Zelitrex

Package leaflet: Information for the user

Zelitrex 250 mg film-coated tablets, 500 mg film-coated tablets, 1000 mg film-coated tablets

Valaciclovir
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Zelitrex is and what it is used for
2. What you need to know before taking Zelitrex
3. How to take Zelitrex
4. Possible side effects
5. How to store Zelitrex
6. Contents of the pack and other information

1. What Zelitrex is and what it is used for

Zelitrex belongs to a group of medicines called antivirals. It works by killing or
blocking the growth of viruses known as herpes simplex (HSV), varicella zoster (VZV), and
cytomegalovirus (CMV).
Zelitrex can be used for:

• treating shingles (in adults)
• treating HSV skin infections and genital herpes (in adults and adolescents over 12 years of age). It is also used to help prevent the recurrence of these infections.
• treating cold sores (in adults and adolescents over 12 years of age)
• preventing CMV infections after organ transplantation (in adults and adolescents over 12 years of age)
• treating and preventing recurrent HSV eye infections (in adults and adolescents over 12 years of age)

2. Before taking Zelitrex

Do not take Zelitrex

• If you are allergic to valaciclovir or aciclovir, or to any of the other ingredients of this medicine (listed in section 6).
• Do not take Zelitrex if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Zelitrex.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zelitrex if:

• you have kidney problems
• you have liver problems
• you are over 65 years of age
• your immune system is weakened

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Zelitrex.
To prevent transmission of genital herpes to other people
If you are taking Zelitrex to treat or prevent genital herpes, or if you have previously had genital herpes, you must practice protected sex, including the use of condoms. This is important to prevent spreading the infection to others. You should not have sexual intercourse if you have pain or blisters in the genital area.

Other medicines and Zelitrex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal medicines.
Inform your doctor or pharmacist if you are taking any other medicine that affects the kidneys.
These include: aminoglycosides, platinum-containing compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.
Always inform your doctor or pharmacist about any other medicines you are taking while being treated with Zelitrex for shingles or following an organ transplant.

Pregnancy and breastfeeding
Zelitrex is generally not recommended during pregnancy. If you are pregnant, think you might be pregnant, or are planning to become pregnant, do not take Zelitrex without first consulting your doctor.
Your doctor will assess the benefits to you and the risks to your unborn child of taking Zelitrex during pregnancy or while breastfeeding.

Driving and using machines
Zelitrex may cause side effects that could affect your ability to drive.
Do not drive or operate machinery unless you are certain you are not affected.

3. How to take Zelitrex

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The dose you should take depends on why your doctor has prescribed Zelitrex for you. Your doctor will discuss this with you.

Treatment of herpes zoster (shingles)

• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• You should take Zelitrex for seven days.

Treatment of cold sores (herpes labialis)

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
• You should take Zelitrex for one day only (two doses).

Treatment of HSV skin infections and genital herpes

• The recommended dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.
• For a first infection, you should take Zelitrex for five days, or up to ten days if your doctor recommends it. For recurrent infections, the treatment duration is usually between 3 and 5 days.

To help prevent recurrence of HSV infections after you have had them

• The recommended dose is one 500 mg tablet once a day.
• Some people with frequent recurrent infections may benefit from taking one 250 mg tablet twice a day.
• You should take Zelitrex until your doctor tells you to stop.

To prevent CMV (Cytomegalovirus) infection

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• Each dose should be taken approximately 6 hours apart.
• You will normally start taking Zelitrex as soon as possible after transplantation.
• You will need to take Zelitrex for about 90 days after transplantation, or until your doctor tells you to stop.

Your doctor may adjust your dose of Zelitrex if:

• you are over 65 years of age
• you have a weakened immune system
• you have kidney problems. Inform your doctor before taking Zelitrex if any of the above apply to you.

How to take the medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Zelitrex at the same time each day.
• Take Zelitrex exactly as directed by your doctor or pharmacist.

