VALCYTE 50 mg/ml ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Valcyte 50 mg/ml powder for oral solution

Valganciclovir

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Read all of this leaflet carefully because it contains important information for you.

Contents of the pack

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

1. What is Valcyte and what is it used for

Valcyte belongs to a group of medicines that act directly to prevent the growth of viruses. In the body, the active substance of the powder, valganciclovir, is converted to ganciclovir. Ganciclovir prevents the virus called cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause an infection in the body's organs. This can be life-threatening.

Valcyte is used:

• to treat retinitis (infection of the retina of the eye) caused by cytomegalovirus in adult patients with Acquired Immune Deficiency Syndrome (AIDS). CMV infection in the eye can cause vision problems and even blindness.
• to prevent cytomegalovirus (CMV) disease in adults and children who have not had this virus, but have received a solid organ transplant from a donor who was infected with CMV.

2. What you need to know before you take Valcyte

Do not takeValcyte

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

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 for viral infections.
• if you have a low number of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform a blood test before you start taking Valcyte and will perform more tests while you are being treated.

• if you are receiving radiotherapy.

• if you have kidney problems. Your doctor may prescribe a lower dose and may need to perform frequent blood tests during treatment.

Using Valcyte with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use other medicines, including those obtained without a prescription.

If you take other medicines at the same time as Valcyte, the combination may affect the amount of medicine that reaches the bloodstream or may cause harmful effects. Tell your doctor if you are already taking any of the following medicines:

• imipenem-cilastatin (antibiotic). Taking this medicine with Valcyte may cause seizures (fits).
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine or similar medicines for the treatment of AIDS.
• adefovir or any other medicine for the treatment of Hepatitis B.
• probenecid (medicine for the treatment of gout). Taking probenecid and Valcyte at the same time may increase the amount of ganciclovir in the blood.
• mycophenolate mofetil, cyclosporin or tacrolimus (used after transplants).
• vincristine, vinblastine, doxorubicin, hydroxyurea or similar medicines for the treatment of cancer.
• trimethoprim, trimethoprim/sulfa combinations and dapsone (antibiotics).
• pentamidine (medicine for the treatment of parasites or lung infections),
• flucytosine or amphotericin B (antifungal agents)

Using Valcyte with food and drinks

Valcyte should be taken with food. If for any reason you cannot eat, you should continue to take your usual dose of Valcyte.

Pregnancy, breast-feeding and fertility

Talk to your doctor or pharmacist before taking any medicine.

You should not take Valcyte if you are pregnant, unless your doctor advises you to. If you are pregnant or planning to become pregnant, you must tell your doctor. If you take Valcyte while pregnant, it may harm the unborn baby.

You should not take Valcyte during breast-feeding. Before starting treatment, you must stop breast-feeding.

Women of childbearing age must use an effective method of contraception while taking Valcyte and for at least 30 days after treatment has finished.

Men whose partners may be pregnant or may become pregnant must use a condom while taking Valcyte and for 90 days after treatment has finished.

Driving and using machines

Do not drive or use machines if you feel dizzy, tired, agitated or confused while taking this medicine.

Talk to your doctor or pharmacist before taking any medicine.

Valcyte contains sodium benzoate and sodium(salt)

This medicine contains 100 mg of sodium benzoate in each 12 g vial, which is equivalent to 1 mg/ml after reconstitution. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains less than 1 mmol of sodium (23 mg)/ml after reconstitution; this is essentially "sodium-free".

3. How to take Valcyte

Follow the instructions for administration of this medicine exactly as told by your doctor. Talk to your doctor or pharmacist if you have any questions.

You must be careful when handling the Valcyte solution. You must avoid the solution coming into contact with skin and eyes. If the solution accidentally comes into contact with the skin, the area must be washed with water and soap. If the solution accidentally gets into the eyes, the eyes must be rinsed immediately with plenty of water.

To avoid an overdose, you must stick to the daily dose of the oral solution that your doctor has prescribed.

The Valcyte oral solution should be taken with food, whenever possible - see section 2.

It is important that you use the dosing dispenser that comes with the pack to measure your dose of the Valcyte solution.Two dosing dispensers are included, discard each dispenser after 20 uses. Each dispenser is designed to measure up to 10 ml (500 mg) of solution, with graduations of 0.5 ml (25 mg).

After taking your dose, always rinse the dispenser thoroughly with distilled or boiling water and let it dry.

Contact your doctor or pharmacist if you have discarded, lost or broken both dispensers, they will tell you how to continue taking your medication.

Adults

Prevention of CMV infection in transplant patients

You should start taking this medicine within 10 days of the transplant. The recommended dose is 900 mg of Valcyte solution ONCE a day. Use the dosing dispenser that comes with the pack to take two 9 ml (450 mg) doses of solution (i.e. 2 dispensers filled to the 9 ml (450 mg) mark). You should continue with this dose until 100 days after the transplant. If you have received a kidney transplant, your doctor may advise you to take this dose for 200 days.

