VALTREX tablets valaciclovir 500 mg New Zealand Consumer Medicine Information

What is in this leaflet Ask your doctor if you have any Safety and effectiveness in children questions about why this medicine have not been established. Please read this leaflet carefully has been prescribed for you. Do not take this medicine after the before you start using VALTREX Your doctor may have prescribed it expiry date printed on the pack or tablets. for another reason. if the packaging is torn or shows This leaflet answers some common This medicine is not addictive. signs of tampering. questions about VALTREX tablets. If it has expired or is damaged, return It does not contain all the available There is not enough information to it to your pharmacist for disposal. information. It does not take the recommend the use of this medicine place of talking to your doctor or for children. If you are not sure whether you pharmacist. should start taking this medicine, talk to your doctor. All medicines have risks and benefits. Your doctor has weighed Before you start to take it the risks of you taking VALTREX Before you take tablets against the benefits they VALTREX tablets Tell your doctor if you have expect it will have for you. allergies to any other medicines, If you have any concerns about When you must not take it foods, preservatives or dyes. taking this medicine, ask your Do not take VALTREX tablets if Tell your doctor if: doctor or pharmacist. you have an allergy to: • you have kidney or liver Keep this leaflet with the medicine. • any medicine containing problems. You may need to read it again. valaciclovir or aciclovir Care should be taken to ensure • any of the ingredients listed at the adequate fluid intake in those who end of this leaflet. are at risk of dehydration, such as the elderly. Some of the symptoms of an allergic What VALTREX reaction may include: If you are taking VALTREX to treat tablets are used for or prevent genital herpes, or you • shortness of breath have had genital herpes in the past, VALTREX tablets belong to a group • wheezing or difficulty breathing you should still practice safe sexual of medicines called antivirals. It • swelling of the face, lips, tongue intercourse, including the use of works by killing or stopping the or other parts of the body condoms. This is important to growth of viruses called herpes prevent you passing the infection on • rash, itching or hives on the skin. simplex (HSV), varicella zoster to others. You should not have sex if (VZV) and cytomegolovirus (CMV). Do not take this medicine if you you have genital sores or blisters. are pregnant, trying to become VALTREX tablets can be used to: pregnant or breastfeeding, unless Tell your doctor if you are pregnant or plan to become • treat shingles (herpes zoster) your doctor says you should. pregnant or are breast-feeding. • treat HSV infections of the skin Your doctor will weigh up the benefit Your doctor can discuss with you the and genital herpes. It is also used of you taking VALTREX tablets to help prevent these infections against the risk to your baby while risks and benefits involved. from returning you are pregnant or breastfeeding. If you have not told your doctor • treat shingles affecting the eye Do not give this medicine to about any of the above, tell region (ophthalmic zoster) children. him/her before you start taking VALTREX tablets. • prevent infection with CMV after organ transplants.

VALTREX tablets 1 Taking other medicines Adults: The usual dose is 500 mg back to taking it as you would twice a day. normally. Tell your doctor or pharmacist if you are taking any other Prevention (suppression) of Do not take a double dose to make medicines, including any that you recurrences of herpes simplex up for the dose that you missed. get without a prescription from infections: If you are not sure what to do, ask your pharmacy, supermarket or Adults: The usual dose is 500 mg your doctor or pharmacist. health food shop. once a day. If you have trouble remembering Some medicines and VALTREX Some people with frequent to take your medicine, ask your tablets may interfere with each other. recurrences may benefit from taking pharmacist for some hints. These include: one 500 mg tablet once a day as a • aminoglycosides divided dose (250 mg twice a day). If you take too much (overdose) • organoplatinum compounds For adults whose immune system is impaired or weakened, the dose is • iodinated contrast media Immediately telephone your doctor 500 mg twice a day. or the National Poisons Centre • methotrexate Prevention of cytomegalovirus (telephone 0800 POISON or 0800 • pentamidine infection (CMV) and disease: 764 766), or go to accident and • foscarnet Adults and adolescents (from 12 emergency at your nearest hospital, if you think that you or • ciclosporin years old): The usual dose is 2 g (four 500 mg tablets) four times a anyone else may have taken too • tacrolimus. day. VALTREX tablets should be much VALTREX tablets. These medicines may affect how taken for 90 days. Do this even if there are no signs of well VALTREX tablets works. Your doctor may adjust the dose of discomfort or poisoning. Your doctor and pharmacist have VALTREX tablets if: Symptoms of an overdose may more information on medicines to be • you are over 65 years of age include kidney failure, confusion, careful with or avoid while taking hallucination, agitation, decreased this medicine. • you have kidney problems consciousness and coma, nausea and • you have a weak immune system. vomiting.

