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Valganciclovir Sandoz valganciclovir hydrochloride tablet Consumer Medicine Information WHAT IS IN THIS LEAFLET neutrophils (a type of white blood cell Taking other medicines which defends against infection) or low Tell your doctor or pharmacist if you are This leaflet answers some common questions haemoglobin (oxygen carrying substance about Valganciclovir Sandoz. taking any other medicines, including any in the blood). that you get without a prescription from It does not contain all the available Some of the symptoms of an allergic reaction your pharmacy, supermarket or health information. It does not take the place of may include: food shop. talking to your doctor or pharmacist. • shortness of breath Valganciclovir Sandoz may interfere with All medicines have risks and benefits. Your • wheezing or difficulty breathing other medicines. doctor has weighed the risks of you taking this medicine against the benefits they expect • swelling of the face, lips, tongue or other These include: it will have for you. parts of the body • medicines used to treat gout such as If you have any concerns about taking this • rash, itching or hives on the skin medicine, ask your doctor or pharmacist. Do not take this medicine after the expiry • medicines used to treat HIV infection, Keep this leaflet with the medicine. date printed on the pack or if the such as (AZT) and packaging is torn or shows signs of (ddI) WHAT IS USED FOR tampering. • a combination of medicines used to treat If it has expired or is damaged, return it to some infections, such as This medicine is used to treat: your pharmacist for disposal. imipenem/cilastatin • CMV retinitis in patients with acquired If you are not sure whether you should • medicine used to prevent organ rejection syndrome (AIDS) start taking this medicine, talk to your after a transplant such as mycophenolate • Prophylaxis of CMV infection and doctor. mofetil, ciclosporin, disease following solid organ Use in children • medicines for the treatment of cancer transplantation in patients at risk of There is limited information on the safety such as vincristine, adriamycin and CMV disease. and effectiveness of the use of hydroxyurea It contains the active ingredient Valganciclovir in children. Your doctor will • anti-infective medications such as valganciclovir hydrochloride. advise you whether Valganciclovir is suitable dapsone, pentamidine, flucytosine and Valganciclovir belongs to a group of for your child. amphotericin B medicines used to prevent the growth of Before you start to take it • other medications for the treatment of viruses. Tell your doctor if you have allergies to HIV or HIV related infections such as It works by acting against a virus called any other medicines, foods, preservatives nucleoside analogues or CMV (a type of herpes or dyes. Especially any medicine which • (, also known as 3TC; virus). It prevents this virus from growing you have taken previously to treat your stavudine, also known as D4T; and multiplying in the body. In people with current condition. zalcitabine also known as ddc; abacavir; poor immunity, CMV can cause infections. lamivudine / zidovudine or; abacavir / Poor immunity can be caused by: HIV/AIDS Tell your doctor if you have or have had lamivudine /zidovudine combinations). or by medicines taken after an organ any of the following medical conditions: transplant. • history of low blood counts for platelets These medicines may be affected by Valganciclovir Sandoz or may affect how Valganciclovir is also used to: (), neutrophils () or anaemia well it works. You may need different • CMV eye infections in AIDS patients, • you have or previously have had poor amounts of your medicines, or you may need which if left untreated may cause to take different medicines. blindness. It is not a cure for CMV eye function Your doctor and pharmacist will have more infections Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. information on medicines to be careful with • Prevent CMV infection in patients or avoid while taking this medicine. following . Valganciclovir Sandoz is not recommended for use during . It may affect your Valganciclovir Sandoz is not effective developing baby if you take it during HOW TO TAKE VALGANCICLOVIR against any underlying HIV infection pregnancy. Your doctor can discuss with you SANDOZ Ask your doctor if you have any questions the risks and benefits involved. Follow all directions given to you by your about why this medicine has been Tell your doctor if you are breast feeding or doctor or pharmacist carefully. prescribed for you. intend to breast feed. It is not known whether They may differ from the information Your doctor may have prescribed it for Valganciclovir Sandoz passes into breast contained in this leaflet. another reason. milk. Breast feeding is not recommended If you do not understand the instructions, This medicine is