500 mg film-coated tablets
valaciclovir
WHAT VALACICLOVIR ORION IS AND WHAT IT IS USED FOR
Valaciclovir Orion is a medicine against viral infections. It works by killing or inhibiting the virus’s ability to reproduce, against viral infections caused by herpes simplex ( HSV ), varicella zoster ( VZV ), and cytomegalovirus ( CMV ).
Valaciclovir Orion is used to:
- treat shingles in adults
- treat genital (genital) herpes ( herpes simplex virus ( HSV ) infection ) in adults and adolescents over 12 years of age.
It is also used preventively against the recurrence of these infections.
- treat mouth ulcers (in adults and adolescents over 12 years of age)
- prevent infection caused by cytomegalovirus ( CMV ) after organ transplantation (in adults and adolescents over 12 years of age)
- treat eye infections.
Valaciclovir contained in Valaciclovir Orion may also be approved to treat other conditions not mentioned in this product information. 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 ORION
Do not take Valaciclovir Orion
- if you are allergic to valaciclovir, aciclovir, or any of the other ingredients of this medicine (listed in section 6)
- if you have ever developed a widespread rash with fever, enlarged lymph nodes, increased liver enzyme levels, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
Do not take Valaciclovir Orion if any of these apply to you. If you are unsure, consult a doctor or pharmacist before taking Valaciclovir Orion.
Warnings and precautions
Tell your doctor or pharmacist before treatment with Valaciclovir Orion if you:
- have reduced kidney function
- have reduced liver function
- are older than 65 years
- have a weakened immune system.
If you are not sure whether this applies to you, talk to your doctor or pharmacist before taking Valaciclovir Orion.
Prevent transmission of genital herpes to others
If you are taking Valaciclovir Orion to treat genital herpes or if you have had genital herpes in the past, practice safe sex, including using a condom. This is important to prevent transmission of the virus to your partner. You should avoid sex if you have sores or blisters on your genitals.
Be especially careful with valaciclovir
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with the use of valaciclovir. DRESS presents initially with cold-like symptoms and a rash on the face, followed by a widespread rash and high fever, increased 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 rash with fever and enlarged lymph nodes, stop taking valaciclovir and contact a doctor or seek medical help immediately.
Use of other medicines together with Valaciclovir Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter and herbal medicines.
Tell your doctor or pharmacist if you are taking any medicine that affects the kidneys. This includes, for example, aminoglycoside, platinum-containing drugs, iodine-containing contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.
Always tell your doctor or pharmacist what other medicines you are using when you are treated with Valaciclovir Orion for shingles or after organ transplantation.
Pregnancy and breastfeeding
Valaciclovir Orion should not normally be used 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 weigh the benefits of the treatment against any risks to the fetus if you take Valaciclovir Orion during pregnancy or breastfeeding.
Driving ability and use of machinery
Valaciclovir Orion can cause side effects that affect the ability to drive. Do not drive or use machines if you experience such side effects.
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 ORION
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose you should take depends on what your doctor has prescribed Valaciclovir Orion for. The doctor will discuss it with you.
Treatment of shingles ( herpes zoster):
- The usual dose is 1000 mg (2 tablets of 500 mg) three times daily.
- Take Valaciclovir Orion for 7 days.
Treatment of mouth ulcers:
- The usual dose is 2000 mg (4 tablets of 500 mg) twice daily.
- The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
- Take Valaciclovir Orion for only one day (two doses ).
Treatment of herpes simplex virus ( HSV ) infection of the skin and genital herpes:
- The usual dose is 500 mg (1 tablet of 500 mg) twice daily.
- At the first instance of infection, you should take Valaciclovir Orion for 5 days or up to 10 days if your doctor instructs you to do so. In case of recurrent infection, the treatment period is normally 3–5 days.
Preventive treatment of recurrent herpes simplex virus ( HSV ) infection:
- The usual dose is one 500 mg tablet once daily.
- Some people with frequent recurrent infections may get better treatment results from taking half a 500 mg tablet (250 mg) twice daily.
- Take Valaciclovir Orion until your doctor tells you to stop.
Preventive treatment of cytomegalovirus ( CMV ) infection and disease:
- The usual dose is 2000 mg (4 tablets of 500 mg) 4 times daily.
- Each dose should be taken approximately 6 hours apart.
- Treatment should be started as early as possible after the organ transplant.
- Take Valaciclovir Orion for about 90 days after the organ transplant, or until your doctor says you can stop.
The doctor may need to adjust the dose of Valaciclovir Orion if you:
- are older than 65 years
- have a weakened immune system
- have reduced kidney function.
