Package leaflet: Tell your doctor or pharmacist if you are affect the kidney or Frequency Not known (cannot be Information taking any other medicines that affect the nervous system. Your estimated from the available data) for the user kidneys. These include: aminoglycosides, doctor will closely Drug Reaction with Eosinophilia and organoplatinum compounds, iodinated monitor you for signs of Systemic Symptoms also known as DRESS Valaciclovir contrast media, methotrexate, pentamidine, these. or drug hypersensitivity syndrome, which is Nervous system side 500 mg foscarnet, ciclosporin, tacrolimus, cimetidine characterised by widespread rash, high effects might include and probenecid. body temperature, liver enzyme elevations, film-coated tablets feeling confused or blood abnormalities (eosinophilia), enlarged Valaciclovir Always tell your doctor or pharmacist about agitated, or feeling other medicines if you are taking Valaciclovir unusually sleepy or lymph nodes and possibly other body for treatment of shingles or after having an drowsy. organs involvement. See also section 2. Read all of this leaflet carefully before organ transplant. you start taking this medicine because it If you take more Valaciclovir than you Reporting of side effects If you get any side effects, talk to your contains important information for you. Pregnancy and breast-feeding should - Keep this leaflet. You may need to read it If you are pregnant or breast-feeding, think Valaciclovir is not usually harmful, unless doctor or pharmacist. This includes any again. you may be pregnant or are planning to you take too much over several days. If you possible side effects not listed in this leaflet. - If you have any further questions, ask have a baby, ask your doctor or pharmacist take too many tablets you may feel sick, You can also report side effects directly via your doctor or pharmacist. for advice before taking this medicine. vomit, get kidney problems, may be Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for - This medicine has been prescribed for Valaciclovir is not usually recommended for confused, agitated, feel less aware, see MHRA Yellow Card in the Google Play or you only. Do not pass it on to others. It use during pregnancy. If you are pregnant, things that aren’t there, or become Apple App Store. By reporting side effects may harm them, even if their signs of or think you could be, or if you are planning unconscious.. Talk to your doctor or you can help provide more information on illness are the same as yours. to become pregnant, don’t take Valaciclovir pharmacist if you take too much Valaciclovir. the safety of this medicine. - If you get any side effects, talk to your without checking with your doctor. Your Take the medicine pack with you. doctor or pharmacist . This includes any doctor will weigh up the benefit to you If you forget to take Valaciclovir 5. How to store Valaciclovir possible side effects not listed in this against the risk to your baby of taking • If you forget to take Valaciclovir, take it leaflet. See section 4. Valaciclovir while you're pregnant or as soon as you remember. However, if it Keep this medicine out of the sight and breastfeeding. is nearly time for your next dose, skip the reach of children. What is in this leaflet missed dose. 1. What Valaciclovir is and what it is used Driving and using machines Do not use this medicine after the expiry • Do not take a double dose to make up for for Valaciclovir can cause side effects that date which is stated on the label, carton and affect your ability to drive. a forgotten dose. bottle after ‘EXP:’. The expiry date refers to 2. What you need to know before you take If you have any further questions on the use Valaciclovir  Don’t drive or use machines unless you the last day of the month. are sure you’re not affected. of this product, ask your doctor or 3. How to take Valaciclovir pharmacist. This medicine does not require any special 4. Possible side effects 3. How to take Valaciclovir storage conditions. 