VORICONAZOLO 50 mg Фильм-Coated Таблетки

Содержание инструкции

1. Voriconazole Mylan 50 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Voriconazolo Mylan and what is it used for
   2. What you need to know before taking Voriconazolo Mylan
2. Voriconazole Mylan should not be taken during pregnancy unless it has been
   1. How to take Voriconazolo Mylan
   2. Possible side effects
   3. How to store Voriconazolo Mylan
   4. Package contents and other information

Voriconazole Mylan 50 mg film-coated tablets, 200 mg film-coated tablets

Voriconazole

Generic medicine
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Voriconazole Mylan is and what it is used for
• 2. What you need to know before you take Voriconazole Mylan
• 3. How to take Voriconazole Mylan
• 4. Possible side effects
• 5. How to store Voriconazole Mylan
• 6. Contents of the pack and other information

1. What is Voriconazolo Mylan and what is it used for

Voriconazolo Mylan contains the active ingredient voriconazole. Voriconazolo Mylan is an
antifungal medicine. It works by stopping the growth or killing fungi that cause infections.
It is used for the treatment of patients (adults and children over 2 years of age) suffering from:

• Invasive aspergillosis (a type of fungal infection caused by the species of Aspergillus)
• Candidemia (another type of fungal infection caused by the species of Candida) in non-neutropenic patients (patients who do not have an unusually low white blood cell count)
• Serious and invasive infections caused by the species of Candida, when the fungus is resistant to fluconazole (another antifungal medicine)
• Serious fungal infections caused by the species of Scedosporiumor Fusarium(two different species of fungi).

Voriconazolo Mylan is indicated for patients with worsening fungal infections and
potentially life-threatening.
Prevention of fungal infections in patients undergoing bone marrow transplantation at high
risk.
This medicine should only be used under medical supervision.

2. What you need to know before taking Voriconazolo Mylan

Do not take Voriconazolo Mylan

• If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).

It is very important that you tell your doctor or pharmacist if you are taking or have taken any other
medicines, even those without a prescription, or herbal medicines.
The medicines included in the list below should not be used during
treatment with Voriconazolo Mylan:

• Terfenadine (for allergies)
• Astemizole (for allergies)
• Cisapride (for stomach problems)
• Pimozide (for the treatment of mental illnesses)
• Ivabradine (used for the symptoms of chronic heart failure)
• Quinidine (for irregular heartbeat)
• Rifampicin (for the treatment of tuberculosis)
• Efavirenz (for the treatment of AIDS) in doses equal to or greater than 400 mg once a day
• Carbamazepine (for the treatment of seizures)
• Phenobarbital (for severe insomnia and seizures)
• Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used for migraine)
• Sirolimus (in patients undergoing organ transplantation)
• Ritonavir (for the treatment of AIDS) in doses of 400 mg and over, twice a day
• St John's Wort (herbal supplement)
• Naloxegol (used to treat constipation specifically caused by pain medications, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine))
• Tolvaptan (used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function in patients with polycystic kidney disease)
• Lurasidone (used to treat depression)
• Venetoclax (used for the treatment of patients with chronic lymphocytic leukemia-CLL)
• Warnings and precautionsTalk to your doctor, pharmacist or nurse before taking Voriconazolo Mylan if:
• you have had an allergic reaction to other azoles
• you suffer from or have suffered from a liver disease .If you have a liver disease, your doctor may prescribe you a lower dose of Voriconazolo Mylan. Your doctor must check your liver function during treatment with Voriconazolo Mylan by performing blood tests.
• you know you have cardiomyopathy, an irregular heartbeat, a slowing of the heart rate or an alteration on an electrocardiogram (ECG) called “long QT syndrome”.

You should avoid any exposure to the sun and sunlight during treatment. It is important
to cover areas of skin exposed to the sun and use sunscreens with a high protection factor
(SPF), as increased skin sensitivity to the sun's UV rays can occur. This
may be further increased by other drugs that sensitize the skin to sunlight,
such as methotrexate. These precautions also apply to children.
During treatment with Voriconazolo Mylan:
immediately inform your doctor if you develop:

• Sunburn
• Severe skin reaction or blisters
• Bone pain

If you develop any of the skin conditions described above, your doctor may refer you to a
dermatologist, who after consultation may decide that it is important to subject you to regular visits.
With long-term use of Voriconazolo Mylan, there is a small risk of
developing skin cancer.
If you develop signs of "adrenal insufficiency" in which the adrenal glands do not produce
adequate amounts of certain steroid hormones such as cortisol, which can lead to symptoms
such as: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss,
abdominal pain, inform your doctor.
If you develop signs of "Cushing's syndrome" in which the body produces an amount
excessive cortisol hormone that can lead to symptoms such as: weight gain, fat hump
between the shoulders, rounded face, darkening of the skin on the stomach, thighs breasts and arms, thinning skin, bruising easily, high blood sugar, excessive hair growth, excessive sweating,
inform your doctor.
Your doctor must check liver and kidney function by performing blood tests.

