Valcyte

Patient Information Leaflet

Valcyte, 50 mg/ml, powder for oral solution
Valganciclovirum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Valcyte is and what it is used for
2. What you need to know before you take 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 work by directly preventing the multiplication of viruses. Valganciclovir, the active substance in the powder, is converted in the body to ganciclovir. Ganciclovir prevents the cytomegalovirus (CMV) from multiplying and infecting healthy body cells. In patients with weakened immune systems, CMV may cause infections in various organs, which can be life-threatening.

Valcyte is used:

• for the treatment of CMV retinitis in adult patients with acquired immunodeficiency syndrome (AIDS); CMV infection of the retina may lead to vision disorders and even blindness;
• for the prevention of CMV infections in CMV-negative children and adults who have received a solid organ transplant from a CMV-positive donor.

2. Important information before using Valcyte

When not to use Valcyte

• 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 taking Valcyte, discuss the following with your doctor or pharmacist:

• if the patient is allergic to acyclovir, penciclovir, valacyclovir, or famciclovir. These are other medicines used to treat viral infections.

When to take special care with Valcyte

• If the patient has a low number of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). The doctor will arrange for blood tests before starting Valcyte treatment and may require additional blood tests during treatment.
• If the patient is undergoing radiotherapy.
• If the patient has kidney problems; the doctor may prescribe a reduced dose and may recommend regular blood tests during treatment.

Valcyte with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes medicines obtained without a prescription.
Taking Valcyte together with other medicines may affect the blood concentration of the drug and could cause harmful effects. If the patient is currently taking a medicine containing any of the following active substances, inform the doctor:

• imipenem with cilastatin (antibiotics); taking these together with Valcyte may cause seizures;
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar types of medicines used in the treatment of AIDS;
• adefovir or any other medicines used in the treatment of hepatitis B;
• probenecid (a medicine used to treat gout); concomitant use of probenecid and Valcyte may increase the blood concentration of ganciclovir;
• mycophenolate mofetil, cyclosporine, or tacrolimus (used after organ transplantation);
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar types of medicines used in the treatment of cancer;
• trimethoprim, trimethoprim-sulfonamide combinations, and dapsone (antibacterial medicines);
• pentamidine (a medicine used to treat parasitic diseases or lung infections);
• flucytosine or amphotericin B (antifungal medicines).

Valcyte with food and drink
Valcyte should be taken with food. If the patient is unable to eat for any reason, the prescribed dose of Valcyte should still be taken.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, she should not use Valcyte unless otherwise advised by a doctor. If the patient is pregnant or planning to become pregnant, she must inform her doctor before taking Valcyte. Taking Valcyte during pregnancy may harm the unborn child.
Do not take Valcyte while breastfeeding. If the doctor recommends starting treatment with Valcyte, the patient must stop breastfeeding before beginning treatment.
Women of childbearing age must use effective contraception during treatment with Valcyte and for at least 30 days after treatment ends.
If a man is taking Valcyte, he should use a condom during sexual intercourse with a partner who could become pregnant, both during treatment and for 90 days after treatment ends.
Driving and using machines
The patient should not drive or operate any machinery if dizziness, fatigue, tremors, or confusion occur during treatment with Valcyte.
Before taking any medicine, consult your doctor or pharmacist.
Valcyte contains sodium benzoate and sodium (salt)
One 12 g bottle of the medicine contains 100 mg of sodium benzoate, equivalent to 1 mg/ml of the prepared solution. Sodium benzoate may worsen jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
1 ml of the prepared solution contains 0.188 mg of sodium, meaning the medicine is essentially "sodium-free"; however, this should be considered in patients who need to control their sodium intake.

3. How to use Valcyte

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Handle the Valcyte solution with care. Avoid contact of the solution with skin and eyes. If accidental
contact with the skin occurs, wash thoroughly with water and soap. If the solution gets into the eyes
accidentally, rinse the eyes thoroughly with water.
It is essential to follow your doctor's instructions regarding the daily dose of oral solution to
avoid overdose.
If possible, the Valcyte oral solution should be taken during meals – see section 2.
It is important that the patient uses the dosing device supplied in the package to measure the
Valcyte solution dose. These dosing devices must not be used to administer any other medicinal
product. Two dosing devices are supplied; each dosing device should be discarded after 20 uses.
Each dosing device is intended for measuring up to 10 ml (500 mg) of solution, with markings every
0.5 ml (25 mg). 1 ml of Valcyte oral solution corresponds to 50 mg of valganciclovir.
After measuring each dose, the dosing device should be thoroughly washed with distilled or boiled
water and left to dry.
If both dosing devices are discarded, 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 recipients
Treatment should be started within 10 days after transplantation. The usual recommended dose is
900 mg of Valcyte solution taken ONCE daily. Using the supplied dosing device, draw up two times
9 ml (450 mg) [i.e. 2 dosing devices filled with solution up to the level marked 9 ml (450 mg)].
Continue taking this dose for 100 days. In kidney transplant recipients, your doctor may recommend
continuing treatment for 200 days.