5. How to store Valaciclovir 4. Possible side effects Do not throw away any medicines via Always take this medicine exactly as your 6. Contents of the pack and other wastewater or household waste. Ask your information doctor or pharmacist has told you. Check Like all medicines, this medicine can cause with your doctor or pharmacist if you are not side effects, although not everybody gets pharmacist how to throw away medicines 1. What Valaciclovir is and what it is sure. them. The following side effects may you no longer use. These measures will used for happen with this medicine: help protect the environment. The dose that you should take will depend Valaciclovir belongs to a group of medicines on why your doctor has prescribed Conditions you need to look out for 6. Contents of the pack and other called antivirals. It works by killing or Valaciclovir for you. Your doctor will discuss • severe allergic reactions (anaphylaxis). information this with you. stopping the growth of viruses called herpes These are rare in people taking What Valaciclovir contains simplex (HSV), varicella zoster (VZV) and Treatment of shingles Valaciclovir. Rapid development of • The active substance is valaciclovir. cytomegalovirus (CMV). • The recommended dose is 1000 mg (one symptoms including: Each film-coated tablet contains • flushing, itchy skin rash Valaciclovir can be used to: 1000 mg tablet or two 500 mg tablets) valaciclovir hydrochloride (hydrated) • swelling of the lips, face, neck and throat, • treat shingles (in adults) three times a day. equivalent to 500 mg valaciclovir. • treat HSV infections of the skin and • You should take Valaciclovir for seven causing difficulty in breathing genital herpes (in adults and adolescents days. (angiodema) • fall in blood pressure leading to collapse. • The other ingredients are: over 12 years old). It is also used to help Tablet core: Cellulose, microcrystalline, prevent these infections from returning. Treatment of cold sores  If you have an allergic reaction, stop • The recommended dose is 2000 mg (two taking Valaciclovir and see a doctor crospovidone (Type A), povidone (K-90), • treat cold sores (in adults and magnesium stearate adolescents over 12 years old) 1000 mg tablets or four 500 mg tablets) straight away. twice a day. Film coat: Hypromellose 6cP, indigo • prevent infection with CMV after organ (may affect more than 1 in • The second dose should be taken 12 Very Common carmine aluminium lake (E132), titanium transplants (in adults and adolescents 10 people): hours (no sooner than 6 hours) after the dioxide (E171), macrogol 400, over 12 years old) • headache first dose polysorbate 80 • treat and prevent HSV infections of the • You should take Valaciclovir for one day Common (may affect up to 1 in 10 people) eye What Valaciclovir look like and contents (two doses) only. • feeling sick of the pack • dizziness 2. What you need to know before you Treatment of HSV infections of the skin and Film-coated tablet. take Valaciclovir • vomiting genital herpes • diarrhoea Blue, film-coated, capsule shaped tablets • The recommended dose is 500 mg (one Do not take Valaciclovir • skin reaction after exposure to sunlight with a partial score bar on both sides 500 mg tablet) twice a day. • if you are allergic to valaciclovir or (photosensitivity). containing ‘F’ on one side and ‘9’ and ‘3’ on • For the first infection you should take aciclovir or any of the other ingredients of • rash the other side. Valaciclovir for five days or for up to ten this medicine (listed in Section 6). • itching (pruritus) The tablet can be divided into equal doses. days if your doctor tells you to. For • Don’t take Valaciclovir if this applies to recurrent infection the duration of Uncommon (may affect up to 1 in 100 Valaciclovir film-coated tablets are available you. If you are not sure, talk to your treatment is normally 3-5 days. people) in clear PVC/PVdC Aluminium foil blister or doctor or pharmacist before taking • feeling confused in HDPE bottle. Valaciclovir. Helping to prevent HSV infections from • seeing or hearing things that aren’t there Pack sizes; • If you have ever developed an extended returning after you have had them (hallucinations) Blister: 7, 10, 21, 30, 42, 50, 90 & 112 rash associated with fever, enlarged • The recommended dose is one 500 mg • feeling very drowsy tablets lymph node, increased levels of liver tablet once a day. • tremors Bottle: 30 & 500 tablets enzymes and/or eosinophilia (drug • Some people with frequent recurrences • feeling agitated reaction with eosinophilia and systemic may benefit from taking one 250 mg twice Marketing Authorisation Holder a day. These nervous system side effects usually symptoms) after taking valaciclovir. occur in people with kidney problems, the Milpharm Limited • You should take Valaciclovir until your Ares Block, Odyssey Business Park Warnings