What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0632 .

Valaciclovir 500 mg Film Coated Tablets

Package Leaflet: Information for the patient

Valaciclovir 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, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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 is a prescription only anti-viral medicine.

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 infections of the eye

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).
  • Do not take Valaciclovir if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir.

Warnings and precautions

Talk to your doctor, pharmacist or nurse 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.

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. 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 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're pregnant or breast-feeding.

Driving and using machines

Valaciclovir can cause side effects such as dizziness 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 or pharmacist 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.

You should start taking the tablets at the earliest symptoms of cold sores (e.g. tingling, itching or burning)

Treatment of HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old)

  • 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 (in adults and adolescents over 12 years old)

  • 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, 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 forget to take Valaciclovir

  • If you forget to take Valaciclovir take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Valaciclovir

You should not stop or adjust valaciclovir treatment without consulting your medical professional. Also when the symptoms disappear, the course of treatment should be finished. Otherwise the infection may recur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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). This is 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 (angioedema)
  • 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

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 (may affect up to 1 in 100 people)

  • 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 (may affect up to 1 in 100 people)

  • frequent infections such as fever, severe chills, sore throat or mouth ulcers. These symptoms may be due to 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
  • acute confusional state (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 (may affect up to 1 in 1,000 people):

  • kidney problems where you pass little or no urine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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 this medicine out of the sight and reach of children.

Do not use Valaciclovir after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store Valaciclovir below 30 °C.

Store Valaciclovir in the original packaging.

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

What Valaciclovir contains

  • The active substance is valaciclovir (as hydrochloride)
  • The other ingredients are microcrystalline cellulose (E460), crospovidone (E1202), FD&C Blue #2 Aluminium Lake (11-14%) (E132), povidone (K 30) (E1201), povidone (K 90D) (E1201), magnesium stearate (E470b), opadry 02C 50740 Blue consisting of: hypromellose (5 cP) (E464), titanium dioxide (E171), macrogol/PEG 400, macrogol/PEG 6000, FD&C Blue #2 Aluminium Lake (30-36%) (E132), polysorbate 80 (E433).

What Valaciclovir looks like and contents of the pack

Valaciclovir are blue, capsule shaped, biconvex, film-coated tablets with ‘V’ and ‘5’ embossed on either side of the score line on one side and a notch on either side of the score line and smooth on the other side of the tablet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ranbaxy (UK) Limited
5th floor
Hyde Park
Hayes 3
11 Millington Road
Hayes
UB3 4AZ
United Kingdom

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania

This leaflet was last revised in May 2019.