VALACICLOVIR 500MG TABLETS
Active substance: VALACICLOVIR HYDROCHLORIDE
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Valaciclovir 250mg, 500mg and 1000mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir tablets for treatment of shingles or after having an organ transplant.
Pregnancy and breast-feeding
Valaciclovir is not usually recommended for use during pregnancy. If you are pregnant, or think you could be, or if you are planning to become pregnant, dont take Valaciclovir tablets without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valciclovir tablets while youre pregnant or breastfeeding.
In this leaflet: 1 What Valaciclovir tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information
1 What Valaciclovir tablets are and what they
Driving and using machines
Valaciclovir can cause side effects that affect your ability to drive. Dont drive or use machines unless you are sure youre not affected.
3 How to take
Always take Valaciclovir tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose that you should take will depend on why your doctor has prescribed Valciclovir tablets for you. Your doctor will discuss this with you.
are used for
Valaciclovir belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV). Valaciclovir can be used to: treat shingles (in adults). treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old). It is also used to help prevent these infections from returning. treat cold sores (in adults and adolescents over 12 years old). prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old). treat and prevent HSV infections of the eye.
Treatment of shingles; he usual dose is 1000mg (one 1000mg tablet or two T 500mg tablets) three times a day. You should take Valaciclovir tablets for seven days. Treatment of cold sores he usual dose is 2000mg (two 1000mg tablets or four T 500mg tablets) twice a day. The second dose should be taken 12hours (no sooner than 6hours) after the first dose. You should take valaciclovir for one day (two doses) only.
herpes he usual dose is 500mg (one 500mg tablet or two T 250mg tablets) twice a day. For the first infection you should take Valaciclovir tablets for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3-5 days. after you have had them he usual dose is 250mg twice a day (500mg total T daily dose). Taking one 250mg tablet twice a day may give benefit to some people with frequent recurrences (instead of one 500mg tablet once a day or two 250mg tablets once a day). You should take Valaciclovir tablets until your doctor tells you to stop. (Cytomegalovirus) he usual dose is 2000mg (two 1000mg tablets or four T 500mg tablets) four times a day. You should take each dose about 6hours apart. You will usually start taking Valaciclovir tablets as soon as possible after your surgery. You should take Valaciclovir tablets for around 90 days after your surgery, until your doctor tells you to stop.
Treatment of HSV infections of the skin and genital
2 Before you take Do not take Valaciclovir tablets if you are allergic (hypersensitive) to valaciclovir,
aciclovir or any of the other ingredients of Valaciclovir tablets (see section 6). If you are not sure, talk to your doctor or pharmacist before taking valaciclovir tablets.
Helping to prevent HSV infections from returning
Take special care with Valaciclovir tablets Check with your doctor or pharmacist before taking Valaciclovir tablets if: you have kidney problems you have liver problems you are over 65 years of age your immune system is weak If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking valaciclovir. Prevent passing genital herpes on to others If you are taking Valaciclovir tablets to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.
To stop you being infected with CMV
Children under 12 years of age
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.
continued top of next column L20344ACT-30
Valaciclovir tablets are not recommended for use in children below the age of 12 years due to insufficient data on safety and efficacy.
Talk to your doctor before taking Valaciclovir tablet if any of the above apply.
continued over page
Your doctor may adjust the dose of valaciclovir tablets if: you are over 65 years of age you have a weak immune system you have kidney problems.
Taking this medicine
Take this medicine by mouth. Swallow the tablets whole with a drink of water. Take Valaciclovir tablets at the same time each day. Take Valaciclovir tablets according to instructions from your doctor or pharmacist.
People over 65 years of age or with kidney problems
It is very important while you are taking valaciclovir tablets that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.
Rare (affects 1 to 10 users in 10,000) unsteadiness when walking and lack of coordination (ataxia) slow, slurred speech (dysarthria) fits (convulsions) altered brain function (encephalopathy) unconsciousness (coma) confused or disturbed thoughts disorientation and confusion often accompanied by hallucinations (delirium) These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8grams or more of valaciclovir a day. They usually get better when valaciclovir is stopped or the dose reduced. Other rare side effects: kidney problems where you pass little or no urine. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, or be confused, agitated or unusually sleepy. Talk to your doctor or pharmacist if you take too much valaciclovir. Take the medicine pack with you.
