500 mg film-coated tablet
valaciclovir
What Valaciclovir Mylan is and what it is used for
Valaciclovir Mylan contains the active substance valaciclovir hydrochloride hydrate. Valaciclovir Mylan 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 Mylan 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 recurrent HSV eye infections (in adults and adolescents over 12 years of age).
The valaciclovir contained in Valaciclovir Mylan may also be approved to treat other conditions not mentioned 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 you take Valaciclovir Mylan
Do not take Valaciclovir Mylan
- 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 a widespread rash associated with fever, enlarged lymph nodes, elevated levels of liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Mylan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valaciclovir Mylan:
- 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.
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS initially presents as flu-like symptoms and with a rash on the face, followed by widespread rash and high body temperature, increased levels of liver enzymes (found 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.
If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Valaciclovir Mylan.
Prevent transmission of genital herpes to others
If you are taking Valaciclovir Mylan to treat genital herpes, or if you have previously had genital herpes, 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.
Children under 12 years of age
This medicine is not recommended for children under 12 years of age.
Other medicines and Valaciclovir Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might be taking 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 Valaciclovir Mylan to treat shingles or after an organ transplant.
Pregnancy and breastfeeding
Valaciclovir Mylan is not normally recommended for use during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Your doctor will then consider the benefit to you against the risk to your baby of taking Valaciclovir Mylan while you are pregnant or breastfeeding.
Driving ability and use of machinery
Valaciclovir can have side effects that can affect your ability to drive.
Avoid driving or operating machinery unless you are sure you are unaffected.
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 your doctor or pharmacist if you are unsure.
How to take Valaciclovir Mylan
Always take this medicine as directed by your doctor or pharmacist. 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 recommended dose is 1000 mg (two 500 mg tablets) three times daily.
- You must take Valaciclovir Mylan for seven days.
Treatment of mouth ulcers
- The recommended dose is 2000 mg (four 500 mg tablets) twice daily.
- The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
- You must take Valaciclovir Mylan for only one day (two doses ).
Treatment of HSV skin infections or genital herpes
- The recommended dose is 500 mg (one 500 mg tablet) twice daily.
- For the first infection, you must take Valaciclovir Mylan for five days, or up to ten days, if your doctor has prescribed this. In case of recurrent infection, the treatment period is normally 3-5 days.
Help prevent HSV infection from returning after you’ve had them
• The recommended dose is one 500 mg tablet once daily.
• Some people with frequent recurrent infections may benefit from taking one 250 mg tablet twice daily. For doses lower than 500 mg, Valaciclovir Mylan is not suitable. Lower strengths of other valaciclovir drugs are available. Your doctor will advise you on this.
• You should take Valaciclovir Mylan until your doctor tells you to stop.
To prevent you from becoming infected with CMV ( Cytomegalovirus )
- The recommended dose is 2000 mg (four tablets of 500 mg) four times daily.
- You should have an interval of 6 hours between each dose.
- You should take Valaciclovir Mylan as soon as possible after your operation.
- You should take Valaciclovir Mylan for about 3 months after your operation until your doctor prescribes you stop.
Use for children under 12 years of age
Valaciclovir is not recommended for children under 12 years of age due to insufficient data regarding safety and efficacy.
Your doctor may adjust your dose of Valaciclovir Mylan:
- 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 Valaciclovir Mylan if any of the above applies to you.
How to take the medicine
- Take this medicine by mouth.
- Swallow the tablets whole with water.
- Take Valaciclovir Mylan at the same time each day.
- Take Valaciclovir Mylan as directed by your doctor or pharmacist.
Elderly people who are over 65 or have kidney problems.
While you are taking Valaciclovir Mylan, 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 any 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 Valaciclovir Mylan
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Valaciclovir Mylan 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, become confused, agitated, or unusually sleepy. You may see, feel or hear things that are not there (hallucinations), have kidney problems that manifest as urinating little or no urine or lose consciousness ( coma ). Talk to your doctor or pharmacist if you have taken too much Valaciclovir Mylan. Take the medicine package with you.
If you forget to take Valaciclovir Mylan
- If you forget to take Valaciclovir Mylan, 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.
If you stop taking Valaciclovir Mylan
Do not stop taking this medicine without consulting your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually occur at the beginning of treatment and become milder or disappear within a few weeks. Sometimes it is difficult to distinguish between the symptoms of the disease and a side effect.
Contact your doctor or go to the nearest hospital emergency department immediately if you think you have any of the following side effects. Stop taking this medicine.
Rare (affects up to 1 in 1,000 users)
- severe allergic reactions ( anaphylaxis ). 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
- kidney problems, which manifest themselves as urinating little or no urine
- seizures (convulsions)
- altered brain function ( encephalopathy )
- unconsciousness ( coma )
- confused or disturbed thoughts
Has been reported (occurring in an unknown number of users)
Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, is characterized by widespread rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes, and possible involvement of other organs. See also section 2.
Additional side effects are
Very common (affects more than 1 in 10 users):
- headache
Common (affects up to 1 in 10 users):
- nausea
- dizziness
- vomiting
- diarrhea
- skin reactions, including after exposure to sunlight ( photosensitivity )
- rash.
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 side effects from the nervous system usually occur in people with kidney problems, in the elderly, or in organ transplant patients who take high doses of valaciclovir, ie 8 g or more per day. It usually gets better when Valaciclovir Mylan is stopped or when the dose is reduced.
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.
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)
These side effects from the nervous system usually occur in people with kidney problems, in the elderly, or in organ transplant patients who take high doses of valaciclovir, ie 8 g or more per day. It usually gets better when Valaciclovir Mylan is stopped or when the dose is reduced.
How to store Valaciclovir Mylan
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
- The medicine does not require any special storage instructions.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications 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 hydrochloride hydrate. Each tablet contains valaciclovir hydrochloride hydrate equivalent to 500 mg of valaciclovir.
- Other ingredients in the tablet core are: microcrystalline cellulose, crospovidone, povidone, and magnesium stearate
- Ingredients in the coating are: titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), and hypromellose (E464)
Appearance and package sizes of the medicine
Valaciclovir Mylan is a white to off-white, capsule-shaped, biconvex film-coated tablet.
500 mg film-coated tablets are marked “VC 500” on one side and “G” on the other side
Valaciclovir Mylan is available in blister packs of 10, 21, 24, 30, 42, 60, 90, 100, and 112.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan AB
Box 23033
104 35 Stockholm
Phone: 08-555 227 50
Fax: 08-555 227 51
e-mail: inform@mylan.se
Manufacturer:
McDermott Laboratories Ltd T/A Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, Mylan utca 1, Komarom 2900, Hungary
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire. EN6 1TL, United Kingdom