains 250 mg of famciclovir.

The other components are microcrystalline cellulose E460, sodium glycolate starch (Type A) from potato, anhydrous colloidal silica E551, low-substitution hydroxypropyl cellulose, sodium croscarmellose, sodium stearate fumarate, titanium dioxide E 171, dextrin, hypromellose, triacetin, and macrogol.

Product Appearance and Packaging Contents

Film-coated tablets, white to off-white in color, round, engraved with 8118 on one face and 93 on the other face.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11,

Edificio Albatros B, 1st floor

Alcobendas (Madrid)

Spain

Responsible Manufacturer:

Pharmachemie B.V.

Swensweg 5, Haarlem, 2031 GAHolland

Or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Or

Merckle GmbH,

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

Germany

This medication is authorized in the member states of the European Economic Area with the following names:

This leaflet was approved in June 2015

Detailed information about this medication is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)

You can access detailed and updated information about this medication by scanning the QR code included in the carton 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

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