and precautions doctor tells you to stop. elderly or in organ transplant patients taking Talk to your doctor or pharmacist before high doses of 8 grams or more of West End Road taking Valaciclovir To stop you being infected with CMV Valaciclovir a day. They usually get better Ruislip HA4 6QD • you have kidney problems (Cytomegalovirus) when Valaciclovir is stopped or the dose United Kingdom • The recommended dose is 2000 mg (two • you have liver problems reduced. Manufacturer 1000 mg tablets or four 500 mg tablets) • you are over 65 years of age Other uncommon side effects: APL Swift Services (Malta) Limited • your immune system is weak four times a day. HF26, Hal Far Industrial Estate, Hal Far • You should take each dose about 6 hours • shortness of breath (dyspnoea) • Drug reaction with eosinophilia and Birzebbugia, BBG 3000 apart. • stomach discomfort systemic symptoms (DRESS) has been Malta • You will usually start taking Valaciclovir • rash, sometimes itchy, hive-like rash reported with the use of valaciclovir. (urticaria) as soon as possible after your surgery. This medicinal product is authorised in DRESS appears initially as flu-like • You should take Valaciclovir for around • low back pain (kidney pain) symptoms and a rash on the face then an • blood in urine (haematuria) the Member States of the EEA under the 90 days after your surgery, until your following names: extended rash with a high body doctor tells you to stop. Uncommon side effects that may show up in temperature, increased levels of liver France Valaciclovir Arrow 500 mg, blood tests: comprimé pelliculé enzymes seen in blood tests and an Your doctor may adjust the dose of • reduction in the number of white blood sécable increase in a type of white blood cell Valaciclovir if: cells (leucopenia) Germany Valaciclovir Aurobindo (eosinophilia) and enlarged lymph nodes. • you are over 65 years of age • reduction in the number of blood platelets 500 mg Filmtabletten • If you develop a rash associated with • you have a weak immune system which are cells that help blood to clot Italy Valaciclovir Aurobindo fever and enlarged lymph nodes, stop • you have kidney problems. (thrombocytopenia) 500 mg/ 1000 mg taking valaciclovir and contact your doctor  Talk to your doctor before taking • increase in substances produced by the compresse rivestite con or seek medical attention immediately. Valaciclovir if any of the above apply. liver. film Children under 12 years of age If you are not sure if the above apply to Rare (may affect up to 1 in 1,000 people) Netherlands Valaciclovir Aurobindo Valaciclovir should not be used in children you, talk to your doctor or pharmacist • unsteadiness when walking and lack of 500 mg, filmomhulde before taking Valaciclovir. under 12 years of age. coordination (ataxia) tabletten Prevent passing genital herpes on to Taking this medicine • slow, slurred speech (dysarthria) Portugal Valaciclovir Aurobindo • Take this medicine by mouth. others • fits (convulsions) Spain Valaciclovir Aurovitas • Swallow the tablets whole with a drink of • altered brain function (encephalopathy) If you are taking Valaciclovir to treat or 500 mg/1000 mg water. • unconsciousness (coma) prevent genital herpes, or you have had comprimidos recubiertos • Take Valaciclovir at the same time each • confused or disturbed thoughts (delirium) con película EFG genital herpes in the past, you should day. United Kingdom Valaciclovir 500 mg still practice safe sex, including the use These nervous system side effects usually • Take Valaciclovir according to occur in people with kidney problems, the film-coated tablets of condoms. This is important to prevent instructions from your doctor or you passing the infection on to others. elderly or in organ transplant patients taking pharmacist. This leaflet was last revised in 07/2020. You should not have sex if you have high doses of 8 grams or more of genital sores or blisters. People over 65 years of age or with Valaciclovir a day. kidney problems They usually get better when Valaciclovir is Other medicines and Valaciclovir stopped or the dose reduced. Tell your doctor or pharmacist if you are It is very important while you are taking, have recently taken or might take taking Valaciclovir that you drink Other rare side effects: any other medicines. water regularly during the day. This • kidney problems where you pass little or

will help to reduce side effects that can P15XXXXX no urine.

