Voriconazole Sandoz

1. What is Voriconazole Sandoz and what is it used for

Voriconazole Sandoz contains the active substance voriconazole. Voriconazole Sandoz is an antifungal medicine that kills fungi that cause infections or stops them from growing.
The medicine is used to treat patients (adults and children over 2 years of age) with:
invasive aspergillosis (a type of fungal infection caused by fungi of the genus Aspergillus);
candidemia (another type of fungal infection caused by fungi of the genus Candida) in patients without neutropenia (patients without an abnormally low number of white blood cells);
severe invasive fungal infections caused by fungi of the genus Candida, resistant to fluconazole (another antifungal medicine);
severe fungal infections caused by fungi of the genus Scedosporiumor Fusarium(two different types of fungi).
Voriconazole Sandoz is intended for patients with progressive, life-threatening fungal infections.
It is used to prevent fungal infections in patients at high risk after bone marrow transplantation.
This medicine should only be used under the supervision of a doctor.

2. Important information before taking Voriconazole Sandoz

When not to take Voriconazole Sandoz

• if the patient is allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, even those that are available without a prescription or are herbal medicines.
Do not take the following medicines while being treated with Voriconazole Sandoz:
terfenadine (used to treat allergies);
astemizole (used to treat allergies);
cisapride (used to treat stomach disorders);
pimozide (used to treat mental illnesses);
quinidine (used to treat heart rhythm disorders);
ivabradine (used to treat symptoms of chronic heart failure);
rifampicin (used to treat tuberculosis);
efavirenz (used to treat HIV infection) at doses of 400 mg or higher, taken once a day;
carbamazepine (used to treat epilepsy);
phenobarbital (used to treat severe insomnia and epilepsy);
ergot alkaloids (e.g. ergotamine, dihydroergotamine, used to treat migraines);
sirolimus (used in patients after organ transplantation);
ritonavir (used to treat HIV infection) at doses of 400 mg or higher, taken twice a day;
St. John's wort (herbal medicine);
naloxegol [used to treat constipation caused by painkillers from the opioid group (e.g. morphine, oxycodone, fentanyl, tramadol, codeine)];
tolvaptan [used to treat hyponatremia (low sodium levels in the blood) or to slow down kidney function deterioration in patients with polycystic kidney disease];
luraxadone (used to treat depression);
venetoclax [used to treat patients with chronic lymphocytic leukemia (CLL, ang. chronic lymphocytic leukemia)].

Warnings and precautions

Before taking Voriconazole Sandoz, discuss with your doctor, pharmacist, or nurse if:
⬧ the patient has had an allergic reaction to other azoles in the past;
⬧ the patient has or has had liver disease; the doctor may prescribe a lower dose of Voriconazole Sandoz and recommend blood tests to monitor liver function during treatment;
⬧ the patient has been diagnosed with cardiomyopathy, irregular heart rhythm, slow heart rate, or changes in the electrocardiogram (ECG) called "prolonged QTc interval".
Avoid any exposure to sunlight during treatment. It is essential to wear protective clothing and use sunscreens with a high sun protection factor (SPF), as skin sensitivity to ultraviolet (UV) radiation may occur. This may be further increased by other medicines that make the skin sensitive to sunlight, such as methotrexate. These precautions also apply to children.
Tell your doctor immediately if the patient experiences:
sunburn
severe rash or blisters
bone pain.
If the patient experiences the above skin disorders, the doctor may refer them to a dermatologist, who may decide on the need for regular check-ups after consultation. There is a small risk that long-term use of voriconazole may cause skin cancer.
Tell your doctor if the patient experiences symptoms of "adrenal insufficiency", in which the adrenal glands do not produce enough of certain steroid hormones, such as cortisol. These symptoms include: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain.
If the patient experiences symptoms of "Cushing's syndrome", in which the body produces too much of the hormone cortisol, which can lead to symptoms such as: weight gain, appearance of a hump of fat between the shoulder blades, rounding of the face, darkening of the skin on the abdomen, thighs, chest, and arms, thinning of the skin, increased bruising, increased blood sugar levels, excessive hair growth, excessive sweating, tell your doctor.
The doctor will monitor the patient's liver and kidney function based on blood tests.

