VALACICLOVIR 250 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - VALACICLOVIR 250 MG FILM-COATED TABLETS

Valaciclovir 250 mg and 500 mg film-coated tablets

Valaciclovir

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 only. 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.

What is in this leaflet

1. What Valaciclovir tablets are and what they are used for
2. What you need to know before you take Valaciclovir tablets
3. How to take Valaciclovir tablets
4. Possible side effects
5. How to store Valaciclovir tablets
6. Contents of the pack and other information

1. What Valaciclovir tablets are and what they 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 that continue to come back (in adults and adolescents over 12 years old)

2. what you need to know before you take valaciclovir tablets 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 node, increased

levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after 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
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 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, have recently taken or might take any other 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 breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir while you are pregnant or breast-feeding.

Driving and using machines

Valaciclovir can cause side effects that affect your ability to drive. Do not drive or use machines unless you are sure you are not affected.

3. how to take valaciclovir tablets

Always take this medicine exactly as your doctor has told you. 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, may be confused, agitated, feel less aware, see things that are not 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.
Do not 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.

The following side effects may happen with this medicine:

Conditions you need to look out for

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.

If you have an allergic reaction, stop taking Valaciclovir and see a doctor straight away.

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 (pruritis)

Uncommon (may affect up to 1 in 100 people)

feeling confused
seeing or hearing things that are not 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)

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 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 involvement. 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 tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton or bottle. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information the active substance is valaciclovir.

Each film-coated tablet contains 250 mg or 500 mg of valaciclovir (as valaciclovir

hydrochloride monohydrate).

The other ingredients are microcrystalline cellulose, povidone, magnesium stearate,

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:

250 mg tablets: 13.8 × 6.9 mm with VC1 on one side

500 mg tablets: 17.6 × 8.8 mm with VC2 on one side

All strengths are available in blister packs or plastic tablet containers of 4, 7, 10, 14, 28, 30, 42, 50, 56, 60, 90, 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Torrent Pharma (UK) Ltd.

3rd Floor, Nexus Building,

4 Gatwick Road,

Crawley,

West Sussex,

RH10 9BG,

United Kingdom

Manufacturer

Actavis Hf. Reykjavikurvegi 78, IS-220 Hafnafjordur, Iceland

This leaflet was last revised in 08/2020