Label: information for the user

Valcyte 50 mg/ml powder for oral solution

Valganciclovir

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms of disease, as it may harm them.
• If you experience any adverse effects, inform your doctor or pharmacist, even if they are not listed in this label.See section 4.

Read this label carefully because it contains important information for you.

1. What isValcyteand what it is used for

2. What you need to know before starting to takeValcyte

3. How to takeValcyte

4. Possible adverse effects

5. Storage ofValcyte

6. Contents of the pack and additional information

Valcyte belongs to a group of medications that directly prevent the growth of viruses. In the body, the active ingredient in the powder, valganciclovir, is metabolized 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 pose a life-threatening threat.

Valcyte is used:

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

Do not takeValcyte

• if you are allergic to valganciclovir, ganciclovir, or any of the other components of this medication (listed in section 6).
• if you are breastfeeding your baby.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valcyte.

• if you are allergic to acyclovir, penciclovir, valaciclovir, or famciclovir. These are other medications used for viral infections.
• if you have a low blood count of white blood cells, red blood cells, or platelets (small cells involved in blood clotting). Your doctor will perform a blood test before starting to take Valcyte and will perform more tests while you are on treatment.

• if you are receiving radiation therapy.

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

Use of Valcyte with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, even those obtained without a prescription.

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

• imipenem-cilastatin (antibiotic). Taking this medication with Valcyte may cause seizures (convulsions).
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medications for HIV treatment.
• adefovir or any other medication for hepatitis B treatment.
• probenecid (medication for gout treatment). Taking probenecid and Valcyte at the same time may increase the amount of ganciclovir in the blood.
• micophenolate mofetil, cyclosporine, or tacrolimus (used after transplants).
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medications for cancer treatment.
• trimethoprim, combinations of trimethoprim/sulfamethoxazole, and dapsone (antibiotics).
• pentamidine (medication for parasite or lung infection treatment),
• flucytosine or amphotericin B (antifungal agents)

Use of Valcyte with food and drinks

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

You should not take Valcyte if you are pregnant, unless your doctor recommends it. If you are pregnant or plan to become pregnant, inform your doctor. Taking Valcyte while pregnant may cause harm to the fetus.

You should not take Valcyte during breastfeeding. Before starting treatment, you should stop breastfeeding your baby.

Women of childbearing age should use an effective contraceptive method while taking Valcyte and for at least 30 days after treatment has ended.

Males whose partners may become pregnant should use a condom while taking Valcyte and should continue using it for 90 days after treatment has ended.

Driving and operating machinery

Do not drive or operate machinery if you feel dizzy, tired, agitated, or confused while taking this medication.

Consult your doctor or pharmacist before using any medication.

Valcyte contains benzoate of sodium and sodium(salt)

This medication contains 100 mg of benzoate of sodium in each 12 g bottle, which is equivalent to 1 mg/ml after reconstitution. The sodium benzoate may increase jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks old).

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

You must be especially careful when handling the solution of Valcyte. You must avoid the solution from coming into contact with your skin and eyes. If the solution accidentally comes into direct contact with your skin, the affected area must be washed with water and soap. If the solution accidentally enters your eyes, your eyes must be washed immediately with plenty of water.

To avoid an overdose, you must adhere to the daily dose of the oral solution prescribed by your doctor.

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

It is essential that you use the dosifier provided in the box to measure your dose of Valcyte solution.The dosifier includes two dosifiers, discard each dosifier after 20 applications. Each dosifier is designed to measure a quantity of up to 10 ml (500 mg) of solution, with graduations of 0.5 ml (25 mg).

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

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

Adults

Prevention of CMV infection in transplant patients

You must start taking this medication within 10 days of the transplant. The recommended dose is 900 mg of Valcyte solution ONCE a day. Use the dosifier provided in the box to take twice the amount of 9 ml (450 mg) of solution (i.e., 2 dosifiers filled up to the 9 ml (450 mg) mark). You must 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 HIV patients (also known as induction treatment)

The recommended dose is 900 mg of Valcyte solution TWICE a day for 21 days (3 weeks). Use the dosifier provided in the box to take twice the amount of 9 ml (450 mg) of solution (i.e., 2 dosifiers filled up to the 9 ml (450 mg) mark) in the morning and twice the amount of 9 ml (450 mg) of solution (i.e., 2 dosifiers filled up to the 9 ml (450 mg) mark) in the evening.

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

Maintenance treatment, to prevent the recurrence of active inflammation in HIV patients with CMV retinitis (also known as maintenance treatment)

The recommended dose is 900 mg of Valcyte solution ONCE a day. Use the dosifier provided in the box to take twice the amount of 9 ml (450 mg) of solution (i.e., 2 dosifiers filled up to the 9 ml (450 mg) mark). You must try to take the solution at the same time every day. Your doctor will inform you how long you should continue taking Valcyte. If your retinitis worsens while taking this dose, your doctor will advise you whether to repeat the induction treatment (as above) or may decide to give you a different medication to treat the CMV infection.

Older patients

Valcyte has not been studied in older patients.

Patients with kidney problems

If your kidneys do not function properly, your doctor will advise you to take a lower dose of Valcyte solution every day. It isvery importantthat you follow the dose prescribed by your doctor.

