Voriconazol Polpharma

Leaflet attached to the packaging: patient information

Voriconazol Polpharma, 200 mg, film-coated tablets

Voriconazole

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.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

What is Voriconazol Polpharma and what is it used for

Voriconazol Polpharma contains the active substance voriconazole. Voriconazol Polpharma is an antifungal medicine. It works by killing fungi that cause infections or by stopping 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 accompanying neutropenia (patients who do not have a decreased number of white blood cells),
severe, invasive fungal infections caused by fungi of the genus Candidaresistant to fluconazole (another antifungal medicine),
severe fungal infections caused by fungi of the genus Scedosporiumand Fusarium(two different types of fungi).
Voriconazol Polpharma is intended for patients with progressive, life-threatening fungal infections.
The medicine is intended 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.

Important information before taking Voriconazol Polpharma

When not to take Voriconazol Polpharma

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

terfenadine (used to treat allergies),
astemizole (used to treat allergies),
cisapride (used to treat stomach disorders),
pimozide (used in psychiatry),
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 infections) in doses of 400 mg or higher 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 transplantology),
ritonavir (used to treat HIV infections) in doses of 400 mg or higher twice a day,
St. John's wort (herbal preparation),
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 the deterioration of kidney function in patients with polycystic kidney disease],
luraxadone (used to treat depression),
venetoclax [used to treat patients with chronic lymphocytic leukemia (CLL, English chronic lymphocytic leukemia)].

Warnings and precautions

Before starting Voriconazol Polpharma, the patient should discuss with their doctor or pharmacist if they have:
known hypersensitivity to other azoles.
liver disease, even if it occurred in the past. If the patient has liver disease, the doctor may prescribe a lower dose of Voriconazol Polpharma. The doctor should also monitor the patient's liver function during treatment with Voriconazol Polpharma by ordering blood tests.
cardiomyopathy, heart rhythm disorders, slow heart rate, or changes in the electrocardiogram (ECG) called "prolonged QTc interval".
It is recommended to avoid any exposure to sunlight during treatment. It is important to wear protective clothing and use sunscreen with a high sun protection factor (SPF) to protect against ultraviolet (UV) radiation, as sensitivity to sunlight may occur. These precautions also apply to children.
During treatment with Voriconazol Polpharma:
the doctor should be informed immediately if the patient experiences
sunburn
severe skin rash or blisters
bone pain.
If the above skin disorders occur, the doctor may refer the patient to a dermatologist, who may decide on the need for regular check-ups after consulting with the patient. There is a small risk that long-term use of Voriconazol Polpharma may cause skin cancer.
If the patient experiences symptoms of "adrenal insufficiency"; in which the adrenal glands do not produce enough of certain steroid hormones, such as cortisol; including: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, they should tell their doctor.
If the patient experiences symptoms of "Cushing's syndrome", in which the body produces too much of a hormone called cortisol, which can lead to symptoms such as: weight gain, appearance of a fatty hump 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, they should inform their doctor.
The doctor should regularly monitor the patient's liver and kidney function with blood tests.

Children and adolescents

Voriconazol Polpharma should not be used in children under 2 years of age.

Voriconazol Polpharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines taken at the same time as Voriconazol Polpharma may change its effect, as well as Voriconazol Polpharma may affect the action of other medicines.
The doctor should be informed about taking the following medicine, as it is recommended to avoid taking it at the same time as Voriconazol Polpharma:
ritonavir (used to treat HIV infections) in doses of 100 mg twice a day,
glasdegib (used to treat cancer) - if it is necessary to take both medicines, the doctor will order frequent heart rhythm monitoring.
The doctor should be informed about taking any of the following medicines, as it is recommended to avoid taking them at the same time as Voriconazol Polpharma (if it is necessary to take them, the doctor may change the dose of voriconazole):
rifabutin (used to treat tuberculosis). If the patient is being treated with rifabutin, they should have their blood count and rifabutin side effects monitored.
phenytoin (used to treat epilepsy). If the patient is being treated with phenytoin during treatment with Voriconazol Polpharma, their blood levels should be monitored and the dosage adjusted.
The doctor should be informed about taking any of the following medicines, as it may be necessary to change or monitor the dosage of these medicines and/or Voriconazol Polpharma to ensure they are still effective:
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 ulcers),
oral contraceptives (if Voriconazol Polpharma is taken at the same time as oral contraceptives, side effects such as nausea, menstrual disorders may occur),
vinca alkaloids ( Vinca) ,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),
indinavir and other HIV protease inhibitors (used to treat HIV),
non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz, delavirdine, nevirapine) (used to treat HIV), (some doses of efavirenz should not be taken at the same time as Voriconazol Polpharma),
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 drugs (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 transplants),
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

Voriconazol Polpharma should not be taken during pregnancy, unless the doctor decides otherwise.
During treatment with Voriconazol Polpharma, women of childbearing age must use effective contraception. If the patient becomes pregnant while taking Voriconazol Polpharma, they should contact their doctor immediately.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Voriconazol Polpharma may cause vision disturbances and abnormal reaction to light. In such cases, the patient should avoid driving and operating machines.
The patient should contact their doctor if they experience such disturbances.

