Famciclovir Teva

Patient Information Leaflet

Famciclovir Teva 125 mg film-coated tablets, 250 mg film-coated tablets, 500 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you take 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 only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
  Contents of this 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 Famciclovir Teva is and what it is used for
Famciclovir Teva is an antiviral medicine. It prevents the infecting virus from multiplying. Since the virus begins to multiply immediately at the onset of infection, you will achieve better treatment outcomes if you take Famciclovir Teva as soon as the first symptoms appear.

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

• Herpes zoster, which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Famciclovir Teva prevents the virus from spreading in the body, allowing faster healing.
• Famciclovir Teva is also used to treat infections around or in the eye (ophthalmic zoster).
• Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is usually transmitted sexually. It causes blisters and burning or itching in the genital area, which may be painful. Famciclovir Teva is used for the treatment of genital herpes infections in adults. People who experience frequent episodes of genital herpes may also take Famciclovir Teva to help prevent new episodes.

2. What you need to know before taking Famciclovir Teva

Do not use Famciclovir Teva:

• if you are allergic to famciclovir, to any of the excipients of this medicine (listed in section 6), or to penciclovir (the active metabolite of famciclovir and a component of some other medicines). Consult your doctor if you think you may be allergic.

Warnings and precautions
Talk to your doctor before taking Famciclovir Teva

• If you have kidney problems (or have had them in the past). Your doctor may decide to prescribe a lower dose of Famciclovir Teva.
• If you have any disorders of the immune system.
• If you have liver problems.

If any of these conditions 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.
Prevention of transmission of genital herpes to other individuals
If you are taking Famciclovir Teva for the treatment or suppression of genital herpes, or if you have previously had genital herpes, you should continue to have protected sexual intercourse by using a condom.
This is important to prevent transmission of the infection to others. You must not have sexual intercourse if you have genital blisters.
Other medicines and Famciclovir Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you 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 blood levels of uric acid associated with gout, and to increase blood levels of antibiotics such as penicillin), or any other medicine that may damage the kidneys.

Famciclovir Teva with food
Famciclovir Teva can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Famciclovir Teva must not be used during pregnancy or while breastfeeding unless absolutely necessary. Your doctor will discuss with you the potential risks associated with taking Famciclovir Teva during pregnancy or breastfeeding.
Driving and using machines
In rare cases, Famciclovir Teva may cause dizziness, drowsiness, or confusion. Do not drive or operate machinery if you experience any of these symptoms while taking Famciclovir Teva.
Famciclovir contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Famciclovir Teva

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

• 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 possible after the first signs and symptoms appear.
• Avoid sexual contact if you have symptoms of genital herpes – even if you have already started treatment with Famciclovir Teva. This is because you may transmit the infection to your partner.
• If you have or have had kidney problems, your doctor may decide to prescribe 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 your immune defenses are reduced, the recommended dose is:

• 500 mg three times a day for ten days.

Dose for genital herpes
The dose depends on the condition of your immune system and the stage of the infection.
If you have a normal immune system, the doses are as follows:
For the first outbreak, the recommended dose is:

• 250 mg three times a day for five days.

For the treatment of recurrent outbreaks, the recommended dose is:

• 125 mg twice a day for five days.

For the prevention of future outbreaks, the recommended dose is:

• 250 mg twice a day.

Your doctor will tell you how long you should continue taking the tablets.
If your immune defenses are reduced, the doses are as follows:
For the treatment of the current outbreak, the recommended dose is:

• 500 mg twice a day for seven days.

For the prevention of future outbreaks, the dose is:

• 500 mg twice a day.

Your doctor will tell you how long you should continue taking the tablets.

If you take more Famciclovir Teva than you should
If you have taken more tablets than you were told to, or if someone else has accidentally taken your
medicine, contact your doctor or go to a hospital immediately. Show them your tablet pack.
Taking too much Famciclovir Teva may impair kidney function. In patients who already have kidney problems, if doses are not adequately reduced, it may rarely lead to kidney failure.

