Valaciclovir 250mg, 500mg and 1000mg 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.
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
What Valaciclovir tablets are and what they are used for
Valaciclovir tablets are an antiviral medicine.
Valaciclovir tablets are used in the following situations:
- in patients over 50 years of age, to treat shingles,
- to treat genital herpes simplex virus (HSV) infections,
- to prevent (suppress) recurrent genital herpes simplex virus (HSV) infections in patients who have at least 6 recurrences per year,
- to prevent cytomegalovirus (CMV) infections and disease after organ transplant.
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).
Take special care with Valaciclovir tablets
- If you have kidney disease or are elderly, your doctor may need to adjust the usual dosage. Let your doctor know if you have kidney disease.
- Let your doctor know if you have liver disease.
- Valaciclovir does not cure genital herpes. It does not completely eliminate the risk of your sexual partner becoming contaminated. You must practice safe sex, in particular condom use, even whilst on treatment with Valaciclovir tablets.
- To avoid dehydration, make sure you drink plenty of water whilst taking Valaciclovir tablets, especially if you are elderly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, especially medicines for acid-related stomach problems (e.g. cimetidine), gout (e.g. probenecid) or immunosuppressants (e.g. mycophenolate mofetil, ciclosporin, tacrolimus), and including medicines obtained without a prescription.
Pregnancy and breast-feeding
You must not take this medicine if you are pregnant without the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, as only your doctor can judge whether you need to continue taking the treatment.
You should not breast-feed during treatment with valaciclovir.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Valaciclovir tablets have no or negligible influence on the ability to drive and use machines. Dizziness can be a side effect of valaciclovir, if you experience this, talk to your doctor before attempting such activities.
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 tablets should be taken by mouth with an ample amount of water.
Adults:
For the prevention of pain associated with shingles
The usual dose is 1000mg 3 times a day for 7 days. You should start taking Valaciclovir tablets no more than 3 days after your symptoms first appeared.
To treat a first genital Herpes simplex virus (HSV) infection
The usual dose is 500mg twice daily for 10 days. You should start taking Valaciclovir tablets as soon as possible at the beginning of the attack, preferably when the first signs of infection develop or at the outbreak of the rash.
To treat recurrent genital Herpes simplex virus (HSV) infection
The usual dose is 1000mg a day for 5 days. The dose can be taken in one or two divided doses, for instance, 500mg in the morning and evening. You should start taking Valaciclovir tablets as soon as possible at the beginning of the attack, preferably when the first signs of infection develop or at the outbreak of the rash.
To prevent recurrent genital Herpes simplex virus (HSV) infection
The usual dose is 500mg a day. The dose can be taken in two divided doses, 250mg in the morning and evening. The value of the treatment is to be re-assessed after 6 to 12 months.
To prevent cytomegalovirus (CMV) infection and disease.
The usual dose is 2000mg 4 times a day for 90 days. The treatment should start as early as possible after the organ transplant.
Adolescents over 12 years of age:
To prevent cytomegalovirus (CMV) infections and disease
The usual dose is 2000mg 4 times a day, usually for 90 days. The treatment should be started as early as possible after the organ transplant.
Children under 12 years of age
Valaciclovir tablets are not recommended for use in children below the age of 12 years due to insufficient data on safety and efficacy.
If you have impaired kidney function
The dose will be adapted by your doctor if you have impaired kidney function.
If you feel that the effect of Valaciclovir tablets is too strong or too weak, contact your doctor or pharmacist.
If you take more Valaciclovir tablets than you should
Inform your doctor. You may experience nausea and/or vomiting (feeling and/or being sick), headache, or confusion.
If you forget to take Valaciclovir tablets
Do not take a double dose to make up for a forgotten dose.
If you stop taking Valaciclovir tablets
You should take Valaciclovir tablets for as long as your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Valaciclovir tablets can cause side effects, although not everybody gets them.
If you experience any of the following, contact your doctor or local hospital casualty department immediately:
Sudden difficulty in breathing, speaking and swallowing; swelling of the lips, face and neck; extreme dizziness or collapse; itchy, raised skin rash. This can be a severe allergic reaction which has been reported very rarely.
If you experience any of the following, contact your doctor immediately:
Frequent and/or severe infections (especially sore throats);
Unexplained fever;
Mouth and/or throat ulcers;
Unusual or unexplained bruising or bleeding;
Small (pin-point) red spots on the skin and/or in the mouth.
These can be symptoms of blood disorders (reduction of white blood cells that protect against infections; reduced platelets that help blood to clot), which have been reported very rarely.
If you experience any of the following side effects, contact your doctor as soon as possible:
Stomach upsets such as feeling sick, vomiting, diarrhoea and stomach pain;
Headaches;
Skin rash (which may also occur after exposure to UV light e.g. sunbathing or using a sun bed).
If you experience any of the following side effects, tell your doctor or pharmacist:
Uncommon (affects 1 to 10 users in 1,000)
- difficulty in breathing (dyspnoea).
Rare (affects 1 to 10 users in 10,000)
- dizziness
- confusion
- hallucinations
- altered mental state
- reduced consciousness
- drowsiness
- abdominal discomfort
- itching
- lmpaired kidney function.
Very rare (affects less than 1 user in 10,000)
- agitation
- distortion of contact with reality (psychotic symptoms)
- involuntary trembling or quivering in any part of the body (tremor)
- lack of co-ordination (ataxia)
- speech problems, unclear pronunciation (dysarthria)
- seizures, convulsions
- disorder of the brain (encephalopathy)
- coma
- reversible increases in liver function tests
- hives (itchy skin rash)
- sudden/severe kidney failure.
If you notice any of the above side effects, they get serious or if you notice any effect not listed, please tell your doctor or pharmacist.
How to store
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 30°C.
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.
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 film-coated 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
Manufacturer
This leaflet was last revised in April 2009
If you would like a leaflet with larger text, please contact 01271 311257.
ACTPL076
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