Voriconazol Polpharma contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

How to take Voriconazol Polpharma

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor decides on the dose of the medicine based on the patient's weight and the type of infection.
The recommended dosage for adults (including elderly patients) is presented in the table below:

Tablets

Patients with a body weight of 40 kg or more Patients with a body weight below 40 kg

Loading dose

(first 24 hours)
400 mg every 12 hours
(in the first 24 hours)
200 mg every 12 hours
(in the first 24 hours)

Maintenance dose

(after the first 24 hours)
200 mg twice a day
100 mg twice a day
Depending on the response to treatment, the doctor may increase the daily dose to 300 mg twice a day.
In case of mild or moderate liver cirrhosis, the doctor may decide to reduce the dose of the medicine.
Since Voriconazol Polpharma is not available in 50 mg film-coated tablets or oral suspension, if other doses or oral suspension are necessary, the doctor will prescribe an appropriate medicine available on the market. Voriconazole is also available on the market in the form of 200 mg powder for solution for infusion.

Use in children and adolescents

The recommended dosage for children and adolescents is presented in the table below:

Tablets

Children aged 2 to 12 years and adolescents aged 12 to 14 years with a body weight below 50 kg Adolescents aged 12 to 14 years with a body weight above 50 kg and adolescents over 14 years

Loading dose

(first 24 hours)
Treatment will be started as an intravenous infusion
400 mg every 12 hours
(in the first 24 hours)

Maintenance dose

(after the first 24 hours)
9 mg/kg body weight twice a day
(maximum dose 350 mg twice a day)
200 mg twice a day
Depending on the response to treatment, the doctor may increase or decrease the daily dose.
Treatment in children starts as an intravenous infusion. The doctor will consider oral administration only after significant clinical improvement. The child can be given tablets if they are able to swallow them.
Administration method
Tablets should be taken at least 1 hour before a meal or 1 hour after a meal, swallowed whole, and washed down with water. The film-coated tablet should not be divided.
If the patient is taking Voriconazol Polpharma to prevent fungal infections, in case of treatment-related side effects, the treating doctor may interrupt the administration of the medicine.

Taking a higher dose of Voriconazol Polpharma than recommended

In case of taking a larger number of tablets than recommended (or if someone else takes the tablets), the patient should immediately consult a doctor or go to the nearest hospital, taking the Voriconazol Polpharma packaging with them. As a result of taking a higher dose of Voriconazol Polpharma than recommended, sensitivity to light may occur.

Missing a dose of Voriconazol Polpharma

The patient should remember to take the medicine regularly at the same time of day. If they miss a dose, they should take the next dose at the right time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Voriconazol Polpharma

It has been shown that regular intake of Voriconazol Polpharma at a set time can significantly affect its effectiveness. The patient should not stop treatment on their own, unless the doctor decides otherwise. It is important to use the medicine correctly, as described above.
The doctor will decide how long the patient should take Voriconazol Polpharma. The patient should not stop treatment too early, as this is associated with the risk of not curing the infection. Patients with weakened immunity or severe infections may require long-term treatment to prevent relapse.
If the doctor decides to stop therapy, the patient should not be concerned about the consequences of stopping it.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, they are usually mild and transient. However, some of them can be serious and may require the doctor's intervention.

Severe side effects - stop taking Voriconazol Polpharma and contact a doctor immediately

