Valciclox

Leaflet accompanying the packaging: information for the user

Valcyclox, 450 mg, film-coated tablets

Valganciclovir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What is Valcyclox and what is it used for

Valcyclox belongs to a group of medicines that work directly to prevent the multiplication of viruses. Valganciclovir, the active substance of the tablets, is converted in the body to ganciclovir. Ganciclovir prevents the cytomegalovirus (CMV) from multiplying and infecting healthy cells in the body. In patients with weakened immune systems, CMV can cause infections in various organs. This can be life-threatening.

Valcyclox is used:

• to treat CMV retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). CMV retinitis can cause vision problems and even lead to blindness.
• to prevent CMV infections in adult and pediatric patients who are not infected with CMV and have received a transplanted organ from a CMV-infected donor.

2. Important information before taking Valcyclox

When not to take Valcyclox:

• if you are allergic to valganciclovir or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to ganciclovir, acyclovir, or valacyclovir, which are medicines used to treat other viral infections;
• if you are breastfeeding.

Warnings and precautions

Before taking Valcyclox, discuss this with your doctor or pharmacist.

When to be extra careful while taking Valcyclox

• if you have a low number of white blood cells, red blood cells, or platelets (small cells involved in blood clotting); your doctor will send you for blood tests before starting Valcyclox and for additional blood tests during treatment;
• if you are undergoing radiation therapy or hemodialysis;
• if you have kidney problems. Your doctor may prescribe a lower dose and may order regular blood tests during treatment;
• if you are currently taking ganciclovir in capsule form and your doctor has decided to switch you to Valcyclox in tablet form. It is extremely important not to take more tablets than your doctor has prescribed to avoid the risk of overdose.

Valcyclox with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

• imipenem with cilastatin (an antibacterial medicine); taking them with Valcyclox may cause seizures;
• zidovudine, didanosine, lamivudine, tenofovir, abacavir, emtricitabine, or other similar types of medicines used to treat AIDS;
• ribavirin, pegylated interferons, adefovir, and entecavir, used to treat viral hepatitis B or C;
• probenecid (a medicine used to treat gout); when taken with Valcyclox, it may increase the levels of ganciclovir in the blood.
• mycophenolate mofetil (used after organ transplants);
• vincristine, vinblastine, adriamycin, hydroxyurea, or similar medicines used to treat cancer;
• cidofovir, foscarnet used to treat viral infections;
• trimethoprim, trimethoprim in combination with sulfonamides, and dapsone (antibacterial medicines);
• pentamidine (a medicine used to treat parasitic diseases or lung infections);
• flucytosine or amphotericin B (antifungal medicines).

Valcyclox with food and drink

Valcyclox should be taken with food. If you cannot eat for any reason, you should still take your usual dose of Valcyclox.

Pregnancy, breastfeeding, and fertility

If you are pregnant, you should not take Valcyclox unless your doctor advises you to.

If you are pregnant or think you may be pregnant, or if you plan to have a baby, ask your doctor for advice.

Do not take Valcyclox if you are breastfeeding. If your doctor wants to start treating you with Valcyclox, you should stop breastfeeding before starting to take this medicine.

Women of childbearing age should use effective contraception during treatment with Valcyclox.

Men should use a condom during sexual intercourse with a partner who could become pregnant, for 90 days after treatment with Valcyclox.

Driving and using machines

Do not drive or operate any tools or machines if you experience dizziness, fatigue, tremors, or confusion while taking Valcyclox.

Before taking any medicine, consult your doctor or pharmacist.

3. How to take Valcyclox

Always take this medicine exactly as your doctor or pharmacist has told you.

Handle the tablets carefully. Do not break or crush them. Swallow the tablets whole, if possible, during meals.

Follow the dose recommended by your doctor to avoid overdose.

If possible, take Valcyclox tablets during meals - see section 2.

Adults

Prevention of CMV disease in transplant recipients

Treatment with Valcyclox should be started within 10 days after transplantation. The usual recommended dose is 2 tablets ONCE a day.

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

The usual recommended dose of Valcyclox is 2 tablets TWICE a day for 21 days (3 weeks).

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

The usual recommended dose is 2 tablets ONCE a day.

Children and adolescents

Prevention of CMV disease in transplant recipients

In children and adolescents, treatment with Valcyclox should be started within 10 days after transplantation.

Overdose

If you have taken more Valcyclox than you should, contact your doctor or go to the hospital immediately.

Missed dose

If you forget to take a dose, take the missed dose as soon as possible, and then take the next dose at the usual time.

Stopping treatment

Do not stop taking Valcyclox unless your doctor tells you to.

4. Possible side effects

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

Allergic reactions

Sudden and severe allergic reactions to valganciclovir (anaphylactic shock) occur in less than 1 in 100 patients.

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

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

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

• Blood disorders: decreased white blood cell count (neutropenia), which may increase the risk of infection, decreased red blood cell count (anemia), which may cause fatigue and shortness of breath during exercise.
• Respiratory disorders: shortness of breath or difficulty breathing (dyspnea).
• Gastrointestinal disorders: diarrhea.

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

• Blood disorders: decreased platelet count (thrombocytopenia), which may cause bruising or bleeding; decreased white blood cell count (leukopenia);
• Nervous system disorders: headache, difficulty sleeping (insomnia), taste disturbance, numbness or tingling, seizures.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Valcyclox

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’.

There are no special storage instructions for this medicine.

Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What Valcyclox contains

• The active substance is 450 mg valganciclovir (as 496.3 mg valganciclovir hydrochloride).
• The other ingredients are:

Tablet core: microcrystalline cellulose PH101, crospovidone type A, povidone K30, and stearic acid 50,

Coating: hypromellose 3 cP, hypromellose 6 cP, titanium dioxide (E171), macrogol 400, iron oxide red (E172), and polysorbate 80.

What Valcyclox looks like and contents of the pack

Valcyclox is a film-coated tablet (450 mg) that is pink, oval, and biconvex, with a size of 16.7 mm x 7.8 mm, and has a debossed "J" on one side and "156" on the other.

Valcyclox is available in blisters (OPA-Aluminium-PVC/Aluminium) in a carton containing 10 or 60 tablets, and in HDPE bottles with a PP cap and a child-resistant closure in a carton containing 60 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer:

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000; Malta

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Wien, Austria

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands:

Valcycloxciclovir CF 450 mg, filmomhulde tabletten

Austria:

Valcycloxciclovir STADA 450 mg Filmtabletten

Croatia:

Valcycloxciclovir STADA 450 mg filmom obložene tablete

France:

Valcycloxciclovir EG 450 mg, comprimé pelliculé

Germany:

Valcycloxciclovir STADA 450mg Filmtabletten

Poland:

Valcyclox

Slovenia:

Valcycloxciklovir STADA 450 mg filmsko obložene tablete

Date of last revision of the leaflet: 07/2022