Valtrex

Package leaflet: Information for the user

Valtrex 500 mg film-coated tablets
valacyclovir (valaciclovirum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Valtrex is and what it is used for

Valtrex belongs to a group of medicines called antivirals. It works by killing or inhibiting the growth of viruses that cause herpes simplex virus (HSV), varicella-zoster virus (VZV), and cytomegalovirus (CMV).
Valtrex may be used for:
treatment of shingles (in adults);
treatment of skin and genital infections caused by herpes simplex virus (in adults and adolescents over 12 years of age); it is also used to prevent recurrences of these infections;
treatment of cold sores (in adults and adolescents over 12 years of age);
prevention of cytomegalovirus (CMV) infections after organ transplantation (in adults and adolescents over 12 years of age);
treatment and prevention of recurrent eye infections caused by herpes simplex virus (HSV) (in adults and adolescents over 12 years of age).

2. Important information before using Valtrex

When not to use Valtrex

• If the patient is allergic to valacyclovir or acyclovir, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever experienced a widespread rash together with fever, swollen lymph nodes, increased liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valacyclovir. The patient should not take Valtrex if any of the above apply. If in doubt, consult the doctor or pharmacist before starting Valtrex.

Warnings and precautions
Before starting Valtrex, consult a doctor or pharmacist if the patient:

• has kidney problems
• has liver problems
• is over 65 years old
• has a weakened immune system

If the patient is unsure whether any of the above apply, they should consult their doctor or pharmacist before starting Valtrex.
Exercise special caution when using Valtrex – important information:
Drug reactions with eosinophilia and systemic symptoms (DRESS) have been reported during treatment with valacyclovir.
In the initial phase of DRESS, flu-like symptoms and facial rash occur, followed by widespread rash, high fever, elevated liver enzymes in blood tests, increased white blood cell count (eosinophilia), and swollen lymph nodes.
If the patient develops a rash together with fever and swollen lymph nodes, they must immediately stop taking valacyclovir and contact their doctor or seek medical help.

Preventing transmission of genital herpes to others
If the patient is taking Valtrex to prevent transmission of genital herpes or has previously had such an infection, they should continue practicing safe sexual behaviour, including using condoms. This is important to prevent spreading the infection to others. The patient should avoid sexual contact if they have sores or blisters on their genitals.

Valtrex and other medicines
Inform the doctor or pharmacist about all medicines recently taken, as well as any medicines the patient plans to take.
If the patient is taking any medicines that affect the kidneys, they should inform their doctor or pharmacist. This includes medicines such as: aminoglycosides, platinum-containing compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.
If the patient is taking Valtrex for the treatment of shingles or after an organ transplant, they should always inform their doctor or pharmacist.

Pregnancy and breastfeeding
Valtrex is not usually recommended during pregnancy. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. The treating doctor will assess whether the benefits to the patient of taking Valtrex during pregnancy or breastfeeding outweigh the risks to the child.

Driving and operating machinery
Valtrex may cause side effects that impair the ability to drive. Do not drive or operate machinery unless the patient is certain they feel well.

3. How to take Valtrex

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.
The dose of medicine that a patient should take depends on the reason why the doctor has prescribed Valtrex. Your doctor will discuss this with you.

Treatment of shingles (herpes zoster)

• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times daily.
• Valtrex should be taken for 7 days.

Treatment of cold sores (herpes labialis)

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice daily.
• The second dose should be taken 12 hours (but not earlier than 6 hours) after the first dose.
• Valtrex should be taken for only one day (two doses).

Treatment of herpes simplex skin and genital infections

• The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice daily.
• For first episodes, Valtrex should be taken for 5 days or up to 10 days if directed by the doctor. In case of recurrent infection, treatment usually lasts 3–5 days.

Prevention of recurrent herpes simplex infection

• The usual dose is one 500 mg tablet once daily.
• Some patients with very frequent recurrences may gain additional benefit by taking one 250 mg tablet twice daily.
• Valtrex should be taken until the doctor advises stopping.

Prevention of cytomegalovirus (CMV) infection

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times daily.
• Doses should be taken every 6 hours.
• Valtrex treatment should usually begin as soon as possible after transplantation.
• Valtrex should be taken for approximately 90 days after transplantation, or until the doctor advises stopping.

Your doctor may adjust the dose of Valtrex if:

• the patient is over 65 years of age
• the patient has a weakened immune system
• the patient has kidney problems

If any of the above conditions apply, inform your doctor before starting Valtrex.

