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Valaciclovir 500mg Film Coated Tablets

Informations for option: Valaciclovir 500mg Film Coated Tablets, show other option
Document: leaflet MAH GENERIC_PL 00289-1002 change

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PAGE 2: REAR FACE (OUTSIDE OF REEL)


TEVA UK Ref: 231-30-86543-Y LEA VALACICLOVIR 500mg TAB TUK<DEB    Version: 1    16 December 2015


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Valaciclovir 500 mg Film-Coated Tablets


PACKAGE LEAFLET: INFORMATION FOR THE USER


Read all of this leaflet carefully before you start

taking this medicine.

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, ask your doctor or pharmacist

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

•    If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. See section 4.


In this leaflet:


1.    What Valaciclovir is and what it is used for

2.    Before you take Valaciclovir

3.    How to take Valaciclovir

4.    Possible side effects

5.    How to store Valaciclovir

6.    Further information

OWHAT VALACICLOVIR IS AND WHAT IT IS USED FOR


Valaciclovir belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called varicella zoster (VZV) and cytomegalovirus (CMV).

Valaciclovir can be used to:

•    treat shingles (in adults)

•    prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old).

Valaciclovir which is contained in Valaciclovir 500 mg Film-Coated Tablets may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.



Do NOT take Valaciclovir

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

Take special care with Valaciclovir

Check with your doctor or pharmacist before taking Valaciclovir 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 the above apply to you, talk to your doctor or pharmacist before taking Valaciclovir. Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include aminoglycosides, organoplatinum compounds, iodinated contrast media,


methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir for treatment of shingles or after having an organ transplant.

Pregnancy and breast-feeding

Valaciclovir is not usually recommended for use during pregnancy. If you are pregnant, or think you could be, or if you are planning to become pregnant, don't take Valaciclovir without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir while you're pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Valaciclovir can cause side effects that affect your ability to drive.

Don't drive or use machines unless you are sure you're not affected.

^ HOW TO USE VALACICLOVIR

Always take Valaciclovir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose that you should take will depend on why your doctor has prescribed Valaciclovir for you. Your doctor will discuss this with you.

Treatment of shingles

•    The usual dose is 1000 mg (two 500 mg tablets) three times a day

•    You should take Valaciclovir for seven days.

To stop you being infected with CMV (Cytomegalovirus)

•    The usual dose is 2000 mg (four 500 mg tablets) four times a day

•    You should take each dose about 6 hours apart

•    You will usually start taking Valaciclovir as soon as possible after your surgery

•    You should take Valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir if:

•    you are over 65 years of age

•    you have a weak immune system

•    you have kidney problems.

Talk to your doctor before taking Valaciclovir if any of the above apply.

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole with a drink of water

•    Take Valaciclovir at the same time each day

•    Take Valaciclovir according to instructions from your doctor or pharmacist.

People over 65 years of age or with kidney problems

It is very important while you are taking Valaciclovir that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.


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If you take more Valaciclovir than you should

Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, or be confused, agitated or unusually sleepy.

Talk to your doctor or pharmacist if you take too much Valaciclovir. Take the medicine pack with you.

If you forget to take Valaciclovir

•    If you forget to take Valaciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose

•    Do not take a double dose to make up for a forgotten dose.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Valaciclovir can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

If you experience any of the following, stop taking Valaciclovir and contact your doctor or local hospital casualty department immediately:

•    severe allergic reactions (anaphylaxis).These are rare in people taking Valaciclovir. Rapid development of symptoms including:

•    flushing, itchy skin rash

•    swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema)

•    fall in blood pressure leading to collapse.

The following side effects have also been reported: Very common (affects more than 1 in 10 patients receiving the medicine):

•    headache.

Common (affects less than 1 in 10 patients receiving the medicine):

•    feeling sick

•    dizziness

•    vomiting

•    diarrhoea

•    skin reaction after exposure to sunlight (photosensitivity)

•    rash.

Uncommon (affects less than 1 in 100 patients receiving the medicine):

•    feeling confused

•    seeing or hearing things that aren't there (hallucinations)

•    feeling very drowsy

•    tremors

•    feeling agitated.

These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valaciclovir a day. They usually get better when Valaciclovir is stopped or the dose reduced. Other uncommon side effects:

•    shortness of breath (dyspnoea)

•    stomach discomfort

•    rash, sometimes itchy, hive-like rash (urticaria)

•    low back pain (kidney pain).

Uncommon side effects that may show up in blood tests:

•    reduction in the number of white blood cells (leucopenia)

•    reduction in the number of blood platelets which are cells that help blood to clot (thrombocytopenia)

•    increase in substances produced by the liver.


Rare (affects less than 1 in 1,000 patients receiving the medicine):

•    unsteadiness when walking and lack of coordination (ataxia)

•    slow, slurred speech (dysarthria)

•    fits (convulsions)

•    altered brain function (encephalopathy)

•    unconsciousness (coma)

•    confused or disturbed thoughts.

These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valaciclovir a day. They usually get better when Valaciclovir is stopped or the dose reduced. Other rare side effects:

•    kidney problems where you pass little or no urine. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.


HOW TO STORE VALACICLOVIR


   Keep out of the reach and sight of children

•    Do not use Valaciclovir after the expiry date which is stated on the carton. The expiry date refers to the last day of the month

•    Store below 30°C

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


^ FURTHER INFORMATION

What Valaciclovir contains

•    The active substance is valaciclovir. Each tablet contains 500 mg valaciclovir (as valaciclovir hydrochloride dihydrate)

•    The other ingredients are maize starch, croscarmellose sodium, sodium stearyl fumarate and cellulose powdered in the tablet core, and hypromellose (E464), titanium dioxide (E171), macrogol 400 and polysorbate 80 (E433) in the film coating.

What Valaciclovir looks like and contents of the pack

•    Valaciclovir are white, biconvex, oblong, film-coated tablets, debossed "VL" breakline and "D" on one side and plain on the other. The tablets can be divided into equal halves

•    Valaciclovir are available in pack sizes of 1, 4, 6, 8, 10, 24, 30, 42, 90 and 112 film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets are also available

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and

manufacturer is TEVA UK Limited, Eastbourne,

BN229AG

This leaflet was last revised in December 2015

PL 00289/1002


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