available only with a during treatment with Valganciclovir ask your doctor or pharmacist for help. doctor's prescription. Sandoz. How much to take You are a woman who could become BEFORE YOU TAKE pregnant and you are not using Valganciclovir Sandoz needs to be taken VALGANCICLOVIR SANDOZ contraception. exactly as prescribed. Animal and other laboratory studies have You must use a reliable form of Your doctor will tell you how many shown Valganciclovir causes , birth contraception during Valganciclovir therapy, Valganciclovir Sandoz tablets to take each defects and cancer. It is possible that these and for at least 30 days after stopping day. effects may also occur in humans. Valganciclovir, unless you are not sexually For Treatment of CMV Retinitis in AIDS When you must not take it active. You are a sexually active man. • Induction Treatment (for active CMV retinitis) Do not take this medicine if you have an You should use condoms during and for at The usual dose is 900mg (two 450mg allergy to: least 90 days following treatment with Valganciclovir unless it is certain that your tablets) twice daily with food for 21 days • valganciclovir hydrochloride , the active female partner is not at risk of pregnancy. • Maintenance Treatment (after ingredient(s), or to any of the other induction treatment or for inactive ingredient(s) listed at the end of this Information is limited on the safety and CMV retinitis) leaflet under Product Description effective of Valganciclovir Sandoz in children. Your doctor will advise. The usual dose is 900mg (two 450mg • , or or tablets) once daily with food. any other similar medicines If you have not told your doctor about any of the above, tell him/her before you start Prevention of CMV Disease in • If you have very low blood counts for taking Valganciclovir Sandoz. Transplantation platelets (which help clotting),

Valganciclovir Sandoz Published by MIMS March 2019 1 The usual dose is 900mg (two 450mg tablets) pharmacist that you are taking Valganciclovir helps most people with CMV once daily with food, starting within 10 days VALGANCICLOVIR SANDOZ. infections but it may have unwanted side of your organ transplant until 100 days after A barrier contraceptive should be used effects in a few people. the transplant. while taking VALGANCICLOVIR All medicines can have side effects. If you have received a kidney transplant, the SANDOZ and for 90 days after stopping Sometimes they are serious, most of the time same daily dose is required until 200 days treatment. Tell your doctor if you become they are not. You may need medical attention after the transplant. Your dose may have to pregnant while taking if you get some of the side effects. be reduced or stopped if you have or develop VALGANCICLOVIR SANDOZ. Do not be alarmed by the following lists of low blood counts, have kidney disease or if Condoms should be used by sexually active side effects. You may not experience any you are older than 65 years. men while taking Valganciclovir and for 90 of them. Ask your doctor or pharmacist if you are days after stopping treatment. Ask your doctor or pharmacist to answer unsure of the correct dose for you. Women who are of childbearing potential any questions you may have. They will tell you exactly how much to take. should use contraception during and for at Tell your doctor or pharmacist if you Follow the instructions they give you. least 30 days after stopping Valganciclovir. notice any of the following and they worry If you take the wrong dose, Valganciclovir Tell any other doctors, dentists and you: Sandoz may not work as well and your pharmacists who treat you that you are • Dizziness problem may not improve. taking this medicine. • Looking pale How to take it If you are going to have surgery, tell the • Diarrhoea Swallow the tablets whole with a full glass of surgeon or anaesthetist that you are • Nausea water. Tablets must be taken with food. taking this medicine. It may affect other medicines used during • Fever When to take Valganciclovir Sandoz surgery. • Vomiting Take your medicine at about the same If you become pregnant while taking this • Headache time each day. Take during or medicine, tell your doctor immediately. immediately after a meal. If you take it on These are mild side effects of the medicine If you are about to have any blood tests, an empty stomach, it may not work as and are short-lived. tell your doctor that you are taking this well. Tell your doctor as soon as possible if you medicine. Taking it at the same time each day will have notice any of the following: It may interfere with the results of some the best effect. It will also help you tests. • skin rash remember when to take it. Your doctor may do some tests (blood cell • How long to take Valganciclovir counts) from time to time to make sure the • cough Sandoz medicine is working and to prevent • fatigue (tiredness) Continue taking your medicine for as long unwanted side