CONSUMER MEDICINE INFORMATION Treatment for cytomegalovirus contains the active ingredient valaciclovir (hydrochloride) What is in this leaflet This leaflet answers some common questions about. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. What is used for is used to prevent cytomegalovirus (CMV) infection and disease following solid organ transplantation. belongs to a group of medicines called antivirals. It works by stopping the production of CMV, preventing infection. also prevents herpes simplex infections. CMV is another type of herpes virus. It can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands). Your doctor may have prescribed for another reason. Ask your doctor if you have any questions about why has been prescribed for you. is not recommended for use in children, as there have been no studies of its effects in children. is available only with a doctor's prescription. There is no evidence that is addictive. Before you take When you must not take it Do not take if you are allergic to medicines containing valaciclovir, aciclovir or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives(lumpy rash), swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath or fainting. Do not take if you are pregnant, trying to become pregnant or breastfeeding, 1
CONSUMER MEDICINE INFORMATION Treatment of herpes simplex contains the active ingredient valaciclovir (hydrochloride) What is in this leaflet This leaflet answers some common questions about. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. What is used for is used to treat genital herpes infection. belongs to a group of medicines called antivirals. It works by stopping the multiplication of the virus which causes herpes. can reduce the length and severity of an outbreak and the duration of pain and shorten the time to healing of crusts associated with herpes. They do not eliminate the herpes virus from the body. The herpes virus is also known as the Herpes Simplex Virus, or HSV. tablets help the blisters to heal quicker. Taking the tablets as soon as you feel an outbreak can help to prevent the blisters from developing. tablets can also be taken long term to help prevent the HSV infection returning. tablets are more effective in patients 50 years and over. tablets can also be taken continuously to reduce the risk of transmitting the virus that causes genital herpes or to reduce recurrent outbreaks. It does not cure genital herpes or completely eliminate risk of transmission. Therefore, in addition to therapy with it is recommended that patients avoid contact when symptoms are present and always use condoms. is not a cure for genital herpes. Because genital herpes is a sexually transmitted disease, you should minimise having intercourse when you have an outbreak of herpes or show any symptoms. This will avoid the risk of spreading herpes to your partner. Your doctor may have prescribed for another reason. Ask your doctor if you have any questions 1
about why has been prescribed for you. There is no evidence that is addictive. Before you take When you must not take it Do not take if you are allergic to medicines containing valaciclovir, aciclovir or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives (lumpy rash), swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hayfever, wheezing or shortness of breath or fainting. Do not take if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should. risks and benefits of using when pregnant and during breastfeeding. Do not take if the expiry date (Exp.) printed on the pack has passed. Do not take if the packaging is torn or shows signs of tampering. Before you start to take it allergic to any other medicines, foods, dyes or preservatives pregnant or plan to become pregnant. risks and benefits of taking during pregnancy. breastfeeding or wish to breastfeed. risks and benefits of taking when breastfeeding. Tell your doctor if you have, or have had, any medical conditions, especially the following: kidney or liver condition anaemia If you have not told your doctor about any of the above, tell them before you start taking. Taking other medicines taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by, or may affect how well it works. These include: mycophenolate mofetil cyclosporin tacrolimus Your doctor can tell you what to do if you are taking any of these medicines. If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking. Use in children There is not enough information to recommend the use of in children. 2
How to take How much to take Your doctor will decide what dose you should take, how often you should take it. The dosage may vary depending on your medical history. Short term treatment of genital herpes: If you have had a herpes infection before, you should start to take tablets as early as possible if you think you are about to have another recurrence. Dosing should ideally start before, or straight after the first signs of HSV infection appear. The usual dose is one 500 mg tablet with water twice daily. Long term treatment of genital herpes: If you have been prescribed 500 mg tablets to prevent the herpes infection appearing again, the usual dose to take is 500 mg once daily. Your doctor may recommend that you take this as a divided dose (i.e. 250 mg twice daily). If you have had more than 10 recurrences in one year, your doctor may recommend that you take 1000 mg of once daily to prevent recurrences. Follow all directions given to you by your doctor and pharmacist carefully. When to take The usual times to take the tablets are in the morning and evening. How to take Swallow the tablets with a glass of water. If you forget to take If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally. Do not take a double dose to make up for the dose you missed. If you are not sure what to do, ask your doctor or pharmacist. How long to take for The usual course of treatment is five days. However your doctor may want you to take your tablets for ten days. For prevention of herpes infections, you should continue to take this medicine every day as prescribed by your doctor. Keep taking for as long as the course of treatment states. The herpes outbreak may not be completely over. Do not stop taking, even if you feel better after a few days, unless advised by your doctor. If you take too much (overdose) Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much. Do this even if there are no signs of discomfort or poisoning. 3
