Active ingredient
- valaciclovir hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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.
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.
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:
2. What you need to know before you take Valaciclovir
Do not take Valaciclovir
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Valaciclovir if:
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.
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
Treatment of cold sores
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)
Helping to prevent HSV infections from returning after you have had them (in adults and adolescents over 12 years old)
To stop you being infected with CMV (Cytomegalovirus)
Your doctor may adjust the dose of Valaciclovir if:
Talk to your doctor before taking Valaciclovir if any of the above apply.
Taking this medicine
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 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
Rapid development of symptoms including:
Very Common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
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)
Uncommon side effects that may show up in blood tests (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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):
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
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
This leaflet was last revised in May 2019.
5th Floor, Hyde Park, Hayes, 3, 11 Millington Road, Hayes, UB3 4AZ, UK
+44 (0) 208 848 8688
+44 (0) 208 848 5052