Valaciclovir 500 mg Tablets

(valaciclovir hydrochloride)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

This medicine is available using the above name but will be referred to as Valaciclovir throughout this leaflet. Also available in 250 mg tablets.

What is in this leaflet:

• 1. What Valaciclovir is and what it is used for

• 2. What you need to know before you take Valaciclovir

• 3. How to take Valaciclovir

• 4. Possible side effects

• 5. How to store Valaciclovir

• 6. Contents of the pack and other information

1. what valaciclovir is and what it is 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 that continue to come back (in adults and adolescents over 12 years old)

2. what you need to know before you take valaciclovir do not take valaciclovir

• – if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in Section 6).

• – if you have ever developed an extended rash associated with fever, enlarged lymph nodes, increased levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

• – » Don’t take Valaciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir 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.

Take special care with Valaciclovir – Important Information:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS appears initially as flu like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

• - » If you develop a rash associated with a fever and enlarged lymph nodes, stop taking valaciclovir and contact your doctor or seek medical attention immediately.

Prevent passing genital herpes on to others

If you are taking Valaciclovir 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.

Other medicines and Valaciclovir

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.

Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir 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, don’t take Valaciclovir without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir while you’re pregnant or breastfeeding.

Driving and using machines

Valaciclovir can cause side effects that affect your ability to drive.

^ Don’t drive or use machines unless you are sure you’re not affected.

3. how to take valaciclovir

Always take this medicine 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 Valaciclovir for you. Your doctor will discuss this with you.

Treatment of shingles

• – The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.

• – You should take Valaciclovir for seven days.

Treatment of cold sores

• – The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.

• – The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose

• – You should take Valaciclovir for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

• – The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.

• – For the first infection you should take Valaciclovir 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.

Helping to prevent HSV infections from returning after you have had them

• – The usual dose is one 500 mg tablet once a day.

• – Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.

• – You should take Valaciclovir until your doctor tells you to stop.

To stop you being infected with CMV ( Cytomegalovirus )

• – The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.

• – You should take each dose about 6 hours apart.

• – You will usually start taking Valaciclovir as soon as possible after your surgery.

• – You should take Valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir if:

• – you are over 65 years of age

• – you have a weak immune system

• – you have kidney problems.

^Talk to your doctor before taking Valaciclovir if any of the above apply.

Taking this medicine

• – Take this medicine by mouth.

• – Swallow the tablets whole with a drink of water.

• – Take Valaciclovir at the same time each day.

• – Take Valaciclovir 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 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.

If you take more Valaciclovir than you should

Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, get kidney problems, maybe confused, agitated, feel less aware, see things that aren’t there, or become unconscious. Talk to your doctor or pharmacist if you take too much Valaciclovir. Take the medicine pack with you.

If you forget to take Valaciclovir

• – 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.

• – Don’t take a double dose to make up for a forgotten dose.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for:

^ Stop using Valaciclovir and seek medical attention immediately if you notice any of the following symptoms:

Severe allergic reactions (anaphylaxis ). These are rare in people taking Valaciclovir. 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.

Skin rashes or redness. The adverse reaction of the skin may appear as rashes with or without blisters. Skin irritation, oedema (DRESS syndrome) and fever and flu like symptoms may occur.

The following side effects may also happen with this medicine:

Very Common (may affect more than 1 in 10 people): – headache

Common (may affect up to 1 in 10 people)

• – feeling sick

• – dizziness

• – vomiting

• – diarrhoea

• – skin reaction after exposure to sunlight (photosensiti­vity ).

• – rash

• – Itching (pruritus )

Uncommon (may affect up to 1 in 100 people)

• – feeling confused

• – seeing or hearing things that aren’t 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 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.

Rare (may affect up to 1 in 1,000 people)

• – unsteadiness when walking and lack of coordination (ataxia )

• – slow, slurred speech (dysarthria )

• – fits (convulsions)

• – altered brain function (encephalopathy )

• – unconsciousness (coma)

• – confused or disturbed thoughts (delirium)

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 rare side effects:

• – kidney problems where you pass little or no urine.

Frequency Not Known (cannot be estimated from the available data) Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug reaction hypersensitivity syndrome, which is characterised by widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store valaciclovir

• – Keep out of the sight and reach of children.

• – Do not store above 30°C.

• – Do not use Valaciclovir after the expiry date which is stated on the carton. The expiry date (Exp.) refers to the last day of that month.

• – If your tablets become discoloured or show any signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

• – Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. contents of the pack and other information

What Valaciclovir contains

Each film-coated tablet contains the active ingredient 500 mg valaciclovir (as hydrochloride).

There are also some inactive ingredients in Valaciclovir which are needed to make the tablet. These are microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E 171), macrogol 400, carnauba wax and polysorbate 80.

What Valaciclovir looks like and contents of the pack

Valaciclovir 500 mg Tablets

(valaciclovir hydrochloride)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 signs of illness are the same as yours.