How to take the medicine

• Take the medicine by mouth.
• Swallow the tablets whole with water.
• Valtrex should be taken at the same time each day.
• Take Valtrex exactly as prescribed by your doctor or pharmacist.

Patients over 65 years of age or with kidney problems
It is very important to drink water regularly throughout the day while taking Valtrex. This helps reduce the risk of kidney or nervous system side effects. Your doctor will closely monitor you for such symptoms. Nervous system side effects may include confusion, agitation, unusual drowsiness, or lethargy.

Taking more than the recommended dose of Valtrex
Valtrex is not usually harmful if taken in excess for only a short period. However, in patients taking too many tablets, nausea, vomiting, kidney problems, confusion, agitation, disorientation, hallucinations (seeing things that are not real), or loss of consciousness may occur. If you have taken too many tablets, contact your doctor or pharmacist immediately. Bring the medicine packaging with you.

If you miss a dose of Valtrex

• 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 missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of:
Stop taking Valtrex and contact your doctor immediately if the patient develops any of the
following symptoms:
Severe allergic reactions (anaphylaxis). These occur rarely in people taking Valtrex.
Sudden onset symptoms include:

• redness, itchy skin rash
• swelling (edema) of the lips, face, neck, throat, causing difficulty in breathing (angioedema)
• decrease in blood pressure leading to shock.

Skin rash or redness. Adverse skin reactions may present as a rash with or without blisters.
Skin irritation, swelling (DRESS syndrome), fever, and flu-like symptoms may also occur.
The following adverse reactions may also occur during treatment with this medicine:
Very common adverse reactions (may occur in more than 1 in 10 patients):

• headache

Common adverse reactions (may occur in up to 1 in 10 patients):

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• confusion
• seeing or hearing things that are not real (hallucinations)
• feeling very sleepy
• tremors
• feeling agitated

The above nervous system-related adverse reactions usually occur in patients with kidney disease, elderly patients, or organ transplant recipients receiving high doses of Valtrex, 8 g or more per day. They usually resolve after discontinuation of Valtrex or dose reduction.
Other uncommon adverse reactions:

• feeling short of breath or difficulty breathing (dyspnoea)
• abdominal discomfort
• rash (sometimes itchy), urticaria
• lower back pain (kidney pain)
• blood in the urine (haematuria)

Uncommon adverse reactions that may be revealed in blood tests:

• decrease in white blood cell count (leukopenia)
• decrease in platelet count, which are involved in blood clotting (thrombocytopenia)
• increased activity of certain substances (enzymes) produced in the liver.

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• unsteadiness when moving and lack of coordination (ataxia)
• slowed or slurred speech
• seizures (convulsions)
• disturbances in brain function (encephalopathy)
• loss of consciousness (coma)
• disorientation (confusion) or impaired thinking (delirium)

The above nervous system-related adverse reactions usually occur in patients with kidney disease, elderly patients, or organ transplant recipients receiving high doses of Valtrex, 8 g or more per day. They usually resolve after discontinuation of Valtrex or dose reduction.
Other rare adverse reactions:

• kidney-related problems, when the patient does not pass urine or passes too little urine.

Frequency not known (cannot be estimated from available data)

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or drug-induced hypersensitivity syndrome, characterized by widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possible involvement of other organs. See also section 2.
• Inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl . Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Valtrex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date (EXP) refers to the last day of the specified month.
• Store below 30 °C.
• Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Valtrex contains
The active substance is valacyclovir. Each coated tablet contains 500 mg of valacyclovir
(as valacyclovir hydrochloride).
The other ingredients are:
Core
Microcrystalline cellulose
Crospovidone
Povidone
Magnesium stearate
Colloidal anhydrous silica
Coating
Hypromellose
Titanium dioxide (E 171)
Polyethylene glycol 400
Polysorbate 80
Carnauba wax
What Valtrex looks like and contents of the pack
Valtrex tablets are packed in PCW/Al blisters.
Valtrex 500 mg tablets are supplied in cardboard boxes containing 10, 30, 42 or 112
coated tablets. The tablets are white, with the imprint "GX CF1" on one side.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Manufacturer:
GlaxoSmithKline (Ireland) Limited 1. Glaxo Wellcome SA
12 Riverwalk Avenida de Extremadura 3
Citywest Business Campus 09400 Aranda de Duero
Dublin 24 Burgos
Ireland Spain

2. Delpharm Poznań Spółka Akcyjna ul. Grunwaldzka 189 60-322 Poznań Poland

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