Children and adolescents
Voriconazolo Mylan should not be given to children under 2 years of age.

Other medicines and Voriconazolo Mylan
Please tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines, including those available without a prescription.
Some medicines, when taken at the same time as Voriconazolo Mylan, can
change the activity of Voriconazolo Mylan or Voriconazolo Mylan can change
the activity of these medicines.
Tell your doctor if you are taking the following medicine because, if possible, concomitant treatment with Voriconazolo Mylan should be avoided:

• Ritonavir (for the treatment of AIDS) in doses of 100 mg twice a day
• Glasdegib (used for the treatment of cancer): if it is necessary to use both drugs, the doctor will frequently check the heart rate.

Tell your doctor if you are taking any of the following medicines because, if possible, the
concomitant treatment with Voriconazolo Mylan should be avoided and a dose adjustment of voriconazole may be necessary.

• Rifabutin (for the treatment of tuberculosis). If you are already being treated with rifabutin, the blood cell count and side effects to rifabutin must be monitored.
• Phenytoin (for the treatment of epilepsy). If you are already being treated with phenytoin, phenytoin concentrations in the blood must be monitored during treatment with Voriconazolo Mylan and the dose you are taking may be adjusted.

Tell your doctor if you are taking any of these medicines because a dose adjustment or monitoring of the dose may be necessary to verify that these medicines and/or
Voriconazolo Mylan continue to have the desired effect:

• Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol) (to slow down the blood clotting process)
• Cyclosporine (in patients undergoing organ transplantation)
• Tacrolimus (in patients undergoing organ transplantation)
• Sulfonylureas (e.g. tolbutamide, glipizide and gliburide) (for diabetes)
• Statins (e.g. atorvastatin, simvastatin) (to reduce cholesterol)
• Benzodiazepines (e.g. midazolam, triazolam, alprazolam) (for severe insomnia and stress)
• Omeprazole (for the treatment of ulcers)
• Oral contraceptives (if you take Voriconazolo Mylan during treatment with oral contraceptives, side effects such as nausea and menstrual disorders may occur)
• Vinca alkaloids (e.g. vincristine and vinblastine) (for the treatment of cancer)
• Tyrosine kinase inhibitors (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used for the treatment of cancer)
• Tretinoin (used to treat leukemia)
• Indinavir and other HIV protease inhibitors (for the treatment of AIDS)
• Non-nucleoside reverse transcriptase inhibitors (e.g. efavirenz, delavirdine, nevirapine) (for the treatment of AIDS) (some doses of efavirenz CANNOT be taken together with Voriconazolo Mylan)
• Methadone (for the treatment of heroin addiction)
• Alfentanil and fentanyl and other short-acting opioids such as sufentanil (pain relievers used for surgical techniques)
• Oxycodone and other long-acting opioids such as hydrocodone (used to treat moderate to 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 undergoing transplantation)
• Letermovir (used to prevent cytomegalovirus (CMV) disease after bone marrow transplantation)
• Ivacaftor: used for the treatment of cystic fibrosis
• • Flucloxacillin (antibiotic used against bacterial infections) Pregnancy and breastfeeding

Voriconazole Mylan should not be taken during pregnancy unless it has been

decided by the doctor. Women of childbearing potential must use adequate contraception. Contact
your doctor immediately if you are pregnant during treatment with Voriconazole
Mylan.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking any
medicine.

Driving and operating machinery
Voriconazole Mylan can cause blurred vision, altered visual perception, or a
troublesome sensitivity to light. If this occurs, you should not drive and should not use tools or
machinery. In these cases, contact your doctor.

Voriconazole Mylan contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg tablet, i.e. it is
essentially “sodium-free”.
This medicine contains less than 1 mmol of sodium (23 mg) per 200 mg tablet, i.e. it is
essentially “sodium-free”

3. How to take Voriconazolo Mylan

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
The doctor will establish the appropriate dose for you based on your weight and the type of infection diagnosed.
The recommended dose for adults (including elderly patients) is as follows:

Based on the response to treatment, the doctor may increase the daily dose to 300 mg twice
a day.
If you have mild to moderate cirrhosis, your doctor may decide to reduce the dose.