Black Note: Pharma Code & Text position shall be change as per machine requirement Tell your doctor or pharmacist if you are affect the kidney or Frequency Not known (cannot be taking any other medicines that affect the nervous system. Your estimated from the available data) kidneys. These include: aminoglycosides, doctor will closely Drug Reaction with Eosinophilia and organoplatinum compounds, iodinated monitor you for signs of Systemic Symptoms also known as DRESS contrast media, methotrexate, pentamidine, these. or drug hypersensitivity syndrome, which is Nervous system side foscarnet, ciclosporin, tacrolimus, cimetidine characterised by widespread rash, high effects might include and probenecid. body temperature, liver enzyme elevations, feeling confused or blood abnormalities (eosinophilia), enlarged Always tell your doctor or pharmacist about agitated, or feeling other medicines if you are taking Valaciclovir unusually sleepy or lymph nodes and possibly other body for treatment of shingles or after having an drowsy. organs involvement. See also section 2. Read all of this leaflet carefully before organ transplant. you start taking this medicine because it If you take more Valaciclovir than you Reporting of side effects If you get any side effects, talk to your contains important information for you. Pregnancy and breast-feeding should - Keep this leaflet. You may need to read it If you are pregnant or breast-feeding, think Valaciclovir is not usually harmful, unless doctor or pharmacist. This includes any again. you may be pregnant or are planning to you take too much over several days. If you possible side effects not listed in this leaflet. - If you have any further questions, ask have a baby, ask your doctor or pharmacist take too many tablets you may feel sick, You can also report side effects directly via your doctor or pharmacist. for advice before taking this medicine. vomit, get kidney problems, may be Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for - This medicine has been prescribed for Valaciclovir is not usually recommended for confused, agitated, feel less aware, see MHRA Yellow Card in the Google Play or you only. Do not pass it on to others. It use during pregnancy. If you are pregnant, things that aren’t there, or become Apple App Store. By reporting side effects may harm them, even if their signs of or think you could be, or if you are planning unconscious.. Talk to your doctor or you can help provide more information on illness are the same as yours. to become pregnant, don’t take Valaciclovir pharmacist if you take too much Valaciclovir. the safety of this medicine. - If you get any side effects, talk to your without checking with your doctor. Your Take the medicine pack with you. doctor or pharmacist . This includes any doctor will weigh up the benefit to you If you forget to take Valaciclovir 5. How to store Valaciclovir possible side effects not listed in this against the risk to your baby of taking • If you forget to take Valaciclovir, take it leaflet. See section 4. Valaciclovir while you're pregnant or as soon as you remember. However, if it Keep this medicine out of the sight and breastfeeding. is nearly time for your next dose, skip the reach of children. What is in this leaflet missed dose. 1. What Valaciclovir is and what it is used Driving and using machines Do not use this medicine after the expiry • Do not take a double dose to make up for for Valaciclovir can cause side effects that date which is stated on the label, carton and affect your ability to drive. a forgotten dose. bottle after ‘EXP:’. The expiry date refers to 2. What you need to know before you take If you have any further questions on the use Valaciclovir  Don’t drive or use machines unless you the last day of the month. are sure you’re not affected. of this product, ask your doctor or 3. How to take Valaciclovir pharmacist. This medicine does not require any special 4. Possible side effects 3. How to take Valaciclovir storage conditions. 