Treatment of CMV retinitis in patients with AIDS (also called induction treatment)

The recommended dose is 900 mg of Valcyte solution TWICE a day for 21 days (3 weeks). Use the dosing dispenser that comes with the pack to take two 9 ml (450 mg) doses of solution (i.e. 2 dispensers filled to the 9 ml (450 mg) mark) in the morning and two 9 ml (450 mg) doses of solution (i.e. 2 dispensers filled to the 9 ml (450 mg) mark) in the evening.

Do not continue with this dose for more than 21 days unless your doctor tells you to, as this dose may increase the risk of possible side effects.

Long-term treatment to prevent the recurrence of active inflammation in AIDS patients with CMV retinitis (also called maintenance treatment)

The recommended dose is 900 mg of Valcyte solution ONCE a day. Use the dosing dispenser that comes with the pack to take two 9 ml (450 mg) doses of solution (i.e. 2 dispensers filled to the 9 ml (450 mg) mark). You should try to take the solution at the same time every day. Your doctor will tell you how long you should continue to take Valcyte. If your retinitis gets worse while you are taking this dose, your doctor will decide whether you should repeat the induction treatment (as above) or may decide to give you a different medicine to treat the CMV infection.

Elderly patients

Valcyte has not been studied in elderly patients.

Patients with kidney problems

If your kidneys do not work properly, your doctor will tell you to take a lower dose of the Valcyte solution each day. It is very importantthat you follow the dose prescribed by your doctor.

Use the dosing dispenser that comes with the pack to measure your dose of the Valcyte solution.

Patients with liver problems

Valcyte has not been studied 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 the transplant. The dose to be taken will depend on the size of the child and should be taken ONCE a day. Your doctor will decide the most appropriate dose based on your child's height, weight and kidney function. You should continue with this dose until 100 days. If your child has received a kidney transplant, your doctor may recommend that they take the prescribed dose for 200 days.

Use the dosing dispensers provided in the pack to measure the Valcyte solution.

Contact your doctor or pharmacist if you have discarded, lost or broken both dispensers, they will tell you how to continue taking your medication.

Method and route of administration

It is recommended that the Valcyte solution is prepared by a pharmacist before it is given to you.

Once the solution has been prepared, follow the instructions below to extract and take the medicine.

1. Before each use, shake the closed vial well for about 5 seconds.
2. Remove the child-resistant closure.
3. Before inserting the tip of the dosing dispenser into the adapter of the vial, push the plunger completely towards the tip of the dosing dispenser. Insert the tip firmly into the opening of the adapter of the vial.
4. Turn the entire unit (vial and dosing dispenser) upside down.
5. Slowly pull out the plunger until the desired amount of medicine is released into the dosing dispenser (see figure).
6. Turn the entire unit right side up and slowly separate the dosing dispenser from the vial.
7. Administer it directly into the mouth and swallow the medicine. Do not mix it with any liquid before administration.
8. Close the vial with the child-resistant closure after each use.
9. Immediately after administration:

Disassemble the dosing dispenser, rinse under distilled or boiling water and let it air dry before the next use.

Be careful to avoid contact of the solution with the skin. In case of contact, wash with plenty of water and soap.

Do not use the solution after the expiry date, which is 49 days from the day of preparation.

If you take more Valcyte than you should

Contact your doctor or hospital immediately if you have taken or think you have taken more of the Valcyte solution than you should. Taking more than the recommended dose may cause serious side effects, particularly affecting the blood or kidneys. You may need hospital treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valcyte

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

If you stop taking Valcyte

Do not stop treatment unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Allergic Reactions

In up to 1 in 1,000 people, a sudden and severe allergic reaction to valganciclovir (anaphylactic shock) may occur. STOPtaking Valcyte and go to the emergency department of the nearest hospital when you experience any of the following effects:

• Raised skin rash with itching (hives or wheals)
• Sudden swelling of the throat, face, lips, and mouth that can cause difficulty swallowing or breathing.
• Sudden inflammation of hands, feet, or ankles.

Severe Adverse Effects

Tell your doctor immediately if you notice any of the following severe adverse effects. Your doctor may ask you to stop taking Valcyte, and you may need urgent medical treatment:

Very Common Adverse Effects(may affect more than 1 in 10 patients)

• Decrease in the number of white blood cells in the blood, with signs of infection such as sore throat, mouth ulcers, or fever
• Decrease in the number of red blood cells in the blood, with signs that include shortness of breath or fatigue, palpitations, or pallor

Common Adverse Effects(may affect up to 1 in 10 people)

• Blood infection (sepsis), with signs that include fever, chills, palpitations, confusion, and difficulty speaking
• Decrease in the number of platelets, with signs that include bleeding or bruising more frequently than usual, blood in urine or stool, or bleeding from the gums, which can be intense bleeding
• Severe decrease in the number of blood cells
• Pancreatitis with signs such as severe stomach pain that radiates to the back
• Seizures