Use in children and adolescents
The recommended dose in children and adolescents is as follows:

Based on the response to treatment, the doctor may increase or decrease the daily dose.
The tablets must be administered only if the child is able to swallow the
tablets.
Take the tablets at least one hour before or one hour after meals. Swallow the tablet whole with a
little water.
If you or your child are taking Voriconazolo Mylan to prevent
fungal infections, your doctor may decide to stop administering Voriconazolo Mylan
if you or your child should develop side effects related to treatment.

If you take more Voriconazolo Mylan than you should
If you take a number of tablets greater than those prescribed to you (or if another
person takes your tablets) contact your doctor immediately or go to the nearest
emergency room. Bring the package of Voriconazolo Mylan tablets with you. Abnormal light sensitivity may occur if you take more Voriconazolo Mylan than you should.

If you forget to take Voriconazolo Mylan
It is important to take the Voriconazolo Mylan tablets regularly every day at the same
time. If you forget to take a dose, take the next dose at the scheduled time. Do not take
a double dose to make up for a missed dose.

If you stop taking Voriconazolo Mylan
It has been shown that taking the doses at the right time can significantly increase
the effectiveness of the medicine. Therefore, unless your doctor has told you to stop the
treatment, it is important to continue taking Voriconazolo Mylan correctly, as
described above.
Continue taking Voriconazolo Mylan until your doctor tells you to stop the
treatment. Do not stop treatment prematurely because the infection may not be
cured. Patients with a weakened immune system or those with infections
that are difficult to cure may require long-term treatment to prevent the infection
from returning.
When treatment with Voriconazolo Mylan is stopped at the request of the doctor, no effects should occur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

If side effects occur, most are likely to be minor and temporary.
However, some may be serious and require medical attention.

Serious side effects – Stop taking Voriconazole Mylan and consult a doctor
immediately

• skin rash
• Jaundice; Changes in blood tests of liver function
• Pancreatitis

Other side effects

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

• Visual impairment (altered vision including blurred vision, altered color vision, abnormal intolerance to visual perception of light, color blindness, eye disorders, vision halo, night blindness, oscillating vision, seeing sparks, visual aura, reduced visual acuity, visual brightness, loss of part of the normal visual field, spots in front of the eyes)
• Fever
• Skin rash
• Nausea, vomiting, diarrhea
• Headache
• Swelling of the extremities
• Stomach pains
• Difficulty breathing
• Elevated liver enzymes

Common(may affect up to 1 in 10 people)

• Inflammation of the paranasal sinuses, inflammation of the gums, chills, weakness
• Low number of some types, even serious, of red blood cells (sometimes immune-related) and/or white blood cells (sometimes with fever), low number of cells called platelets that help blood to clot
• Low blood sugar level, low potassium content in the blood, low sodium content in the blood
• Anxiety, depression, confusion, agitation, inability to sleep, hallucinations
• Convulsions, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increased muscle tone, drowsiness, dizziness
• Bleeding in the eyes
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
• Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
• Acute difficulty breathing, chest pain, swelling of the face (mouth, lips and eye area), fluid accumulation in the lungs
• Constipation, indigestion, inflammation of the lips
• Jaundice, inflammation of the liver and liver damage
• Skin rashes that can lead to severe blisters and peeling of the skin characterized by a flat, red area on the skin, skin that is covered with small, confluent bumps, redness of the skin
• Itching
• Hair loss
• Back pain
• Kidney failure, blood in the urine, changes in kidney function tests
• Sunburn or severe skin reactions 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 gastrointestinal tract, inflammation of the gastrointestinal tract causing diarrhea associated with antibiotics, inflammation of the lymphatic vessels
• Inflammation of the thin tissue lining the inner wall of the abdomen and covering the abdominal organ
• Swollen lymph glands (sometimes painful), bone marrow failure, increased eosinophils
• Depressed function of the adrenal gland, underactive thyroid
• Abnormal brain function, Parkinson's-like symptoms, nerve injury resulting in numbness, pain, tingling or burning in the hands or feet
• Problems with balance or coordination
• Brain swelling
• Double vision, serious eye conditions including: pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in impaired vision, swelling of the optic disc
• Decreased sensitivity to touch
• Abnormal sense of taste
• Hearing difficulties, ringing in the ears, dizziness
• Inflammation of some internal organs: pancreas and duodenum, swelling and inflammation of the tongue
• Enlargement of the liver, liver failure, gallbladder diseases, gallstones
• Joint inflammation, inflammation of the superficial veins (which may be associated with the formation of a blood clot)
• Kidney inflammation, protein in the urine, kidney damage
• Very fast heartbeats or skipped heartbeats, sometimes with irregular electrical impulses
• Abnormal electrocardiogram (ECG)
• Increased cholesterol in the blood, increased urea in the blood
• Allergic skin reactions (sometimes severe), including life-threatening skin conditions that cause
• blistering and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, redness and irritation of the skin, reddish or purplish discoloration of the skin that may be caused by low platelet count, eczema
• Reaction at the infusion site
• Allergic reaction or exaggerated immune response
• Inflammation of the tissue surrounding the bone