Treatment of active CMV retinitis in patients with AIDS (so-called initial treatment)
The usual recommended dose is 900 mg of Valcyte solution taken TWICE daily for 21 days (three
weeks). Using the supplied dosing device, draw up 9 ml (450 mg) twice [i.e. 2 dosing devices filled
with solution up to the level marked 9 ml (450 mg)] in the morning, and 9 ml (450 mg) twice [i.e. 2
dosing devices filled with solution up to the level marked 9 ml (450 mg)] in the evening. Unless
otherwise directed by your doctor, do not take this dose for longer than 21 days, as this may increase
the risk of adverse effects.

Long-term treatment to prevent recurrence of active CMV retinitis in patients with AIDS (so-called
maintenance treatment)
The usual recommended dose is 900 mg of Valcyte solution taken ONCE daily. Using the supplied
dosing device, draw up two times 9 ml (450 mg) [i.e. 2 dosing devices filled with solution up to the
level marked 9 ml (450 mg)]. Try to take the solution at the same time each day. Your doctor will
decide how long you should continue taking Valcyte. If retinitis worsens during treatment with this
dose, your doctor may recommend repeating the initial treatment (as above) or decide to administer
another medicine to treat the CMV infection.

Elderly patients
The use of Valcyte has not been studied in elderly patients.

Patients with impaired kidney function
In patients with impaired kidney function, your doctor may recommend a lower daily dose of
Valcyte solution. It is very important to follow your doctor's dosing instructions.

Patients with impaired liver function
The use of Valcyte has not been studied in patients with impaired liver function.

Use in children and adolescents
Prevention of CMV disease in paediatric solid organ transplant recipients
Treatment in children should be started within 10 days after organ transplantation. The recommended
dose may vary depending on the child's size and should be taken ONCE daily. The treating doctor
will determine the appropriate dose based on the child's height, body weight and kidney function.
Continue treatment with this dose for 100 days. If the child has received a kidney transplant, your
doctor may recommend continuing treatment for 200 days.
To measure the Valcyte solution dose, use the dosing devices supplied in the package.
If both dosing devices are discarded, lost or damaged, contact your doctor or pharmacist, who will
advise you on how to continue taking the medicine.

Method and route of administration
It is recommended that the pharmacist prepare the Valcyte solution before dispensing it to the
patient.
After the solution has been prepared, follow the instructions below to draw up and take the medicine.

DOSING DEVICE

Cap Plunger
Safety Connector
Cap
for
Child-
proof
Opening
Tip

1. Shake the closed bottle for about 5 seconds before each use.
2. Remove the child-resistant safety cap.
3. Before inserting the dosing device tip into the connector, push the plunger fully towards the tip of the dosing device. Attach the tip securely into the connector opening.
4. Turn the entire assembly (bottle and dosing device) upside down.
5. Slowly pull back the plunger until the desired amount of solution has been drawn into the dosing device (see illustration).
6. Turn the assembly right-side up and slowly remove the dosing device from the bottle.
7. Administer directly into the mouth and swallow. Do not mix with any liquid before administration.
8. After each use, close the bottle with the child-resistant safety cap.
9. Immediately after administration: disassemble the dosing device, rinse thoroughly under distilled or boiled water, and leave to dry before next use.

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

Taking more Valcyte than prescribed
If you have taken or suspect you have taken more Valcyte solution than prescribed, contact your
doctor immediately or go to hospital. Taking more than the prescribed dose may cause serious
adverse effects, particularly affecting the blood or kidneys. Hospital treatment may be necessary.

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

Stopping Valcyte
Do not stop taking Valcyte unless your doctor tells you to stop treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions
Severe and sudden allergic reactions to valganciclovir (anaphylactic shock) occur no more frequently
than in 1 out of 1,000 patients. If any of the symptoms listed below occur, STOP taking Valcyte immediately and go to hospital without delay:

• raised, itchy skin rash (urticaria);
• sudden swelling of the throat, face, lips or mouth, which may cause difficulty in swallowing or breathing;
• sudden swelling of hands, feet or ankles.

