Valganciclovir Sandoz: detailed information

Package leaflet: Information for the user

Valganciclovir Sandoz 450 mg film-coated tablets

valganciclovir (as hydrochloride)
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Valganciclovir Sandoz is and what it is used for
What you need to know before taking Valganciclovir Sandoz
How to take Valganciclovir Sandoz
Possible side effects
How to store Valganciclovir Sandoz
Contents of the pack and other information

1. What Valganciclovir Sandoz is and what it is used for

Valganciclovir Sandoz belongs to a group of medicines that act directly by preventing the
growth of viruses. Inside the body, the active substance of the tablets, valganciclovir, is
converted to ganciclovir. Ganciclovir prevents a virus called cytomegalovirus (CMV) from
multiplying and invading healthy cells. In patients with a weakened immune system, CMV
can cause infections in organs of the body which may be life-threatening.
Valganciclovir Sandoz 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 but who have received an organ transplant from a CMV-infected donor.

2. What you need to know before taking Valganciclovir Sandoz

Do not take Valganciclovir Sandoz

if you are allergic to valganciclovir, ganciclovir, or any of the other ingredients of this medicine (listed in section 6).
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Valganciclovir Sandoz:

if you are allergic to aciclovir, penciclovir, valaciclovir, or famciclovir, which are medicines used to treat other viral infections.

Special warnings with Valganciclovir Sandoz

if you have low numbers of white blood cells, red blood cells, or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform blood tests before starting treatment with Valganciclovir Sandoz tablets and additional tests during treatment.
if you are undergoing radiotherapy or haemodialysis.
if you have kidney problems. Your doctor may prescribe a reduced dose and may require frequent blood tests during treatment.
if you are currently taking ganciclovir capsules and your doctor intends to switch your treatment to Valganciclovir Sandoz tablets. It is important that you do not take more tablets than prescribed by your doctor, as this may lead to overdose.

Other medicines and Valganciclovir Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Taking other medicines together with Valganciclovir Sandoz may alter the amount of drug entering your bloodstream or may cause harmful effects.
Inform your doctor if you are already taking medicines containing any of the following:

imipenem-cilastatin (an antibiotic). Concomitant use with Valganciclovir Sandoz may cause seizures (epileptic fits).
zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medicines used to treat AIDS.
adefovir and other medicines used to treat hepatitis B.
probenecid (a medicine for gout). Concomitant use of probenecid and Valganciclovir Sandoz may increase the level of ganciclovir in the blood.
mycophenolate mofetil, ciclosporin, or tacrolimus (used after organ transplantation).
vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer.
trimethoprim, trimethoprim/sulfamethoxazole combinations, and dapsone (antibiotics).
pentamidine (a medicine used to treat parasitic or lung infections).
flucytosine or amphotericin B (antifungal agents).

Valganciclovir Sandoz with food and drink
Valganciclovir Sandoz should be taken with food. If you are unable to eat for any reason, you should still take your dose of Valganciclovir Sandoz as usual.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Valganciclovir Sandoz during pregnancy unless specifically recommended by your doctor. If you are pregnant or planning a pregnancy, inform your doctor.
Taking Valganciclovir Sandoz during pregnancy may be harmful to the unborn child.
You must not take Valganciclovir Sandoz if you are breastfeeding. If your doctor decides to start treatment with Valganciclovir Sandoz, you must stop breastfeeding before taking the tablets.
Women of childbearing potential must use an effective method of contraception during treatment and for at least 7 months after stopping treatment with Valganciclovir Sandoz.
Men whose partner could become pregnant must use a condom during treatment with Valganciclovir Sandoz and for 4 months after the end of treatment.

Driving and using machines
Do not drive or operate tools or machinery if you experience dizziness, fatigue, tremor, or confusion while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to take Valganciclovir Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Be careful when handling the tablets. Do not break or crush the tablets. The tablets 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 comes into contact with your eyes, rinse the eyes with sterile water or, if unavailable, with clean water.
To avoid overdose, you must follow exactly the number of tablets prescribed by your doctor.
Valganciclovir Sandoz tablets should be taken with food, when possible – see section 2.
Other dosage strengths more suitable for children and adolescents requiring dose adjustment are available.

