Ceglar
Ask a doctor about a prescription for Ceglar
How to use Ceglar
Leaflet accompanying the packaging: patient information
Ceglar, 450 mg, coated tablets
Valganciclovir
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
- Keep this leaflet, so you can read it again if you need to.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
Table of contents of the leaflet
- 1. What Ceglar is and what it is used for
- 2. Important information before taking Ceglar
- 3. How to take Ceglar
- 4. Possible side effects
- 5. How to store Ceglar
- 6. Contents of the pack and other information
1. What Ceglar is and what it is used for
Ceglar belongs to a group of medicines whose action is based on the direct prevention of virus multiplication. Valganciclovir, the active substance of the tablets, is converted in the body to ganciclovir. Ganciclovir prevents the multiplication of the virus (cytomegalovirus, CMV) and its infection of healthy body cells. In patients with weakened immune systems, cytomegalovirus can cause infections of various organs. This can be life-threatening.
Ceglar is used to:
treat cytomegalovirus retinitis in adult patients with acquired immune deficiency syndrome (AIDS). Cytomegalovirus infection of the retina can cause vision disturbances and even blindness.
prevent cytomegalovirus infections in adult and pediatric patients who are not infected with CMV and have received a transplanted organ from CMV-infected donors.
2. Important information before taking Ceglar
When not to take Ceglar
if the patient is allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6);
if the patient is breastfeeding.
Warnings and precautions
Before starting to take Ceglar, the patient should discuss it with their doctor or pharmacist if:
the patient is allergic to acyclovir, penciclovir, valacyclovir, or famciclovir - other medicines used to treat viral infections.
During Ceglar treatment, the patient should be particularly careful if:
the patient has a low white blood cell count, red blood cell count, or platelet count (small blood cells involved in blood clotting); the doctor will prescribe blood tests before starting Ceglar and additional blood tests during treatment;
the patient is undergoing radiotherapy or hemodialysis;
the patient has kidney function disorders; the doctor may prescribe a reduced dose of the medicine and order regular blood tests during treatment;
the patient is currently taking ganciclovir in capsule form and the doctor has decided to switch to Ceglar tablets. It is essential not to take more tablets than prescribed by the doctor, as this may lead to an overdose.
Ceglar and other medicines
The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
| Taking other medicines at the same time as Ceglar may affect the concentration of the medicine in the blood and cause its harmful effects. | |
| If the patient is currently taking a medicine containing any of the following active substances, they should inform their doctor: | |
| ⬧ imipenem with cilastatin (an antibiotic); taking it with Ceglar may cause seizures; | |
| ⬧ zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medicines used to treat AIDS; | |
| ⬧ adefovir or other medicines used to treat hepatitis B; | |
| ⬧ probenecid (a medicine used to treat gout); taking probenecid and Ceglar at the same time may increase the concentration of ganciclovir in the blood; | |
| ⬧ mycophenolate mofetil, cyclosporine, or tacrolimus (medicines used after organ transplantation); | |
| ⬧ vincristine, vinblastine, doxorubicin, hydroxyurea, or similar types of medicines used to treat cancer; | |
| ⬧ trimethoprim, trimethoprim with sulfonamides, and dapsone (antibacterial medicines); | |
| ⬧ pentamidine (a medicine used to treat parasitic diseases or lung infections); | |
| ⬧ flucytosine or amphotericin B (antifungal medicines). | |
Ceglar with food and drink
Ceglar should be taken with food. If the patient cannot eat for any reason, they should still take the prescribed dose of Ceglar.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnant women should not take Ceglar unless their doctor advises them to. If the patient is pregnant or plans to become pregnant, they must inform their doctor.
Taking Ceglar during pregnancy may harm the unborn child.
Ceglar should not be taken during breastfeeding. If the doctor advises the patient to start taking Ceglar, they should stop breastfeeding before starting treatment.
Women of childbearing age must use effective contraception during treatment and for at least 7 months after its completion.
Men taking Ceglar whose partners may become pregnant should use condoms during treatment and for 4 months after its completion.
Driving and using machines
If the patient experiences dizziness, fatigue, tremors, or confusion while taking Ceglar, they should not drive vehicles, use tools, or operate machines.
The patient should consult their doctor before taking any medicine.
3. How to take Ceglar
This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The patient should handle the tablets with care; they should not be broken or crushed.
The tablets should be swallowed whole, with food if possible. If the patient accidentally touches a damaged tablet, they should wash their hands thoroughly with water and soap. If any powder from the tablet gets into the eyes, they should rinse them thoroughly with sterile water (or clean water if sterile water is not available).
