Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Valganciclovir hydrochloride
Accord-UK Ltd
J05AB14
Valganciclovir hydrochloride
450mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030202; GTIN: 5055565727591
PACKAGE LEAFLET: INFORMATION FOR THE USER VALGANCICLOVIR 450 MG FILM-COATED TABLETS valganciclovir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Valganciclovir tablet is and what it is used for 2. What you need to know before you take Valganciclovir tablets 3. How to take Valganciclovir tablets 4. Possible side effects 5. How to store Valganciclovir tablets 6. Contents of the pack and other information 1. WHAT VALGANCICLOVIR TABLET IS AND WHAT IT IS USED FOR Valganciclovir belongs to a group of medicines, which work directly to prevent the growth of viruses. In the body the active ingredient in the tablets, valganciclovir, is changed into ganciclovir. Ganciclovir prevents a virus called cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause an infection in the body’s organs. This can be life threatening. Valganciclovir tablet is used: for the treatment of CMV-infections of 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-infections in adults and children who are not infected with CMV and who have received an organ transplant from somebody who was infected by CMV. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALGANCICLOVIR TABLETS DO NOT TAKE VALGANCICLOVIR TABLETS: if you are allergic to valganciclovir or any of the other ingredients of this medicine (listed in section 6) Read the complete document
1. NAME OF THE MEDICINAL PRODUCT Valganciclovir 450 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir (as free base). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Oval, biconvex, pink colored film-coated tablets approx16.83 x 7.95 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Valganciclovir is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir is indicated for the prevention of CMV disease in CMV-negative adults and children (aged from birth to 18 years) who have received a solid organ transplant from a CMV-positive donor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology CAUTION – STRICT ADHERENCE TO DOSAGE RECOMMENDATIONS IS ESSENTIAL TO AVOID OVERDOSE (SEE SECTIONS 4.4 AND 4.9). Valganciclovir is rapidly and extensively metabolised to ganciclovir after oral dosing. Oral valganciclovir 900 mg b.i.d. is therapeutically equivalent to intravenous ganciclovir 5 mg/kg b.i.d. TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS _ _ _Adult patients _ _Induction treatment of CMV retinitis: _ For patients with active CMV retinitis, the recommended dose is 900 mg valganciclovir (two Valganciclovir 450 mg tablets) twice a day for 21 days and, whenever possible, taken with food. Prolonged induction treatment may increase the risk of bone marrow toxicity (see section 4.4). _Maintenance treatment of CMV retinitis: _ Following induction treatment, or in patients with inactive CMV retinitis, the recommended dose is 900 mg valganciclovir (two Valganciclovir 450 mg tablets) once daily and, whenever possible, taken with food. Patients whose retinitis worsens may repeat induction treatment; however, consideration should be given to the possibility of viral drug resistance. The duration of maintenance treatment should be determined on a Read the complete document