Valaciclovir 500 mg Film Coated Tablets

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.

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

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.

• Do not 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 breast-feeding.

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.

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 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.
• Do not take a double dose to make up for a forgotten dose.

Conditions you need to look out for:

• Stop using Valciclovir 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 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.

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

Manufacturer