250 mg, 500 mg, and 1000 mg film-coated tablets
valaciclovir
What Valtrex is and what it is used for
Valtrex 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 ).
Valtrex can be used to:
- treat shingles (in adults)
- treat HSV skin infections and genital herpes (in adults and adolescents over 12 years of age)It is also used to help prevent these infections from coming back.
- treat mouth ulcers (in adults and adolescents over 12 years of age)
- prevent CMV – infection after organ transplantation (in adults and adolescents over 12 years)
- treat and prevent HSV – eye infection that keeps coming back (in adults and adolescents over 12 years of age).
The valaciclovir found in Valtrex may also be approved to treat other conditions not listed in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Valtrex
Do not take Valtrex
- if you are allergic to valaciclovir or aciclovir, or to any of the other ingredients of this medicine (see list under section 6).
- if you have ever developed a widespread skin rash with fever, swollen lymph nodes, elevated levels of liver enzymes, and/or eosinophilia (drug reaction with systemic symptoms) after taking valaciclovir.
→ Do not take Valtrex if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valtrex.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valtrex:
- if you have problems with your kidneys
- if you have liver problems
- if you are older than 65 years
- if your immune system is weak.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Valtrex.
Take special care with Valtrex – important information:
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS initially manifests as flu-like symptoms and a rash on the face, then a widespread rash with fever, elevated levels of liver enzymes shown in blood tests, an increase in a type of white blood cell ( eosinophilia ), and swollen lymph nodes.
→ If you develop a skin rash with fever and swollen lymph nodes, stop taking valaciclovir and contact a doctor or seek medical attention immediately.
Prevent transmission of genital herpes to others
If you are taking Valtrex to treat or prevent genital herpes, or if you have had genital herpes in the past, you should still practice safe sex, which means using a condom. It is important to prevent you from infecting others. You should not have sex if you have genital sores or blisters.
Other drugs and Valtrex
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, or other natural products.
Tell your doctor or pharmacist if you are taking other medicines that affect the kidneys. These include aminoglycoside, organoplatinum compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.
Always tell your doctor or pharmacist if you are taking other medicines while taking Valtrex to treat shingles or after an organ transplant.
Pregnancy and breastfeeding
Valtrex is not normally recommended for use during pregnancy. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take Valtrex without consulting your doctor. Your doctor will then weigh the benefit to you against the risk to your baby of taking Valtrex while you are pregnant or breastfeeding.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Valtrex can have side effects that can affect your ability to drive.
Avoid driving or operating machinery unless you are sure that you are unaffected.
How to take Valtrex
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor determines the dose according to the reason for your treatment. Your doctor should discuss this with you.
Treatment of shingles
- The usual dose is 1000 mg (one tablet of 1000 mg or two tablets of 500 mg) three times daily.
- You will take Valtrex for seven days.
Treatment of mouth ulcers
- The usual dose is 2000 mg (two tablets of 1000 mg or four tablets of 500 mg) twice daily.
- The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
- You should take Valtrex for only one day (two doses ).
Treatment of HSV skin infections or genital herpes
- The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice daily.
- For the first infection, take Valtrex for five days, or up to ten days if your doctor has prescribed it. In case of recurrent infection, the treatment period is normally 3-5 days.
To help prevent HSV infections from coming back after you’ve had them
- The usual dose is one 500 mg tablet once daily.
- Some patients with frequent recurrent infections may benefit from taking one 250 mg tablet twice daily.
- You should take Valtrex until your doctor tells you to stop.
To prevent you from becoming infected with CMV ( Cytomegalovirus )
- The usual dose is 2000 mg (two tablets of 1000 mg or four tablets of 500 mg) four times daily.
- You should have an interval of 6 hours between each dose.
- You should take Valtrex as soon as possible after your surgery.
- You should take Valtrex for about 3 months after your surgery until your doctor prescribes you stop.
Your doctor may adjust your dose of Valtrex:
- if you are older than 65 years
- if you have a weak immune system
- if you have kidney problems.
- Talk to your doctor before taking Valtrex if any of the above apply to you.
Taking this medicine
- Take this medicine by mouth.
- Swallow the tablets whole with water.
- Take Valtrex at the same time each day.
- Take Valtrex as directed by your doctor or pharmacist.
People older than 65 or people with kidney problems
While you are taking Valtrex, you must drink water regularly throughout the day. This can help reduce the side effects that can affect the kidneys or nervous system. Your doctor will check if you show signs of this. Side effects from the nervous system can be that you feel confused, agitated, unusually sleepy, or drowsy.