Adults:
Prevention of CMV disease in transplant patients
You should start taking this medicine within 10 days after transplantation.
The recommended dose is two tablets ONCE daily.
Continue this dose up to 100 days after transplantation. If you received a kidney transplant, your doctor may advise you to continue taking the tablets for 200 days.

Treatment of active CMV retinitis in AIDS patients (called induction treatment)
The recommended dose of Valganciclovir Sandoz is two tablets TWICE daily for 21 days (three weeks).
Do not take this dose for longer than 21 days unless your doctor tells you to, as this may increase the risk of side effects.

Long-term treatment to prevent recurrence of active inflammation in AIDS patients with CMV retinitis (called maintenance treatment)
The recommended dose is two tablets ONCE daily. Try to take the tablets at the same time each day.
Your doctor will advise you on how long you should continue taking Valganciclovir Sandoz. If your retinitis worsens while taking this dose, your doctor may recommend repeating the induction treatment (as above) or decide to prescribe another medicine to treat the CMV infection.

Elderly patients
Valganciclovir Sandoz has not been studied in elderly patients.

Patients with kidney problems
If your kidneys do not function properly, your doctor may prescribe a lower number of tablets per day or have you take the tablets only on certain days of the week. It is very important that you take only the number of tablets prescribed by your doctor.

Patients with liver problems
There are no studies with valganciclovir in patients with liver problems.

Use in children and adolescents
Prevention of CMV disease in transplant patients
Children should start taking this medicine within 10 days after transplantation. The dose will depend on the child's size and must be taken ONCE daily. Your doctor will determine the most appropriate dose based on your child’s height, weight, and kidney function. This dose should be continued for up to 100 days. If your child received a kidney transplant, your doctor may recommend continuing the dose for 200 days.
For children unable to swallow Valganciclovir Sandoz film-coated tablets, valganciclovir oral solution powder may be administered instead.

If you take more Valganciclovir Sandoz than you should
If you have taken or think you have taken more tablets than you should, contact your doctor or hospital immediately. Taking too many tablets may cause serious side effects, especially affecting the blood or kidneys. You may require hospital treatment.

If you forget to take Valganciclovir Sandoz
If you forget to take your tablets, take the missed dose as soon as you remember, and then take the next dose at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Valganciclovir Sandoz
Do not stop treatment with this medicine unless your doctor tells you to.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
Up to 1 in 1,000 patients may experience a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). STOP treatment with Valganciclovir Sandoz and go to the nearest hospital emergency department if you experience any of the following reactions:

raised, itchy rash (urticaria)
sudden swelling of the throat, face, lips, and mouth causing difficulty in swallowing or breathing
sudden swelling of the hands, feet, or ankles.

Serious side effects
Inform your doctor immediately if you notice any of the following serious side effects. Your doctor may advise you to stop taking Valganciclovir Sandoz, and you may require urgent medical treatment:
Very common: may affect more than 1 in 10 people

decrease in the number of white blood cells – accompanied by signs of infection such as sore throat, mouth ulcers, or fever
decrease in the number of red blood cells – signs include breathlessness or fatigue, palpitations, or pale skin.

Common: may affect up to 1 in 10 people

blood infection (sepsis) – signs include fever, chills, palpitations, confusion, and difficulty speaking
decrease in platelet levels – signs include increased tendency to bleed or bruise, blood in urine or stools, or bleeding gums, which could be severe
severe decrease in blood cells
pancreatitis – signs are severe abdominal pain spreading to the back
seizures.

Uncommon: may affect up to 1 in 100 people

insufficient production of blood cells in the bone marrow
hallucinations – hearing or seeing things that are not real
unusual thoughts or feelings, loss of contact with reality
impaired kidney function.

The side effects observed during treatment with valganciclovir or ganciclovir are listed below.
Other side effects
Inform your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people)

candidiasis and oral candidiasis
upper respiratory tract infection (e.g. sinusitis, tonsillitis)
loss of appetite
headache
cough
breathlessness
diarrhoea
feeling unwell and malaise
abdominal pain
eczema
fatigue
fever.

