Mint-Valganciclovir: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is MINT-VALGANCICLOVIR used for?

• MINT-VALGANCICLOVIR is used to treat a disease called cytomegalovirus (CMV) retinitis in adults who have acquired immunodeficiency syndrome (AIDS).
• MINT-VALGANCICLOVIR is also used to prevent CMV disease in adults who have received a solid organ transplant and are at risk of developing CMV disease.

How does MINT-VALGANCICLOVIR work?

• MINT-VALGANCICLOVIR is a prescription medicine that belongs to the family of drugs known as “antivirals”. It is used to treat infections caused by viruses.
• MINT-VALGANCICLOVIR works by slowing the growth of the CMV virus.
• MINT-VALGANCICLOVIR contains valganciclovir, which is the starting form of the medicine ganciclovir. This means the valganciclovir is changed to ganciclovir once it is absorbed into the body. Ganciclovir is the active part of the drug that actually slows the growth of CMV virus.
• Your doctor will let you know how long to take MINT-VALGANCICLOVIR for and if it is working for you.

What are the ingredients in MINT-VALGANCICLOVIR?

Medicinal ingredient: valganciclovir hydrochloride.

Non-medicinal ingredients: Crospovidone, hydroxypropyl methylcellulose, macrogol, microcrystalline cellulose, polysorbate 80, povidone, red iron oxide, stearic acid and titanium dioxide.

MINT-VALGANCICLOVIR comes in the following dosage form:

As a pink, film-coated tablet containing 450 mg valganciclovir (as valganciclovir hydrochloride).

Do not use MINT-VALGANCICLOVIR if you:

• Are allergic to valganciclovir or to ganciclovir.
• Are allergic to any of the other ingredients in MINT-VALGANCICLOVIR or to a component of the container.
• Are allergic to the antiviral medicine acyclovir or to valacyclovir, as a similar reaction can occur with MINT-VALGANCICLOVIR.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MINT-VALGANCICLOVIR. Talk about any health conditions or problems you may have, including if you:

• Have kidney problems.
• Have liver problems.
• Are receiving hemodialysis since your dose of MINT-VALGANCICLOVIR will need to be modified.
• Are receiving or have received radiation therapy.

Other warnings you should know about:

Blood problems:

MINT-VALGANCICLOVIR can cause serious blood cell problems. These include reduced numbers of certain white blood cells (granulocytopenia, neutropenia, or leukopenia), reduced numbers of red blood cells (anemia), and reduced numbers of platelets (thrombocytopenia). See “Serious Warnings and Precautions” box. If you have or had a history of blood problems or abnormal results on your blood tests, please talk to your healthcare professional before you take MINT-VALGANCICLOVIR. MINT-VALGANCICLOVIR may also cause blood creatinine elevation and abnormal liver function. Your doctor should recommend that you have blood tests done on a regular basis.

Kidney problems:

MINT-VALGANCICLOVIR can cause an increase in serum creatinine (an indicator of kidney function). An increase in serum creatinine may indicate abnormal kidney function. Your doctor may have blood tests done on a regular basis to monitor your serum creatinine.

Pregnancy and Birth Defects:

Tell your doctor if you are pregnant or planning to become pregnant. MINT-VALGANCICLOVIR may cause birth defects and should not be used during pregnancy. If you are a woman of child-bearing potential, then you should avoid pregnancy. You must use effective contraception during treatment and for 30 days after stopping treatment. Effective contraception includes a barrier method, such as a condom plus an additional method like birth control pills or an intrauterine device. If you are a male taking MINT-VALGANCICLOVIR with a female partner, then you should use a barrier method (e.g. condom) during treatment and for 90 days after stopping treatment. This is because MINT-VALGANCICLOVIR can cause birth defects.

Breast-feeding:

Tell your doctor if you are breast-feeding or planning to breast feed. You should not take MINT-VALGANCICLOVIR while breast-feeding. Women who are HIV positive should not breast-feed because HIV infection can be passed to the baby via the breast milk.