If you have taken too much Valtrex
If you have ingested too much medicine or if, for example, a child has ingested the drug by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Valtrex is usually not harmful unless you use too much for several days in a row. If you take too many tablets, you may feel sick, vomit, have kidney problems, become confused, and agitated, experience altered consciousness, see things that are not there or pass out. If you have taken too much Valtrex, talk to your doctor or pharmacist. Take the medicine package with you.
If you forget to take Valtrex
- If you forget to take Valtrex, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a missed dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you need to be aware of:
→ Stop using Valtrex and see a doctor immediately if you experience any of the following symptoms:
Severe allergic reactions ( anaphylaxis ). These are rare in those taking Valtrex. The rapid development of symptoms such as:
- redness, itchy rash
- swelling of the lips, face, neck, and throat, causing difficulty breathing ( angioedema )
- drop in blood pressure leading to collapse.
Skin rash or redness. Skin side effects can appear as a rash with or without blisters. Skin irritation, edema (accumulation of fluid) (DRES’s syndrome), fever, and flu-like symptoms may occur.
The following side effects can also occur with this medicine:
Very common (may affect more than 1 in 10 users):
- headache
Common (may affect up to 1 in 10 users):
- nausea
- dizziness
- vomiting
- diarrhea
- skin reactions after exposure to sunlight ( photosensitivity )
- rash.
- itching ( pruritus ).
Uncommon (may affect up to 1 in 100 users):
- confusion
- hallucinations (seeing or hearing things that aren’t there)
- drowsiness
- tremor _
- the feeling of outrage.
These nervous system side effects usually occur in people with kidney problems, in the elderly, or in organ transplant patients who take high doses of Valtrex, ie 8 g or more per day. It usually gets better when Valtrex is stopped or when the dose is lowered.
Other less common side effects:
- shortness of breath ( dyspnea )
- stomach upset
- skin rash, sometimes itchy, hives ( urticaria )
- low back pain (kidney pain)
- blood in the urine ( hematuria ).
Less common side effects that can be detected in blood tests:
- decrease in the number of white blood cells ( leukopenia )
- decrease in the number of platelets, which help the blood clot ( thrombocytopenia )
- increase in substances produced by the liver.
Rare (may affect up to 1 in 1,000 users):
- unsteady gait or lack of coordination ( ataxia )
- slow and slurred speech (dysarthria)
- seizures (convulsions)
- altered brain function ( encephalopathy )
- unconsciousness ( coma )
- confused or disturbed thoughts ( delirium ).
These nervous system side effects usually occur in people with kidney problems, in the elderly, or in organ transplant patients who take high doses of Valtrex, ie 8 g or more per day. It usually gets better when Valtrex is stopped or when the dose is lowered.
Other rare side effects:
- kidney problems, which manifest themselves as urinating little or no urine.
Has been reported (occurring in an unknown number of users)
Drug reaction with eosinophilia and systemic symptoms also called DRESS or drug hypersensitivity syndrome, which manifests as a widespread skin rash, fever, elevated liver enzymes, abnormal blood count ( eosinophilia ), swollen lymph nodes, and possible swelling in other organs. See also section 2.
How to store Valtrex
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date (EXP) is the last day of the specified month.
- Store at a maximum of 30 °C.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is valaciclovir. One tablet contains 250 mg, 500 mg, or 1000 mg of valaciclovir (as valaciclovir hydrochloride).
Other ingredients are:
Tablet core
Microcrystalline cellulose
Crospovidone
Povidone
Magnesium stearate
Anhydrous colloidal silica
Film coating
Hypromellose
Titanium dioxide
Macrogol 400
Polysorbate 80 (only in 500 mg and 1000 mg tablets)
Appearance and package sizes of the medicine
Valtrex tablets are packaged in polyvinyl chloride/aluminum foil blisters.
Valtrex 250 mg tablets are supplied in cartons containing 20 or 60 film-coated tablets. They are white and marked with “GX CE7” on one side.
Valtrex 500 mg tablets are supplied in cartons containing 10, 30, 42, or 112 film-coated tablets. They are white and marked with “GX CF1” on one side.
Valtrex 1000 mg tablets are supplied in cartons containing 21 film-coated tablets. They are white and marked with “GX CF2” on one side.
Marketing Authorisation Holder
GlaxoSmithKline AB
Box 516
169 29 Solna
Phone 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer
Glaxo Wellcome SA.
Avenida de Extremadura
ES-09400 Aranda de Duero (Burgos)
Spain
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland
This medicine is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): Valtrex.
France, Belgium, Denmark, Italy, Luxembourg, Netherlands: Zelitrex.