VALCYTE 450mg. 60 tablets
Valcyte belongs to a group of drugs that directly prevent the growth of viruses. The active substance in the tablet, valganciclovir, ganciclovir changes.
Ganciclovir prevents replication and spread of a virus called cytomegalovirus (CMV), in healthy cells. In patients with a weakened immune system, CMV can cause an infection in the body. This can have life-threatening effects.
for the treatment of CMV infections in the retina of the eye in patients who have acquired immunodeficiency syndrome disease (AIDS). CMV infection of the retina of the eye can lead to violation of vision or even blindness;
to prevent CMV infection in patients who are not infected with CMV, but have received an organ transplant from someone who has been infected with CMV.
2. What you need to know before taking Valcyte
Do not take Valcyte:
if you are allergic to valganciclovir or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to ganciclovir, acyclovir or valacyclovir - medicines to treat other viral infections;
if you are breastfeeding.
Warnings and Precautions
C Talk with your doctor or pharmacist before taking Valcyte.
Take special care with Valcyte:
if you have low white blood cells, red blood cells or platelets (small cells involved in blood clotting). Your doctor will perform blood tests before you start taking Valcyte tablets and will continue to check your blood while you are taking tablets;
if you are treated with radiation therapy or are undergoing hemodialysis;
if you have kidney problems. Your doctor may lower your dose and often need to monitor your blood counts during treatment. If you are currently taking ganciclovir capsules and your doctor decide to go to therapy Valcyte tablets. It is important not to take more tablets than prescribed by your doctor or else it may result in a risk of overdose.
Children and adolescents
Currently, survey data are not sufficient to show how the drug works in children.
Other medicines and Valcyte
Tell your doctor or pharmacist if you are taking, have recently taken or taking other medicines, including medicines obtained without a prescription.
If you take other medicines Valcyte combination may affect the amount of medicine in the blood or cause side effects.
Tell your doctor if you are already taking medicines that contain the following:
imipenem-cilastatin (an antibiotic). Taking this medicine with Valcyte can cause seizures;
zalcitabine, zidovudine, didanosine, or other similar drugs used for the treatment of AIDS;
probenecid (for gout). Concomitant administration of probenecid and Valcyte may increase the amount of ganciclovir in your blood;
mycophenolate mofetil (which was used after transplantation);
vincristine, vinblastine, adriamycin, hydroxyurea and similar drugs for cancer;
cidofovir, foscarnet or nucleoside analogs for the treatment of viral infections;
trimethoprim, trimethoprim / sulfa - combinations and dapsone (antibiotics);
pentamidine (for the treatment of parasitic infections or lung);
flucytosine or amphotericin B (antifungal agents).
Valcyte with food and drink
Where possible, these tablets should be taken with food. If for some reason you can not eat, you need to take your dose Valcyte as usual.
Pregnancy, lactation and fertility
You should not take Valcyte if you are pregnant, unless your doctor recommends. If you are pregnant or planning to become pregnant, you should tell your doctor. If you are pregnant and taking Valcyte, it can harm your unborn baby.
If you are breastfeeding, you should not take Valcyte. If your doctor advises you to start treatment with Valcyte should stop breast-feeding before taking these tablets.
Women of childbearing potential should use effective methods of birth control during treatment with Valcyte.
Men whose partners may become pregnant should use condoms while taking Valcyte, and should continue to use condoms for 90 days after treatment is completed.
Driving and using machines
Do not drive or operate machinery if you feel dizzy, tired, sleepy or confused while taking this medicine
Ask your doctor or pharmacist before taking any medicine.
3. How to take Valcyte
Always take this medicine exactly as prescribed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
You should be careful when touching the tablet. Do not crush or crush them. They must be swallowed whole and, if possible, with food. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If the tablet powder gets into your eyes, rinse them thoroughly with sterile or clean water if you do not sterile.
You should take as tablets as your doctor tells you to avoid overdose.
Valcyte tablets should be taken with food whenever possible - see section 2.
Prevention of the occurrence of CMV infection in transplant patients
Should start taking this medicine 10 days after transplantation. The usual dose is two tablets once daily. You should continue with this dose to 100 days after transplantation. If you have a kidney transplant, your doctor may advise you to take the tablets for 200 days.
Treatment of active CMV retinitis in patients with AIDS (called induction therapy)
Valcyte usual dose is two tablets twice daily for 21 days (3 weeks). Do not take this dose more than 21 days unless your doctor tells you, because it may increase the risk of possible side effects.
Long-term treatment to prevent recurrence of active inflammation in patients with AIDS and CMV retinitis with (called maintenance)
The usual dose is two tablets once daily. You should try to take the tablets at the same time each day. Your doctor will advise you how long you should continue taking Valcyte. If you retinitis worsen while being treated with this dose, your doctor may tell you to repeat the induction treatment (as above) or may decide to give you a different medicine for the treatment of CMV infection.
Valcyte not been studied in elderly patients.
Patients c kidney problems
If your kidneys are not working properly, your doctor will tell you to take fewer tablets each day or taking your tablets just a few days a week. It is very important that you take only the tablets as prescribed by your doctor.
Patients with liver problems
Valcyte not been studied in patients with liver problems.