How to take it How to take VALTREX Swallow the tablets whole with a tablets glass of water. While you are taking VALTREX tablets Follow all directions given to you You should drink plenty of fluids by your doctor or pharmacist while taking VALTREX tablets, Things you must do carefully. especially if you are elderly. They may differ from the If you are about to be started on When to take it information contained in this leaflet. any new medicine, remind your Take your medicine at about the doctor and pharmacist that you If you do not understand the are taking VALTREX tablets. instructions on the box, ask your same time each day. Tell any other doctors, dentists, doctor or pharmacist for help. Taking it at the same time each day will have the best effect. It will also and pharmacists who treat you How much to take help you remember when to take it. that you are taking this medicine. If you become pregnant while Treatment of shingles (herpes How long to take it taking this medicine, tell your zoster) including the eye doctor immediately. (ophthalmic zoster): Continue taking your medicine for as long as your doctor tells you. Adults: The usual dose is 1000 mg Things you must not do (two 500 mg tablets) three times a If you forget to take it Do not take VALTREX tablets to day. VALTREX tablets should be treat any other complaints unless taken for seven days. If it is almost time for your next your doctor tells you to. Treatment of herpes simplex dose, skip the dose you missed and infections: take your next dose when you are Do not give your medicine to meant to. Otherwise, take it as anyone else, even if they have the soon as you remember, then go same condition as you.

VALTREX tablets 2 Do not stop taking your medicine hospital. Symptoms of an allergic • brain injury or lower the dosage without reaction usually include some or all • coma checking with your doctor. of the following: • damage to the liver or kidneys, • shortness of breath Things to be careful of which gets better when • wheezing, coughing or difficulty VALTREX treatment is stopped Be careful driving or operating breathing • swelling of the skin machinery until you know how • swelling of the face, lips, tongue VALTREX tablets affects you. • low back pain (kidney pain) or other parts of the body Tell your doctor or pharmacist if • rash, itching, redness or hives on you notice anything that is making the skin you feel unwell. Side effects • suddenly feeling weak or light Other side effects not listed above headed (may lead to collapse or may also occur in some people. Tell your doctor or pharmacist as loss of consciousness). soon as possible if you do not feel well while you are taking Rare side effects VALTREX tablets. These may affect up to 1 in 1,000 After taking VALTREX This medicine helps most people, but people: tablets it may have unwanted side effects in • dizziness a few people. All medicines can have Storage side effects. Sometimes they are • confusion serious, most of the time they are not. • hallucinations Keep your tablets in the pack until You may need medical attention if it is time to take them. • decreased consciousness you get some of the side effects. Keep your tablets in a place where • abdominal pain Do not be alarmed by the following the temperature stays below 30°C. • vomiting lists of side effects. You may not Do not store VALTREX tablets or experience any of them. • diarrhoea any other medicine in the Ask your doctor or pharmacist to • itching (pruritus) bathroom or near a sink. Do not answer any questions you may • kidney failure. leave it on a window sill or in the have. car. Very rare side effects Heat and dampness can destroy some Common side effects medicines. These may affect up to 1 in 10,000 These may affect up to 1 in 10 people: Keep it where children cannot people: reach it. • low white blood cell count • headache A locked cupboard at least one-and- • low platelet count • nausea. a-half metres above the ground is a • allergic reaction. Symptoms of an good place to store medicines. Uncommon side effects allergic reaction include: − wheezing Disposal These may affect up to 1 in 100 people: − swelling of the lips/mouth If your doctor tells you to stop taking VALTREX tablets or the • difficulty breathing − difficulty breathing expiry date has passed, ask your

• rashes − hayfever pharmacist what to do with any • sensitivity to UV light, such as − lumpy rash (hives) medicine that is left over. development of a rash like − fainting sunburn even after short exposure • agitation to UV light. • tremor If you think you are having an Product description allergic reaction to VALTREX • uncoordinated muscle movement tablets, stop using this medicine (ataxia) and speech (dysarthria) What it looks like and tell your doctor immediately • psychotic episodes VALTREX tablets 500 mg are white, or go the accident and emergency • convulsions biconvex, elongated, film coated department at your nearest

VALTREX tablets 3 tablets with a white to off-white core. The tablets are unscored and engraved ‘GX CF1’ on one side. They are available in a pack size of 30 tablets.

Ingredients VALTREX tablets contain the active ingredient valaciclovir. They also contain: • microcrystalline cellulose • crospovidone • povidone • magnesium stearate • colloidal silicon dioxide • purified water • carnauba wax • hydroxypropylmethylcellulose • titanium dioxide • polyethylene glycol • polysorbate 80.

Supplier VALTREX tablets are supplied in New Zealand by: GlaxoSmithKline NZ Limited Private Bag 106600 Downtown Auckland New Zealand

Ph: (09) 367 2900 Fax: (09) 367 2910

This leaflet was prepared on 21 June 2017.

Version 1.0

Trade marks are owned by or licensed to the GSK group of companies.

© 2017 GSK group of companies or its licensor.

VALTREX tablets 4