VALACICLOVIR 500 mg Film-Coated Tablets

Зміст інструкції

1. Valaciclovir Mylan Generics 500 mg and 1000 mg film-coated tablets
   1. What is Valaciclovir Mylan Generics and what it is used for
   2. What you need to know before taking Valaciclovir Mylan Generics
   3. How to take Valaciclovir Mylan Generics
   4. Possible side effects
   5. How to store Valaciclovir Mylan Generics
   6. Contents of the pack and other information

Valaciclovir Mylan Generics 500 mg and 1000 mg film-coated tablets

Valaciclovir

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.>
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Valaciclovir Mylan Generics contains the active substance valaciclovir hydrochloride hydrate.
Valaciclovir Mylan Generics belongs to a group of medicines called antivirals. It works by killing
or blocking the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus
(CMV).
Valaciclovir Mylan Generics can be used for:

• treating shingles (in adults).
• treating HSV infections of the skin and genital herpes (in adults and adolescents over 12 years of age). It is also used to help prevent the recurrence of these infections.
• treating cold sores (in adults and adolescents over 12 years of age).
• preventing CMV infections after organ transplantation (in adults and adolescents over 12 years of age).
• treating and preventing recurrent HSV infections of the eye (in adults and adolescents over 12 years of age).

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

Do not take Valaciclovir Mylan Generics

• If you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients (listed in section 6). If you are not sure, ask your doctor or pharmacist before taking Valaciclovir Mylan Generics.

Warnings and precautions
Before taking Valaciclovir Mylan Generics, talk to your doctor or pharmacist if:

• you have kidney problems
• you have liver problems
• you are over 65 years of age
• your immune system is weak. If you are not sure if any of the above applies to you, ask your doctor or pharmacist before taking Valaciclovir Mylan Generics.

To prevent transmission of genital herpes to other people
If you are taking Valaciclovir Mylan Generics to treat or prevent genital herpes, or if you have had genital herpes in the past, you should have protected sexual intercourse, including the use of a condom.
This is important to prevent the transmission of the infection to others. You should not have sexual intercourse if you have pain or blisters in the genital area.

Children under 12 years of age
This medicine is not recommended for children under 12 years of age.

Other medicines and Valaciclovir Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription and herbal medicines.
Tell your doctor or pharmacist if you are taking any other medicine that has effects on the kidneys.
These include aminoglycosides, platinum-based compounds, iodinated contrast agents, methotrexate,
pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine and probenecid.
Always tell your doctor or pharmacist about any other medicines you are taking while taking Valaciclovir
Mylan Generics for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding
Generally, the use of Valaciclovir Mylan Generics is not recommended during pregnancy. If you are pregnant, or
think you might be or are planning a pregnancy, ask your doctor for advice before taking
this medicine.
The doctor will assess the benefit to you and the risk to your baby of taking
Valaciclovir Mylan Generics while pregnant or breastfeeding.

Driving and using machines
Valaciclovir Mylan Generics can cause side effects that affect your ability to drive.
Do not drive or use machines unless you are sure you are not affected.

3. How to take Valaciclovir Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The dose you need to take will depend on the reason why your doctor has prescribed Valaciclovir Mylan
Generics. The doctor will discuss this with you.
Treatment of herpes zoster (shingles)

• The recommended dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• You must take Valaciclovir Mylan Generics for seven days.

Treatment of cold sores

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
• The second dose must be taken 12 hours (not less than 6 hours) after the first dose.
• You must take Valaciclovir Mylan Generics for only one day (two doses).

Treatment of HSV infections of the skin and genital herpes

• The recommended dose is 500 mg (one 500 mg tablet) twice a day.
• For the first infection you must take Valaciclovir Mylan Generics for five days or up to ten days if your doctor recommends it. For recurrent infections the duration of treatment is normally from 3 to 5 days.

To help prevent the recurrence of HSV infections after you have had them

• The recommended dose is one 500 mg tablet once a day.
• Some people with frequent recurrent infections benefit from taking one 250 mg tablet twice a day. Valaciclovir Mylan Generics is not available for dosages lower than 500 mg, lower dosages of other medicinal products are available. Your doctor will be able to advise you appropriately.
• You must take Valaciclovir Mylan Generics until your doctor tells you to stop.

To prevent contracting CMV ( Cytomegalovirus) infection

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• You must take each dose approximately 6 hours apart.
• Normally you will start taking Valaciclovir Mylan Generics as soon as possible after surgery.
• You will need to take Valaciclovir Mylan Generics for about 90 days after surgery until your doctor tells you to stop.

Use in children under 12 years of age
Valaciclovir is not recommended for use in children under 12 years of age due to insufficient
data regarding safety and efficacy.
The doctor may modify the dose of Valaciclovir Mylan Generics if:

• you are over 65 years of age
• you have a weakened immune system
• you have kidney problems.

Inform your doctor before taking Valaciclovir Mylan Generics if any of the above situations
apply to you.

Taking the medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir Mylan Generics at the same time each day.
• Take Valaciclovir Mylan Generics following the instructions of your doctor or pharmacist.

