450 mg film-coated tablets
valganciclovir
What Valganciclovir Orion is and what it is used for
Valganciclovir Orion belongs to a group of drugs that act directly to prevent the multiplication of viruses. The active ingredient in the tablets, valganciclovir, is converted in the body to ganciclovir. Ganciclovir prevents a virus called cytomegalovirus ( CMV ) from multiplying and attacking healthy cells. In patients with a weakened immune system, CMV can cause infection in the body’s organs. This can be life-threatening.
Valganciclovir Orion is used for:
- treatment of CMV infection in the retina of the eye in adult patients with acquired immunodeficiency syndrome ( AIDS ). CMV – infection of the retina of the eye can cause vision problems and even blindness.
- to prevent CMV infection in adults and children who are not infected with CMV and who have received an organ transplant from someone who was infected with CMV.
The valganciclovir contained in Valganciclovir 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 use Valganciclovir Orion
Do not use Valganciclovir Orion
Do not take Valganciclovir Orion
- if you are allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valganciclovir Orion.
- if you are allergic to aciclovir, penciclovir, valaciclovir or famciclovir. Other drugs are used in viral infections.
Take special care with Valganciclovir Orion
- if you have too few white blood cells, red blood cells, or platelets (small cells involved in blood clotting ) in your blood. Your doctor will carry out blood tests before you start taking Valganciclovir Orion tablets and more tests will be done while you are using the tablets.
- if you are undergoing radiation therapy or hemodialysis
- if you have kidney problems. Your doctor may need to prescribe you a lower dose and your blood levels may need to be checked frequently during treatment.
- if you are currently taking ganciclovir capsules and your doctor wants you to switch to Valganciclovir Orion tablets. You mustn’t take more tablets than you are prescribed by your doctor, otherwise, there is a risk of overdose.
Other medicines and Valganciclovir Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you take other medicines at the same time as Valganciclovir Orion, the combination may affect the amount of medicine absorbed into your blood or possibly cause harmful effects. Tell your doctor if you are already taking medicines that contain any of the following:
- imipenem and cilastatin as a combination preparation (an antibiotic ). May cause seizures if taken with Valganciclovir Orion.
- zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines used to treat AIDS
- adefovir or inhaled medicines used to treat hepatitis B
- probenecid (a medicine for gout ). The amount of ganciclovir in the blood may increase if probenecid and Valganciclovir Orion are taken at the same time
- mycophenolate mofetil, ciclosporin, or tacrolimus (used after transplantation)
- vincristine, vinblastine, doxorubicin, hydroxyurea, or similar anticancer drugs
- trimethoprim, combinations with trimethoprim/sulfa and dapsone ( antibiotics )
- pentamidine (medicine to treat parasites or lung infections)
- flucytosine or amphotericin B (medicines against fungal infections).
Valganciclovir Orion with food, drink, and alcohol
Valganciclovir Orion should be taken with food. If for some reason you cannot eat, you should still take Valganciclovir Orion as usual.
Pregnancy, breastfeeding, and fertility
You should not take Valganciclovir Orion if you are pregnant unless your doctor advises you to do so. You must tell your doctor if you are pregnant or planning to become pregnant. Taking Valganciclovir Orion during pregnancy can harm your unborn baby.
You should not take Valganciclovir Orion if you are breastfeeding. If your doctor wants to start treatment with Valganciclovir Orion, you must stop breastfeeding before you start taking the tablets.
Women of childbearing potential must use effective contraception while being treated with Valganciclovir Orion and for at least 30 days after stopping treatment.
Men whose partners could become pregnant should use a condom while being treated with Valganciclovir Orion and they should continue to use a condom for 90 days after stopping treatment.
Driving ability and use of machinery
Do not drive or use tools or machines if you feel dizzy, tired, shaky, or confused while taking this medicine.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
How to use Valganciclovir Orion
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
You must handle the tablets carefully. The tablets must not be split or crushed. You should swallow the tablets whole and they should, if possible, be taken with food. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if sterile water is not available.
You must stick to the number of tablets prescribed by your doctor to avoid overdose.
Valganciclovir Orion tablets should, if possible, be taken with food – see section 2.
Adults:
Prevention of CMV disease in organ transplant patients
You must start taking this medicine within 10 days of the transplant. The usual dose is two tablets taken ONCE daily. You should continue this dose until 100 days after the transplant. If you have received a kidney transplant, your doctor may advise you to take the tablets for 200 days.
Treatment of active CMV – infection in the retina of the eye in patients with AIDS (so-called induction treatment)
The usual dose is two tablets of Valganciclovir Orion taken TWICE daily for 21 days (three weeks). Do not take this dose for more than 21 days unless your doctor tells you to, as your risk of side effects may increase.
Long-term treatment to prevent recurrent active inflammation in AIDS patients with CMV infection in the retina of the eye (so-called maintenance treatment)
The usual dose is two tablets taken ONCE daily. You should try to take the tablets at the same time each day. Your doctor will tell you how long to continue taking Valganciclovir Orion. If your retinitis worsens while taking this dose, your doctor may ask you to repeat the induction treatment (as above) or decide to give you another medicine to treat CMV infection.
Elderly patients
Valganciclovir has not been studied in elderly patients.
Patients with kidney problems
If your kidneys are not fully functioning, your doctor may instruct you to take fewer tablets per day or to only take the tablets on certain days of the week. It is very important that you only take the number of tablets prescribed by your doctor.
Patients with liver problems
Valganciclovir has not been studied in patients with liver problems.
