Valhit

Package Leaflet: Information for the User

Valhit, 450 mg, Film-Coated Tablets

Valganciclovir

Read all of this leaflet carefully before taking this medicine.

• 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. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What Valhit is and what it is used for

Valhit belongs to a group of medicines that work directly to prevent viruses from multiplying. Valganciclovir, the active substance in 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.

Valhit is used:

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

2. Before taking Valhit

Do not take Valhit:

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

Warnings and precautions

Before taking Valhit, talk to your doctor or pharmacist.

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

When to be extra careful with Valhit

• 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 Valhit.
• If you are undergoing radiotherapy or haemodialysis.
• If you have kidney problems. Your doctor may prescribe a lower dose and monitor your blood counts regularly during treatment.
• If you are currently taking ganciclovir capsules and your doctor decides to switch you to Valhit tablets. It is very important not to take more tablets than your doctor prescribes to avoid the risk of overdose.

Valhit with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

Taking Valhit with other medicines can affect the levels of the medicine in your blood and may cause harmful side effects. If you are currently taking a medicine that contains any of the following active substances, tell your doctor:

• imipenem with cilastatin (antibiotics); taking them with Valhit may cause seizures;
• zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, or emtricitabine, or similar medicines used to treat AIDS;
• adefovir or other medicines used to treat hepatitis B;
• probenecid (a medicine used to treat gout); taking probenecid and Valhit together may increase the levels of ganciclovir in your blood;
• mycophenolate mofetil, cyclosporin, or tacrolimus (used after organ transplants);
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer;
• trimethoprim, trimethoprim-sulfamethoxazole combinations, or dapsone (antibacterial medicines);
• pentamidine (a medicine used to treat parasitic infections or pneumocystis pneumonia);
• flucytosine or amphotericin B (antifungal medicines).

Valhit with food and drink

Take Valhit with food. If you cannot eat for any reason, you should still take your prescribed dose of Valhit.

Pregnancy, breastfeeding, and fertility

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

Do not take Valhit while breastfeeding. If your doctor wants you to start treatment with Valhit, you should stop breastfeeding before starting to take this medicine.

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

If you are a man taking Valhit, you should use a condom during sexual intercourse with a woman who could become pregnant, during treatment and for 90 days after treatment.

Driving and using machines

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

Before taking any medicine, consult your doctor or pharmacist.

3. How to take Valhit

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Handle the tablets with care. Do not break or crush them. Swallow the tablets whole, if possible, with food. If you accidentally touch a broken tablet, wash your hands thoroughly with soap and water. If the powder from the tablet gets into your eyes, rinse them thoroughly with sterile water or, if not available, clean water.

Take the dose prescribed by your doctor to avoid overdose.

Take Valhit tablets with food, if possible - see section 2.

Adults

Prevention of CMV disease in transplant patients

Start taking Valhit within 10 days after transplantation. The usual recommended dose is 2 tablets ONCE a day. Continue taking this dose for 100 days.

In patients who have received a kidney transplant, your doctor may recommend taking the tablets for 200 days.

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

The typical dose of Valhit is 2 tablets TWICE a day for 21 days (3 weeks). Unless your doctor advises otherwise, do not take this dose for more than 21 days, as this may increase the risk of side effects.

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

The typical dose of Valhit is 2 tablets ONCE a day. Try to take the tablets at the same time each day. Your doctor will decide how long you should take Valhit. If your retinitis worsens while taking this dose, your doctor may recommend repeating the induction treatment (as above) or decide to give you another medicine to treat the CMV infection.

Elderly patients

Valhit has not been studied in elderly patients.

Patients with kidney problems

In patients with kidney problems, your doctor may recommend taking a lower dose or taking the tablets only on certain days of the week. It is very important to take the exact dose prescribed by your doctor.

Patients with liver problems

Valhit has not been studied in patients with liver problems.

Use in children and adolescents

Prevention of CMV disease in patients who have received a transplanted organ

Start giving Valhit to the child within 10 days after transplantation. The recommended dose may vary depending on the size of the child and should be taken ONCE a day.

Your doctor will choose the right dose based on the child's height, weight, and kidney function. Continue giving this dose for 100 days. If the child has received a kidney transplant, your doctor may recommend taking the tablets for 200 days.

If the child cannot swallow the film-coated Valhit tablets, valganciclovir can be given as an oral solution.

Overdose of Valhit

If you have taken more tablets than prescribed, contact your doctor or go to the hospital immediately. Taking more than the prescribed dose may cause serious side effects, especially affecting your blood or kidneys.

Hospital treatment may be necessary.