effects. If blood cell counts • oral thrush (sore, creamy yellow raised as your doctor tells you. are low then this may reduce your ability to patches in the mouth) This medicine helps to control your fight infection or for your blood to clot condition, but does not cure it. It is important efficiently. If left undetected these effects on • (inability to sleep) to keep taking your medicine even if you feel blood cells may contribute to death of serious • worsening of your eyesight well. illness. The above list includes serious side effects Continue taking your medicine until your If you have a CMV eye infection, you must that may require medical attention. Serious doctor tells you to stop. also see your doctor regularly to monitor the side effects are rare If you forget to take it condition of your retina (part of the eye). If If any of the following happen, tell your you have not taken your medicine exactly as doctor immediately or go to Accident and Take your dose as soon as you remember, prescribed, you must tell your doctor. Emergency at your nearest hospital: and continue to take it as you would Otherwise, your doctor may think it was not normally. • swelling of the tongue, lips or throat effective and change your treatment • any sign of infection such as fever, If it is almost time for your next dose, skip unnecessarily. the dose you missed and take your next dose chills, sore throat or mouth ulcers Keep all of your doctor's appointments so when you are meant to. • unexplained bruising or bleeding that your progress can be checked. Do not take a double dose to make up for • thinking, hearing or seeing things that the dose that you missed. Things you must not do are not real This may increase the chance of you getting Do not take Valganciclovir Sandoz to treat • confusion an unwanted side effect. any other complaints unless your doctor tells you to. • agitation If you are not sure what to do, ask your • fits doctor or pharmacist. Do not give your medicine to anyone else, even if they have the same condition as The above list includes very serious side If you have trouble remembering to take your effects. You may need urgent medical medicine, ask your pharmacist for some you. Do not stop taking your medicine without attention or hospitalisation. These side hints. effects are very rare. If you take too much (overdose) checking with your doctor. Do not let yourself run out of medicine Tell your doctor or pharmacist if you Immediately telephone your doctor or the over the weekend or on holidays. Do not notice anything else that is making you Poisons Information Centre (telephone break or crush the tablets. feel unwell. Australia 13 11 26 or New Zealand 0800 Other side effects not listed above may also POISON or 0800 764766) for advice, or go Things to be careful of occur in some people. to Accident and Emergency at the nearest Be careful driving or operating machinery hospital, if you think that you or anyone until you know how Valganciclovir Sandoz AFTER TAKING else may have taken too much affects you. VALGANCICLOVIR SANDOZ Valganciclovir Sandoz. Do this even if This medicine may cause dizziness, there are no signs of discomfort or confusion, seizures, drowsiness in some Storage poisoning. people. If you have any of these symptoms, Keep your medicine in the original container. You may need urgent medical attention. do not drive, operate machinery or do If you take it out of its original container it anything else that could be dangerous. may not keep well. WHILE YOU ARE TAKING Keep your medicine in a cool dry place VALGANCICLOVIR SANDOZ SIDE EFFECTS where the temperature stays below 25°C. Things you must do Tell your doctor or pharmacist as soon as Do not store Valganciclovir Sandoz or any If you are about to be started on any new possible if you do not feel well while you other medicine in the bathroom or near a medicine, remind your doctor and are taking Valganciclovir Sandoz. sink. Do not leave it on a window sill or in the car.

Valganciclovir Sandoz Published by MIMS March 2019 2 Heat and dampness can destroy some medicines. Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION What it looks like Valganciclovir Sandoz 450mg - pink, convex oral tablets with 'J' on one side and '156' on the other side. Available in blisters of 60 tablets Ingredients Active ingredients: • Each Valganciclovir Sandoz tablet contains 450mg of valganciclovir (as hydrochloride). Inactive ingredients: • microcrystalline cellulose • crospovidone • stearic acid • povidone • hypromellose • titanium dioxide • macrogol 400 • iron oxide red • polysorbate 80 This medicine does not contain lactose, sucrose, gluten and tartrazine, Supplier Sandoz Pty Ltd ABN 60 075 449 553 54 Waterloo Road Macquarie Park Australia Tel: 1800 726 369 This leaflet was prepared in January 2019. Australian Registration Numbers 450mg Tablet: AUST R 227605

Valganciclovir Sandoz Published by MIMS March 2019 3