Rare(may affect up to 1 in 1,000 people)

• Hyperactive thyroid gland
• Deterioration of brain function that is a serious complication of liver disease
• Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movement
• Bullous photosensitivity
• A disorder in which the body's immune system attacks part of the peripheral nervous system
• Heart rhythm or conduction problems (sometimes life-threatening)
• Life-threatening allergic reaction
• Blood clotting system disorder
• Allergic skin reactions (sometimes severe), including a rapid swelling (edema) of the dermis, subcutaneous tissue, mucous membranes and submucosal tissues, itchy or painful thick and reddish skin patches with silvery scales, skin irritation and mucous membrane irritation, life-threatening skin condition that causes the detachment of large portions of the epidermis, the outermost layer of skin, from the underlying skin layers
• Small, scaly, dry skin patches, sometimes thick with points or "horns"

Adverse events with frequency not known:

• Freckles and pigmented spots

Other significant side effects whose frequency is unknown, but must be reported
immediately to the doctor:
Red and scaly patches or ring-shaped skin lesions that may be a
symptom of an autoimmune disease called cutaneous lupus erythematosus
Since voriconazole is known to have effects on the liver and kidneys, the doctor must monitor
liver and kidney function by performing blood tests. Please inform your doctor if
you have stomach pains or if your stools have a different consistency.
Skin cancer has been reported in patients treated with voriconazole for a long
period of time.
A sunburn or a severe skin reaction following exposure to light or sun has been
observed more frequently in children. If you or your child should develop skin disorders
your doctor may refer you to a dermatologist, after consultation who may
decide whether it is important for you or your child to continue regular visits.
Elevated liver enzymes have also been observed more frequently in children.

If any of these side effects persists or is bothersome, inform your doctor.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Voriconazolo Mylan

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 box and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voriconazolo Mylan contains

• The active ingredient is voriconazole. Each tablet contains 50 mg or 200 mg of voriconazole.
• The other ingredients are: Tablet core: Lactose (see section 2 “Voriconazolo Mylan contains lactose monohydrate and sodium”), sodium croscarmellose, pregelatinized corn starch, povidone and magnesium stearate. Coating: Lactose monohydrate, hypromellose, titanium dioxide (E171) and triacetin.

Description of the appearance of Voriconazolo Mylan and package contents
Voriconazolo Mylan 50 mg film-coated tablets: Film-coated tablets of
white to off-white color, oval, biconvex with “V26” imprinted on one side of the tablet and
smooth on the other side.
Voriconazolo Mylan 200 mg film-coated tablets: Film-coated tablets of
white to off-white color, capsule-shaped, biconvex with “M164” imprinted on one side of the
tablet and smooth on the other side.
Voriconazolo Mylan is available in blister packs of:
20, 28, 30, 90, 100, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 ,100 x 1 film-coated tablets
for Voriconazolo Mylan 50 mg film-coated tablets.
14, 20, 28, 30, 90, 100, 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1 ,100 x 1 for Voriconazolo
Mylan 200 mg film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturers
Generics (UK) Limited, Station Close, Potters Bar, Herts EN6 1TL, United Kingdom
GE Pharmaceuticals Ltd., Industrial Zone, Chekanitza-South area, 2140 Botevgrad, Bulgaria
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900 Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France:Voriconazole Viatris 50 mg and 200 mg, comprimé pelliculé

Italy:Voriconazolo Mylan

Netherlands:Voriconazol Viatris 50 mg and 200 mg, filmomhulde tabletten

Portugal:Voriconazol Mylan

Czech Republic:Vorikonazol Viatris 200 mg, potahované tablety