- if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

This medicine is available using the above name but will be referred to as Valaciclovir throughout this leaflet. Also available in 250 mg tablets.

What is in this leaflet:

• 1. What Valaciclovir is and what it is used for

• 2. What you need to know before you take Valaciclovir

• 3. How to take Valaciclovir

• 4. Possible side effects

• 5. How to store Valaciclovir

• 6. Contents of the pack and other information

1. what valaciclovir is and what it is 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 that continue to come back (in adults and adolescents over 12 years old)

2. what you need to know before you take valaciclovir do not take valaciclovir

• – if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in Section 6).

• – if you have ever developed an extended rash associated with fever, enlarged lymph nodes, increased levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

• – » Don’t take Valaciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir 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.

Take special care with Valaciclovir – Important Information:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS appears initially as flu like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

• - » If you develop a rash associated with a fever and enlarged lymph nodes, stop taking valaciclovir and contact your doctor or seek medical attention immediately.

Prevent passing genital herpes on to others

If you are taking Valaciclovir 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.

Other medicines and Valaciclovir

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.

Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir 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, don’t take Valaciclovir without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir while you’re pregnant or breastfeeding.

Driving and using machines

Valaciclovir can cause side effects that affect your ability to drive.

^ Don’t drive or use machines unless you are sure you’re not affected.

3. how to take valaciclovir

Always take this medicine 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 Valaciclovir for you. Your doctor will discuss this with you.

Treatment of shingles

• – The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.

• – You should take Valaciclovir for seven days.

Treatment of cold sores

• – The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.

• – The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose

• – You should take Valaciclovir for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

• – The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.

• – For the first infection you should take Valaciclovir 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.

Helping to prevent HSV infections from returning after you have had them

• – The usual dose is one 500 mg tablet once a day.

• – Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.

• – You should take Valaciclovir until your doctor tells you to stop.

To stop you being infected with CMV ( Cytomegalovirus )

• – The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.

• – You should take each dose about 6 hours apart.

• – You will usually start taking Valaciclovir as soon as possible after your surgery.

• – You should take Valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir if:

• – you are over 65 years of age

• – you have a weak immune system

• – you have kidney problems.

^Talk to your doctor before taking Valaciclovir if any of the above apply.

Taking this medicine

• – Take this medicine by mouth.

• – Swallow the tablets whole with a drink of water.

• – Take Valaciclovir at the same time each day.

• – Take Valaciclovir 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 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.

If you take more Valaciclovir than you should

Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, get kidney problems, maybe confused, agitated, feel less aware, see things that aren’t there, or become unconscious. Talk to your doctor or pharmacist if you take too much Valaciclovir. Take the medicine pack with you.

If you forget to take Valaciclovir

• – 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.

• – Don’t take a double dose to make up for a forgotten dose.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for:

^ Stop using Valaciclovir and seek medical attention immediately if you notice any of the following symptoms:

Severe allergic reactions (anaphylaxis ). These are rare in people taking Valaciclovir. 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.

Skin rashes or redness. The adverse reaction of the skin may appear as rashes with or without blisters. Skin irritation, oedema (DRESS syndrome) and fever and flu like symptoms may occur.

The following side effects may also happen with this medicine:

Very Common (may affect more than 1 in 10 people): – headache

Common (may affect up to 1 in 10 people)

• – feeling sick

• – dizziness

• – vomiting

• – diarrhoea

• – skin reaction after exposure to sunlight (photosensiti­vity ).

• – rash

• – Itching (pruritus )

Uncommon (may affect up to 1 in 100 people)

• – feeling confused

• – seeing or hearing things that aren’t 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 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.

Rare (may affect up to 1 in 1,000 people)

• – unsteadiness when walking and lack of coordination (ataxia )

• – slow, slurred speech (dysarthria )

• – fits (convulsions)

• – altered brain function (encephalopathy )

• – unconsciousness (coma)

• – confused or disturbed thoughts (delirium)

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 rare side effects:

• – kidney problems where you pass little or no urine.

Frequency Not Known (cannot be estimated from the available data) Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug reaction hypersensitivity syndrome, which is characterised by widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store valaciclovir

• – Keep out of the sight and reach of children.

• – Do not store above 30°C.

• – Do not use Valaciclovir after the expiry date which is stated on the carton. The expiry date (Exp.) refers to the last day of that month.

• – If your tablets become discoloured or show any signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

• – Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. contents of the pack and other information

What Valaciclovir contains

Each film-coated tablet contains the active ingredient 500 mg valaciclovir (as hydrochloride).

There are also some inactive ingredients in Valaciclovir which are needed to make the tablet. These are microcrystalline cellulose, crospovidone, povidone K90, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E 171), macrogol 400, carnauba wax and polysorbate 80.

What Valaciclovir looks like and contents of the pack

Valaciclovir is available as white capsule shaped bi-convex film-coated tablets.

Comes In blister strips pack of 42 tablets.