5. How to store Valaciclovir 4. Possible side effects Do not throw away any medicines via Always take this medicine exactly as your 6. Contents of the pack and other wastewater or household waste. Ask your information doctor or pharmacist has told you. Check Like all medicines, this medicine can cause with your doctor or pharmacist if you are not side effects, although not everybody gets pharmacist how to throw away medicines 1. What Valaciclovir is and what it is sure. them. The following side effects may you no longer use. These measures will used for happen with this medicine: help protect the environment. The dose that you should take will depend Valaciclovir belongs to a group of medicines on why your doctor has prescribed Conditions you need to look out for 6. Contents of the pack and other called antivirals. It works by killing or Valaciclovir for you. Your doctor will discuss • severe allergic reactions (anaphylaxis). information this with you. stopping the growth of viruses called herpes These are rare in people taking What Valaciclovir contains simplex (HSV), varicella zoster (VZV) and Treatment of shingles Valaciclovir. Rapid development of • The active substance is valaciclovir. cytomegalovirus (CMV). • The recommended dose is 1000 mg (one symptoms including: Each film-coated tablet contains • flushing, itchy skin rash Valaciclovir can be used to: 1000 mg tablet or two 500 mg tablets) valaciclovir hydrochloride (hydrated) • swelling of the lips, face, neck and throat, • treat shingles (in adults) three times a day. equivalent to 500 mg valaciclovir. • treat HSV infections of the skin and • You should take Valaciclovir for seven causing difficulty in breathing genital herpes (in adults and adolescents days. (angiodema) • fall in blood pressure leading to collapse. • The other ingredients are: over 12 years old). It is also used to help Tablet core: Cellulose, microcrystalline, prevent these infections from returning. Treatment of cold sores  If you have an allergic reaction, stop • The recommended dose is 2000 mg (two taking Valaciclovir and see a doctor crospovidone (Type A), povidone (K-90), • treat cold sores (in adults and magnesium stearate adolescents over 12 years old) 1000 mg tablets or four 500 mg tablets) straight away. twice a day. Film coat: Hypromellose 6cP, indigo • prevent infection with CMV after organ (may affect more than 1 in • The second dose should be taken 12 Very Common carmine aluminium lake (E132), titanium transplants (in adults and adolescents 10 people): hours (no sooner than 6 hours) after the dioxide (E171), macrogol 400, over 12 years old) • headache first dose polysorbate 80 • treat and prevent HSV infections of the • You should take Valaciclovir for one day Common (may affect up to 1 in 10 people) eye What Valaciclovir look like and contents (two doses) only. • feeling sick of the pack • dizziness 2. What you need to know before you Treatment of HSV infections of the skin and Film-coated tablet. take Valaciclovir • vomiting genital herpes • diarrhoea Blue, film-coated, capsule shaped tablets • The recommended dose is 500 mg (one Do not take Valaciclovir • skin reaction after exposure to sunlight with a partial score bar on both sides • if you are allergic to valaciclovir or 500 mg tablet) twice a day. (photosensitivity). containing ‘F’ on one side and ‘9’ and ‘3’ on • For the first infection you should take aciclovir or any of the other ingredients of • rash the other side. Valaciclovir for five days or for up to ten this medicine (listed in Section 6). • itching (pruritus) The tablet can be divided into equal doses. days if your doctor tells you to. For • Don’t take Valaciclovir if this applies to recurrent infection the duration of Uncommon (may affect up to 1 in 100 Valaciclovir film-coated tablets are available you. If you are not sure, talk to your treatment is normally 3-5 days. people) in clear PVC/PVdC Aluminium foil blister or doctor or pharmacist before taking • feeling confused in HDPE bottle. Valaciclovir. Helping to prevent HSV infections from • seeing or hearing things that aren’t there Pack sizes; • If you have ever developed an extended returning after you have had them (hallucinations) Blister: 7, 10, 21, 30, 42, 50, 90 & 112 rash associated with fever, enlarged • The recommended dose is one 500 mg • feeling very drowsy tablets lymph node, increased levels of liver tablet once a day. • tremors Bottle: 30 & 500 tablets enzymes and/or eosinophilia (drug • Some people with frequent recurrences • feeling agitated reaction with eosinophilia and systemic may benefit from taking one 250 mg twice Marketing Authorisation Holder a day. These nervous system side effects usually symptoms) after taking valaciclovir. occur in people with kidney problems, the Milpharm Limited • You should take Valaciclovir until your Ares Block, Odyssey Business Park Warnings