Missing a dose of Valhit

If you forget to take a tablet, 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 forgotten dose.

Stopping Valhit treatment

Do not stop taking Valhit unless your doctor advises you to.

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

4. Possible side effects

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

Allergic reactions

Severe allergic reactions to valganciclovir (anaphylaxis) occur in less than 1 in 1000 patients. If you experience any of the following symptoms, stop taking Valhit and go to the hospital immediately:

• hives, itching, swelling of the face, lips, tongue, or throat, 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 side effects - your doctor may advise you to stop taking Valhit and may need to give you urgent treatment:

Very common:may affect more than 1 in 10 people

low white blood cell count - signs of infection such as sore throat, mouth ulcers, or fever

low red blood cell count - symptoms may include shortness of breath or feeling tired, fast heartbeat, or pale skin

Common:may affect up to 1 in 10 people

blood infection (sepsis) - symptoms include fever, chills, fast heartbeat, confusion, and slurred speech

low platelet count - symptoms may include easy bruising or bleeding, blood in urine or stools, or bleeding from the gums; bleeding may be severe

severe decrease in blood cell counts

pancreatitis - symptoms include stomach pain that radiates to the back

seizures

Uncommon:may affect up to 1 in 100 people

bone marrow failure

hallucinations - hearing or seeing things that do not exist

thought or mood disorders, loss of contact with reality

kidney problems

Other side effects

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

Very common:may affect more than 1 in 10 people

• thrush or fungal infections of the mouth
• upper respiratory tract infections (e.g., sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• shortness of breath
• diarrhea
• nausea or vomiting
• stomach pain
• rash
• feeling tired
• fever

Common:may affect up to 1 in 10 people

• flu
• urinary tract infection - symptoms include fever, frequent urination, pain while urinating
• skin and subcutaneous tissue infections
• mild allergic reaction - symptoms may include redness and itching of the skin
• weight loss
• feeling depressed, anxious, or confused
• sleep problems
• feeling weak or numb in the hands or feet, which may cause balance problems
• changes in sensation, feeling of numbness, tingling, pricking, 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
• difficulty swallowing
• constipation, gas, indigestion, stomach pain, abdominal distension
• mouth ulcers
• abnormal liver or kidney test results
• night sweats
• itching, rash
• hair loss
• back, muscle, or joint pain, muscle spasms
• dizziness, weakness, or general feeling of being unwell

Uncommon:may affect up to 1 in 100 people

• feeling agitated
• tremors, chills
• hearing loss
• irregular heartbeat
• hives, dry skin
• blood in urine
• infertility in men - see section "Fertility"
• chest pain

Detachment of the inner layer of the eye (retinal detachment) has occurred only in AIDS patients treated with Valhit for CMV infection.

Additional side effects in children and adolescents

Side effects in children and adolescents are similar to those in adults.

Reporting 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.

Side effects can be reported to the national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme (www.mhra.gov.uk/yellowcard). You can also report side effects directly to the manufacturer.

5. How to store Valhit

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 carton and blister after EXP. The expiry date refers to the last day of that month.

No special storage precautions are required.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Valhit contains

• The active substance is valganciclovir. Each film-coated tablet contains 496.3 mg valganciclovir hydrochloride, equivalent to 450 mg valganciclovir.
• The other ingredients are Core:microcrystalline cellulose PH101, crospovidone (type A), povidone K-30, stearic acid 50. Coating Opadry Pink 15B24005:hypromellose 3cP, hypromellose 6cP, titanium dioxide (E 171), macrogol 400, iron oxide red (E 172), polysorbate 80.

What Valhit looks like and contents of the pack

Valhit is available as film-coated tablets. The tablets are described below.

Valhit tablets are pink, oval, biconvex (16.7 x 7.8 mm), with "J" engraved on one side and "156" on the other side.

Blister pack (OPA/Aluminium/PVC/Aluminium) in a cardboard box. The pack contains 30, 60, 90, or 120 tablets.

HDPE bottle with a PP cap and a child-resistant closure, in a cardboard box. The pack contains 60 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Accord Healthcare Polska Sp. z o.o.

Taśmowa 7

02-677 Warsaw

Manufacturer:

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp. z o.o.

Lutomierska 50

95-200 Pabianice

Accord Healthcare B.V

Winthontlaan 20

3526 KV Utrecht

Netherlands

For further information on this medicine, contact:

Accord Healthcare Polska Sp. z o.o.

Taśmowa 7, 02-677 Warsaw

tel: +48 22 577 28 00

fax: + 48 22 577 29 01

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

Date of last revision of the leaflet: December 2022