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VALGANCICLOVIR MYLAN contains the active ingredient valganciclovir Consumer Medicine Information What is in this leaflet Some of the symptoms of an allergic reaction • you must use a reliable form of may include: contraception during This leaflet answers some common questions • shortness of breath VALGANCICLOVIR MYLAN therapy, about VALGANCICLOVIR MYLAN • wheezing or difficulty breathing and for at least 30 days after stopping tablets. VALGANCICLOVIR MYLAN, unless It does not contain all the available • swelling of the face, lips, tongue or other you are not sexually active. parts of the body information. you are a sexually active man • rash, itching or hives on the skin It does not take the place of talking to your • you should use condoms during and for doctor or pharmacist. Do not take VALGANCICLOVIR at least 90 days following treatment with All medicines have benefits and risks. Your MYLAN if you have very low blood counts VALGANCICLOVIR MYLAN unless it doctor has weighed the risks of you taking for platelets (which help clotting), is certain that your female partner is not VALGANCICLOVIR MYLAN against the neutrophils (a type of white blood cell at risk of . benefits expected for you. which defends against infection) or low haemoglobin (oxygen carrying substance If you have not told your doctor about any If you have any concerns about taking this in the blood). of the above, tell him/her before you start medicine, talk to your doctor or taking VALGANCICLOVIR MYLAN. pharmacist. Do not take VALGANCICLOVIR MYLAN after the expiry date (EXP) Taking other medicines Keep this leaflet with your medicine. printed on the pack has passed or if the Tell your doctor or pharmacist if you are You may need to read it again. packaging is torn or shows signs of taking any other medicines, including any tampering. that you get without a prescription from a What VALGANCICLOVIR MYLAN is If it has expired or is damaged, return it to pharmacy, supermarket or health food used for your pharmacist for disposal. shop. VALGANCICLOVIR MYLAN contains the If you are not sure whether you should Some medicines and VALGANCICLOVIR active ingredient valganciclovir. In the body start taking VALGANCICLOVIR MYLAN may interfere with each other. valganciclovir rapidly changes to MYLAN, talk to your doctor. These medicines include: . Use in children • imipenem/cilastatin (Primaxin®), a VALGANCICLOVIR MYLAN belongs to a There is limited information on the safety combination of medicines used to treat class of medicines used to prevent the growth and effectiveness of the use of some infections of viruses. VALGANCICLOVIR MYLAN in children. • (e.g. Benemid®), a medicine VALGANCICLOVIR MYLAN acts against Your doctor will advise you whether used to treat gout a virus called or CMV (a VALGANCICLOVIR MYLAN is suitable • (AZT, Retrovir®, Combivir), type of herpes virus). It prevents this virus for your child. (ddl or Videx®), stavudine, from growing and multiplying in the body. Before you start to take it also known as D4T, other medicines CMV causes infections, mainly in people used to treat HIV infection Tell your doctor if: with poor immunity. Poor immunity can be • medicines for the treatment of cancer • you are allergic to medicines such as caused by HIV/AIDS or by medications such as vincristine, adriamycin, , , , taken after an organ transplant. hydroxyurea VALGANCICLOVIR MYLAN is used to . These medicines are from the same class as • mycophenolate mofetil (CellCept®), and treat CMV eye infections (known as CMV other medicines used to prevent organ retinitis) in AIDS patients, which, if left VALGANCICLOVIR MYLAN and allergic reactions may occur. rejection after a transplant e.g. untreated can cause blindness. It is not a cure ciclosporin, tacrolimus for CMV eye infections. • you are allergic to any other • anti-infective agents such as VALGANCICLOVIR MYLAN is not medicines, foods, dyes or preservatives, especially any medicine trimethoprim / sulphonamides dapsone, effective against any underlying HIV pentamidine, flucytosine, pegylated infection. which you have taken previously to treat your current condition. plus and VALGANCICLOVIR MYLAN is also used amphotericin B to prevent CMV infection in patients You have, any other health problems, especially the following: These medicines may be affected by following . VALGANCICLOVIR MYLAN, or may • you have a history of low blood counts Your doctor, however, may have prescribed affect how well it works. You may need for platelets (), VALGANCICLOVIR MYLAN for another different amounts of your medicine, or you neutrophils () or anaemia purpose. may need to take different medicines. • you have, or previously have had, poor Ask your doctor if you have any questions Your doctor or pharmacist have more function. about why VALGANCICLOVIR MYLAN information on medicines to be careful with has been prescribed for you. you are pregnant or intend to become or avoid while