To avoid overdose, the patient should strictly follow the number of tablets prescribed by the doctor.
If possible, Ceglar tablets should be taken with meals - see section 2.
For children and adolescents who require dose adjustment, the medicine is available in a different pharmaceutical form.
Adults
Prevention of cytomegalovirus disease in transplant recipients
Treatment with Ceglar should be started within 10 days after transplantation.
The recommended dose is two tablets taken ONCE a day.
This dose should be taken for 100 days after transplantation. Patients who have received a kidney transplant may be advised by their doctor to take the medicine for 200 days.
Treatment of active cytomegalovirus retinitis in patients with AIDS (initial treatment)
The recommended dose is two tablets taken TWICE a day for 21 days (three weeks).
Without the doctor's advice, the medicine should not be taken for more than 21 days, as this may increase the risk of side effects.
Patients with impaired kidney function may be advised by their doctor to take a smaller number of tablets each day or to take them on specific days of the week. It is very importantto follow the doctor's prescribed number of tablets.
Patients with liver function disorders
The use of valganciclovir has not been studied in patients with abnormal liver function.
Use in children and adolescents
Prevention of cytomegalovirus disease in transplant recipients
Treatment with Ceglar should be started within 10 days after transplantation. The dose may vary depending on the child's size and should be taken ONCE a day.
The doctor will determine the appropriate dose based on the child's growth, body weight, and kidney function.
The recommended dose should be taken for 100 days. If the child has received a kidney transplant, the doctor may advise taking the medicine for 200 days.
For children who are unable to swallow Ceglar tablets, valganciclovir can be used in the form of oral solution powder.
Taking a higher dose of Ceglar than recommended
If the patient has taken or suspects they have taken more tablets than prescribed, they should immediately contact their doctor or the nearest hospital. Taking an overdose of the medicine may cause severe side effects, especially those related to the blood or kidneys. Hospital treatment may be necessary.
Missing a dose of Ceglar
If a dose is missed, the patient should take it as soon as they remember, and the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.
Stopping Ceglar treatment
The patient should not stop taking the medicine without their doctor's advice.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.
4. Possible side effects
Like all medicines, Ceglar can cause side effects, although not everybody gets them.
Allergic reactions
Less than 1 in 1000 people may experience a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). If the patient experiences any of the following symptoms, they should STOPtaking the medicine and go to the emergency department of the nearest hospital:
swollen, itchy skin rash (hives)
sudden swelling of the throat, face, lips, and mouth, which can cause difficulty swallowing or breathing
sudden swelling of the hands, feet, or ankles
Severe side effects
If the patient experiences any of the following severe side effects, they should immediately consult their doctor. The doctor may advise stopping Ceglar treatment, and the patient may require urgent treatment.
Very common:may occur more often than in 1 in 10 people
- low white blood cell count - with symptoms of infection, such as sore throat, mouth ulcers, or fever
- low red blood cell count - symptoms include shortness of breath, fatigue, palpitations, or pale skin
Common:may occur less often than in 1 in 10 people
- blood infection (sepsis) - symptoms include fever, chills, palpitations, confusion, and slurred speech
- low platelet count - symptoms include easier-than-usual bleeding or bruising, blood in the urine or stool, or bleeding from the gums; bleeding can be severe
- significantly reduced blood cell count
- pancreatitis - a symptom is severe abdominal pain radiating to the back
- seizures
Uncommon:may occur less often than in 1 in 100 people
- bone marrow failure (inability of the bone marrow to produce blood cells)
- hallucinations - hearing or seeing things that do not exist
- abnormal thinking or feeling, loss of contact with reality
- kidney failure
The following side effects have been reported during treatment with valganciclovir or ganciclovir.