If you take more valaciclovir tablets than you should
If you forget to take valaciclovir tablets
5 How to store
If you forget to take valaciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Dont take a double dose to make up for a forgotten dose. Like all medicines, Valaciclovir tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
4 Possible side effects
Keep out of the reach and sight of children. Do not use Valaciclovir tablets after the expiry date stated on the label, carton or bottle as EXP. The expiry date refers to the last day of that month. Do not store above 30C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
people taking valaciclovir tablets. Rapid development of symptoms including: flushing, itchy skin rash, swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema), fall in blood pressure leading to collapse. f you have an allergic reaction, stop taking valaciclovir I tablets and see a doctor straight away. Very Common (affects more than 1 user in 10): headache Common (affects 1 to 10 users in 100): feeling sick dizziness vomiting diarrhoea skin reaction after exposure to sunlight (photosensitivity). rash Uncommon (affects 1 to 10 users in 1,000): feeling confused seeing or hearing things that arent there (hallucinations) feeling very drowsy tremors feeling agitated These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of valaciclovir a day. They usually get better when valaciclovir is stopped or the dose reduced. Other uncommon side effects: shortness of breath (dyspnoea) stomach discomfort rash, sometimes itchy, hive-like rash (urticaria) low back pain (kidney pain) blood in the urine (haematuria) Uncommon side effects that may show up in blood tests: reduction in the number of white blood cells (leucopenia) reduction in the number of blood platelets which are cells that help blood to clot (thrombocytopenia) increase in substances produced by the liver.
Conditions you need to look out for severe allergic reactions (anaphylaxis). These are rare in
6 Further information What Valaciclovir tablets contain The active substance is valaciclovir. Each tablet
contains either 250mg, 500mg, 1000mg valaciclovir (as valaciclovir hydrochloride monohydrate). The other ingredients are tablet core: cellulose microcrystalline, povidone, magnesium stearate, tablet coating (Opadry White Y-5-7068): hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol 400, hypromellose.
What Valaciclovir tablets look like and contents of the pack
Valaciclovir tablets are oval, white, biconvex and filmcoated with the following size and markings: 250mg tablets: 13.8 x 6.9mm with VC1 on one side 500mg tablets: 17.6 x 8.8mm with VC2 on one side 1000mg tablets: 22.0 x 11.0mm with VC3 on one side PVC/aluminium blister Pack sizes (Blisters): 10, 20, 21, 24, 30, 42, 60, 90 film-coated tablets HDPE containers with tamper evident LDPE cap Pack sizes (Bottles): 10, 30, 100, 250 film-coated tablets Not all pack sizes may be marketed. Marketing Authorisation Holder Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland Manufacturer Actavis hf Reykjavikurvegur 76 IS-220 Hafnarfjordur, Iceland This leaflet was last revised in June 2011.
Ifyouwouldlikea leafletwithlarger text,pleasecontact 01271311257.
continued top of next column L20344ACT-30
Actavis,Barnstaple,EX328NS,UK
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir tablets for treatment of shingles or after having an organ transplant.
Pregnancy and breast-feeding
Valaciclovir is not usually recommended for use during pregnancy. If you are pregnant, or think you could be, or if you are planning to become pregnant, dont take Valaciclovir tablets without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valciclovir tablets while youre pregnant or breastfeeding.
In this leaflet: 1 What Valaciclovir tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information
1 What Valaciclovir tablets are and what they
Driving and using machines
Valaciclovir can cause side effects that affect your ability to drive. Dont drive or use machines unless you are sure youre not affected.
3 How to take
Always take Valaciclovir tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose that you should take will depend on why your doctor has prescribed Valciclovir tablets for you. Your doctor will discuss this with you.
are used for
Valaciclovir belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV). Valaciclovir can be used to: treat shingles (in adults). treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old). It is also used to help prevent these infections from returning. treat cold sores (in adults and adolescents over 12 years old). prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old). treat and prevent HSV infections of the eye.
Treatment of shingles; he usual dose is 1000mg (one 1000mg tablet or two T 500mg tablets) three times a day. You should take Valaciclovir tablets for seven days. Treatment of cold sores he usual dose is 2000mg (two 1000mg tablets or four T 500mg tablets) twice a day. The second dose should be taken 12hours (no sooner than 6hours) after the first dose. You should take valaciclovir for one day (two doses) only.
herpes he usual dose is 500mg (one 500mg tablet or two T 250mg tablets) twice a day. For the first infection you should take Valaciclovir tablets for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3-5 days. after you have had them he usual dose is 250mg twice a day (500mg total T daily dose). Taking one 250mg tablet twice a day may give benefit to some people with frequent recurrences (instead of one 500mg tablet once a day or two 250mg tablets once a day). You should take Valaciclovir tablets until your doctor tells you to stop. (Cytomegalovirus) he usual dose is 2000mg (two 1000mg tablets or four T 500mg tablets) four times a day. You should take each dose about 6hours apart. You will usually start taking Valaciclovir tablets as soon as possible after your surgery. You should take Valaciclovir tablets for around 90 days after your surgery, until your doctor tells you to stop.
Treatment of HSV infections of the skin and genital
2 Before you take Do not take Valaciclovir tablets if you are allergic (hypersensitive) to valaciclovir,
aciclovir or any of the other ingredients of Valaciclovir tablets (see section 6). If you are not sure, talk to your doctor or pharmacist before taking valaciclovir tablets.