taking VALGANCICLOVIR VALGANCICLOVIR MYLAN is not pregnant. MYLAN. addictive. • VALGANCICLOVIR MYLAN is not Ask your doctor or pharmacist if you are This medicine is available only with a recommended for use during pregnancy. not sure about this list of medicines. doctor's prescription. VALGANCICLOVIR MYLAN may affect your developing baby if you take How to take VALGANCICLOVIR Before you take VALGANCICLOVIR it during pregnancy. Your doctor will MYLAN discuss the risks and benefits of using MYLAN VALGANCICLOVIR MYLAN if you Follow all directions given to you by your Animal and other laboratory studies have are pregnant. doctor or pharmacist carefully. shown VALGANCICLOVIR MYLAN you are breast-feeding or intend to breast- They may differ from the information causes , birth defects and cancer. It feed. contained in this leaflet. is possible that these effects may also occur • It is not known whether If you do not understand the instructions in humans. VALGANCICLOVIR MYLAN passes on the bottle, ask your doctor or When you must not take it into breast milk. Breast-feeding is not pharmacist for help. Do not take VALGANCICLOVIR recommended during therapy with MYLAN if you have had an allergy to VALGANCICLOVIR MYLAN. VALGANCICLOVIR MYLAN, you are a woman who could become ganciclovir or any ingredients at the end pregnant and you are not using of this leaflet: contraception

VALGANCICLOVIR MYLAN Published by MIMS September 2019 1 How much to take think that you or anyone else may have Be careful driving or operating machinery Take VALGANCICLOVIR MYLAN taken too much VALGANCICLOVIR until you know how VALGANCICLOVIR exactly as your doctor has prescribed. MYLAN. Do this even if there are no signs MYLAN affects you. Your doctor will tell you how many of discomfort or poisoning. VALGANCICLOVIR MYLAN may cause VALGANCICLOVIR MYLAN tablets to You may need urgent medical attention. drowsiness, dizziness, confusion or seizures take each day. Keep telephone numbers for these places (fits) in some people and therefore may affect alertness. If you have any of these Treatment of CMV Retinitis in AIDS handy. If you are not sure what to do, contact symptoms, do not drive or operate machinery • Induction Treatment for adults (for or do anything else that could be dangerous. active CMV retinitis) your doctor or pharmacist. The usual dose is 900 mg (two 450 mg Side effects tablets) twice daily with food for 21 While you are taking days. VALGANCICLOVIR MYLAN Tell your doctor or pharmacist as soon as possible if you do not feel well while you • Maintenance Treatment for adults Things you must do (after induction treatment or for are taking VALGANCICLOVIR Tell all doctors, dentists and pharmacists inactive CMV retinitis) MYLAN. who treat you that you are taking The usual dose is 900 mg (two 450 mg VALGANCICLOVIR MYLAN helps most VALGANCICLOVIR MYLAN. tablets) once daily with food. people with CMV infections but it may have See your doctor regularly so that your Prevention of CMV Disease in unwanted side effects in a few people. CMV disease, blood cell counts and any Transplantation for adults All medicines can have side effects. other potential side effects may be The usual dose is 900 mg (two 450 mg Sometimes they are serious, most of the time monitored carefully. they are not. Your doctor has weighed the tablets) once daily with food, starting within If blood cell counts are low then this may 10 days post transplantation until 100 days risks of using this medicine against the reduce your ability to fight infection, or for benefits they expect it will have for you. post transplantation. your blood to clot efficiently. If left If you are over 65 years of age you may have If you have received a kidney transplant, the undetected these effects on blood cells may an increased chance of getting side effects. same daily dose is required until 200 days contribute to death or serious illness. Don't be alarmed by the list of possible post transplantation. If you have a CMV eye infection, you must side effects. Your dose may have to be reduced or also see your doctor regularly to monitor You may not experience any of them stopped if you have or develop low blood the condition of your retina (part of the counts, have kidney disease, or if you are eye). Ask your doctor or pharmacist to answer any questions you may have. older than 65 years. If you become pregnant while taking Prevention of CMV Disease in VALGANCICLOVIR MYLAN, tell your Tell your doctor if you notice any of the Transplantation for children doctor immediately. following and they worry you: Your doctor will let you know how many Condoms should be used by sexually • dizziness VALGANCICLOVIR MYLAN tablets you active men while taking • looking pale should give your child each day. VALGANCICLOVIR MYLAN and for 90 • diarrhoea How to take it days after stopping treatment. • nausea Swallow tablets whole with a glass of water. Women who are of childbearing potential • fever should use contraception