Children and adolescents

Voriconazole Sandoz should not be used in children under 2 years of age.

Voriconazole Sandoz and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
Some medicines taken at the same time as Voriconazole Sandoz may change its effect, as well as Voriconazole Sandoz may affect the action of other medicines.
If you are taking any of the following medicines, tell your doctor, as it is recommended to avoid taking them at the same time as Voriconazole Sandoz:
⬧ ritonavir (used to treat HIV infection) at a dose of 100 mg taken twice a day
⬧ glasdegib (used to treat cancer) — if it is necessary to take both medicines, the doctor will order frequent heart rhythm monitoring.
If you are taking any of the following medicines, tell your doctor, as it may be necessary to avoid taking them at the same time as Voriconazole Sandoz or to modify the voriconazole dose.
Rifabutin (used to treat tuberculosis). If you are being treated with rifabutin, it will be necessary to monitor your blood count and observe whether you experience any side effects of rifabutin.
Phenytoin (used to treat epilepsy). If you are being treated with phenytoin, it will be necessary to monitor its blood levels during Voriconazole Sandoz treatment, and the doctor may adjust the dosage.
If you are taking any of the following medicines, tell your doctor, as it may be necessary to modify or monitor the dosage to ensure that the mentioned medicines and/or Voriconazole Sandoz still have the expected effect:
warfarin and other anticoagulant medicines (e.g. phenprocoumon, acenocoumarol; used to reduce blood clotting);
cyclosporine (used after organ transplantation);
tacrolimus (used after organ transplantation);
sulfonylurea derivatives, e.g. tolbutamide, glipizide, and gliburide (used to treat diabetes);
statins, e.g. atorvastatin, simvastatin (used to lower cholesterol levels);
benzodiazepines, e.g. midazolam, triazolam (used to treat severe insomnia and stress);
omeprazole (used to treat stomach ulcers);
oral contraceptives (if Voriconazole Sandoz is used at the same time as oral contraceptives, side effects such as nausea, menstrual disorders may occur);
vinca alkaloids, e.g. vincristine and vinblastine (used to treat cancer);
tyrosine kinase inhibitors (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancer);
tretinoin (used to treat leukemia);
HIV protease inhibitors (e.g. indinavir and other HIV protease inhibitors) (used to treat HIV infection);
non-nucleoside reverse transcriptase inhibitors, e.g. efavirenz, delavirdine, nevirapine (used to treat HIV infection); certain doses of efavirenz should NOT be taken at the same time as Voriconazole Sandoz;
methadone (used to treat heroin addiction);
alfentanil, fentanyl, and other short-acting opioids, such as sufentanil (painkillers used during surgical procedures);
oxycodone and other long-acting opioids, such as hydrocodone (used to treat moderate or severe pain);
non-steroidal anti-inflammatory medicines, e.g. ibuprofen, diclofenac (used to treat pain and inflammation);
fluconazole (used to treat fungal infections);
everolimus (used to treat advanced kidney cancer and in patients after organ transplantation);
letermovir [used to prevent cytomegalovirus (CMV) disease after bone marrow transplantation];
ivacaftor: used to treat cystic fibrosis
flucloxacillin (an antibiotic used to treat bacterial infections)

Pregnancy and breastfeeding

Do not take Voriconazole Sandoz during pregnancy, unless your doctor decides otherwise. During treatment with Voriconazole Sandoz, women of childbearing age must use effective contraception. If you become pregnant while taking Voriconazole Sandoz, contact your doctor immediately.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Voriconazole Sandoz may cause vision disturbances and discomforting sensitivity to light. Avoid driving vehicles and operating machines in such cases.
If such disturbances occur, contact your doctor.

Voriconazole Sandoz contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, tell your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Voriconazole Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The doctor will determine the dose of the medicine based on the patient's body weight and the type of infection.
The recommended dosage for adults (including elderly patients) is shown below.

