Famciclovir Mylan Generics

Package Leaflet: Information for the Patient

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

Famciclovir
Generic Medicine
Read this leaflet carefully before 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 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, contact 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 taking 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 Famciclovir Mylan Generics is 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. Since the virus begins to replicate immediately at the onset
of infection, you will achieve better treatment outcomes if you take Famciclovir Mylan Generics as soon as
the first symptoms appear.
Famciclovir Mylan Generics 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 Mylan Generics prevents the virus from spreading in the body, allowing faster healing.
• Famciclovir Mylan Generics is also used to treat infections around or within 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 Mylan Generics is used for the treatment of genital herpes infections in adults. Individuals who experience frequent episodes of genital herpes may also take Famciclovir Mylan Generics to prevent recurrences.

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 an ingredient in some other medicines). Consult your doctor if 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.
Preventing 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 previously had genital herpes, you should continue to practice protected sex 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 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 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 penicillin-type antibiotics).
• any other medicine that may damage the kidneys.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Famciclovir Mylan Generics must not be used during pregnancy unless clearly necessary. Your doctor will discuss with you the potential risks associated with taking Famciclovir Mylan Generics during pregnancy.
Famciclovir Mylan Generics must not be used during breastfeeding unless clearly necessary, as it is not known whether famciclovir passes 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 age and suffer from genital herpes, you should avoid sexual intercourse when symptoms are present, even if treatment has already started.
Driving and using machines
Famciclovir Mylan Generics may cause dizziness, drowsiness, or confusion. Do not drive or operate machinery 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 prescribed by your doctor or pharmacist.
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 Mylan Generics, as you may still 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 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 weakened, 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 subsequent 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 inform you how long you should continue taking the tablets.
If your immune defenses are weakened, 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 inform you how long you should 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 prescribed, 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 Mylan Generics may impair kidney function. In patients who already have kidney problems, failure to appropriately reduce the dose may rarely lead to kidney failure.
If you forget to take Famciclovir Mylan Generics
If you forget to take a dose of Famciclovir Mylan Generics, take it as soon as you remember. Then take the next dose at the usual time. However, do not take two doses within less than 1 hour of each other: in this case, you should skip the missed dose.
Also, do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects caused by Famciclovir Mylan Generics are generally mild to moderate in intensity.
Contact a doctor or go to the nearest hospital emergency department if any of the following
serious side effects occur:

• Severe blistering rash on the skin or mucous membranes of the lips, eyes, mouth, nose or genitals (these could be signs of a severe skin allergic reaction).
• Swelling beneath the skin surface (e.g. facial swelling, swelling around the eyes or eyelids, throat swelling)
• Unexplained bruising, reddish or purplish spots on the skin, or nosebleeds (these could be signs of a reduced platelet count).
• 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):

• Inflammation of blood vessels appearing as persistent red or purple skin discolouration
• Seizures or epileptic fits
• Difficulty breathing or swallowing. Skin rash, itching, hives, shortness of breath or cough, dizziness, vertigo, changes in level of consciousness. Drop in blood pressure, with or without generalized itching, skin redness, swelling of face/throat, bluish discolouration 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
• Diarrhoea
• Dizziness
• Skin rash
• Itching
• Abnormal liver function test results

Uncommon (may affect up to 1 in 100 people)

• Confusion (usually in elderly people)
• Drowsiness (usually in elderly people)
• Hives (skin erythema with red, itchy rash)

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

• Hallucinations (seeing or hearing things that are not really there)
• Sensation of the heart pounding in the chest (palpitations)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 above 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date 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 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 Mylan Generics contains
The active substance is famciclovir.
{250 mg tablet}: Each tablet contains 250 mg of famciclovir.
{500 mg tablet}: Each tablet contains 500 mg of famciclovir.
The other components are:
Tablet core:
Pregelatinized starch, sodium lauryl sulfate, microcrystalline cellulose, sodium croscarmellose,
anhydrous colloidal 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 tablets, with a score line on one side and a diameter of approximately 10.6 mm.
{500 mg film-coated tablets}: White, oval, film-coated tablets, 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 may be divided into two equal parts. Use tablets with the lower dosage strength 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 Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

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