Elderly people over 65 years of age or with kidney problems
It is very important while you are taking Valaciclovir Mylan Generics that you drink plenty of
waterduring the day. This will help to reduce side effects that may affect the kidneys or the
nervous system. Your doctor will carefully monitor you for signs of these effects. Nervous system side effects may include feeling confused or agitated, feeling unusually sleepy or numb.

If you take more Valaciclovir Mylan Genericsthan you should
Valaciclovir Mylan Generics is normally not harmful unless you take too much and for several days.
If you take too many tablets you may experience nausea, vomiting, be confused, agitated or in an unusual state of
sleepiness, see, feel or hear things that do not exist (hallucinations), have kidney problems
with little or no urine output or loss of consciousness (coma). Inform your doctor or pharmacist if
you have taken too much Valaciclovir Mylan Generics. Bring the package of the medicine with you.

If you forget to take Valaciclovir Mylan Generics

• If you forget to take Valaciclovir Mylan Generics, take it as soon as possible when you remember. However, if it is almost time for the next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose.

If you stop taking Valaciclovir Mylan Generics
Do not stop treatment with Valaciclovir Mylan Generics without first consulting your doctor.

If you should have any further questions on 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.
Side effects usually appear at the beginning of treatment and become milder or disappear
completely within a few weeks. Sometimes it is difficult to distinguish between the symptoms of an illness and the side
effects.

If you think you have any of the following side effects, stop taking this medicine and contact
your doctor or go to the nearest emergency room immediately:

• severe allergic reactions (anaphylaxis). Rapid development of symptoms including: o redness, itchy rash or swelling of the lips, face, neck and throat causing difficulty breathing (angioedema)o sudden drop in blood pressure leading to collapse.
• kidney problems with little or no urine output.
• epilepsy (seizures)
• impaired brain function (encephalopathy)
• state of unconsciousness (coma)
• confused or disturbed thoughts (psychosis)

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

• headache

Common (may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight ( photosensitivity)
• rash

Uncommon (may affect up to 1 in 100 people):

• state of confusion
• seeing or hearing things that are not there ( hallucinations)
• state of severe numbness
• tremors
• state of agitation

These nervous system side effects generally occur in people with kidney problems,
in the elderly or in patients with organ transplant who are taking high doses, 8 grams or more, of Valaciclovir
Mylan Generics per day. These effects normally improve when Valaciclovir Mylan Generics is
stopped or the dose is reduced.
Other uncommon side effects:

• shortness of breath (dyspnea)
• stomach disorders
• rash, sometimes itchy, hives
• pain in the lower back (kidney pain)
• blood in the urine

Uncommon side effects that can be detected by blood tests:

• reduction in the number of white blood cells (leukopenia)
• reduction in the number of blood platelets, which are the cells needed for coagulation (thrombocytopenia)
• increased substances produced by the liver.

Rare (may affect up to 1 in 1000):

• instability in walking and lack of coordination (ataxia)
• words spoken slowly and defectively (dysarthria)

These nervous system side effects generally occur in people with kidney problems,
in the elderly or in patients with organ transplant who are taking high doses, 8 grams or more, of Valaciclovir
Mylan Generics per day. These effects normally improve when Valaciclovir Mylan Generics is
stopped or the dose is reduced.

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
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Valaciclovir Mylan Generics

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is indicated on the carton after EXP. The expiry
date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valaciclovir Mylan Generics contains
The active ingredient is valaciclovir hydrochloride, hydrate. Each film-coated tablet contains valaciclovir
hydrochloride, hydrate equivalent to 500 mg or 1000 mg of valaciclovir, respectively.
The excipients of the tablet core are: microcrystalline cellulose, crospovidone, povidone and
magnesium stearate.
The excipients of the coating are: titanium dioxide (E171), macrogol 400, polysorbate 80 (E433) and
hypromellose (E464).

Description of the appearance of Valaciclovir Mylan Generics and contents of the pack
Valaciclovir Mylan Generics are biconvex, film-coated tablets, from white to off-white in colour, capsule-shaped.
The 500 mg film-coated tablets have “VC 500” on one side and “G” on the other side.
The 1000 mg film-coated tablets have “VC 1000” on one side and “G” on the other side.
Valaciclovir Mylan Generics is available in blisters in packs of 10, 21, 24, 30, 42, 60, 90, 100 and 112
film-coated tablets.
Not all pack sizes may be marketed.

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

Manufacturer
McDermott Laboratories Ltd T/A Gerard Laboratories
35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft
H-2900
Komarom, Mylan Utca 1
Hungary
Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire
EN6 1TL
United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Austria Valaciclovir Arcana 500 mg, 1000 mg - Filmtabletten
Belgium Valaciclovir Mylan 500 mg, 1000 mg filmomhulde tabletten
Czech Republic Valacilovir Mylan 500 mg, potahované tablety
Denmark Valaciclovir Mylan
Finland Valaciclovir Mylan
Ireland Myval
Italy Valaciclovir Mylan Generics
Norway Valaciclovir Mylan
Slovenia Valaciklovir Mylan 500 mg filmsko oblozene tablete
Sweden Valaciclovir Mylan
Netherlands Valaciclovir Mylan 500 mg, filmomhulde tabletten
United Kingdom Valaciclovir 500 mg Film-coated Tablets

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