Valganciclovir Tablets - Consumer Medicine Information
|Manufacture:||Dr. Reddy's Laboratories, Inc.|
|Condition:||Cytomegalovirus Infection, CMV Retinitis|
|Class:||Antiviral agents, Purine nucleosides|
|Ingredients:||valganciclovir hydrochloride, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, hypromellose, iron oxide red, polyethylene glycol, polysorbate, titanium dioxide|
What is the Most Important Information I Should Know About Valganciclovir
- Valganciclovir can affect your blood cells and bone marrow causing serious and life-threatening problems .
- Valganciclovir can lower the amount of your white blood cells, red blood cells, and platelets. Your doctor may do regular blood tests to check your blood cells while you are taking valganciclovir. Based on these tests, your doctor may change your dose or tell you to stop taking valganciclovir. Valganciclovir may cause cancer. Valganciclovir causes cancer in animals. It is not known if Valganciclovir causes cancer in people.
- Valganciclovir may cause birth defects . Valganciclovir causes birth defects in animals. It is not known if valganciclovir causes birth defects in people. If you are pregnant, talk to your doctorbefore taking valganciclovir.
- Tell your doctor right away if you become pregnant while taking valganciclovir.
- If you are a female who can become pregnant, you should use effective birth control during treatment with valganciclovir and for at least 30 days after treatment.
- Men should use a condom during treatment with valganciclovir , and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your doctor if you have questions about birth control.
- Valganciclovir may lower the amount of sperm in a man’s body and cause fertility problems.
- Valganciclovir can affect your kidney, including serious problems such as kidney failure. Your doctor may do regular blood tests to check your kidney function while you are taking valganciclovir. Your doctor may adjust your dose based on these tests
- Valganciclovir changes into the medicine ganciclovir once it is in your body. Ganciclovir is also the active ingredient in Cytovene®-IV and ganciclovir capsules. Do not take ganciclovir capsules or Cytovene-IV if you are taking valganciclovir . The dose of medicine in valganciclovir tablets and ganciclovir capsules is different. One tablet of valganciclovir has more medicine thanone capsule of ganciclovir. This means that one valganciclovir tablet cannot be substituted for one ganciclovir capsule. You could overdose and become very sick if valganciclovir is taken with ganciclovir capsules or Cytovene-IV. Talk to your doctor or pharmacist if you have questions about your medicine.
What is Valganciclovir
Valganciclovir is an “antiviral” medicine.
In adults, valganciclovir tablets are used:
- to treat cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS). When CMV virus infects the eyes, it is called CMV retinitis. If CMV retinitis is left untreated, it can cause blindness.
- to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, orkidney-pancreas transplant and who have a high risk for getting CMV disease.
In children (4 months to 16 years of age) valganciclovir tablets used:
- to prevent cytomegalovirus (CMV) disease in children who have received a heart or kidney transplant and have a high risk for getting CMV disease.
Valganciclovir is not for use in adults or children who have received a liver transplant.
It is not known if valganciclovir is safe and effective:
- to prevent CMV disease in people who have had other types of organ transplants such as lung or intestine.
- to prevent CMV disease in children under 4 months of age who receive an organ transplant.
- to treat CMV disease that a baby might be born with (congenital CMV disease)
- in adults older than age 65.
Valganciclovir does not cure CMV retinitis . You may still get retinitis or worsening of retinitis during or after treatment with valganciclovir. It is important to stay under a doctor’s care and have your eyes checked regularly.
Who Should not Take Valganciclovir
Do not take valganciclovir tablets if you are receiving hemodialysis . The use of ganciclovir capsules rather than valganciclovir tablets are recommended.
Do not take valganciclovir if you are allergic to any of its ingredients or if you have ever had a serious allergic reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to valganciclovir may include: sudden trouble breathing, wheezing, hives all over your body, swelling around your mouth, or feeling anxious.
See the end of this leaflet for a list of the ingredients in valganciclovir.
What Should I Tell My Doctor Before Taking Valganciclovir
Before taking valganciclovir, tell your doctor if you:
- have kidney problems. Your doctor may give you a lower dose of valganciclovir , or check you more often if you are taking valganciclovir .
- have blood cell problems
- are having radiation treatment have any other medical conditions Tell your doctor right away if youbecome pregnant while taking valganciclovir. See “What is the most important information I should know about valganciclovir?”
- are breast-feeding or plan to breast-feed.It is not known if valganciclovir passes into your milk and if it may harm your baby. You should not breast-feed if you are HIV-positive because of the chance of passing the HIV virus to your baby through your milk.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Valganciclovir and other medicines may affect each other and cause serious side effects. Especially tell your doctor if you take:
- didanosine (Videx)
- zidovudine (Retrovir, Trizivir, Combivir)
- probenecid (Col-Probenecid, Probenacid and Colchicine)
- mycophenolate mofetil (CellCept)
How Should I Take Valganciclovir
- Take valganciclovir exactly as your doctor prescribes it. Your dose of valganciclovir will depend on your medical condition.
- Adults should only take valganciclovir tablets. Children may take either valganciclovir tablets or oral solution.
- Take valganciclovir with food.
- Do not break or crush valganciclovir tablets. Avoid contact with your skin or eyes. If you come in contact with the contents of the tablet, wash your skin well with soap and water or rinse your eyes well with plain water.
- If you miss a dose of valganciclovir , take the missed dose as soon as you remember. Then, take the next dose at the usual scheduled time. However, if it is almost time for your next dose, do not takethe missed dose.
- Do not let your valganciclovir run out. The amount of virus in your blood may increase if your medicine is stopped, even for a short time. If you take too much valganciclovir , call your local poison control center or emergency room right away. You may need treatment in a hospital.
- Do not substitute valganciclovir tablets for ganciclovir capsules. Talk to your doctor, nurse or pharmacist if you have questions about your medicine.
What Should I Avoid While Taking Valganciclovir
- Valganciclovir can cause seizures, sleepiness, dizziness, unsteady movements, and confusion. You should not drive a car or operate other dangerous machinery until you know how valganciclovir affects you.
What are the Possible Side Effects of Valganciclovir
Valganciclovir may cause serious side effects, including:
- See “What is the most important information I should know about valganciclovir?”
Common side effects of valganciclovir in adults and children include:
- nausea, vomiting
- shaky movements (tremors)
- low white cell, red cell and platelet cell counts in blood tests
- rejection of the transplanted organ (graft)
Other common side effects in children include:
- high blood pressure
- cough and colds
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of valganciclovir . For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How Should I Store Valganciclovir Tablets
- Store valganciclovir tablets at room temperature between, 20°C-25°C (68°F-77°F)
- Do not keep medicine that is out of date or that you no longer need.
- Keep valganciclovir tablets and all medicines out of the reach of children.
General Information About Valganciclovir
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use valganciclovir for a condition for which it was not prescribed. Do not give valganciclovir to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about valganciclovir. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about valganciclovir that is written for health professionals.
For more information about valganciclovir call 1-888-375-3784.
What are the Ingredients in Valganciclovir Tablets
Active Ingredient: valganciclovir hydrochloride
Inactive Ingredients for Tablets: crospovidone, magnesium stearate, microcrystalline cellulose and povidone. The film- coat applied to the tablets contains hypromellose, iron oxide red, polyethylene glycol, polysorbate and titanium dioxide.
To reorder additional Patient Information Sheets, contact Dr. Reddy’s customer service at 1-866-733-3952.
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA