Valcyte

Package leaflet: Information for the user

Valcyte 50 mg/mL powder for oral solution

valganciclovir
Please read all of this leaflet carefully before 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. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Valcyte is and what it is used for
2. What you need to know before taking Valcyte
3. How to take Valcyte
4. Possible side effects
5. How to store Valcyte
6. Contents of the pack and other information

1. What Valcyte is and what it is used for

Valcyte belongs to a group of medicines that act directly by preventing the growth of viruses.
Inside the body, the active substance of the powder, valganciclovir, is converted 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 organ infections that may be life-threatening.
Valcyte is used:

• for the treatment of CMV infections of the eye's retina in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the eye's retina 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 donor infected with CMV.

2. What you need to know before taking Valcyte

Do not take Valcyte

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

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

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

Be especially careful with Valcyte

• if you have low levels 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 Valcyte and additional tests during treatment.
• if you are undergoing radiotherapy.
• if you have kidney problems. Your doctor may prescribe a reduced dose and decide to perform frequent blood tests during treatment.

Other medicines and Valcyte
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 Valcyte may alter the amount of drug entering the 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 Valcyte may cause seizures (epileptic fits).
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medicines used to treat AIDS.
• adefovir or any other medicine used to treat hepatitis B.
• probenecid (a medicine for gout). Concomitant use of probenecid and Valcyte may increase the amount of ganciclovir in the blood.
• mycophenolate mofetil, cyclosporine, or tacrolimus (used after organ transplants).
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer.
• trimethoprim, trimethoprim/sulfamethoxazole combinations, or dapsone (an antibiotic).
• pentamidine (a medicine for parasitic or lung infections).
• flucytosine or amphotericin B (antifungal agents).

Valcyte with food and drink
Valcyte should be taken with food. If for any reason you cannot eat, you should still take your usual dose of Valcyte.
Pregnancy, breastfeeding and fertility
Do not use this medicine during pregnancy unless recommended by your doctor. If you are pregnant or planning a pregnancy, inform your doctor. Taking Valcyte during pregnancy may be harmful to the unborn child.
Do not take Valcyte if you are breastfeeding. If your doctor decides to prescribe Valcyte, stop breastfeeding before taking the medicine.
Women of childbearing age must use an effective contraceptive method during treatment with Valcyte and for at least 30 days after treatment ends.
Men whose partners could become pregnant must use a condom during treatment with Valcyte and for 90 days after treatment ends.
Driving and using machines
If you experience dizziness, fatigue, tremor, or confusion while taking this medicine, do not drive or operate machinery.
Ask your doctor or pharmacist for advice before taking any medicine.
Valcyte contains sodium benzoate and sodium (salt)
This medicine contains 100 mg of sodium benzoate in each 12 g vial, equivalent to 1 mg/mL after reconstitution. Benzoate salts may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
For patients on a low-sodium diet: this medicine contains 0.188 mg of sodium per mL, which is essentially "sodium-free".

3. How to take Valcyte

Always take this medicine exactly as directed by your doctor. If you have any doubts, you must
consult your doctor or pharmacist.
Be careful when handling Valcyte solution. You must avoid contact of the solution with the skin or eyes. If the solution accidentally comes into contact with the skin, wash the area thoroughly with soap and water. If the solution accidentally comes into contact with the eyes, rinse the eyes thoroughly with water.
To avoid overdose, you must adhere strictly to the daily dose of oral solution prescribed by your doctor.
Valcyte oral solution should, if possible, be taken with food – see section 2.
It is important that you use the dispenser provided in the package to measure the dose of Valcyte. Do not use these dispensers for any other product. The package contains two dispensers; dispose of each dispenser after 20 uses. Each dispenser is designed to measure solution volumes up to 10 mL (500 mg), with increments of 0.5 mL (25 mg). 1 mL of Valcyte oral solution corresponds to 50 mg of valganciclovir.
After taking the dose, always wash the dispenser thoroughly with distilled or boiled water and allow it to air dry.
If both dispensers have been disposed of, or if both are lost or damaged, contact your doctor or pharmacist, who will advise you on how to continue taking the medicine.

Adults
Prevention of CMV disease in transplant patients
You should start taking this medicine within 10 days after transplantation. The usual dose is 900 mg of Valcyte solution, taken ONCE daily. Use the provided dispenser and take two 9 mL doses (450 mg) (i.e., two dispensers filled to 9 mL [450 mg]) of solution. Continue this dose for up to 100 days. If you received a kidney transplant, your doctor may advise you to take the dose for 200 days.

Treatment of active CMV retinitis in patients with AIDS (so-called induction treatment)
The usual dose is 900 mg of Valcyte solution, taken TWICE daily for 21 days (three weeks). Use the provided dispenser and take two 9 mL doses (450 mg) (i.e., two dispensers filled to 9 mL [450 mg]) of solution in the morning and two 9 mL doses (450 mg) (i.e., two dispensers filled to 9 mL [450 mg]) in the evening.
Do not take this dose for longer than 21 days unless instructed otherwise by your doctor, as this may increase the risk of adverse effects.

Long-term treatment to prevent recurrence of active infection in patients with AIDS and CMV retinitis (so-called maintenance treatment)
The usual dose is 900 mg of Valcyte solution, taken ONCE daily. Use the provided dispenser and take two 9 mL doses (450 mg) of solution (i.e., two dispensers filled to 9 mL [450 mg]). Try to take the solution at the same time each day. Your doctor will tell you how long you should continue taking Valcyte. If retinitis worsens at this dose, your doctor may recommend repeating the induction treatment (as described above) or may decide to prescribe another medicine to treat the CMV infection.

Elderly patients
There are no studies with Valcyte in elderly patients.

Patients with kidney problems
If your kidneys are not functioning properly, your doctor may prescribe a lower daily dose of Valcyte solution. It is very important that you follow the dose prescribed by your doctor.

Patients with liver problems
There are no studies with Valcyte 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 administered will depend on the child’s size and should 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.
Use the dispensers provided in the package to measure the dose of Valcyte solution.
If both dispensers have been disposed of, or if both are lost or damaged, contact your doctor or pharmacist, who will advise you on how to continue administering the medicine.

Instructions for use and route of administration
It is recommended that the Valcyte solution be prepared by the pharmacist before it is dispensed to you.
Once the solution has been prepared, follow the instructions below to withdraw and take the medicine.

DISPENSER

1. Shake the closed bottle vigorously for about 5 seconds before each withdrawal.
2. Remove the child-resistant cap.
3. Before inserting the tip of the dispenser into the bottle adapter, push the plunger fully down towards the tip of the dispenser. Insert the tip securely into the opening of the bottle adapter.
4. Invert the entire assembly (bottle and dispenser).
5. Slowly pull back the plunger to withdraw the desired amount of solution into the dispenser (see illustration).
6. Turn the assembly upright and slowly remove the dispenser from the bottle.
7. Administer the suspension directly into the mouth and swallow. Do not mix with other liquids before dispensing.
8. Close the bottle with the child-resistant cap after each use.
9. Immediately after administration: disassemble the dispenser, rinse it with distilled or boiled water, and allow it to air dry before reuse.

Carefully avoid contact between the suspension and the skin. If contact occurs, wash thoroughly with soap and water.
Do not use the solution after the expiry date, which is 49 days from the date of preparation.

If you take more Valcyte than you should
If you have taken or think you have taken more Valcyte solution than prescribed, contact your doctor or hospital immediately. Taking a higher dose than recommended may cause serious adverse effects, particularly affecting the blood or kidneys. You may require hospital treatment.

If you forget to take Valcyte
If you forget to take your dose of Valcyte, take the missed dose as soon as possible, and then take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Valcyte
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 everyone gets them.
Allergic reactions
Up to 1 in 1,000 patients may experience a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). STOP taking Valcyte and go immediately to the nearest hospital emergency department if you experience any of the following:

• intense, itchy skin rash (urticaria)
• sudden swelling of the throat, face, lips, or mouth causing difficulty 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 Valcyte, and you may require urgent medical treatment.
Very common: may affect more than 1 in 10 people

• decrease in white blood cells – accompanied by signs of infection such as sore throat, mouth ulcers, or fever
• decrease in red blood cells – signs include shortness of breath or tiredness, 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
• reduction in platelet levels – signs include increased tendency to bleed or bruise more easily than normal, blood in urine or stools, or bleeding gums, which could be severe
• severe reduction in blood cells
• pancreatitis – signs are severe abdominal pain spreading to the back
• seizures

Uncommon: may affect up to 1 in 100 people

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

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
• shortness of breath
• diarrhoea
• feeling unwell or 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
• disturbances in sense of touch, tingling sensation, tickling, pricking, or burning
• 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 discomfort, abdominal bloating
• mouth ulcers
• abnormalities in laboratory test results for 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

• agitation
• tremor, chills
• deafness
• irregular heartbeat
• urticaria, dry skin
• blood in urine
• infertility in men – see section “Pregnancy, breastfeeding and fertility”
• chest pain

Separation of the inner lining layer of the eye (so-called "retinal detachment") has occurred only in AIDS patients treated with Valcyte for CMV infection.
Other 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 https://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 Valcyte

Keep this medicine out of the sight and reach of children.
Do not use the powder after the expiry date stated on the carton and on the label of the vial (Exp.). The expiry date refers to the last day of the month.
Powder: no special storage conditions are required.
Reconstituted solution: store in a refrigerator (2°C – 8°C).
The oral solution is stable for 49 days. Do not use the solution beyond 49 days from the date of preparation or after the expiry date which the pharmacist will write on the vial.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Valcyte contains
The active substance is valganciclovir hydrochloride. After the powder has been dissolved, 1 mL of solution contains 55 mg of valganciclovir hydrochloride, equivalent to 50 mg of valganciclovir (as hydrochloride).
The excipients are povidone, fumaric acid, sodium benzoate (E211), sodium saccharin, mannitol, and tutti-frutti flavour [maltodextrins (corn), propylene glycol, gum arabic E414, and natural-identical flavouring substances, particularly banana, pineapple, and peach flavour].

Description of the appearance of Valcyte and contents of the pack
Valcyte powder is a granulate ranging in colour from white to almost yellow. A quantity of 12 g of powder is supplied in a glass vial. After reconstitution, the solution volume is 100 mL and the minimum usable volume is 88 mL. The solution is clear, ranging from colourless to brown.
The pack also contains a vial adapter and 2 graduated dispensers up to 10 mL (500 mg), with 0.5 mL (25 mg) graduations.
Pack: one vial containing 12 g of powder.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer responsible for batch release
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 - 24
17489 Greifswald
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany

This medicinal product is authorised in the European Economic Area Member States and in the
United Kingdom under the following names:
Valcyte: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Slovenia, Spain, Sweden, United Kingdom
RoValcyte: France, Portugal

This leaflet was last approved on:
________________________________________________________________________

The following information is intended exclusively for medical or paramedical personnel:
It is recommended that the Valcyte solution be prepared by the pharmacist as follows:

1. Measure 91 mL of water using a graduated cylinder.
2. Remove the child-resistant cap, add the water to the vial, close the vial with the child-resistant cap, and shake thoroughly until the powder is completely dissolved.
3. Remove the child-resistant cap and push the adapter into the neck of the vial.
4. Close the vial securely with the child-resistant cap to ensure proper placement of the adapter in the vial and to maintain the child-resistant function of the cap.
5. Write the expiry date of the solution on the vial label.

During the reconstitution procedure and during cleaning of the external surface of the vial/cap and work surface after reconstitution, it is recommended to wear disposable gloves.
Avoid inhalation or direct contact of the powder or solution with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water and rinse eyes with running water.

Package Leaflet: Information for the user

Valcyte 450 mg film-coated tablets

valganciclovir
Please read this leaflet carefully before taking this medicine, as 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Valcyte is and what it is used for
2. What you need to know before taking Valcyte
3. How to take Valcyte
4. Possible side effects
5. How to store Valcyte
6. Contents of the pack and other information

1. What Valcyte is and what it is used for

Valcyte 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 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 infections in the body's organs which may be life-threatening.
Valcyte is used:

• for the treatment of CMV infections of the eye's retina in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the eye's retina 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 donor infected with CMV.

2. What you need to know before taking Valcyte

Do not take Valcyte

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

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

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

Be especially careful with Valcyte, particularly

• if you have low levels 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 Valcyte tablets and additional tests during the time you are taking the tablets.
• if you are undergoing radiotherapy or haemodialysis.
• if you have kidney problems. Your doctor may prescribe a reduced dose and may perform frequent blood tests during treatment.
• if you are currently taking ganciclovir capsules and your doctor wants to switch your treatment to Valcyte tablets. It is important that you do not take more tablets than prescribed by your doctor, as you may risk an overdose.

Other medicines and Valcyte
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
If you take other medicines together with Valcyte, the combination may alter the amount of drug entering the 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 Valcyte may cause seizures (epileptic fits).
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medicines used to treat AIDS.
• adefovir or any other medicine used to treat hepatitis B.
• probenecid (a medicine for gout). Concomitant use of probenecid and Valcyte may increase the amount of ganciclovir in the blood.
• mycophenolate mofetil, cyclosporine, or tacrolimus (used after transplants).
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer.
• trimethoprim, trimethoprim/sulfamethoxazole combinations, and dapsone (antibiotics).
• pentamidine (a medicine to treat parasitic or lung infections).
• flucytosine or amphotericin B (antifungal agents).

Valcyte with food and drink
Valcyte should be taken with food. If you are unable to eat for any reason, you should still take your dose of Valcyte as usual.
Pregnancy, breastfeeding, and fertility
Do not take Valcyte during pregnancy unless recommended by your doctor. If you are pregnant or planning a pregnancy, inform your doctor. Taking Valcyte during pregnancy may be harmful to the unborn child.
You must not take Valcyte if you are breastfeeding. If your doctor decides to start you on Valcyte treatment, you must stop breastfeeding before taking the tablets.
Women of childbearing age must use an effective method of contraception during treatment with Valcyte and for at least 30 days after treatment ends.
Men whose partner could become pregnant must use a condom during treatment with Valcyte and for 90 days after treatment ends.
Driving and using machines
Do not drive or operate tools or machinery if you experience dizziness, tiredness, tremor, or confusion while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to take Valcyte

Always 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, taken 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 your 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.
Valcyte tablets should be taken with food, when possible (see section 2).

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

Treatment of active CMV retinitis in patients with AIDS (called induction treatment)
The usual dose of Valcyte 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 usual 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 Valcyte. 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
There are no studies with Valcyte 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 instruct you to 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 Valcyte 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 of transplantation. The dose
administered will depend on the child's size and should 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 has received a kidney transplant,
your doctor may recommend continuing the dose for 200 days.
For children unable to swallow Valcyte film-coated tablets, Valcyte oral solution powder may be used.

If you take more Valcyte 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 adverse effects,
especially affecting the blood or kidneys. You may require hospital treatment.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 Valcyte and go immediately to the nearest hospital emergency department if you experience any of the following reactions:

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

Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects. Your doctor may advise you to stop taking Valcyte, and you may require urgent medical treatment.

Very common: may affect more than 1 in 10 people

• reduction in the number of white blood cells – accompanied by signs of infection such as sore throat, mouth ulcers, or fever
• reduction in the number of red blood cells – signs include breathlessness or tiredness, 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
• reduction in platelet levels – signs include increased tendency to bleed or bruise, blood in urine or stools, or severe gum bleeding
• severe reduction 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
• kidney function impairment.

The following side effects have been reported during treatment with valganciclovir or ganciclovir.

Other side effects
Tell 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
• 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
• altered 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
• abnormal laboratory test results related to 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

• agitation
• tremor, chills
• deafness
• irregular heartbeat
• urticaria, dry skin
• blood in urine
• infertility in men – see section “Pregnancy, breastfeeding and fertility”
• chest pain.

Detachment of the inner lining layer of the eye (so-called "retinal detachment") has occurred only in patients with AIDS treated with Valcyte for CMV infection.

Other 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 https://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 Valcyte

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of 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 Valcyte contains
The active substance is valganciclovir 450 mg, present as 496.3 mg of valganciclovir hydrochloride.
The tablet excipients are povidone K30, crospovidone, microcrystalline cellulose and stearic acid.
The coating excipients are hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172) and polysorbate 80.
Description of the appearance of Valcyte and contents of the pack
Valcyte tablets are film-coated oval-shaped, pink tablets, imprinted with "VGC" on one side and "450" on the other.
They are packaged in bottles containing 60 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Responsible manufacturer for batch release
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23 - 24
17489 Greifswald
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Valcyte: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Germany, Greece, Hungary, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Netherlands, Norway, Slovenia, Spain, United Kingdom (Northern Ireland)
RoValcyte: France, Portugal
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