500 mg film-coated tablets
valaciclovir
What Valaciclovir Bluefish is and what it is used for
Valaciclovir Bluefish 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 Bluefish can be used for:
- treat shingles (in adults).
- treat HSV skin infections and genital herpes (in adults and adolescents over 12 years of age).
- 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 of age).
- Treat and prevent HSV – eye infection.
Valaciclovir contained in Valaciclovir Bluefish 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 taking Valaciclovir Bluefish
Do not take Valaciclovir Bluefish:
- if you are allergic to valaciclovir, aciclovir, or to any of the other ingredients of this medicine (listed in section 6).
- if you have ever had a widespread rash associated with fever, enlarged lymph nodes, elevated liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
Do not take Valaciclovir Bluefish if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Bluefish.
Warnings and precautions
Talk to your doctor before using Valaciclovir Bluefish:
- 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 Valaciclovir Bluefish.
Be especially careful with Valaciclovir Bluefish
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS first manifests as cold-like symptoms and a rash on the face, then a widespread rash with fever, elevated liver enzyme levels seen in blood tests and an increase in a type of white blood cell ( eosinophilia ) as well as enlarged lymph nodes .
If you develop a widespread rash associated with fever and enlarged lymph nodes , stop using valaciclovir and contact your doctor or seek medical attention immediately.
Prevent transmission of genital herpes to others
If you are taking Valaciclovir Bluefish to treat or prevent 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.
Other medicines and Valaciclovir Bluefish
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
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 Bluefish for the treatment of shingles or after an organ transplant.
Pregnancy, breastfeeding and fertility
Valaciclovir Bluefish is not normally 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 using this medicine. Your doctor will then consider the benefit to you against the risk to your baby of taking Valaciclovir Bluefish while you are pregnant or breastfeeding.
Driving ability and use of machinery
You yourself 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 . 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.
Valaciclovir Bluefish can have side effects that can affect your ability to drive.
Avoid driving or operating machinery unless you are sure you are unaffected.
How to take Valaciclovir Bluefish
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Treatment of shingles
- The usual dose is 1000 mg (one tablet of 1000 mg or two tablets of 500 mg) three times daily.
- You must take Valaciclovir Bluefish 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 one should be taken 12 hours (not earlier than 6 hours) after the first dose one
- You must take Valaciclovir Bluefish 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, you must take Valaciclovir Bluefish 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.
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 Valaciclovir Bluefish as soon as possible after your operation.
- You should take Valaciclovir Bluefish for about 3 months after your operation, until your doctor prescribes you to stop.
Your doctor may adjust your dose of Valaciclovir Bluefish:
- 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 Bluefish if any of the above applies to you.
Take this medicine
- Take this medicine by mouth.
- Swallow the tablets whole with water.
- Take Valaciclovir Bluefish at the same time each day.
- Take Valaciclovir Bluefish as directed by your doctor or pharmacist.
People older than 65 or people with kidney problems
While you are taking Valaciclovir Bluefish, it is very important that you 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 Valaciclovir Bluefish
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 Bluefish 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. Talk to your doctor or pharmacist if you have taken too much Valaciclovir Bluefish. Take the medicine package with you.
If you forget to take Valaciclovir Bluefish
- If you forget to take Valaciclovir Bluefish, take it as soon as you remember. However, if it is almost time for the next dose , skip the missed dose one.
- 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:
- severe allergic reactions ( anaphylaxis ). These are rare in those taking Valaciclovir Bluefish.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
- If you get an allergic reaction , stop taking Valaciclovir Bluefish and see a doctor immediately.
Very common (may affect more than 1 in 10 users):
- Headache
Common (affects up to 1 in 10 users):
- nausea
- dizziness
- vomiting
- diarrhea
- skin reactions 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 _
- feeling of outrage
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 rash, fever, elevated liver enzyme levels, blood abnormalities ( eosinophilia ), enlarged lymph nodes , and possibly involvement of other body organs. See also section 2.
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 Valaciclovir Bluefish doses , ie. 8 g or more per day. It usually gets better when Valaciclovir Bluefish 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 ( dysatri )
- convulsions ( convulsions )
- altered brain function ( encephalopathy )
- unconsciousness ( coma )
- confused or disturbed thoughts
- delirium (confusional state with hallucinations)
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 Valaciclovir Bluefish doses , ie. 8 g or more per day. It usually gets better when Valaciclovir Bluefish is stopped or when the dose is reduced.
Other rare side effects:
- kidney problems, which manifests itself as urinating little or no urine.
How to store Valaciclovir Bluefish
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date (Ug. dat.) is the last day of the month.
- This medicine does not need to be stored in any special way.
- Medicines must not be thrown into the drain or among 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. Each tablet contains 500 mg of valaciclovir (valaciclovir hydrochloride monohydrate).
- Other ingredients are magnesium stearate, povidone, crospovidone, microcrystalline cellulose, titanium dioxide, hypromellose, macrogol 400 and polysorbate 80.
Appearance and package sizes of the medicine
- Valaciclovir 500 mg tablets are white, oblong and film-coated. The tablets are embossed with “V” on one side and “500” on the other side.
- The tablets are available in Al/Al blister packs with 4, 6, 10, 24, 30, 42, 80, 84, 90 and 112 tablets.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
Pharmadox Healthcare Ltd.
KW20A Corradino Industrial Estate,
Paola, PLA 3000
Malta
This medicine is approved within the European Economic Area under the names :
| Member country | Name of the medicine |
| Austria | Valaciclovir Bluefish 500 mg Film-coated tablet |
| Denmark | Valaciclovir Bluefish |
| Finland | Valaciclovir Bluefish 500 mg tabletti, kalvövärvementinenValaciclovir Bluefish 500 mg film-coated tablets |
| France | Valaciclovir Bluefish 500 mg tablets peliculés |
| Germany | Valaciclovir Bluefish 500 mg Film-coated tablet |
| Ireland | Valaciclovir Bluefish 500 mg film-coated tablets |
| Portugal | Valaciclovir Bluefish 500 mg comprimidos revestidos por película |
| Sweden | Valaciclovir Bluefish 500 mg film-coated tablets |
| Iceland | Valaciclovir Bluefish 500 mg film-coated tablets |