FAMCICLOVIR 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. Famciclovir Mylan Generics 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Famciclovir Mylan Generics and what it is used for
   2. What you need to know before taking Famciclovir Mylan Generics
   3. How to take Famciclovir Mylan Generics
   4. Possible side effects
   5. How to store Famciclovir Mylan Generics
   6. Package Contents and Other Information

Famciclovir Mylan Generics 250 mg film-coated tablets, 500 mg film-coated tablets

Famciclovir

Generic Medicine
Read 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 only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist immediately. See section 4.

Contents of this leaflet:

• 1. What Famciclovir Mylan Generics is and what it is used for
• 2. What you need to know before you take Famciclovir Mylan Generics
• 3. How to take Famciclovir Mylan Generics
• 4. Possible side effects
• 5. How to store Famciclovir Mylan Generics
• 6. Contents of the pack and other information

1. What is Famciclovir Mylan Generics and what it is used for

Famciclovir Mylan Generics contains the active substance famciclovir and is an antiviral medicine.
It prevents the infecting virus from reproducing. Because the virus reproduces immediately at the onset
of the infection, you will obtain better results in treatment if you take Famciclovir Mylan Generics as soon
as the first symptoms appear.
Famciclovir Mylan Generics is used for the treatment in adults of 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 Mylan Generics prevents the virus from spreading throughout the body so that healing can occur more quickly.
• Famciclovir Mylan Generics is also used for the treatment of infections in the area surrounding 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 sexually. It causes blisters and burning or itching in the genital area, which can be painful. Famciclovir Mylan Generics is used for the treatment of genital herpes infections in adults. People who suffer from frequent episodes of genital herpes may also take Famciclovir Mylan Generics to prevent these attacks.

2. What you need to know before taking Famciclovir Mylan Generics

Do not take Famciclovir Mylan Generics

• 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 a component of some other medicines). Ask your doctorif you think you may be allergic.

Warnings and precautions
Talk to your doctor or pharmacist before taking Famciclovir Mylan Generics:

• If you have kidney problems (or have had them in the past). Your doctor may decide to prescribe a lower dose of Famciclovir Mylan Generics.
• 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 Mylan
Generics.

Children and adolescents
Famciclovir Mylan Generics is not recommended for use in children and adolescents.

Prevention of transmission of genital herpes to others
If you are taking Famciclovir Mylan Generics for the treatment or suppression of genital
herpes, or if you have suffered from genital herpes in the past, you must continue to have protected sexual intercourse, using a condom. This is important to prevent the transmission of the infection
to others. You should not have sexual intercourse if you have blisters in the genital area.

Other medicines and Famciclovir Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is particularly 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 in the blood associated with gout and to increase the levels of penicillin-type antibiotics in the blood).
• any other medicine that may damage the kidneys.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to become
pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Famciclovir Mylan Generics should not be used during pregnancy unless absolutely
necessary. Your doctor will discuss with you the potential risks associated with taking Famciclovir Mylan
Generics during pregnancy.
Famciclovir Mylan Generics should not be used during breastfeeding unless absolutely
necessary, because it is not known whether famciclovir can pass into breast milk. Your doctor will discuss
with you the possible risks associated with taking Famciclovir Mylan Generics during breastfeeding.
If you are of childbearing potential and suffer from genital herpes, you should avoid sexual intercourse if symptoms are present, even if treatment has already started.

Driving and using machines
Famciclovir Mylan Generics can cause dizziness, drowsiness or confusion. Do not drive or use
machines if you experience any of these symptoms while taking Famciclovir Mylan
Generics.

This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take Famciclovir Mylan Generics

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have doubts, ask 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.
• To get the best results, start taking the medicine as soon as possible after the first signs and symptoms appear.
• Avoid having sexual contact if you experience symptoms of genital herpes - even if you have already started treatment with Famciclovir Mylan Generics. This is because you could transmit the infection to your partner.
• If you have or have had kidney problems, your doctor may decide to give you a lower dose of Famciclovir Mylan Generics.

Dose for Herpes Zoster
If you have a normal immune system, the recommended dose is

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

If your immune defenses are reduced, the recommended dose is

• one 500 mg tablet 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:

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

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

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

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

• one 250 mg tablet twice a day.