Consult your doctor before taking Valaciclovir Orion if any of these apply to you.
Use of this medicine
- The tablets should be swallowed whole with plenty of water.
- Take Valaciclovir Orion at the same time every day
- Take Valaciclovir Orion as directed by your doctor or pharmacist.
Patients over 65 years of age with reduced kidney function
It is very important during treatment with Valaciclovir Orion to drink water regularly during the day. It relieves side effects that can affect the kidneys and nervous system. Your doctor will check you regularly for signs of these. Nervous system side effects may include confusion or agitation or feeling unusually sleepy or drowsy.
If you use too much Valaciclovir Orion
Valaciclovir Orion is normally not harmful if you do not take too much for several days. If you take too much, you may experience nausea, vomiting, confusion, agitation, or unusual tiredness.
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. Take the medicine package with you.
If you forget to take Valaciclovir Orion
- If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, then skip the forgotten dose.
- Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions you should pay particular attention to
severe allergic reactions (anaphylactic shock ) has beenhaveported in rare cases in people taking Valaciclovir Orion. Signs of this can be the sudden appearance of the following symptoms:
- redness, itchy rash
- swelling of the lips, face, neck, and throat, difficulty breathing ( angioedema )
- drop in blood pressure that can lead to collapse.
If you have an allergic reaction, stop taking Valaciclovir Orion and contact your doctor immediately.
Very common (may affect more than 1 in 10 users):
- headache.
Common (may affect up to 1 in 100 users):
- nausea
- dizziness
- vomiting
- diarrhea
- skin reactions to sunlight
- rash.
- itching ( pruritus )
Uncommon (may affect up to 1 in 100 users):
- confusion
- seeing and hearing unreal things (hallucinations)
- severe drowsiness
- tremors
- indignation.
These side effects from the nervous system usually occur in people with reduced kidney function, in the elderly, or in people with organ transplants who receive doses of 8 g or more of Valaciclovir Orion per day. It usually gets better if you stop taking Valaciclovir Orion or if the dose is reduced.
Other less common side effects are
- shortness of breath ( dyspnea )
- discomfort in the abdomen
- skin rash, sometimes itchy, hives-like rash ( urticaria )
- pain in the lower back (pain from the kidney)
- blood in the urine (often in connection with other side effects from the kidneys).
Less common side effects that can be detected in blood tests
- abnormally reduced number of white blood cells ( leukopenia )
- reduced number of platelets leading to a reduced ability of the blood to clot ( thrombocytopenia )
- increase in liver function values.
Rare (may affect up to 1 in 1,000 users):
- unsteadiness when walking and coordination difficulties ( ataxia )
- slow, slurred speech ( dysarthria )
- convulsions, convulsions
- brain damage ( encephalopathy )
- unconsciousness ( coma )
- confusion or worrying thoughts.
These side effects from the nervous system usually occur in people with reduced kidney function, in the elderly, or organ transplant recipients receiving doses of 8 g or more of Valaciclovir Orion per day. It usually gets better if you stop taking Valaciclovir Orion or if the dose is reduced.
Other rare side effects are
- impaired kidney function where little or no urine is excreted.
Has been reported ( occurring in an unknown number of users ):
- drug reaction with eosinophilia and systemic symptoms also called DRESS, or drug hypersensitivity syndrome characterized by widespread rash, fever, increased liver enzyme levels, blood abnormalities ( eosinophilia ), enlarged lymph nodes, and possible involvement of other body organs. See also section 2.
HOW TO STORE VALACICLOVIR ORION
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 carton and can or blister after EXP. The expiration date is the last day of the specified month.
No 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.
PACKAGING CONTENTS AND OTHER INFORMATION
Contents declaration
The active substance is valaciclovir. Each tablet contains 500 mg of valaciclovir which
valaciclovir hydrochloride hydrate.
– Other ingredients are microcrystalline cellulose, crospovidone (type A), povidone K90, magnesium stearate, paddy blue 13B50578 (hypromellose, indigo carmine aluminum lake (E132), titanium dioxide (E171), macrogol 400, polysorbate.
Appearance and package sizes of the medicine
Film-coated tablet.
Blue, film-coated, capsule-shaped tablet with a score on both sides, marked “F” on one side and “9” and “3” on the other side. The tablet can be divided into two equal doses.
Valaciclovir Orion film-coated tablets are available in blister packs of PVC/PVdC aluminum foil in or in HDPE cans.
Blister packaging:
5, 8, 10, 21, 24, 30, 42, 50, 90 and 112 tablets
Can:
Marketing Authorisation Holder
Orion Corporation
Orionvägen 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionvägen 1
FI-02200 Espoo
Finland
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com