Use the dosifier provided in the box to measure the dose of 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 must start taking this medication within 10 days of receiving the transplant. The dose to be taken will depend on the child's size and must be taken ONCE a day. Your doctor will decide which dose is most suitable based on the child's height, weight, and renal function. You must continue with that dose until 100 days. If your child has received a kidney transplant, your doctor may recommend that they take the prescribed dose until 200 days.

Use the dosifiers provided in the package to measure the Valcyte solution.

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

Method and route of administration

The Valcyte solution should be prepared by the pharmacist before giving it to you.

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

1. Before each use, shake the closed bottle well for about 5 seconds.
2. Remove the child-resistant closure.
3. Before inserting the dosifier tip into the bottle adapter, push the plunger all the way to the end of the dosifier. Insert the tip firmly into the bottle adapter opening.
4. Place the entire unit (bottle and dosifier) upside down.
5. Draw the plunger slowly until the desired amount of medication is released into the dosifier (see figure).
6. Place the entire unit right side up and slowly separate the dosifier from the bottle.
7. Administer it directly into the mouth and swallow the medication. Do not mix it with any liquid before administering it
8. Close the bottle with the child-resistant closure after each use.
9. Immediately after administration:

Disassemble thedosifier, rinse under distilled or boiling water, and dry it before the next use.

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

Do not use the solution after the expiration 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 believe you have taken more of the Valcyte solution than you should. Taking more doses than the recommended dose can cause serious side effects, particularly affecting the blood or kidneys. You may need hospital treatment.

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

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 compensate for the missed doses.

If you interrupt treatment with Valcyte

You must not interrupt treatment unless your doctor advises you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 nearest hospital emergency department when you experience any of the following effects:

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

Severe side effects

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

Very common side effects(may affect more than 1 in 10 patients)

• Decreased white blood cell count, with signs of infection such as sore throat, mouth ulcers, or fever
• Decreased red blood cell count, with signs that include shortness of breath or fatigue, palpitations, or paleness

Common side effects(may affect up to 1 in 10 people)

• Blood infection (sepsis), with signs that include fever, chills, palpitations, confusion, and difficulty speaking
• Decreased platelet count, with signs that include frequent bruising or bleeding, blood in urine or stool, or bleeding gums, which may be severe
• Intense decrease in blood cell count
• Pancreatitis with signs such as severe stomach pain that radiates to the back
• Seizures

Uncommon side effects(may affect up to 1 in 100 people)

• Bone marrow failure to produce blood cells
• Hallucinations (seeing or hearing things that are not real)
• Disturbed thinking or feelings, loss of contact with reality
• Renal function failure

The side effects reported with valganciclovir or ganciclovir are as follows:

Other side effects

Inform your doctor, pharmacist, or nurse if you notice any of the following side effects:

Very common side 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
• Dyspepsia
• Diarrhea
• Sensation of illness or illness
• Abdominal pain
• Eczema
• Fatigue
• Fever.

Common side effects(may affect up to 1 in 10 people)

• Influenza
• Urinary tract infection, with signs that include fever, frequent urination, and pain while urinating
• Skin and subcutaneous tissue infection
• Mild allergic reactions, with signs that include skin redness and swelling
• Weight loss
• Sensation of depression, anxiety, or confusion
• Sleep disturbances
• Numbness or weakness in hands and feet, which may affect balance
• Changes in sensation, tingling, pins and needles, or burning sensation
• Changes in taste
• Chills
• Eye inflammation (conjunctivitis), eye pain, or vision problems
• Ear pain
• Low blood pressure, which may cause dizziness or blurred vision
• Dysphagia
• Constipation, gas, indigestion, stomach pain, abdominal distension
• Mouth ulcers
• Abnormal results in liver and kidney function tests
• Nocturnal sweating
• Itching, rash
• Hair loss
• Back, muscle, or joint pain, muscle spasms
• Sensation of dizziness, weakness, or general malaise

Uncommon side effects(may affect up to 1 in 100 people)

• Restlessness
• Tremors
• Deafness
• Irregular heartbeat
• Urticaria 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, retinal detachment has occurred.

Additional side effects in children and adolescents

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

Reporting side effects

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

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

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

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

Powder: no special storage conditions are required.

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

The oral solution shelf life 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 disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. By doing so, you will help protect the environment.

Composition of Valcyte

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

Appearance of Valcyte and contents of the package

Valcyte powder is a granule with a white to slightly yellowish color. The glass bottle contains12 gof 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 brownish. The box also contains a bottle adapter and 2 graduated dosing syringes up to 10 ml (500 mg) with graduations of 0.5 ml (25 mg).

Package size: one bottle with 12g of powder.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization

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

Last review date of this leaflet:November2023

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

This information is intended solely for doctors or healthcare professionals.

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

1. Measure 91 ml of water in a graduated pipette.
2. Remove the child-resistant cap, add the water to the bottle and close the bottle with the child-resistant cap. Shake the closed bottle until all the powder is dissolved, forming a clear, colorless to brownish solution.
3. Remove the child-resistant cap and put the adapter on the neck of the bottle.
4. Close the bottle tightly with the child-resistant cap. This will ensure the proper seating of the adapter on the bottle and the function of the child-resistant cap.
5. Write the expiration date of the reconstituted solution on the label of the bottle.

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

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