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• Inability of the bone marrow to produce blood cells
• Hallucinations (seeing or hearing things that are not real)
• Disturbed thinking or feelings, loss of contact with reality
• Kidney failure

The adverse effects reported with valganciclovir or ganciclovir are the following:

Other Adverse Effects

Tell your doctor, pharmacist, or nurse if you notice any of the following adverse effects:

Very Common Adverse Effects(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
• Diarrhea
• Feeling of illness or sickness
• Abdominal pain
• Eczema
• Fatigue
• Fever

Common Adverse Effects(may affect up to 1 in 10 people)

• Flu
• Urinary tract infection, with signs that include fever, frequent urination, pain when urinating
• Skin and subcutaneous tissue infection
• Mild allergic reactions, with signs that include redness and swelling of the skin
• Weight loss
• Feeling of depression, anxiety, or confusion
• Sleep disorders
• Numbness or weakness in hands and feet, which can affect your balance
• Changes in touch, tingling, prickling, pinching, or burning sensation
• Changes in taste
• Chills
• Eye inflammation (conjunctivitis), eye pain, or vision problems
• Ear pain
• Low blood pressure, which can make you feel dizzy or have blurred vision
• Difficulty swallowing
• Constipation, gas, indigestion, stomach pain, abdominal distension
• Mouth ulcers
• Abnormal liver and kidney laboratory test results
• Nocturnal sweats
• Itching, rash
• Hair loss
• Back, muscle, or joint pain, muscle spasms
• Feeling of dizziness, weakness, or general malaise

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• Agitation
• Tremors
• Deafness
• Irregular heartbeat
• Hives and dry skin
• Blood in urine
• Infertility in men (see section on fertility)
• Chest pain

Only in patients with AIDS treated with Valcyte for CMV infection has separation of the inner layer of the eye (retinal detachment) occurred.

Additional Adverse Effects in Children and Adolescents

The adverse effects reported in children and adolescents are similar to the adverse effects reported for adults.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Valcyte

Keep this medicine out of the sight and reach of children.

Do not use the powder after the expiration date that appears on the packaging and on the label of the vial after CAD. The expiration date is the last day of the month indicated.

Powder: no special storage conditions are required.

Reconstituted solution: Store in the refrigerator (2°C - 8°C)

The validity period of the oral solution is 49 days. Do not use the solution 49 days after preparation or after the expiration date written on the vial by the pharmacist.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Valcyte

• The active ingredient is valganciclovir hydrochloride. After dissolution of the powder, 1 ml of solution contains 55 mg of valganciclovir hydrochloride, which corresponds to 50 mg of valganciclovir.
• The other components (excipients) are: povidone, fumaric acid, sodium benzoate (E211), sodium saccharin, and mannitol, tutti-frutti flavor [maltodextrin (corn), propylene glycol, gum arabic E414, and natural substances that give flavor mainly of banana, pineapple, and peach]

Appearance of Valcyte and Package Contents

Valcyte powder is a granulate with a white to slightly yellowish color. The glass vial contains 12 g of powder. When reconstituted, the volume of the solution is 100 ml, providing a minimum usable volume of 88 ml. The solution is clear and colorless to brown. The box also contains a vial adapter and 2 graduated dosers up to 10 ml (500 mg) with graduations of 0.5 ml (25 mg).

Package size: one vial with 12g of powder.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23 - 24

17489 Greifswald Germany

Prestige Promotion Verkaufsfoerderung & Werbeservice GmBH

Lindigstrasse 6

63801 Kleinstheim

Germany

Prestige Promotion Verkaufsfoerderung & Werbeservice GmBH

Borsigstrasse 2

63755 Alzenau

Germany

Local Representative

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom with 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

Date of the last revision of this prospectus:November 2023

Other Sources of Information

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for doctors or healthcare professionals.

It is recommended that the Valcyte solution be reconstituted by a pharmacist as follows:

1. Measure 91 ml of water in a graduated measuring cup.
2. Remove the child-resistant cap, add the water to the vial, and close the vial with the child-resistant cap. Shake the closed vial until all the powder is dissolved, forming a clear, colorless to brown solution.
3. Remove the child-resistant cap and place the adapter on the neck of the vial.
4. Tighten the child-resistant cap well. This will ensure the proper settling of the adapter to the vial and the function of the child-resistant cap.
5. Write the expiration date of the reconstituted solution on the label of the vial.

It is recommended to use disposable gloves during reconstitution and when cleaning the external surface of the vial/cap and the table after reconstitution.

Avoid inhaling and direct contact of the powder and solution with skin and mucous membranes. If such contact occurs, wash thoroughly with water and soap; rinse eyes thoroughly with water.