Your doctor will tell you how long you will need to 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:

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

For the prevention of future outbreaks, the dose is:

• one 500 mg tablet twice a day.

Your doctor will tell you how long you will need to continue taking the tablets.
Method of administration
Famciclovir Mylan Generics can be taken with or without food.

If you take more Famciclovir Mylan Generics than you should
If you have taken more tablets than you have been told to take, or if someone else has taken
accidentally your medicine, seek immediate medical attention or go to a hospital. Show
them your box of tablets.
Taking too much Famciclovir Mylan Generics can impair the kidneys. In patients who already
have kidney problems, if the doses are not adequately reduced, this can rarely lead to
renal failure.

If you forget to take Famciclovir Mylan Generics
If you forget to take a dose of Famciclovir Mylan Generics, you should take it as soon as
you remember. Then take the next dose as scheduled. However, do not take two doses within
a time interval of less than 1 hour: in this case you should skip the dose you forgot.
Also, do not take a double dose to make up for the missed dose.
If you have any doubts 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. The side effects caused by Famciclovir Mylan Generics are generally mild to moderate in intensity.

Contact a doctor or go to the nearest hospital emergency room if any of the following serious side effects occur:

• Severe blistering rashon the skin or mucous membranes of the lips, eyes, mouth, nasal cavities or genitals (these could be signs of a severe allergic skin reaction).
• Swellingunder the skin surface (e.g. swelling of the face, swelling around the eyes or eyelids, swelling of the throat)
• Bruising without an explainable cause, reddish or purplish spots on the skin or bleeding from the nose (these could be signs of a decrease in the number of platelets).
• Yellowingof the skin and/or eyes (signs of jaundice).

The frequency of the side effects listed below is not known (cannot be estimated based on available data):

• Inflammation of blood vessels appearing as a reddish or purplish discoloration of the skin that is persistent
• Convulsions or seizures
• Difficulty in breathing and swallowing. Skin rash, itching, hives, shortness of breath or cough, dizziness, lightheadedness, changes in level of consciousness. Drop in blood pressure, with or without generalized itching, skin flushing, swelling of face/throat, bluish discoloration of lips, tongue or skin (signs of a severe allergic reaction).

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

• Headache.

Common (may affect up to 1 in 10 people)

• Feeling unwell (nausea)
• Vomiting
• Stomach pain
• Diarrhea
• Dizziness
• Skin rash
• Itching
• Abnormal values in liver function tests.

Uncommon (may affect up to 1 in 100 people)

• Confusion (usually in elderly people)
• Drowsiness (usually in elderly people)
• Hives (skin rash with red and itchy eruptions).

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

• Hallucinations (seeing or hearing things that are not really present)
• Feeling of the heart “pounding” in the chest (palpitations).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://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 Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the label after Exp. The expiry
date refers to the last day of that month.
Do not use this medicine if you notice that the package is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Famciclovir Mylan Generics contains
The active ingredient is famciclovir.
{250 mg tablet}: Each tablet contains 250 mg of famciclovir.
{500 mg tablet}: Each tablet contains 500 mg of famciclovir.
The other ingredients are:

Tablet core:
Pregelatinized starch, sodium lauryl sulfate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous
silica, stearic acid.

Film coating:
Hypromellose (E464), titanium dioxide (E171), macrogol 4000, macrogol 6000.

Description of the appearance of Famciclovir Mylan Generics and package contents
{250 mg film-coated tablets}: White, round, biconvex, film-coated, with a
score line on one side and a diameter of approximately 10.6 mm.
{500 mg film-coated tablets}: White, oval, film-coated, with a score line
on both sides and dimensions of approximately 18.2 x 8.6 mm.
{250 mg and 500 mg film-coated tablets}: The tablet can be divided into two equal
halves. Use the tablets with the lowest dosage, when available.
Famciclovir Mylan Generics is available in blister packs of:
{250 mg}: 10, 15, 21, 56, 60 tablets
{500 mg}: 10, 14, 21, 30, 56 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturers
Specifar S.A., 1, 28 Octovriou str., Ag. Varvara, 12351 Athens, Greece
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland