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Valaciclovir 500mg Tablets

Document: leaflet MAH BRAND_PLPI 20636-1435 change

Valtrex® 500 mg Tablets Valaciclovir® 500 mg Tablets

(valaciclovir hydrochloride)

PATIENT INFORMATION LEAFLET

This medicine is available using any of the above names but will be referred to as Valtrex throughout this leaflet.

Read all of 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 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 signs of illness are the same as yours.

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

What is in this leaflet:

1. What Valtrex is and what it is used for

2. What you need to know before you take Valtrex

3. How to take Valtrex

4. Possible side effects

5. How to store Valtrex

6. Contents of the pack and other information

1.    WHAT VALTREX IS AND WHAT IT IS USED FOR

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

Valtrex can be used to:

-    treat shingles (in adults)

-    treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old). It is also used to help prevent these infections from returning.

-    treat cold sores (in adults and adolescents over 12 years old)

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

-    treat and prevent HSV infections of the eye that continue to come back (in adults and adolescents over 12 years old)

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALTREX Don’t take Valtrex

-    if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in Section 6).

Don't take Valtrex if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valtrex.

Warnings and precautions

Check with your doctor or pharmacist before taking Valtrex 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 Valtrex.

Prevent passing genital herpes on to others

If you are taking Valtrex to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.

Other medicines and Valtrex

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 Valtrex for treatment of shingles or after having an organ transplant.

Pregnancy and breast-feeding

Valtrex 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 Valtrex without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valtrex while you're pregnant or breastfeeding.

Driving or using machines

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

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

3. HOW TO TAKE VALTREX

Always take this medicine 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 Valtrex for you. Your doctor will discuss this with you.

Treatment of shingles

-    The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.

-    You should take Valtrex for seven days.

Treatment of cold sores

-    The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.

-    The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose

-    You should take Valtrex for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

-    The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.

-    For the first infection you should take Valtrex for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3-5 days.

Helping to prevent HSV infections from returning after you have had them

-    The usual dose is one 500 mg tablet once a day.

-    Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.

-    You should take Valtrex until your doctor tells you to stop.

To stop you being infected with CMV (Cytomegalovirus)

-    The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.

-    You should take each dose about 6 hours apart.

-    You will usually start taking Valtrex as soon as possible after your surgery.

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

Your doctor may adjust the dose of Valtrex if:

-    you are over 65 years of age

-    you have a weak immune system

-    you have kidney problems.

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

Taking this medicine

-    Take this medicine by mouth.

-    Swallow the tablets whole with a drink of water.

-    Take Valtrex at the same time each day.

-    Take Valtrex 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 Valtrex 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.

If you take more Valtrex than you should

Valtrex is not usually harmful, unless you take too much over several days.

If you take too many tablets you may feel sick, vomit, get kidney problems, maybe confused, agitated, feel less aware, see things that aren't there, or become unconscious. Talk to your doctor or pharmacist if you take too much Valtrex. Take the medicine pack with you.

If you forget to take Valtrex

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

-    Don't take a double dose to make up for a forgotten dose.

POM


PL No: 20636/1435


4. POSSIBLE SIDE EFFECTS

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

Conditions you need to look out for

-    severe allergic reactions (anaphylaxis). These are rare in people taking Valtrex. 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.

^ If you have an allergic reaction, stop taking Valtrex and see a doctor straight away.

Very Common (may affect more than 1 in 10 people):

-    headache

Common (may affect up to 1 in 10 people)

-    feeling sick

-    dizziness

-    vomiting

-    diarrhoea

-    skin reaction after exposure to sunlight (photosensitivity).

-    rash

-    Itching (pruritus)

Uncommon (may affect up to 1 in 100 people)

-    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 Valtrex a day. They usually get better when Valtrex 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)

-    blood in urine (haematuria)

5.    HOW TO STORE VALTREX

Keep your Valtrex tablets in a safe place where children cannot see or reach them.

Keep your tablets below 30°C.

Do not use Valtrex after the expiry date which is stated on the carton. The expiry date (Exp.) refers to the last day of that month.

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

If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Valtrex contains

Each film-coated tablet contains the active ingredient 500mg valaciclovir (as hydrochloride).

There are also some inactive ingredients in Valtrex which are needed to make the tablet. These are microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E 171), macrogol 400, carnauba wax and polysorbate 80.

What Valtrex looks like and contents of the pack

Valtrex is available as white capsule shaped bi-convex film-coated tablets come in blister strips pack of 10 or 42 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Glaxo Operations U.K. Ltd., Ware, U.K. Procured from within the Eu by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 01.09.14[8]

Valtrex is a registered trademark of the GlaxoSmithKline group of companies.

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

-    unsteadiness when walking and lack of coordination (ataxia)

-    slow, slurred speech (dysarthria)

-    fits (convulsions)

-    altered brain function (encephalopathy)

-    unconsciousness (coma)

-    confused or disturbed thoughts (delirium)

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 Valtrex a day. They usually get better when Valtrex 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 or pharmacist.

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.