Use for children and adolescents
Prevention of CMV disease in organ transplant patients
Children should start taking this medicine within 10 days of the transplant. The dose given varies depending on the size of the child and should be taken ONCE daily. Your doctor will decide on the most appropriate dose based on your child’s height, weight, and kidney function. You should continue with this dose up to 100 days after the transplant. If your child has received a kidney transplant, your doctor may advise you to take the medicine for 200 days.
For children who cannot swallow valganciclovir film-coated tablets, valganciclovir powder for an oral solution can be used.
If you use too much Valganciclovir Orion
If you have ingested or think you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice. If you have taken too many tablets, you can have serious side effects, especially in the blood and kidneys can be affected. You may need hospital care.
If you forget to use Valganciclovir Orion
If you forget to take your tablets, take the missed dose as soon as you remember and take the next dose at the usual time. Do not take a double dose to make up for missed tablets.
If you stop using Valganciclovir Orion
Do not stop taking this medicine unless your doctor tells you to.
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.
Allergic reactions
Up to 1 in 1,000 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock ). STOP taking valganciclovir and go to the emergency department of the nearest hospital
if you experience any of the following:
– increasing itchy rash ( hives )
– sudden swelling of the throat, face, lips, and mouth which may cause difficulty swallowing
breathing difficulties
– sudden swelling of hands, feet, or ankles.
Serious side effects are
Tell your doctor immediately if you notice any of the following serious side effects – your doctor may tell you to stop taking valganciclovir and you may need urgent medical treatment:
Very common: may affect more than 1 in 10 users
- low white blood cell count – with signs of infection such as sore throat, mouth sores, or fever
- low red blood cell count – signs include shortness of breath or tiredness, palpitations, or pale skin
Common: may affect up to 1 in 10 users
- blood poisoning ( sepsis ) – signs include fever, chills, palpitations, confusion, and slurred speech
- low platelet count – signs include bleeding or bruising more easily than usual,
- blood in the urine or stool or bleeding from the gums. Bleeding can be heavy
- severely low blood levels
- inflammation of the pancreas – signs are severe abdominal pain that spreads to the back
- cramps
Uncommon: may affect up to 1 in 100 users
- failure of the bone marrow’s ability to form blood cells
- hallucinations – hearing or seeing things that are not real
- abnormal thoughts or feelings, losing touch with reality impaired kidney function
Side effects that occurred during treatment with valganciclovir or ganciclovir are reported below:
Other side effects are
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 users):
- mushrooms and cod in the mouth
- upper respiratory tract infection (e.g. sinusitis, inflammation of the tonsils)
- loss of appetite
- headache
- cough
- shortness of breath
- diarrhea
- nausea or vomiting
- abdominal pain
- eczema
- fatigue
- fever
Common (may affect up to 1 in 10 users):
- influenza
- urinary tract infection – signs include fever, urinating more often than usual, pain when urinating
- infection in the skin and tissues under the skin
- mild allergic reaction – signs may include red and itchy skin
- weight loss
- feeling depressed, anxious, or confused
- sleep difficulties
- hands or feet feel weak and numb, which can affect balance
- changes in sensation, tingling, tickling, stinging, or burning sensation
- taste changes
- overindulge
- eye inflammation ( conjunctivitis ), pain in the eyes, or vision problems
- earache
- low blood pressure, which can make you feel dizzy or faint
- trouble swallowing
- constipation, flatulence, indigestion, stomach ache, swollen abdomen
- mouth ulcers
- abnormal results on liver and kidney tests
- night sweats
- itching, rash
- hair loss
- back pain, pain in muscles or joints, muscle cramps
- feel dizzy, weak, or generally unwell
Uncommon (may affect up to 1 in 100 users):
- feel upset
- tremors, tremors
- deafness
- irregular heartbeat
- hives, dry skin
- blood in the urine
- infertility in men – see section “fertility”
- chest pain
Separation of the inner part of the eye (retinal detachment) has only occurred in AIDS patients treated with valganciclovir for CMV infection.
Additional side effects in children and adolescents
Side effects reported in children and adolescents are similar to those reported in adults.
Reporting of side effects are
If you experience side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can contribute to increasing information about drug safety.
Additional side effects in children and adolescents
Side effects reported in children and adolescents are similar to those reported in adults.
How to store Valganciclovir Orion
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton after Ex. Date. and on the 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.
Contents of the packaging and other information
Contents declaration
The active substance is valganciclovir.
Each film-coated tablet contains valganciclovir hydrochloride, equivalent to 450 mg of valganciclovir.
Other ingredients are:
Tablet core: Microcrystalline cellulose (type 101 and type 102), crospovidone (Type B), povidone (K‑30), magnesium stearate.
Tablet coating: Hypromellose (3 cP, 6 cP), titanium dioxide (E171), macrogol 400, polysorbate 80, red iron oxide (E172).
Appearance and package sizes of the medicine
Film-coated tablet.
Pink, oval, biconvex, film-coated tablets with “H” printed on one side and “96” on the other side. The size is 16.8mm x 7.9mm.
Valganciclovir Orion film-coated tablets are available in Polyamide/ Aluminum/ PVC – Aluminum blister packs and HDPE bottles with polypropylene closure and cotton insert.
Package sizes:
Blister pack: 10, 30, 60, and 100 film-coated tablets.
HDPE can: be 60 and 1000 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Ltd
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
UK
or
ARROW Generics
26 Avenue Tony Garnier
69007 Lyon
France
or
Generis Farmaceutica, SA,
Rua Joao de Deus, 19,
2700-487 Amadora,
Portugal
For further information about this medicine, contact your local representative:
Orion Pharma AB, Danderyd, medinfo@orionpharma.com