450 mg film-coated tablets
valganciclovir
What Valganciclovir Teva is and what it is used for
Valganciclovir Teva belongs to a group of medicines that act directly to prevent the multiplication of viruses. The active ingredient, 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 various organs, which can even be life-threatening.
Valganciclovir Teva is used for
- treatment of CMV – infection in the retina of the eye in adult patients with AIDS (so-called acquired immunodeficiency syndrome). 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 themselves infected with CMV, but who have received an organ transplant from someone who was infected with CMV.
The valganciclovir contained in Valganciclovir Teva 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 Teva
Do NOT use Valganciclovir Teva
- 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 using Valganciclovir Teva
- if you are allergic to aciclovir, penciclovir, valaciclovir, or famciclovir. These are other drugs used in viral infections.
Take special care with Valganciclovir Teva
- 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 do blood tests before you start taking Valganciclovir Teva 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 Teva 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 Teva
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
If you take other medicines at the same time as Valganciclovir Teva, 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-cilastatin ( antibiotics ). May cause seizures if taken with Valganciclovir Teva
- zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines used to treat AIDS .
- adefovir or other medicines used to treat hepatitis B.
- probenecid (medicine for gout ). The amount of ganciclovir in the blood may increase if probenecid and Valganciclovir Teva are taken at the same time.
- mycophenolate mofetil, cyclosporin, 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 (antifungal).
Valganciclovir Teva with food and drink
Valganciclovir Teva should be taken with food. If for some reason you cannot eat, you should still take your medicine as usual.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do NOT take Valganciclovir Teva if you are pregnant unless your doctor specifically tells you to do so. If you are pregnant or planning a possible pregnancy, you MUST tell the doctor about this. Taking Valganciclovir Teva during pregnancy can be harmful to the fetus.
Breast-feeding
Do NOT take Valganciclovir Teva if you are breastfeeding. If the doctor wishes to start medication with Valganciclovir Teva, YOU MUST STOP breastfeeding before starting the drug treatment.
Fertility
Women of childbearing age
Women of childbearing potential MUST use an effective method of contraception while using Valganciclovir Teva and for at least 30 days after stopping treatment.
Men
Men, whose partners may become pregnant, should use a condom while being treated with Valganciclovir Teva and for 90 days after stopping treatment.
Driving ability and use of machinery
DO NOT drive or use tools or machines if you experience dizziness, tiredness, tremors, or confusion while being treated with Valganciclovir Teva.
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.
Valganciclovir Teva contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to use Valganciclovir Teva
Always use 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 into the eyes, rinse the eyes with sterile or clean water (if sterile water is not available).
Always take the number of tablets prescribed by the doctor. This is to avoid overdose.
Valganciclovir Teva should always be taken with a meal when this is possible (see section 2 “Valganciclovir Teva with food and drink”).
Adults
Prevention of CMV infection in organ transplant patients
You should start taking this medicine within 10 days after the transplant. A usual dose is two tablets ONCE daily. You should continue with this dose up to 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 infections in the retina of the eye in patients with AIDS (so-called induction treatment)
A usual dose is two tablets of Valganciclovir Teva TWICE daily for 21 days (three weeks). Do not take this dose for more than 21 days, unless your doctor tells you to do so, as the risk of side effects may increase.
Long-term treatment to prevent recurrent active infection in AIDS patients with CMV – infection in the retina of the eye (so-called maintenance treatment)
A usual dose is two tablets of Valganciclovir Teva ONCE daily. You should try to take the tablets at the same time each day. The doctor will tell you how long to continue taking Valganciclovir Teva. If your retinitis worsens while you are taking this dose, your doctor may ask you to repeat the induction treatment (see above) or decide to prescribe you another medicine to treat CMV infection.
Older
The use of Valganciclovir Teva has not been studied in the elderly.
Impaired kidney function
If your kidneys are not working normally, 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.
Impaired liver function
The use of Valganciclovir Teva 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.
If you have used too much Valganciclovir Teva
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor o hospital for an assessment of the risk and advice. Taking too many tablets can cause serious side effects and, above all, hurt the blood and kidneys. You may need hospital care.
If you forget to use Valganciclovir Teva
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 Teva
DO NOT stop taking this medicine unless your doctor tells you to.
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.
Allergic reactions
Up to 1 in 1,000 people may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock ). STOP taking Valganciclovir Teva and go to the emergency department of your nearest hospital immediately if you experience any of the following:
- raised and itchy rash ( hives )
- sudden swelling of the throat, face, lips, or mouth, which may cause difficulty swallowing and breathing
- 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 emergency care:
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 are shortness of breath, 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
- very low blood cell count
- 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, loss of contact with reality
- kidney failure
Side effects that occurred during treatment with valganciclovir or ganciclovir are reported below:
Other side effects are
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, need to urinate more often, pain when urinating
- infection in the skin and tissues under the skin
- mild allergic reaction – signs may include red, 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 ), swelling of the eyes ( edema ), retinal detachment*, pain in the eyes, or vision problems
- earache
- low blood pressure, which can make you feel dizzy or faint
- trouble swallowing
- constipation, flatulence, indigestion, abdominal pain, bloating
- 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 pulse
- hives, dry skin
- blood in the urine
- infertility in men – see section 2 “Pregnancy, breastfeeding and fertility”
- chest pain
Rare (may affect up to 1 in 1,000 users):
- Effect on the blood and bone marrow: reduced production of all types of blood cells ( red blood cells, white blood cells, and platelets ) in the bone marrow.
*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.
How to store Valganciclovir Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton 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 450 mg of valganciclovir, which is included in the form of 496.3 mg of valganciclovir hydrochloride
- Other ingredients in the tablet core are microcrystalline cellulose (E460(i)), mannitol (E421), magnesium stearate (E470b), colloidal anhydrous silica (E551), and crospovidone type A (E1202). Other ingredients in the film coating are hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin (E1518), and red iron oxide (E172).
Appearance and package sizes of the medicine
Valganciclovir Teva isan oval, pink, film-coated tablet with beveled edges, debossed with “93” on one side and “5465” on the other side.
Valganciclovir Teva is available in the following packs:
PVC/ACLAR/PVC//Aluminium blister packs of 10, 30, 30×1, 60 or 60×1 tablets
HDPE plastic cans with a desiccant container (3 g) and polypropylene (PP) child-resistant lid in pack sizes of 30 and 60 tablets.
For cans: Use within 9 months after first opening.
Not all pack sizes may be marketed.