Depending on the patient's response to treatment, the doctor may increase the daily dose to 300 mg twice a day.
If the patient has mild or moderate liver cirrhosis, the doctor may decide to reduce the dose of Voriconazole Sandoz.

Use in children and adolescents

The recommended dosage for children and adolescents is shown below.

Depending on the patient's response to treatment, the doctor may increase or decrease the daily dose.
⬧ Tablets can only be given to a child if they are able to swallow them.
Tablets should be taken at least 1 hour before a meal or 1 hour after a meal, swallowed whole, and washed down with water.
If a patient taking Voriconazole Sandoz to prevent fungal infections experiences treatment-related side effects, the doctor may stop the administration of this medicine.

Taking a higher dose of Voriconazole Sandoz than recommended

If you (or anyone else) take a larger dose of tablets than recommended, seek medical help or go to the nearest hospital immediately. Take the packaging of Voriconazole Sandoz with you. Taking a higher dose of Voriconazole Sandoz than recommended may cause sensitivity to light.

Missing a dose of Voriconazole Sandoz

It is essential to take Voriconazole Sandoz tablets regularly, at the same time every day.
If you forget to take one dose, take the next dose at the right time. Do not take a double dose to make up for the missed dose.

Stopping Voriconazole Sandoz treatment

It has been shown that taking Voriconazole Sandoz regularly at the set time can significantly increase its effectiveness. Therefore, it is essential to take the medicine as described above, unless your doctor decides to stop the treatment.
Take Voriconazole Sandoz until your doctor tells you to stop. Do not stop treatment early, as this may lead to the risk of not curing the infection.
In patients with weakened immunity or severe infections, long-term treatment may be necessary to prevent the disease from recurring.
If your doctor decides to stop Voriconazole Sandoz treatment, do not worry about the consequences of stopping.
If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Voriconazole Sandoz can cause side effects, although not everybody gets them.
If a side effect occurs, it is usually mild and temporary. However, some of them can be severe and may require medical attention.

Severe side effects:

rash
jaundice; changes in blood test results assessing liver function
pancreatitis

