Valcite

Package Leaflet: Information for the User

Valcyte, 50 mg/ml, Powder for Oral Solution

Valganciclovir

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 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.

Contents of the Pack and Other Information

• 1. What Valcyte is and what it is used for
• 2. 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 called antivirals. It works by preventing viruses from multiplying in the body. Valganciclovir, the active ingredient in Valcyte, is converted to ganciclovir in the body. Ganciclovir stops the cytomegalovirus (CMV) from multiplying and infecting healthy cells in the body. In people with weakened immune systems, CMV can cause infections that may be life-threatening.

Valcyte is used:

• to treat CMV retinitis (infection of the retina of the eye) in adults with acquired immune deficiency syndrome (AIDS); CMV infection of the retina can cause blindness;
• to prevent CMV infection in children and adults who are not infected with CMV and have received an organ transplant from a CMV-infected donor.

2. Before you take Valcyte

Do not take Valcyte

• 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

Before taking Valcyte, tell your doctor or pharmacist:

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

Special care to be taken when taking Valcyte

• If you have a low white blood cell, red blood cell or platelet count. Your doctor will monitor your blood counts before and during treatment with Valcyte.
• If you are undergoing radiotherapy.
• If you have kidney problems; your doctor may prescribe a lower dose and monitor your blood counts regularly during treatment.

Valcyte with food and drink

Take Valcyte with food. If you are unable to eat, take your dose of Valcyte as prescribed.

Pregnancy, breast-feeding and fertility

If you are pregnant or think you may be pregnant, do not take Valcyte unless your doctor tells you to. If you are pregnant or planning to become pregnant, tell your doctor before taking Valcyte. Taking Valcyte during pregnancy may harm your unborn baby.

Do not breast-feed while taking Valcyte. If your doctor wants you to start treatment with Valcyte, you must stop breast-feeding before you start taking this medicine.

Women of childbearing age must use effective contraception during and for at least 30 days after treatment with Valcyte.

Men taking Valcyte must use condoms during and for at least 90 days after treatment, if their partner is of childbearing age and could become pregnant.

Driving and using machines

Do not drive or operate machinery if you experience dizziness, tiredness, tremors or confusion while taking Valcyte.

Valcyte contains sodium and benzyl alcohol

One 12 g bottle of Valcyte contains 100 mg of benzyl alcohol, which is equivalent to 1 mg/ml of the prepared solution. Benzyl alcohol can cause allergic reactions in infants, especially when used for longer periods of time or in high doses.

1 ml of the prepared solution contains 0.188 mg of sodium, which is essentially sodium-free.

3. How to take Valcyte

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Handle the solution with care. Avoid contact with the skin and eyes. If the solution accidentally comes into contact with the skin, wash the area thoroughly with soap and water. If it accidentally gets into the eyes, rinse them thoroughly with water.

Follow your doctor's instructions for the dose of the oral solution to avoid overdose.

Take the oral solution with food, if possible - see section 2.

It is important to use the dispenser provided with the pack to measure the dose of Valcyte solution. Do not use these dispensers with other medicines.

Twodispensers are provided; each dispenser should be discarded after 20 uses.

Each dispenser is designed to measure up to 10 ml (500 mg) of solution, with markings for every 0.5 ml (25 mg). 1 ml of the oral solution contains 50 mg of valganciclovir.

Always rinse the dispenser with distilled or tap water and allow it to air dry after measuring the dose.

If both dispensers are discarded, lost or damaged, contact your doctor or pharmacist for advice on how to continue taking your medicine.

Adults

Prevention of CMV disease in transplant patients

Start taking the medicine within 10 days of the transplant. The usual dose is 900 mg of Valcyte solution, taken once daily. Use the provided dispenser to measure two 9 ml (450 mg) doses.

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

The usual dose is 900 mg of Valcyte solution, taken twice daily for 21 days (3 weeks). Use the provided dispenser to measure two 9 ml (450 mg) doses in the morning and two 9 ml (450 mg) doses in the evening.

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

The usual dose is 900 mg of Valcyte solution, taken once daily. Use the provided dispenser to measure two 9 ml (450 mg) doses.

Elderly

Valcyte has not been studied in elderly patients.

Patients with kidney problems

Your doctor may prescribe a lower dose if you have kidney problems.

Patients with liver problems

Valcyte has not been studied in patients with liver problems.

Children and adolescents

Prevention of CMV disease in transplant patients

Start taking the medicine within 10 days of the transplant. The dose will depend on the size of the child and should be taken once daily.

Method and route of administration

It is recommended that the pharmacist prepares the Valcyte solution before dispensing it to the patient.

DOSER

Connector

Child-resistant cap

Before
opening
by
children
plunger
tip

• 1. Shake the closed bottle well for about 5 seconds before each use.
• 2. Remove the child-resistant cap before opening.
• 3. Before inserting the tip of the dispenser into the connector, push the plunger to the end, towards the tip of the dispenser. Secure the tip in the connector opening.
• 4. Turn the entire unit (bottle and dispenser) upside down.
• 5. Slowly pull the plunger until the desired amount of solution is drawn into the dispenser (see diagram).
• 6. Turn the entire unit right side up and slowly remove the dispenser 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 cap.
• 9. Immediately after administration: disassemble the dispenser, rinse with distilled or tap water, and let it air dry before the next use.

Be careful to avoid skin contact with the solution. If contact occurs, wash the area thoroughly with soap and water.