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 usual time. However, do not take two doses within an interval of less than 1 hour: in this case, skip the missed dose. Also, do not take a double dose to make up for a forgotten dose.

If you have any 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 everyone gets them.
Serious side effects of Famciclovir Teva include:
Most of these side effects are rare or uncommon (occurring in 1 – 100 patients in 10,000)

• Severe blistering rash on the skin or mucous membranes of the lips, eyes, mouth, nasal cavity, or genitals (these may be signs of a severe skin allergic reaction).
• Unexplained bruising, reddish or purplish spots on the skin, or nosebleeds (these may be signs of a reduced platelet count).
• Swelling beneath the skin surface (e.g., facial swelling, swelling around the eye, eyelid swelling, throat swelling).
  • Yellowing of the skin and/or eyes (signs of jaundice).

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

• Purple skin spots, itching, burning (signs of inflammation of blood vessels).
• Seizures or epileptic fits.
• Difficulty breathing or swallowing. Skin rash, itching, hives, breathing difficulties or cough, feeling of emptiness in the head, dizziness, altered state of consciousness. Hypotension, with or without generalized itching, skin redness, swelling of the face and throat, bluish discoloration of the lips, tongue, or skin (signs of a severe allergic reaction).

Contact a doctor or go to the nearest hospital emergency department if you experience any of these
side effects.
Very common side effects (these affect more than 1 in 10 people)

• Headache

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

• Feeling unwell (nausea)
• Vomiting
• Abdominal pain
• Diarrhea
• Dizziness
• Skin rash
• Itching
• Abnormal liver function test results

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

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

Rare side effects (these affect up to 1 in 1000 people)

• Hallucinations (seeing or hearing things that are not really present)
• Palpitations (signs of abnormal heartbeat)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 stated on the pack or blister after “EXP.”. The expiry date refers to the last day of that month.
• Keep the blister in the outer packaging to protect the medicine from light. Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Famciclovir Teva contains
The active substance is famciclovir. One tablet contains 125 mg, 250 mg or 500 mg of famciclovir.
The other excipients are microcrystalline cellulose E460, sodium carboxymethyl starch (Type A), anhydrous colloidal silica E551, low-substituted hydroxypropylcellulose, sodium croscarmellose, sodium stearyl fumarate, titanium dioxide E171, polydextrose, hypromellose, triacetin and macrogol.

Description of the appearance of Famciclovir Teva and package contents
Famciclovir Teva is available as tablets in 3 different strengths, each identified by its own imprint:
125 mg: white to off-white, round, film-coated tablets, engraved with "8117" on one side and "93" on the other.
250 mg: white to off-white, round, film-coated tablets, engraved with "8118" on one side and "93" on the other.
500 mg: white, capsule-shaped, film-coated tablets, engraved with "93" on one side and "8119" on the other.

The 125 mg tablets are available in packages containing: 1, 10, 21 and 30 film-coated tablets.
Hospital pack: 50 (50 x 1) film-coated tablets.

The 250 mg tablets are available in packages containing: 1, 12, 14, 15, 20, 21, 30, 56 and 60 film-coated tablets.
Hospital pack: 50 (50 x 1) film-coated tablets.

The 500 mg tablets are available in packages containing: 1, 10, 14, 15, 20, 21, 30, 56 and 60 film-coated tablets.
Hospital pack: 50 (50 x 1) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Responsible manufacturer for batch release:

• Teva UK Ltd. - Brampton Road - Hampden Park - BN229AG Eastbourne - East Sussex (United Kingdom)
• Pharmachemie B.V. - Swensweg 5 - P.O. Box 552 - 2003 RN Haarlem (The Netherlands)
• Teva Pharmaceutical Works Private Limited Company - Tàncsics Mihàly st. 82 - H-2100 Gödöllő (Hungary)
• Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
• Teva Czech Industries, s.r.o. - Ostravskà 29, c.p. 305 - 747 70 Opava - Komarov (Czech Republic)

This medicinal product is authorized in the European Economic Area countries under the following names:

This patient information leaflet was last approved on