Other side effects

Very common(may affect more than 1 in 10 people)
vision disturbances (including blurred vision, changes in color vision, abnormal light tolerance, lack of color vision, eye disorders, seeing flashes of light, aura, decreased sharpness of vision, bright vision, loss of part of the normal field of vision, floaters)
fever
rash
nausea, vomiting, diarrhea
headache
swelling of limbs
abdominal pain
breathing difficulties
increased liver enzyme activity
Common(may affect up to 1 in 10 people)
sinusitis, gingivitis, chills, weakness
low red blood cell count, sometimes severe (occasionally associated with an immune system reaction) and/or low white blood cell count (occasionally with fever), low platelet count
low blood sugar levels, low potassium levels, low sodium levels
anxiety, depression, confusion, agitation, insomnia, hallucinations
seizures, tremors or uncontrolled muscle movements, tingling or abnormal sensations on the skin, increased muscle tension, drowsiness, dizziness
eye bleeding
heart rhythm disturbances, including very fast or very slow heart rate, fainting
low blood pressure, vein inflammation (which may be associated with blood clot formation)
sudden breathing difficulties, chest pain, facial swelling (of the mouth, lips, eyes), fluid accumulation in the lungs
constipation, indigestion, mouth inflammation
jaundice, liver inflammation, and liver damage
skin rash, which may progress to a severe form with blisters and skin peeling, characterized by a flat, red area of skin covered with small, merging bumps, redness of the skin
itching
hair loss
back pain
kidney failure, blood in the urine, changes in kidney function test results
sunburn or severe skin reaction after exposure to light or sun
skin cancer
Uncommon(may affect up to 1 in 100 people)
flu-like symptoms, irritation and inflammation of the mucous membrane of the digestive tract, antibiotic-associated diarrhea, inflammation of the peritoneum (a thin tissue that lines the inner wall of the abdomen and surrounds the abdominal organs)
lymph node enlargement (sometimes painful), bone marrow failure, increased eosinophil count
adrenal insufficiency, hypothyroidism
abnormal brain function, Parkinson's disease-like symptoms, nerve damage causing numbness, pain, tingling, or burning sensation in the hands or feet
balance or coordination disorders
brain swelling
double vision, severe eye disorders, including eye pain and inflammation, involuntary eye movements, abnormal eye movements, optic nerve damage causing vision disturbances, optic disc swelling
decreased sensitivity to touch
taste disorders
hearing disorders, ringing in the ears, dizziness of labyrinthine origin
inflammation of certain internal organs — pancreas and duodenum
tongue swelling and inflammation
liver enlargement, liver failure, gallbladder disease, gallstones
joint inflammation, superficial vein inflammation (which may cause blood clot formation)
kidney inflammation, protein in the urine, kidney damage
very fast heart rate or skipped heartbeats, sometimes with abnormal electrical impulses
abnormal electrocardiogram (ECG)
increased cholesterol levels in the blood, increased urea levels in the blood
allergic reactions (sometimes severe), including a life-threatening condition that causes painful blisters with skin and mucous membrane sensitivity, skin inflammation, hives, redness and irritation of the skin, purple or red skin discoloration, which may be caused by a low platelet count, rash
bone inflammation
Rare(may affect up to 1 in 1000 people)
hyperthyroidism
impaired brain function, as a severe complication of liver disease
loss of most of the optic nerve fibers, corneal clouding, involuntary eye movement
blistering due to sensitivity to light
a condition in which the immune system attacks part of the peripheral nervous system
heart rhythm disturbances or conduction disorders (sometimes life-threatening)
life-threatening allergic reaction
blood clotting disorders
severe skin allergic reactions (sometimes severe), including sudden swelling of the skin, subcutaneous tissue, mucous membranes, and submucosal tissues, itching or painful patches of thickened, red skin with silver scales, skin and mucous membrane irritation, life-threatening skin disease characterized by the separation of large areas of the epidermis (outer layer of the skin) from the underlying layers of the skin
appearance of small, dry, flaky skin patches, sometimes thickened, with sharp protrusions or "horns"
Side effects with unknown frequency:
pigmentation and skin discoloration
Other important side effects, the frequency of which is unknown, but which should be reported to the doctor immediately:

• -red, flaky patches or ring-shaped lesions on the skin, which may be a symptom of an autoimmune disease called cutaneous lupus erythematosus

Due to the known effect of Voriconazole Sandoz on the liver and kidneys, the doctor will monitor the function of these organs by ordering blood tests. If you experience abdominal pain or changes in stool consistency, consult your doctor.
There have been reports of skin cancer in patients taking Voriconazole Sandoz for a long time.
Sunburn or severe skin reactions after exposure to light or sun occurred more frequently in children. If the patient experiences skin disorders, the doctor may refer them to a dermatologist, who may decide on the need for regular check-ups after consultation. Children also experienced more frequent increases in liver enzyme activity.
If any of these side effects persist or are troublesome, tell your doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Voriconazole Sandoz

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 blister, carton, and bottle after "EXP". The expiry date refers to the last day of that month.
There are no special storage precautions.
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 Voriconazole Sandoz contains

• The active substance is voriconazole. Each film-coated tablet contains 200 mg of voriconazole.
• The other ingredients are: tablet core:lactose monohydrate, maize starch, croscarmellose sodium, povidone K-30, magnesium stearate tablet coating (Opadry II White 33K58715):hypromellose 6 cP, lactose monohydrate, titanium dioxide (E 171), triacetin.

The medicine is available in blister packs of 20, 28, 30, 56, and 60 film-coated tablets.

What Voriconazole Sandoz looks like and contents of the pack

White or almost white, biconvex, film-coated tablets in the shape of a capsule, with the number "200" embossed on one side and smooth on the other.
The tablets are packaged in PVC/PVDC/Aluminum blisters and placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer/Importer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
S.C. Sandoz, S.R.L.
Str. Livezeni nr 7A
RO-540472 Targu-Mures, Romania
Lek Pharmaceuticals d.d.,
Trimlini 2d,
9220 Lendava, Slovenia

For more information about this medicine and its names in other EU countries, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of leaflet approval:02/2025
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