Driving and using machines:

Be careful when driving a car or using machines. MINT-VALGANCICLOVIR and/or ganciclovir can cause seizures, dizziness, ataxia (unsteadiness) and confusion. You should not drive a car or use machines until you know how MINT-VALGANCICLOVIR affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MINT-VALGANCICLOVIR:

• Drugs that treat AIDS such as zidovudine, didanosine, stavudine. These drugs may need to have their dose changed when taken with MINT-VALGANCICLOVIR.
• Drugs that reduce your immune system such as cyclosporine, tacrolimus, mycophenolate mofetil.
• Drugs that treat cancer such as vincristine, vinblastine, doxorubicin, hydroxyurea.
• Drugs that fight infections such as trimethoprim/sulphonamides, dapsone, amphotericin B, flucytosine, pentamidine, pegylated interferons with ribavirin.
• Drugs that stop the growth of infections such as Imipenem-cilastin. Seizures have occurred in patients taking imipenem-cilastin and ganciclovir. You may discuss different options with your doctor.
• Probenecid, a medicine used to treat gout. Taking probenecid and MINT-VALGANCICLOVIR at the same time could increase the amount of ganciclovir in your blood to toxic levels.

How to take MINT-VALGANCICLOVIR:

• Take MINT-VALGANCICLOVIR exactly as your doctor has told you to.
• Do not skip any doses or take more than the recommended dose.

• Take MINT-VALGANCICLOVIR with food.

• Do not break or crush MINT-VALGANCICLOVIR tablets. Avoid contact with broken MINT-VALGANCICLOVIR tablets on your skin, lips, in your nose or in your eyes. If contact occurs, wash your skin well with soap and water or rinse your eyes well with sterile or plain water if sterile water is not available.
• If you have kidney problems, your doctor might prescribe a lower dose.

Usual Dose:

Treatment of CMV Retinitis in Patients with AIDS

• The usual dosage for adults to get active CMV retinitis under control (induction therapy) is two 450 mg tablets twice a day for 21 days.
• The usual dosage for adults to help keep CMV retinitis under control (maintenance therapy) is two 450 mg tablets once a day.

Prevention of CMV Disease in Solid Organ Transplantation

• The usual dosage to prevent CMV in adults who received a solid organ transplant is two 450 mg tablets once a day. Treatment starts within 10 days of transplant and continues until 100 days after the transplant.

Overdose:

Missed Dose:

• If you forget to take a dose of MINT-VALGANCICLOVIR, take it as soon as possible, then just carry on with the regular times you take your medication. If you remember your missed dose close to the time for your next dose, do not take the missed dose. Do not take two doses of MINT-VALGANCICLOVIR at the same time.
• Do not let your MINT-VALGANCICLOVIR run out. The amount of virus in your blood may increase if your medicine is stopped, even for a short time.
• It may be a good idea to ask your doctor or pharmacist ahead of time what to do about missed doses.

What are possible side effects from using MINT-VALGANCICLOVIR?

These are not all the possible side effects you may have when taking MINT-VALGANCICLOVIR. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Diarrhea, nausea, vomiting
• Constipation
• Fever
• Headache
• Trembling
• Swelling of the legs
• Back pain
• Insomnia (sleeplessness)
• High blood pressure
• Dizziness, unsteadiness
• Confusion
• Increased potassium in the blood.

Other side effects. MINT-VALGANCICLOVIR causes cancer in animals and may cause cancer in people.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Keep out of reach and sight of children.
• Store MINT-VALGANCICLOVIR tablets in a clean dry area at room temperature (15-30°C).
• Keep container tightly closed.
• Do not use medication after the expiry date on the package.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

If you want more information about MINT-VALGANCICLOVIR:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the importer’s website (www.mintpharma.com) or by calling 1-877-398-9696

Last revised: SEP 15, 2026