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.

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:

Date of last revision of the leaflet:03/2025

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