Helping to prevent HSV infections from returning
Take special care with Valaciclovir tablets Check with your doctor or pharmacist before taking Valaciclovir tablets if: you have kidney problems you have liver problems you are over 65 years of age your immune system is weak If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking valaciclovir. Prevent passing genital herpes on to others If you are taking Valaciclovir tablets to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.
To stop you being infected with CMV
Children under 12 years of age
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.
continued top of next column L20344ACT-30
Valaciclovir tablets are not recommended for use in children below the age of 12 years due to insufficient data on safety and efficacy.
Talk to your doctor before taking Valaciclovir tablet if any of the above apply.
continued over page
Your doctor may adjust the dose of valaciclovir tablets if: you are over 65 years of age you have a weak immune system you have kidney problems.
Taking this medicine
Take this medicine by mouth. Swallow the tablets whole with a drink of water. Take Valaciclovir tablets at the same time each day. Take Valaciclovir tablets according to instructions from your doctor or pharmacist.
People over 65 years of age or with kidney problems
It is very important while you are taking valaciclovir tablets that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.
Rare (affects 1 to 10 users in 10,000) unsteadiness when walking and lack of coordination (ataxia) slow, slurred speech (dysarthria) fits (convulsions) altered brain function (encephalopathy) unconsciousness (coma) confused or disturbed thoughts disorientation and confusion often accompanied by hallucinations (delirium) These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8grams or more of valaciclovir a day. They usually get better when valaciclovir is stopped or the dose reduced. Other rare side effects: kidney problems where you pass little or no urine. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, or be confused, agitated or unusually sleepy. Talk to your doctor or pharmacist if you take too much valaciclovir. Take the medicine pack with you.
If you take more valaciclovir tablets than you should
If you forget to take valaciclovir tablets
5 How to store
If you forget to take valaciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose. Dont take a double dose to make up for a forgotten dose. Like all medicines, Valaciclovir tablets can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
4 Possible side effects
Keep out of the reach and sight of children. Do not use Valaciclovir tablets after the expiry date stated on the label, carton or bottle as EXP. The expiry date refers to the last day of that month. Do not store above 30C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
people taking valaciclovir tablets. Rapid development of symptoms including: flushing, itchy skin rash, swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema), fall in blood pressure leading to collapse. f you have an allergic reaction, stop taking valaciclovir I tablets and see a doctor straight away. Very Common (affects more than 1 user in 10): headache Common (affects 1 to 10 users in 100): feeling sick dizziness vomiting diarrhoea skin reaction after exposure to sunlight (photosensitivity). rash Uncommon (affects 1 to 10 users in 1,000): feeling confused seeing or hearing things that arent there (hallucinations) feeling very drowsy tremors feeling agitated These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of valaciclovir a day. They usually get better when valaciclovir is stopped or the dose reduced. Other uncommon side effects: shortness of breath (dyspnoea) stomach discomfort rash, sometimes itchy, hive-like rash (urticaria) low back pain (kidney pain) blood in the urine (haematuria) Uncommon side effects that may show up in blood tests: reduction in the number of white blood cells (leucopenia) reduction in the number of blood platelets which are cells that help blood to clot (thrombocytopenia) increase in substances produced by the liver.
Conditions you need to look out for severe allergic reactions (anaphylaxis). These are rare in
6 Further information What Valaciclovir tablets contain The active substance is valaciclovir. Each tablet
contains either 250mg, 500mg, 1000mg valaciclovir (as valaciclovir hydrochloride monohydrate). The other ingredients are tablet core: cellulose microcrystalline, povidone, magnesium stearate, tablet coating (Opadry White Y-5-7068): hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol 400, hypromellose.
What Valaciclovir tablets look like and contents of the pack
Valaciclovir tablets are oval, white, biconvex and filmcoated with the following size and markings: 250mg tablets: 13.8 x 6.9mm with VC1 on one side 500mg tablets: 17.6 x 8.8mm with VC2 on one side 1000mg tablets: 22.0 x 11.0mm with VC3 on one side PVC/aluminium blister Pack sizes (Blisters): 10, 20, 21, 24, 30, 42, 60, 90 film-coated tablets HDPE containers with tamper evident LDPE cap Pack sizes (Bottles): 10, 30, 100, 250 film-coated tablets Not all pack sizes may be marketed. Marketing Authorisation Holder Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland Manufacturer Actavis hf Reykjavikurvegur 76 IS-220 Hafnarfjordur, Iceland This leaflet was last revised in June 2011.
Ifyouwouldlikea leafletwithlarger text,pleasecontact 01271311257.
continued top of next column L20344ACT-30
Actavis,Barnstaple,EX328NS,UK
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