You may need urgent medical attention. While you are taking Things you must do Before starting any new medicine, tell your doctor or pharmacist that you are taking. Tell all the doctors, dentists and pharmacists who are treating you that you are taking. If you become pregnant or are trying to become pregnant or intend to breastfeed while you are taking, tell your doctor. Drink plenty of fluids while you are taking. Things you must not do Do not stop taking tablets, or alter the dose, without first checking with your doctor. Do not use to treat any other conditions unless your doctor tells you to. Do not give to anyone else, even if they have the same condition as you. Things to be careful of Be careful driving or operating machinery until you know how affects you. does not normally affect alertness; however make sure you know how affects you before driving, operating machinery or anything else that could be dangerous. Side Effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking. Like all other medicines, may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: headache gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain and indigestion dry mouth fever difficulty sleeping chills back pain nervousness skin rash which may be itchy weakness. Some people are allergic to medicines. Symptoms of an allergic reaction may be mild or severe. If you think you are having a allergic reactions to tablets stop taking the tablets and tell your doctor immediately or go to Accident and Emergency at the nearest hospital. 4
Symptoms usually include some or all of the following: wheezing swelling of the lips/mouth difficulty in breathing hay fever lumpy rash (hives) fainting. Some rare side effects of are as follows: sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV light swelling of the lips or mouth damage to the kidney, which gets better when treatment is stopped unusual bruising or bleeding Tell your doctor immediately if you notice any bruising or bleeding, as this may indicate that your blood is not clotting properly. damage to the liver, which get better when treatment is stopped. Tell your doctor if you notice any of the following side effects which are more common in patients with kidney disease or those taking high doses of : confusion or imagining sights or sounds (hallucinations) dizziness drowsiness. Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell. After using Storage Keep 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. Keep your tablets in their pack until it is time to take them. If you take the tablets out of the pack they may not keep well. Keep your tablets in a cool dry place where the temperature stays below 25 C. Do not store or any other medicine in the bathroom or near a sink. Do not leave in the car or on window sills. Heat and dampness can destroy some medicines. Disposal If your doctor tells you to stop taking, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over. Product description What it looks like 500 is an oval white tablet marked with VC2 on one side. Each pack contains 10, 30, 42 or 100 tablets. 5
Ingredients The active ingredient in is valaciclovir hydrochloride. each 500 tablet contains 500 mg of valaciclovir Sponsor Generic Health Pty Ltd Suite 1, 1175 Toorak Rd Camberwell VIC 3124 Australian registration numbers 500 AUST R 170178 Date of preparation December 2012 The tablets also contain: microcrystalline cellulose povidone magnesium stearate Opadry Y 5 7068 White (ARTG 11771) The tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes. 6
unless your doctor says you should. risks and benefits of using when pregnant and during breastfeeding. Do not take if the expiry date (Exp.) printed on the pack has passed. Do not take if the packaging is torn or shows signs of tampering. Before you start to take it allergic to any other medicines, foods, dyes or preservatives. pregnant or plan to become pregnant. risks and benefits of taking during pregnancy. breastfeeding or wish to breastfeed. risks and benefits of taking when breastfeeding. Tell your doctor if you have, or have had, any medical conditions, especially the following: Anaemia a kidney or liver condition If you have not told your doctor about any of the above, tell them before you start taking. Taking other medicines taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by, or may affect how well it works. These include: mycophenolate mofetil cyclosporin tacrolimus These medicines are commonly taken by transplant patients and require close attention. Your doctor can tell you what to do if you are taking any of these medicines. If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking. Use in children There is not enough information to recommend the use of in children. How to take How much to take The dose varies from patient to patient. The usual dose for adults and children over 12 years of age is four 500 mg tablets (2 grams) four times a day for ninety days. Patients with kidney disease may need a reduced dose. Follow all directions given to you by your doctor and pharmacist carefully. How to take Swallow the tablets with a glass of water. When to take them For the prevention of CMV infection, must be taken four times a day (morning, noon, afternoon and evening). If you forget to take If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take the missed dose as soon as you remember, and then go back 2