Manufacturer and product licence holder

Manufactured by Glaxo Operations U.K. Ltd., Priory Street, Ware, U.K.

Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

| POM | | PL 20636/1435 ~~|

Leaflet revision and issue date (Ref) 10.06.21[13]

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

Valaciclovir 500 mg Tablets

(valaciclovir hydrochloride)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 signs of illness are the same as yours.

– if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

This medicine is available using the above name but will be referred to as Valaciclovir throughout this leaflet. Also available in 250 mg tablets.

What is in this leaflet:

• 1. What Valaciclovir is and what it is used for

• 2. What you need to know before you take Valaciclovir

• 3. How to take Valaciclovir

• 4. Possible side effects

• 5. How to store Valaciclovir

• 6. Contents of the pack and other information

1. what valaciclovir is and what it is 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 that continue to come back (in adults and adolescents over 12 years old)

2. what you need to know before you take valaciclovir do not take valaciclovir

• – if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in Section 6).

• – if you have ever developed an extended rash associated with fever, enlarged lymph nodes, increased levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

• – » Don’t take Valaciclovir if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir 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.

Take special care with Valaciclovir – Important Information:

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS appears initially as flu like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

• - » If you develop a rash associated with a fever and enlarged lymph nodes, stop taking valaciclovir and contact your doctor or seek medical attention immediately.

Prevent passing genital herpes on to others

If you are taking Valaciclovir 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.

Other medicines and Valaciclovir

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.

Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir 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, don’t take Valaciclovir without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir while you’re pregnant or breastfeeding.

Driving and using machines

Valaciclovir can cause side effects that affect your ability to drive.

^ Don’t drive or use machines unless you are sure you’re not affected.

3. how to take valaciclovir

Always take this medicine 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 Valaciclovir for you. Your doctor will discuss this with you.

Treatment of shingles

• – The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.

• – You should take Valaciclovir for seven days.

Treatment of cold sores

• – The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.

• – The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose

• – You should take Valaciclovir for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

• – The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.

• – For the first infection you should take Valaciclovir 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.

Helping to prevent HSV infections from returning after you have had them

• – The usual dose is one 500 mg tablet once a day.

• – Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.

• – You should take Valaciclovir until your doctor tells you to stop.

To stop you being infected with CMV ( Cytomegalovirus )

• – The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.

• – You should take each dose about 6 hours apart.

• – You will usually start taking Valaciclovir as soon as possible after your surgery.

• – You should take Valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir if:

• – you are over 65 years of age

• – you have a weak immune system

• – you have kidney problems.

^Talk to your doctor before taking Valaciclovir if any of the above apply.

Taking this medicine

• – Take this medicine by mouth.

• – Swallow the tablets whole with a drink of water.

• – Take Valaciclovir at the same time each day.

• – Take Valaciclovir 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 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.

If you take more Valaciclovir than you should

Valaciclovir is not usually harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, get kidney problems, maybe confused, agitated, feel less aware, see things that aren’t there, or become unconscious. Talk to your doctor or pharmacist if you take too much Valaciclovir. Take the medicine pack with you.

If you forget to take Valaciclovir

• – 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.

• – Don’t take a double dose to make up for a forgotten dose.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions you need to look out for:

^ Stop using Valaciclovir and seek medical attention immediately if you notice any of the following symptoms:

Severe allergic reactions (anaphylaxis ). These are rare in people taking Valaciclovir. 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.

Skin rashes or redness. The adverse reaction of the skin may appear as rashes with or without blisters. Skin irritation, oedema (DRESS syndrome) and fever and flu like symptoms may occur.

The following side effects may also happen with this medicine:

Very Common (may affect more than 1 in 10 people): – headache

Common (may affect up to 1 in 10 people)

• – feeling sick

• – dizziness

• – vomiting

• – diarrhoea

• – skin reaction after exposure to sunlight (photosensiti­vity ).

• – rash

• – Itching (pruritus )

Uncommon (may affect up to 1 in 100 people)

• – feeling confused

• – seeing or hearing things that aren’t 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 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.

Rare (may affect up to 1 in 1,000 people)

• – unsteadiness when walking and lack of coordination (ataxia )

• – slow, slurred speech (dysarthria )

• – fits (convulsions)

• – altered brain function (encephalopathy )

• – unconsciousness (coma)

• – confused or disturbed thoughts (delirium)

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 rare side effects:

• – kidney problems where you pass little or no urine.

Frequency Not Known (cannot be estimated from the available data) Drug Reaction with Eosinophilia and Systemic Symptoms also known as DRESS or drug reaction hypersensitivity syndrome, which is characterised by widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other body organs. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store valaciclovir

• – Keep out of the sight and reach of children.

• – Do not store above 30°C.

• – Do not use Valaciclovir after the expiry date which is stated on the carton. The expiry date (Exp.) refers to the last day of that month.

• – If your tablets become discoloured or show any signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

• – Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.