Patient leaflet - VALACICLOVIR 1000 MG FILM-COATED TABLETS
1. what valaciclovir is and what it is used for
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:
- treat shingles (in adults)
- treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old).
It is also used to help prevent these infections from returning.
- treat cold sores (in adults and adolescents over 12 years old)
- prevent infection with CMV after organ transplants (in adults and adolescents over 12 years of old)
- treat infections in the eye
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, do not 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 are pregnant or breastfeeding.
Driving and using machines
Valaciclovir can cause side effects that affect your ability to drive.
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> Do not drive or use machines unless you are sure you are not affected.
2. what you need to know before you take valaciclovir
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 node, increased levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking Valaciclovir.
Do not take Valaciclovir if this 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.
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.
Drug reaction with eosinophilia and systemic symptoms (DRESS) 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 fever and enlarged lymph nodes, stop taking Valaciclovir and contact your doctor or seek medical attention immediately.
3. how to take valaciclovir
Always take Valaciclovir exactly as your doctor 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
- The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day
- You should take Valaciclovir for seven days.
- The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
- The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose
- You should take Valaciclovir for one day (two doses) only.
Treatment of HSV infections of the skin and genital herpes
- The usual dose is 500 mg (one 500 mg tablet) twice a day.
- For the first infection you should take Valaciclovir for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3–5 days.
- The usual dose is one 500 mg tablet once a day.
- Some people with frequent recurrences may benefit from taking half of 500 mg tablet [250 mg] twice a day.
- You should take Valaciclovir until your doctor tells you to stop.
To stop you being infected with CMV (Cytomegalovirus)
- The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
- You should take each dose about 6 hours apart.
- You will usually start taking Valaciclovir as soon as possible after your surgery.
- You should take Valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.
- you are over 65 years of age
- you have a weak immune system
- you have kidney problems.
Talk to your doctor before taking Valaciclovir if any of the above apply to you.
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 the 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 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 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.
4. possible side effects
drug reaction with eosinophilia and systemic symptoms also known as dress or drug 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 involvement. see section 2. “what you need to know before you take valaciclovir”.
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 wwww.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 this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information
What Valaciclovir contains
The active substance is valaciclovir.
Each 500 mg film-coated tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride hydrated).
Each 1000 mg film-coated tablet contains 1000 mg of valaciclovir (as valaciclovir hydrochloride hydrated).
The other ingredients are microcrystalline cellulose, crospovidone (Type A), povidone K90, magnesium stearate, Opadry blue 13B5058 (hypromellose, indigo carmine aluminium lake (E132), titanium dioxide (E171), macrogol 400, polysorbate).
What Valaciclovir looks like and contents of the pack
Valaciclovir 500 mg film-coated tablets
Blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing ‘F’ on one side and ‘9’ and ‘3’ on the other side.
The tablet can be divided into equal halves.
Valaciclovir 1000 mg film-coated tablets
Blue, film coated, capsule shaped tablets with partial scorebar on both sides containing ‘F’ on one side and ‘8’ and ‘3’ on the other side.
The tablet can be divided into equal halves.
Valaciclovir film-coated tablets are available in clear PVC/PVdC Aluminium foil blister packs.
500 mg: 5, 10, 21, 24, 30, 42, 50, 90 and 112 tablets 1000 mg: 5, 10, 14, 21, 24, 30, 42, 50 and 90 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder StraBe 8–10
Berlin 13435
Germany
Arasto
This leaflet was last revised in 08/2021
GI936000/03/UK/0821
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