Rash
Jaundice; changes in liver function test results
Pancreatitis

Other side effects

Very common(occurring in more than 1 in 10 patients)
Visual disturbances (changes in vision, including blurred vision, changes in color vision, abnormal light intolerance, color blindness, eye disorders, seeing flashes of light, night blindness, sensation of flickering images, seeing sparks, visual aura, decreased visual acuity, 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(occurring in less than 1 in 10 patients)
Sinusitis, gingivitis, chills, weakness
Low levels of certain types of blood cells, including severe cases, red blood cells (sometimes associated with immunity) and/or white blood cells (sometimes with fever), low levels of platelets, which help blood to clot
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 skin sensations, increased muscle tension, drowsiness, dizziness
Bleeding in the eye
Heart rhythm disorders, including very fast or very slow heart rate, fainting
Low blood pressure, vein inflammation (which may be associated with blood clot formation)
Breathing difficulties with a sudden onset, chest pain, facial swelling (oral cavity, lips, and around the eyes), fluid accumulation in the lungs
Constipation, indigestion, mouth inflammation
Jaundice, liver inflammation, and liver damage
Rashes that can lead to severe blistering and skin peeling characterized by a flat, red area on the skin, covered with small merging bumps, redness of the skin
Itching
Hair loss
Back pain
Kidney failure, blood in urine, changes in kidney function tests
Uncommon(occurring in less than 1 in 100 patients)
Flu-like symptoms, gastrointestinal inflammation, antibiotic-associated diarrhea, inflammation of the lining of the abdomen and the organs it contains
Lymph node enlargement (sometimes painful), bone marrow failure, increased eosinophil count
Adrenal disorders, hypothyroidism
Brain disorders, Parkinson's disease-like symptoms, nerve damage causing numbness, pain, tingling, or burning sensations in the hands or feet
Balance or coordination disorders
Brain swelling
Double vision, severe eye disorders, including eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage causing vision disturbances, swelling of the optic disc
Decreased skin sensitivity
Taste disorders
Hearing impairment, 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, vein inflammation under the skin (which may be associated with blood clot formation)
Kidney inflammation, proteinuria, kidney damage
Very fast or skipped heartbeats, sometimes with abnormal electrical impulses
Abnormal electrocardiogram (ECG) readings
Increased cholesterol levels, increased urea levels in the blood
Skin allergic reactions (sometimes severe), including a life-threatening skin disease characterized by painful blisters with skin and mucous membrane sensitivity, skin inflammation, hives, sunburn or severe skin reaction to light or sun exposure, skin redness and irritation, red or purple skin discoloration, which may be caused by a low platelet count, rash
Infusion site reaction
Allergic reaction or excessive immune response
Rare(occurring in less than 1 in 1,000 patients)
Hyperthyroidism
Worsening of brain function, which is a severe complication of liver disease
Loss of most of the nerve fibers, corneal clouding, involuntary eye movement
Blisters due to sensitivity to light
Disorders in which the immune system attacks part of the peripheral nervous system
Heart rhythm disorders or conduction disorders (sometimes life-threatening)
Life-threatening allergic reaction
Blood clotting disorders
Skin allergic reactions (sometimes severe), including sudden swelling (sudden swelling) of the skin, subcutaneous tissue, mucous membranes, and submucosal tissues, itchy or painful thickened, red skin patches with silver scales, skin and mucous membrane irritation, life-threatening skin disease characterized by peeling off large patches of the outer layer of the skin from the underlying layers
Small, dry, flaky skin patches, sometimes thickened with sharp protrusions or "horns"
Frequency not known(cannot be estimated from the available data)

• Pigmentation and skin spots

Other important side effects, the frequency of which is not known, but which should be reported to the doctor immediately:
Skin cancer, including squamous cell carcinoma (may look like a lump or a red, flaky spot; most often occurs in areas exposed to sunlight, such as the head, neck, and arms) and Bowen's disease (a very early stage of skin cancer; the main symptom is a red, flaky spot on the skin)
Inflammation of the tissue surrounding the bone
Red, flaky patches or ring-shaped skin changes, which may be a symptom of an autoimmune disease called discoid lupus erythematosus
In relation to the known effect of Voriconazol Polpharma on the liver and kidneys, the function of these organs should be monitored with appropriate blood tests. The patient should also inform their doctor about abdominal pain or changes in stool consistency.
There have been reports of skin cancer in patients treated with voriconazole for a long time.
Sunburn or severe skin reactions to light or sun exposure 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 consulting with the patient. Increased liver enzyme activity was also observed more frequently in children.
If any of these side effects persist or are troublesome, the patient should inform their doctor.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 gather more information on the safety of the medicine.

How to store Voriconazol Polpharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Contents of the packaging and other information

What Voriconazol Polpharma contains

• The active substance of the medicine is voriconazole. Each tablet contains 200 mg of voriconazole.
• Other ingredients are: lactose monohydrate, cornstarch, croscarmellose sodium, povidone K-25, magnesium stearate, which make up the core of the tablet, and Opadry 85F 18422 White (polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc), which make up the tablet coating.

What Voriconazol Polpharma looks like and what the packaging contains

Voriconazol Polpharma film-coated tablets are white or almost white, elongated, and biconvex.

Marketing authorization holder and manufacturer

Polpharma Pharmaceutical Works S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of last revision of the leaflet:July 2023