If you take more than you should Valcyte
Immediately contact your doctor or the hospital if you take or think you have taken more tablets than you should. The adoption of more than the prescribed dose can cause serious side effects, particularly those affecting the blood or kidney. This may require hospital treatment.
If you forget to take Valcyte
If you forget to take a tablet take the missed dose as soon as you remember and then take your next dose as usual. Do not take a double dose to make up for the missed tablets.
If you stop taking Valcyte
You should not stop taking your medicine unless the doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Up to 1 in every 100 people may cause sudden and severe allergic reaction to valganciclovir (anaphylactic shock). Stop taking Valcyte and contact the emergency department of the nearest hospital if you experience any of the following symptoms:
aggravated, itchy rash (urticaria);
sudden swelling of the throat, face, lips and mouth, which may cause difficulty in swallowing or breathing;
sudden swelling of the hands, feet, ankles.
Adverse effects on the observed during treatment with ganciclovir or valganciclovir are presented below:
Very common is that the effect may occur in more than 1 in 10 patients;
Common means that the effect may occur in 1 to 10 of 100 patients;
Uncommon means that the effect may occur in 1 to 10 patients in 1000;
Rare means that the effect may occur in 1 to 10 of 10,000 patients.
Very common side effects (may affect more than 1 in 10 patients):
Effects on blood, decrease the number of white blood cells in the blood (neutropenia), which will make it more susceptible to infections, reduction of the pigment in the blood, the oxygen-carrying (anemia), which may cause fatigue and dyspnea on exertion;
Effects on respiration: a feeling of shortness of breath or difficulty breathing (dyspnea);
Effects on the stomach or digestive system: diarrhea.
Common side effects (may affect 1 to 10 users in 100):
Effects on the blood: a reduction in the number of leukocytes (blood cells that fight infection) in the blood (leucopenia), reduction in the number of blood platelets (thrombocytopenia), which can cause bruising and bleeding, reduction in the number of several types cells simultaneously (pancytopenia);
Effects on the nervous system: headache, difficulty sleeping (insomnia), strange taste (dysgeusia), decreased sensitivity to touch (hypoaesthesia), a sense of numbness or tingling of the skin (paraesthesia), numbness in the arms or legs (peripheral neuropathy) , dizziness, seizure (convulsions);
Effects in the eye: eye pain, eye swelling (edema), separating the back of the eye (detached retina) particles floating in the eye;
Effects ears: ear pain;
Effects on respiration: coughing;
Effects on the stomach or digestive system: nausea and vomiting, stomach pain, constipation, flatulence, indigestion (dyspepsia), difficulty swallowing (dysphagia);
Effects on the skin, inflamed skin (dermatitis), itching (pruritus), night sweats;
Effects on the muscles, joints or bones, back pain, muscle pain (myalgia), joint pain (arthralgia), muscle stiffness (rigor), muscle cramps;
Infections: fungal infection in the mouth (oral thrush), infections caused by bacteria or virus in the blood, inflammatory cell tissue (cellulitis), inflammation or infection of the kidney or bladder;
Hepatic effects: increases in some liver enzymes, as determined with blood tests;
Renal effects: changes in the normal activity of the kidneys;
Effects on nutrition, loss of appetite (anorexia), weight loss;
General effects: fatigue, fever, pain, chest pain, decreased energy (asthenia), feeling bad state (malaise);
Effects on mood or behavior: depression, anxiety, confusion, unusual thoughts.
Uncommon side effects (may affect 1 to 10 users in 1,000):
Effects on the heart: changes in the normal heart rhythm (arrhythmia);
Effects on blood circulation, low blood pressure (hypotension), which can lead to dizziness or fainting;
Effects on blood: decreased production of blood cells in the bone marrow;
Effects on nerves, instability or shaking (tremors);
Effects in the eye: red, swollen eyes (conjunctivitis), visual disturbances;
Effects ears deafness;
Effects on the stomach or digestive system: bloated stomach, mouth ulcers, inflammation of the pancreas (pancreatitis) in which you may have pain in the stomach and back;
Effects on the skin: hair loss (alopecia), itchy rash or swelling (urticaria), dry skin;
Renal effects: blood in the urine (hematuria), renal failure;
Hepatic effects: increased liver enzyme called alanine aminotransferase (finding only blood tests);
Effects on fertility: impaired fertility in men;
Effects on mood or behavior: unusual changes in mood or behavior, loss of contact with reality, eg. hearing voices or seeing things that are not there, feeling agitated.
Rare side effects (may affect 1 to 10 users in 10,000 users):
Effects on blood: insufficient production of all types of blood cells (red cells, white cells and platelets) in the bone marrow.
If you get any side effects, tell your doctor or pharmacist. This includes any not listed in this leaflet.
5. How to store Valcyte
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label and carton which is stated after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and further information
The active substance is 450 mg of valganciclovir in the form of valganciclovir hydrochloride 496,3 mg.
The other ingredients (excipients) in the tablet are: povidone K30, crospovidone, microcrystalline cellulose, and stearic acid. Ingredients in coated coating are: hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172) and polysorbate 80.
Valcyte looks like and contents of pack
Valcyte are pink, oval film-coated tablet imprinted with "VGC" on one side and "450" on the other side.
Each pack contains one bottle of 60 tablets.