Serious adverse reactions
Tell your doctor immediately if you notice any of the following serious adverse reactions – your doctor may instruct you to stop taking Valcyte and you may require urgent treatment:
Very common: these may occur in more than 1 in 10 patients

• low white blood cell count – symptoms include sore throat, mouth ulcers or fever
• low red blood cell count – symptoms include breathlessness or fatigue, palpitations or pale skin
  Common: these may occur in up to 1 in 10 patients
• blood infection (sepsis) – symptoms include fever, chills, palpitations, confusion and slurred speech
• low platelet count – symptoms include bleeding or bruising more easily than usual, blood in urine or stools, or bleeding gums, which may be severe
• very marked decrease in blood cells
• pancreatitis – symptom is severe abdominal pain radiating to the back
• seizures
  Uncommon: these may occur in up to 1 in 100 patients
• bone marrow failure (inability of the bone marrow to produce blood cells)
• hallucinations – hearing or seeing things that are not real
• disturbances in thinking or perception, loss of contact with reality
• kidney failure

The adverse reactions listed below have been observed during treatment with valganciclovir or
ganciclovir.
Other adverse reactions
Tell your doctor, pharmacist or nurse if you experience any of the following:
Very common: these may occur in more than 1 in 10 patients

• oral thrush or fungal infections in the mouth
• upper respiratory tract infections (e.g. sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• breathlessness
• diarrhoea
• nausea or vomiting
• abdominal pain
• eczema
• feeling tired
• fever

Common: these may occur in up to 1 in 10 patients

• influenza
• urinary tract infection – symptoms include fever, more frequent urination, pain during urination
• skin and subcutaneous tissue infections
• mild allergic reaction – symptoms may include skin redness and itching
• weight loss
• feeling depressed, anxious or confused
• sleep disturbances
• weakness or numbness in hands or feet, affecting body balance
• changes in sensation, such as tingling, tickling, pricking or burning
• changes in taste sensation
• 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 pain, abdominal swelling
• mouth ulcers
• abnormal laboratory test results for liver and kidney function
• night sweats
• itching, rash
• hair loss
• back pain, muscle or joint pain, muscle cramps
• dizziness, weakness or general malaise

Uncommon: these may occur in up to 1 in 100 patients

• feeling of restlessness
• tremor, shaking
• deafness
• irregular heartbeat
• urticaria, dry skin
• blood in urine
• male infertility – see section “Pregnancy, breastfeeding and fertility”
• chest pain

Detachment of the inner lining of the eye (retinal detachment), occurs only in patients with AIDS
in whom CMV infection is being treated with Valcyte.
Additional adverse reactions in children and adolescents
Adverse reactions reported in children and adolescents are similar to those seen in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 label on the bottle (‘Expiry date’). The expiry date refers to the last day of the stated month.
Powder: no special storage conditions required.
Oral solution: store in a refrigerator (2ºC−8ºC).
The oral solution may be stored for up to 49 days. Do not use the oral solution after 49 days from the date of preparation or after the expiry date marked on the bottle by the pharmacist.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Valcyte contains
The active substance is valganciclovir hydrochloride.
After dissolving the powder, 1 ml of solution contains 50 mg of valganciclovir in the form of hydrochloride,
i.e. 55 mg of valganciclovir hydrochloride.
The other ingredients (excipients) are: povidone, fumaric acid, sodium benzoate (E211),
sodium saccharin, mannitol, and Tutti Frutti flavour [maltodextrins (corn), propylene glycol,
arabic gum E414, and flavours identical to natural ones, mainly banana, pineapple and peach].

What Valcyte looks like and contents of the pack
Valcyte powder is a white to slightly yellow granulate. The glass bottle contains 12 g of powder.
After reconstitution, the solution volume is 100 ml, providing a usable volume of 88 ml.
The solution is clear, colourless to brownish. The pack also contains a bottle adapter and 2 oral dosing syringes for measuring doses up to 10 ml (500 mg), graduated in 0.5 ml increments (25 mg).
Pack size: one bottle containing 12 g of powder.

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

Importer
CHEPLAPHARM Arzneimittel GmbH,
Ziegelhof 23 - 24,
17489 Greifswald,
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Lindigstrasse 6
63801 Kleinostheim
Germany
Prestige Promotion Verkaufsfoerderung & Werbeservice GmbH
Borsigstrasse 2
63755 Alzenau
Germany

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

Other sources of information
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://urpl.gov.pl

Information intended exclusively for medical professionals

It is recommended that the Valcyte solution be prepared by a pharmacist in the following manner:

1. Measure 91 mL of water using a graduated cylinder.
2. Remove the child-resistant cap, add the water to the bottle, and then close the bottle with the child-resistant cap. Shake the closed bottle until the powder dissolves completely.
3. Remove the child-resistant cap and insert the adapter into the neck of the bottle.
4. Securely close the bottle with the child-resistant cap. This ensures proper attachment of the adapter in the bottle and maintains child-resistant protection.
5. Record the expiry date of the prepared solution on the bottle label.

It is recommended to wear disposable protective gloves during reconstitution of the medication and to wipe the external surface of the bottle and/or cap, as well as the work surface, after reconstitution.
Avoid inhaling or having direct contact with the powder or solution on the skin or mucous membranes. In case of direct contact, wash the skin thoroughly with soap and water, and rinse eyes with water.