Other side effects
If the patient experiences any of the following side effects, they should inform their doctor, pharmacist, or nurse:
Very common(may occur more often than in 1 in 10 people)
candidiasis, thrush in the mouth
upper respiratory tract infection (e.g., sinusitis, tonsillitis)
loss of appetite
headache
cough
shortness of breath
diarrhea
nausea or vomiting
abdominal pain
rash
fatigue
fever
Common(may occur less often than in 1 in 10 people)
flu
urinary tract infection - symptoms include fever, frequent urination, pain during urination)
skin and subcutaneous tissue infections
mild allergic reaction - symptoms include skin redness and itching
weight loss
feeling depressed, anxious, or confused
difficulty sleeping
weakness or numbness of the hands or feet, which can affect balance
changes in touch sensation, tingling, itching, pricking, or burning
changes in taste sensation
chills
conjunctivitis, eye pain, or vision disturbances
low blood pressure, which can cause dizziness or fainting
difficulty swallowing
constipation, gas, indigestion, stomach pain, abdominal swelling
mouth ulcers
abnormal liver and kidney function test results
night sweats
itching, rash
hair loss
back pain, muscle pain, or joint pain, muscle spasms
dizziness, weakness, or general malaise
Uncommon(may occur less often than in 1 in 100 people)
agitation
tremors
deafness
irregular heartbeat
hives, dry skin
blood in the urine
male infertility (see section "Fertility")
chest pain
Retinal detachment has been reported only in CMV-infected patients with AIDS treated with valganciclovir.
Additional side effects in children and adolescents
Side effects in children and adolescents are similar to those observed in adult patients.
Reporting side effects
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.
5. How to store Ceglar
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, or bottle after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Shelf life after first opening the bottle: 2 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
What Ceglar contains
- The active substance is valganciclovir (in the form of valganciclovir hydrochloride). Each coated tablet contains 450 mg of valganciclovir (in the form of valganciclovir hydrochloride).
- The other ingredients are: Tablet core: microcrystalline cellulose (PH101), crospovidone (type A), povidone (K-30), stearyl fumarate. Coating: Opadry Pink 15B24005: hypromellose (3 cP), hypromellose (6 cP), titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), polysorbate 80.
What Ceglar looks like and contents of the pack
Ceglar tablets are pink, oval, biconvex (16.7 x 7.8 mm), with the symbol "J" embossed on one side and "156" on the other side.
The coated tablets are packaged in blisters of OPA/Aluminum/PVC/Aluminum foil in a carton or in HDPE bottles with a cotton plug and a PP cap with a child-resistant closure and tamper-evident ring, in a carton.
Blisters: 10, 30, 60, 90, and 120 coated tablets.
Bottle: 60 coated tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer/importer
Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
tel. +48 22 209 70 00
Manufacturer/Importer
Lek S.A.
ul. Domaniewska 50C
02-672 Warsaw
This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
| Salutas Pharma GmbH | ||
| Otto-von-Guericke-Allee 1 | ||
| 39179 Barleben, Germany | ||
| Lek Pharmaceuticals d.d. | |
| Verovškova 57 | |
| 1526 Ljubljana, Slovenia | |
| Austria | Valganciclovir Sandoz 450 mg - Filmtablette |
| Belgium | Valganciclovir Sandoz 450 mg filmomhulde tabletten |
| Croatia | Nyctos 450 mg filmom obložene tablete |
| Cyprus | Valganciclovir HCL Sandoz 450 mg |
| Czech Republic | Valganciclovir Sandoz 450 mg potahované tablety |
| Denmark | Valganciclovir Sando |
| Estonia | Valganciclovir Sandoz |
| Finland | Valganciclovir Sandoz |
| France | VALGANCICLOVIR SANDOZ 450 mg, comprimé pelliculé |
| Greece | Valganciclovir /Sandoz |
| Spain | Valganciclovir Sandoz 450 mg comprimidos recubiertos con película EFG |
| Netherlands | Valganciclovir Sandoz 450 mg, filmomhulde tablet |
| Ireland | Valganciclovir Rowex 450 mg Film-coated tablets |
| Lithuania | Valganciclovir Sandoz 450 mg plėvele dengtos tabletės |
| Luxembourg | Valganciclovir Sandoz 450 mg comprimés pelliculés |
| Latvia | Valganciclovir Sandoz 450 mg apvalkotās tabletes |
| Germany | Valganciclovir HEXAL 450 mg Filmtabletten |
| Norway | Valganciclovir Sandoz |
| Poland | Ceglar |
| Portugal | Valganciclovir Sandoz |
| Romania | VALGANCICLOVIR SANDOZ 450 mg comprimate filmate |
| Slovenia | Valganciklovir Lek 450 mg filmsko obložene tablete |
| Sweden | Valganciclovir Sandoz |
| Italy | VALGANCICLOVIR SANDO |
| United Kingdom (Northern Ireland) | Valganciclovir 450mg Film-coated Tablets |
Date of last revision of the leaflet:03/2025
Sandoz logo
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterLEK Pharmaceuticals d.d. LEK S.A. Salutas Pharma GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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