during and for at VALGANCICLOVIR MYLAN must be • vomiting taken with food. least 30 days after stopping VALGANCICLOVIR MYLAN. • headache When to take it Tell your doctor if for any reason you These are the more common side effects of Take VALGANCICLOVIR MYLAN have not taken your medicine exactly as VALGANCICLOVIR MYLAN and are during or immediately after a meal. prescribed. Otherwise, your doctor may usually short lived. If you take VALGANCICLOVIR MYLAN think that it was not effective and change Tell your doctor immediately if you notice on an empty stomach, it may not work as your treatment unnecessarily. any of the following: well. Keep all of your doctor's appointments so • skin rash Take VALGANCICLOVIR MYLAN at that your progress can be checked. about the same time each day. • Taking your medicine at the same time each Things you must not do • cough day will have the best effect. It will also help Do not take VALGANCICLOVIR • fatigue (tiredness) you remember when to take MYLAN to treat any other complaints • oral thrush (sore, creamy yellow raised VALGANCICLOVIR MYLAN. unless your doctor tells you to. patches in the mouth) How long to take it for Do not give VALGANCICLOVIR • (inability to sleep) MYLAN to anyone else even if they have Continue taking VALGANCICLOVIR • worsening of your eyesight MYLAN until your doctor tells you to the same condition as you. Do not stop taking VALGANCICLOVIR These side effects may be serious. You may stop. require urgent medical attention. If you forget to take it MYLAN or change the dosage without first checking with your doctor. Tell your doctor immediately, or go to If it is almost time for your next dose, skip Do not let yourself run out of medicine Accident and Emergency at your nearest the dose you missed and take your next over the weekend or on holidays. hospital, if you notice any of the following. dose when you are meant to. Do not take any other medicines whether • swelling of the tongue, lips or throat Otherwise, take it as soon as you they require a prescription or not without • any sign of infection such as fever, remember and then go back to taking it as first telling your doctor or consulting a chills, sore throat or mouth ulcers you would normally. pharmacist. • unexplained bruising or bleeding Do not take a double dose to make up for Be careful when handling • thinking, hearing or seeing things that the dose you missed. VALGANCICLOVIR MYLAN tablets. are not real If you are not sure what to do, ask your Do not break or crush them. If you • confusion doctor or pharmacist. accidentally touch broken or crushed • agitation If you have trouble remembering your tablets, wash your hands thoroughly with dose, ask your pharmacist for some hints. soap and water. If any powder from the • fits If you take too much (overdose) tablet gets in your eyes, rinse your eyes Tell your doctor or pharmacist if you thoroughly with water. notice anything else that is making you Immediately telephone your doctor, or the feel unwell, even if it is not on the list. Poisons Information Centre (telephone 13 This is not a complete list of all possible side 11 26) for advice, or go to Accident and effects. Others may occur in some people Emergency at your nearest hospital, if you

VALGANCICLOVIR MYLAN Published by MIMS September 2019 2 Ask your doctor or pharmacist if you This leaflet was prepared on 05 July 2019. don't understand anything in this list. VALGANCICLOVIR MYLAN_cmi\Jul19/00 After using VALGANCICLOVIR MYLAN Storage Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well. Keep VALGANCICLOVIR MYLAN in a cool dry place where the temperature stays below 25°C. Do not store it or any other medicine in a bathroom or near a sink. Do not leave it in the car or on a window sill. Heat and dampness can destroy some medicines. Keep VALGANCICLOVIR MYLAN 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 VALGANCICLOVIR MYLAN, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description Availability VALGANCICLOVIR MYLAN comes in 450 mg film-coated tablets, in bottles containing 60 tablets. What VALGANCICLOVIR MYLAN looks like VALGANCICLOVIR MYLAN - valganciclovir 450 mg are pink, biconvex, oval, beveled edge film-coated tablets with "M" on one side and "V45" on the other side. Ingredients Active Ingredients - valganciclovir: • each VALGANCICLOVIR MYLAN tablet contains 450 mg of valganciclovir Inactive Ingredients - VALGANCICLOVIR MYLAN film-coated tablets also contain • Crospovidone • Stearic acid • Microcrystalline cellulose • Hypromellose • Titanium dioxide • Macrogol 400 • Polysorbate 80 • Iron oxide red VALGANCICLOVIR MYLAN tablets are lactose and gluten free. Supplier VALGANCICLOVIR MYLAN is supplied in Australia by: Alphapharm Pty Limited (ABN 93 002 359 739) Level 1, 30 The Bond 30-34 Hickson Road Millers Point NSW 2000 Phone: (02) 9298 3999 www.mylan.com.au Australian registration numbers: VALGANCICLOVIR MYLAN: AUST R 218477

VALGANCICLOVIR MYLAN Published by MIMS September 2019 3