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

Overdose of Valcyte

If you take more Valcyte than you should, contact your doctor or go to the hospital immediately. Taking too much Valcyte may cause serious side effects, especially affecting the blood or kidneys.

Missed dose of Valcyte

If you forget to take a dose, take it as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Valcyte treatment

Do not stop taking Valcyte unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Valcyte can cause side effects, although not everybody gets them.

Allergic reactions

Severe allergic reactions to valganciclovir (anaphylaxis) occur in less than 1 in 1,000 patients. If you experience any of the following symptoms, stop taking Valcyte and go to the hospital immediately:

• hives, itching, swelling, dizziness;
• sudden swelling of the throat, face, lips, or tongue, which may cause difficulty swallowing or breathing;
• sudden swelling of the hands, feet, or ankles.

Serious side effects

Tell your doctor immediately if you experience any of the following serious side effects - your doctor may tell you to stop taking Valcyte, and you may need urgent medical treatment:

• low white blood cell count - with signs of infection such as sore throat, mouth ulcers, or fever;
• low red blood cell count - with symptoms such as shortness of breath, tiredness, palpitations, or pale skin;
• blood infection (sepsis) - with symptoms such as fever, chills, rapid heartbeat, confusion, and slurred speech;
• low platelet count - with symptoms such as bleeding or bruising more easily than usual, blood in urine or stools, or bleeding from the gums;
• severe reduction in blood cell counts;
• pancreatitis - with symptoms such as severe abdominal pain radiating to the back;
• seizures;

The following side effects have also been reported with valganciclovir or ganciclovir:

Other side effects

Tell your doctor or pharmacist if you experience any of the following side effects:

• thrush or oral thrush;
• upper respiratory tract infections (such as sinusitis, tonsillitis);
• loss of appetite;
• headache;
• cough;
• shortness of breath;
• diarrhea;
• nausea or vomiting;
• abdominal pain;
• eczema;
• fatigue;
• fever;

Frequently:these side effects may occur in up to 1 in 10 patients

• flu;
• urinary tract infection - with symptoms such as fever, frequent urination, pain while urinating;
• skin and soft tissue infections;
• mild allergic reaction - with symptoms such as redness and itching of the skin;
• weight loss;
• depression, anxiety, or confusion;
• sleep disturbances;
• weakness or numbness of the hands or feet, affecting balance;
• changes in sensation, such as tingling, prickling, or burning;
• changes in taste;
• chills;
• eye inflammation (conjunctivitis), eye pain, or vision problems;
• ear pain;
• low blood pressure, which may cause dizziness or fainting;
• swallowing difficulties;
• constipation, gas, indigestion, stomach pain, bloating;
• mouth ulcers;
• abnormal liver or kidney test results;
• night sweats;
• itching, rash;
• hair loss;
• back pain, muscle pain, or joint pain;
• dizziness, weakness, or general feeling of being unwell.

Less frequently:these side effects may occur in up to 1 in 100 patients

• agitation;
• tremors, convulsions;
• hearing loss;
• irregular heartbeat;
• hives, dry skin;
• blood in urine;
• infertility in men - see section "Pregnancy, breast-feeding and fertility";
• chest pain;

Detachment of the retina (retinal detachment) has been reported in patients with AIDS being treated with Valcyte for CMV infection.

Additional side effects in children and adolescents

The side effects in children and adolescents are similar to those seen in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 which is stated on the carton and bottle label (‘Expiry date’). The expiry date refers to the last day of that month.

Powder: no special storage conditions.

Prepared solution: store in a refrigerator (2°C-8°C).

The shelf-life of the prepared solution is 49 days. Do not use the solution after 49 days from the date of preparation or after the expiry date stated on the bottle label by the pharmacist.

Medicines should 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 reconstitution, 1 ml of solution contains 50 mg of valganciclovir, equivalent to 55 mg of valganciclovir hydrochloride.

The other ingredients are povidone, fumaric acid, sodium benzoate (E211), sodium saccharin, mannitol, and Tutti Frutti flavor [maltodextrin (corn), propylene glycol, gum arabic E414, and natural identical flavorings mainly banana, pineapple, and peach].

What Valcyte looks like and contents of the pack

Valcyte powder is a white to light yellow granule. The 12 g bottle contains 100 ml of solution after reconstitution.

The solution is clear, colorless to brown. The pack also contains a connector and two oral dispensers to measure up to 10 ml (500 mg) of solution, with markings for every 0.5 ml (25 mg).

Pack size: one bottle containing 12 g of powder.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicinal product is authorized in the Member States of the European Economic Area and in 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

Date of last revision of the leaflet: September 2024

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 for healthcare professionals only

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

• 1. Measure 91 ml of water in a measuring cylinder.
• 2. Remove the child-resistant cap, add water to the bottle, and then close the bottle with the child-resistant cap. Shake the closed bottle until the powder dissolves.
• 3. Remove the child-resistant cap and insert the connector into the neck of the bottle.
• 4. Close the bottle tightly with the child-resistant cap. This will ensure the connector is properly seated in the bottle and the cap is child-resistant.
• 5. Write the expiry date of the prepared solution on the bottle label.

It is recommended to wear disposable protective gloves when handling the medicine and wiping the outside of the bottle and/or cap after handling the medicine.

Avoid inhaling or coming into direct contact with the powder or solution and skin or mucous membranes. If direct contact occurs, wash the skin thoroughly with soap and water, and rinse the eyes with water.