Common (may affect up to 1 in 10 people):

influenza
urinary tract infection – signs include fever, more frequent urination, pain during urination
skin and subcutaneous tissue infection
mild allergic reaction – signs may include skin redness and itching
weight loss
depression, anxiety, or confusion
difficulty sleeping
weakness or numbness in hands or feet, which may affect balance
changes in sense of touch, tingling, tickling, pricking, or burning sensations
taste disturbances
chills
eye inflammation (conjunctivitis), eye pain, or vision problems
ear pain
low blood pressure, which may cause dizziness or fainting
difficulty swallowing
constipation, flatulence, indigestion, stomach ache, abdominal bloating
mouth ulcers
abnormalities in laboratory tests of liver and kidney function
night sweats
itching, skin rash
hair loss
back pain, muscle or joint pain, muscle spasms
dizziness, weakness, or general feeling of malaise.

Uncommon (may affect up to 1 in 100 people):

restlessness
tremor, chills
deafness
irregular heartbeat
urticaria, dry skin
blood in the urine
infertility in men – see section “Fertility”
chest pain.

Separation of the inner layer of the eye (retinal detachment) has occurred only in patients with AIDS treated with valganciclovir for CMV infection.
Additional side effects in children and adolescents
The side effects reported in children and adolescents are similar to those reported in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Valganciclovir Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, the carton, or the bottle after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Validity after first opening:
Bottle: 2 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valganciclovir Sandoz contains

The active substance is valganciclovir (as hydrochloride). Each tablet contains 450 mg of valganciclovir (as hydrochloride).
The other components are:
Tablet core: microcrystalline cellulose (PH101), crospovidone (Type A), povidone (K-30), stearic acid 50
Tablet coating: Rosa Opadry 15B24005: hypromellose (E 464) (3 cP), hypromellose (E 464) (6 cP), titanium dioxide (E171), Macrogol 400 (E 1521), iron oxide red (E172), polysorbate 80 (E 433)

Description of the appearance of Valganciclovir Sandoz and package contents
Valganciclovir Sandoz are pink, oval-shaped, film-coated tablets (16.7 x 7.8 mm), biconvex, with “J” printed on one side and “156” on the other.
The film-coated tablets are packaged in aluminum/PVC/aluminum/OPA blisters and placed in cartons, or packaged in HDPE containers with child-resistant polypropylene screw caps, with an aluminum seal and including a cotton wad.
Blister packs: 10, 30, 60, 90, 120 film-coated tablets.
Bottle: 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
LEK S.A.
ul. Domaniewska 50 C, 02-672 Warszawa
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57, 1526 Ljubljana
Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands: Valganciclovir Sandoz 450 mg, filmomhulde tabletten
Austria: Valganciclovir Sandoz 450 mg - Filmtabletten
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 Sandoz
Estonia: Valganciclovir Sandoz
Finland: Valganciclovir Sandoz
France: VALGANCICLOVIR SANDOZ 450 mg, comprimé pelliculé
Germany: Valganciclovir HEXAL 450 mg Filmtabletten
Greece: Valganciclovir /Sandoz
Ireland: Valganciclovir Rowex 450 mg Film-coated tablets
Italy: Valganciclovir Sandoz
Latvia: Valganciclovir Sandoz 450 mg apvalkotās tabletes
Lithuania: Valganciclovir Sandoz 450 mg plėvele dengtos tabletės
Luxembourg: Valganciclovir Sandoz 450 mg comprimés pelliculés
Norway: Valganciclovir Sandoz
Poland: Ceglar
Portugal: Valganciclovir Sandoz
Romania: VALGANCICLOVIR SANDOZ 450 mg comprimate filmate
Slovenia: Valganciklovir Lek 450 mg filmsko obložene tablete
Spain: Valganciclovir Sandoz 450 mg comprimidos recubiertos con película EFG
Sweden: Valganciclovir Sandoz
United Kingdom: Valganciclovir 450mg Film-coated Tablets