and precautions doctor tells you to stop. elderly or in organ transplant patients taking Talk to your doctor or pharmacist before high doses of 8 grams or more of West End Road taking Valaciclovir To stop you being infected with CMV Valaciclovir a day. They usually get better Ruislip HA4 6QD • you have kidney problems (Cytomegalovirus) when Valaciclovir is stopped or the dose United Kingdom • you have liver problems • The recommended dose is 2000 mg (two reduced. Manufacturer • you are over 65 years of age 1000 mg tablets or four 500 mg tablets) APL Swift Services (Malta) Limited four times a day. Other uncommon side effects: • your immune system is weak • shortness of breath (dyspnoea) HF26, Hal Far Industrial Estate, Hal Far • Drug reaction with eosinophilia and • You should take each dose about 6 hours Birzebbugia, BBG 3000 apart. • stomach discomfort systemic symptoms (DRESS) has been Malta • You will usually start taking Valaciclovir • rash, sometimes itchy, hive-like rash reported with the use of valaciclovir. as soon as possible after your surgery. (urticaria) DRESS appears initially as flu-like This medicinal product is authorised in • You should take Valaciclovir for around • low back pain (kidney pain) symptoms and a rash on the face then an • blood in urine (haematuria) the Member States of the EEA under the 90 days after your surgery, until your following names: extended rash with a high body doctor tells you to stop. Uncommon side effects that may show up in temperature, increased levels of liver France Valaciclovir Arrow 500 mg, blood tests: comprimé pelliculé enzymes seen in blood tests and an Your doctor may adjust the dose of • reduction in the number of white blood sécable increase in a type of white blood cell Valaciclovir if: cells (leucopenia) Germany Valaciclovir Aurobindo (eosinophilia) and enlarged lymph nodes. • you are over 65 years of age • reduction in the number of blood platelets 500 mg Filmtabletten • If you develop a rash associated with • you have a weak immune system which are cells that help blood to clot Italy Valaciclovir Aurobindo fever and enlarged lymph nodes, stop • you have kidney problems. (thrombocytopenia) 500 mg/ 1000 mg taking valaciclovir and contact your doctor  Talk to your doctor before taking • increase in substances produced by the compresse rivestite con or seek medical attention immediately. Valaciclovir if any of the above apply. liver. film If you are not sure if the above apply to Children under 12 years of age Rare (may affect up to 1 in 1,000 people) Netherlands Valaciclovir Aurobindo you, talk to your doctor or pharmacist Valaciclovir should not be used in children • unsteadiness when walking and lack of 500 mg, filmomhulde before taking Valaciclovir. under 12 years of age. coordination (ataxia) tabletten Prevent passing genital herpes on to Taking this medicine • slow, slurred speech (dysarthria) Portugal Valaciclovir Aurobindo • fits (convulsions) others • Take this medicine by mouth. Spain Valaciclovir Aurovitas • Swallow the tablets whole with a drink of • altered brain function (encephalopathy) 500 mg/1000 mg If you are taking Valaciclovir to treat or water. • unconsciousness (coma) comprimidos recubiertos prevent genital herpes, or you have had • Take Valaciclovir at the same time each • confused or disturbed thoughts (delirium) con película EFG genital herpes in the past, you should day. United Kingdom Valaciclovir 500 mg still practice safe sex, including the use These nervous system side effects usually • Take Valaciclovir according to occur in people with kidney problems, the film-coated tablets of condoms. This is important to prevent instructions from your doctor or you passing the infection on to others. elderly or in organ transplant patients taking pharmacist. This leaflet was last revised in 07/2020. You should not have sex if you have high doses of 8 grams or more of genital sores or blisters. People over 65 years of age or with Valaciclovir a day. kidney problems They usually get better when Valaciclovir is Other medicines and Valaciclovir stopped or the dose reduced. Tell your doctor or pharmacist if you are It is very important while you are taking, have recently taken or might take taking Valaciclovir that you drink Other rare side effects: any other medicines. water regularly during the day. This • kidney problems where you pass little or

will help to reduce side effects that can no urine. P15XXXXX