to taking your tablets as you would normally. Do not take a double dose to make up for the dose you missed. If you are not sure what to do, ask your doctor or pharmacist. How long to take for Keep taking for as long as your doctor recommends. is usually taken for 90 days. If you take too much (overdose) Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. While you are taking Things you must do Before starting any new medicine, tell your doctor or pharmacist that you are taking. Tell all the doctors, dentists and pharmacists who are treating you that you are taking. If you become pregnant or are trying to become pregnant or intend to breastfeed while you are taking, tell your doctor. Visit your doctor regularly so they can check on your progress. Drink plenty of fluids while you are taking. Things you must not do Do not use to treat any other conditions unless your doctor tells you to. Do not give to anyone else, even if they have the same condition as you. Do not stop taking tablets, or alter the dose, without first checking with your doctor. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily. 3 Things to be careful of Be careful driving or operating machinery until you know how affects you. does not normally affect alertness; however make sure you know how affects you before driving, operating machinery or anything else that could be dangerous. Side Effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking. Like all other medicines, may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: headache
gastrointestinal discomfort such as vomiting, nausea, diarrhoea, constipation, abdominal pain and indigestion. dry mouth fever difficulty sleeping chills back pain nervousness skin rash which may be itchy weakness. These should be reported to the doctor or pharmacist if they are severe or become troublesome. Tell your doctor if you notice any of the following side effects which are more common in patients with kidney disease or those taking high doses of : hallucinations confusion dizziness drowsiness Allergic reactions to are rare. However, if you think you are having an allergic reaction, tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following: wheezing swelling of the lips or mouth difficulty in breathing hay fever lumpy rash fainting Rare side effects of include unusual bruising or bleeding Tell your doctor immediately if you notice any bruising or bleeding, as this may indicate that your blood is not clotting properly. sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV light. Talk to your doctor or pharmacist if you experience this damage to kidney, which get better when treatment is stopped damage to liver, which get better when treatment is stopped. Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell. After using Storage Keep 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. Keep your tablets in their pack until it is time to take them. If you take the tablets out of their pack they may not keep well. Keep your tablets in a cool dry place where the temperature stays below 25 C. Do not store or any other medicine in the bathroom or near a sink. Do not leave in the car or on window sills. Heat and dampness can destroy some medicines. Disposal If your doctor tells you to stop taking, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over. 4
Product Description What it looks like 500 is an oval white tablet marked with VC2 on one side. Each pack contains 10, 30, 42 or 100 tablets. Ingredients The active ingredient in is valaciclovir hydrochloride. each 500 tablet contains 500 mg of valaciclovir The tablets also contain: microcrystalline cellulose povidone magnesium stearate Opadry Y 5 7068 White (ARTG 11771) The tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes. Sponsor Generic Health Pty Ltd Suite 1, 1175 Toorak Rd Camberwell VIC 3124 Australian registration numbers 500 AUST R 170178 Date of preparation December 2012 5
CONSUMER MEDICINE INFORMATION Treatment of zoster and herpes labialis contains the active ingredient valaciclovir (hydrochloride) What is in this leaflet This leaflet answers some common questions about. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. What is used for is used to treat shingles (herpes zoster), ophthalmic zoster (shingles affecting the eye region) and cold sores (herpes labialis). belongs to a group of medicines called antivirals. It works by stopping the multiplication of the virus which causes the shingles and cold sores. reduces the length and severity of an outbreak and the duration of pain associated with the shingles and cold sores. It is important to start treatment within three days of the shingles attack. For treatment of cold sores the tablets should be taken at the earliest symptom of a cold sore (e.g. tingling, itching, or burning). tablets are more effective in patients 50 years and over. Your doctor may have prescribed for another reason. Ask your doctor if you 1 have any questions about why has been prescribed for you. is not recommended for use in children, as there have been no studies of its effects in children. is available only with a doctor s prescription. There is no evidence that is addictive. Before you take When you must not take it Do not take if you are allergic to medicines containing valaciclovir, aciclovir or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include
skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hayfever, wheezing or shortness of breath or fainting. Do not take if you are pregnant, trying to become pregnant or breastfeeding, unless your doctor says you should. risks and benefits of using when pregnant and during breastfeeding. Do not take if the expiry date (Exp.) printed on the pack has passed. Do not take if the packaging is torn or shows signs of tampering. Before you start to take it allergic to any other medicines, foods, dyes or preservatives pregnant or plan to become pregnant. risks and benefits of taking during pregnancy. breastfeeding or wish to breastfeed. risks and benefits of taking when breastfeeding. Tell your doctor if you have, or have had, any medical conditions, especially the following: anaemia kidney or liver condition If you have not told your doctor about any of the above, tell them before you start taking. Taking other medicines taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by, or may affect how well it works. These include: mycophenolate mofetil cyclosporin tacrolimus These medicines are commonly taken by transplant patients and require close attention. Your doctor can tell you what to do if you are taking any of these medicines. If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking. Use in children There is not enough information to recommend the use of in children. How to take How much to take for the treatment of shingles If you have been prescribed 500 mg tablets, the normal dose to take is two tablets with water three times a day. If you have been prescribed 1000 mg tablets, the normal dose to take is one tablet with water three times a day. Follow all directions given to you by your doctor and pharmacist carefully. 2
How much to take for the treatment of cold sores If you have been prescribed 500 mg tablets, the normal dose to take for the one day regimen is four tablets with water twice a day, with the second dose taken about 12 hours after the first dose. For treatment of cold sores, take the second dose as soon as possible once 12 hours have passed. Do not take a double dose to make up for the dose that you missed. If you are not sure what to do, ask your doctor or pharmacist. signs of discomfort or poisoning. You may need urgent medical attention. While you are taking How to take Swallow the tablets with a glass of water. For the treatment of shingles the usual times to take the tablets are in the morning, afternoon and evening. For the treatment of cold sores the tablets should be taken at the earliest symptom of a cold sore (e.g. tingling, itching, or burning). Treatment for cold sores should not exceed 1 day (2 doses) and the doses should be taken 12 hours apart. If you forget to take For treatment of shingles, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, then go back to taking it as you would normally. How long to take for For shingles the usual course of treatment is seven days Do not stop taking tablets before the course of treatment is finished just because you feel better. The shingles may not be completely over. For cold sores the course of the treatment should not exceed 1 day (2doses) and the doses should be taken 12 hours apart. If you take too much (overdose) Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much. Do this even if there are no 3 Things you must do Before starting any new medicine, tell your doctor or pharmacist that you are taking. Tell all the doctors, dentists and pharmacists who are treating you that you are taking. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily. Drink plenty of fluids while you are taking. Things you must not do Do not stop taking tablets, or alter the dose, without first checking with your doctor.
Do not use to treat any other conditions unless your doctor tells you to. Do not give to anyone else, even if they have the same condition as you. Things to be careful of Be careful driving or operating machinery until you know how affects you. does not normally affect alertness; however make sure you know how affects you before driving, operating machinery or anything else that could be dangerous. Side Effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking. Like all other medicines, may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: headache gastrointestinal discomfort (vomiting, nausea, diarrhoea, constipation, abdominal pain and indigestion) dry mouth fever difficulty sleeping chills back pain nervousness skin rash which may be itchy weakness. Some people are allergic to medicines. Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (hives) or fainting. If you think you are having a allergic reactions to 4 tablets stop taking the tablets and tell your doctor immediately or go to Accident and Emergency at the nearest hospital. Some rare side effects of are as follows: sensitivity to UV light, such as development of a rash like sunburn even after short exposure to UV light swelling of the lips or mouth unusual bruising or bleeding Tell your doctor immediately if you notice any bruising or bleeding, as this may indicate that your blood is not clotting properly. damage to kidney, which get better when treatment is stopped damage to liver, which get better when treatment is stopped. Tell your doctor if you notice any of the following side effects which are more common in patients with kidney disease or those taking high doses of :
confusion or imagining sights or sounds (hallucinations) confusion dizziness drowsiness. Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell. After using Storage Keep 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. Keep your tablets in their pack until it is time to take them. If you take the tablets out of the pack they may not keep well. Keep your tablets in a cool dry place where the temperature stays below 25 C. Do not store or any other medicine in the bathroom or near a sink. Do not leave in the car or on window sills. Heat and dampness can destroy some medicines. Disposal If your doctor tells you to stop taking, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over. Product Description What it looks like 500 is an oval white tablet marked with VC2 on one side. Each pack contains 10, 30, 42 or 100 tablets. Ingredients The active ingredient in is valaciclovir hydrochloride. each 500 tablet contains 500 mg of valaciclovir The tablets also contain: microcrystalline cellulose povidone magnesium stearate Opadry Y 5 7068 White (ARTG 11771) Sponsor The tablets do not contain gluten, lactose, sucrose, tartrazine or any other azo dyes. Generic Health Pty Ltd Suite 1, 1175 Toorak Rd Camberwell VIC 3124 Australian registration numbers 500 AUST R 170178 Date of preparation December 2012 5