People over 65 years of age or with kidney problems
It is very important that you drink water regularly throughout the day while taking Zelitrex.
This will help reduce the risk of unwanted effects on the kidneys or nervous system. Your doctor will monitor you closely for signs of such effects. Nervous system side effects may include confusion or agitation, unusual drowsiness or numbness.

If you take more Zelitrex than you should
Zelitrex is generally not harmful unless you take too much for several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, confusion, agitation, reduced awareness, hallucinations (seeing things that are not there), or loss of consciousness. Inform your doctor or pharmacist immediately if you have taken too much Zelitrex. Take the medicine pack with you.

If you forget to take Zelitrex

• If you forget to take a dose, 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Conditions you should pay attention to

• severe allergic reactions (anaphylaxis). These are rare in people taking Zelitrex. Rapid onset of symptoms including:
• flushing, itchy skin rash
• swelling of the lips, face, neck and throat causing breathing difficulties (angioedema)
• sudden drop in blood pressure leading to collapse. If you experience an allergic reaction, stop taking Zelitrex and contact your doctor immediately.

Very common (may affect more than 1 in 10 people):

• headache

Common (may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight (photosensitivity)
• skin rash
• itching

Uncommon (may affect up to 1 in 100 people):

• confusion
• seeing or hearing things that are not there (hallucinations)
• marked numbness
• tremors
• agitation

These nervous system side effects generally occur in people with kidney problems, elderly patients, or organ transplant patients taking high doses, 8 grams or more, of Zelitrex per day. These effects usually improve when Zelitrex is discontinued or the dose is reduced.
Other uncommon side effects:

• shortness of breath (dyspnoea)
• stomach disturbances
• skin rash, sometimes with itching, hives
• lower back pain (kidney pain)
• blood in the urine (haematuria)

Uncommon side effects that may be detected by blood tests:

• reduction in the number of white blood cells (leucopenia)
• reduction in the number of blood platelets, which are the cells responsible for blood clotting (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 or slurred speech (dysarthria)
• seizures
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disturbed thinking (delirium)

These nervous system side effects generally occur in people with kidney problems, elderly patients, or organ transplant patients taking high doses, 8 grams or more, of Zelitrex per day. These effects usually improve when Zelitrex is discontinued or the dose is reduced.
Other rare side effects:

• kidney problems with little or no urine output.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zelitrex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack. The expiry date (Exp) refers to the last day of that month.
• Store below 30°C.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Zelitrex contains

• The active substance is valaciclovir. Each tablet contains 250 mg, 500 mg, or 1000 mg of valaciclovir (as valaciclovir hydrochloride).

The other components are:
Tablet core
Microcrystalline cellulose
Crospovidone
Povidone
Magnesium stearate
Anhydrous colloidal silica
Coating
Hypromellose
Titanium dioxide
Macrogol 400
Polysorbate 80 (only for 500 mg and 1000 mg tablets)
Carnauba wax

Description of the appearance of Zelitrex and pack contents
Zelitrex tablets are contained in polyvinyl chloride/aluminum blisters.
Zelitrex 250 mg tablets are supplied in packs containing 20 or 60 film-coated tablets. They are white in colour and marked with “GX CE7” on one side.
Zelitrex 500 mg tablets are supplied in packs containing 10, 24, 30, 42, 90, or 112 film-coated tablets. They are white in colour and marked with “GX CF1” on one side.
Zelitrex 1000 mg tablets are supplied in packs containing 21 film-coated tablets. They are white in colour and marked with “GX CF2” on one side.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithkline S.p.A. – Via A. Fleming, 2 - Verona, Italy.

Manufacturer:
Glaxo Wellcome S.A. – Avenida de Extremadura 3 – Aranda De Duero – Burgos – Spain
or
GlaxoSmithKline Pharmaceuticals S.A. – ul. Grunwaldzka 189 – 60-322 Poznań – Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Greece, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: Valtrex
Germany: Valtrex S 250 mg, Valtrex
France, Belgium, Denmark, Italy, Luxembourg, Netherlands: Zelitrex

This patient information leaflet was last approved on: