VORICONAZOLO 50 mg Film-Coated Tablets

Зміст інструкції

1. Voriconazolo Sandoz 50 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Voriconazolo Sandoz and what is it used for
   2. What you need to know before taking Voriconazolo Sandoz
   3. How to take Voriconazolo Sandoz
   4. Possible side effects
   5. How to store Voriconazolo Sandoz
   6. Package contents and other information

Voriconazolo Sandoz 50 mg film-coated tablets, 200 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start using 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 their symptoms are the same as yours, as it could 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 Voriconazolo Sandoz is and what it is used for
• 2. What you need to know before you take Voriconazolo Sandoz
• 3. How to take Voriconazolo Sandoz
• 4. Possible side effects
• 5. How to store Voriconazolo Sandoz
• 6. Contents of the pack and other information

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

Voriconazolo Sandoz contains the active ingredient voriconazole. Voriconazolo Sandoz is an
antifungal medicine. It works by killing fungi that cause infections or stopping their
growth.
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 Aspergillusspp)
• candidemia (another type of fungal infection caused by Candidaspp) in non-neutropenic patients (patients who do not have an unusually low white blood cell count)
• serious and invasive infections caused by Candidaspp, when the fungus is resistant to fluconazole (another antifungal medicine)
• serious fungal infections caused by Scedosporiumspp and Fusariumspp (two different species of fungi).

Voriconazolo Sandoz is intended for patients with worsening, potentially life-threatening fungal
infections.
Prevention of fungal infections in patients undergoing high-risk bone marrow transplantation.
This product must be used only under the supervision of a physician.

2. What you need to know before taking Voriconazolo Sandoz

Do not take Voriconazolo Sandoz
If you are allergic to voriconazole or to any of the other ingredients of this medicine
(listed in section 6).
Tell your doctor or pharmacist if you are taking or have taken any other medicines, including those
obtained without a prescription, or herbal products.
The medicines included in the following list must not be used during treatment with
Voriconazolo Sandoz:

• Terfenadine (used for allergies)
• Astemizole (used for allergies)
• Cisapride (used for stomach disorders)
• Pimozide (used for the treatment of mental illnesses)
• Quinidine (used to treat irregular heartbeats)
• Rifampicin (used for the treatment of tuberculosis)
• Efavirenz (used for the treatment of HIV) in doses equal to or greater than 400 mg once a day
• Carbamazepine (used for the treatment of seizures)
• Phenobarbital (used for severe insomnia and seizures)
• Ergot alkaloids (for example ergotamine, dihydroergotamine; used to treat migraine)
• Sirolimus (used in patients undergoing transplantation)
• Ritonavir (used for the treatment of HIV) in doses equal to or greater than 400 mg twice a day
• St John's Wort (herbal supplement)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Voriconazolo Sandoz if:

• you have had an allergic reaction to other azoles
• you suffer from or have suffered from a liver disease. If you suffer from liver disorders, your doctor may prescribe you a lower dose of Voriconazolo Sandoz. Your doctor must also check your liver function during treatment with Voriconazolo Sandoz, by means of blood tests
• you suffer from cardiomyopathy, irregular heartbeat, slowed heartbeat or an alteration in the electrocardiogram (ECG) called “long QT syndrome”.

You must 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 an increased sensitivity of the skin to the sun's UV rays can occur. These
precautions also apply to children.
During treatment with Voriconazolo Sandoz, immediately inform your doctor if you develop:

• sunburn
• a severe skin rash 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 visits with
regular frequency. With the use of voriconazole for a long period, there is a small risk of developing
skin cancer.
Your doctor will need to check your liver and kidney function by performing blood tests.

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

Other medicines and Voriconazolo Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine, even those obtained without a prescription.
Some medicines, when taken at the same time as Voriconazolo Sandoz, can
affect the activity of Voriconazolo Sandoz or Voriconazolo Sandoz can affect
the activity of these medicines.
Tell your doctor if you are taking the following medicine because, if possible, concomitant treatment with Voriconazolo Sandoz should be avoided:

• Ritonavir (for the treatment of HIV) at doses of 100 mg twice a day

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

• Rifabutin (used for the treatment of tuberculosis). If you are already being treated with rifabutin, the blood cell count and the side effects of rifabutin must be monitored
• Phenytoin (used 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 Sandoz and the dose may require adjustment.

Tell your doctor if you are taking any of the following medicines, as it may be
necessary to adjust or monitor the dose to verify that these medicines and/or Voriconazolo
Sandoz continue to have the desired effect:

• Warfarin and other anticoagulants (for example phenprocoumone, acenocoumarol; used to slow down the blood clotting process)
• Cyclosporine (used in patients undergoing transplantation)
• Tacrolimus (used in patients undergoing transplantation)
• Sulfonylureas (for example tolbutamide, glipizide and gliburide) (used for diabetes)
• Statins (for example atorvastatin, simvastatin) (used to reduce cholesterol)
• Benzodiazepines (for example midazolam, triazolam) (used for severe insomnia and stress)
• Omeprazole (used for the treatment of ulcers)
• Oral contraceptives (if you take Voriconazolo Sandoz while using oral contraceptives you may experience side effects such as nausea and menstrual disorders)
• Vinca alkaloids (for example vincristine and vinblastine) (used for the treatment of cancer)
• Indinavir and other HIV protease inhibitors (used for the treatment of HIV)
• Non-nucleoside reverse transcriptase inhibitors (for example efavirenz, delavirdine, nevirapine) (used for the treatment of HIV) (some doses of efavirenz CANNOT be taken at the same time as Voriconazolo Sandoz)
• Methadone (used for the treatment of heroin addiction)
• Alfentanil and fentanyl and other short-acting opioids, such as sufentanil (pain relievers used for surgical operations)
• Oxycodone and other long-acting opioids, such as hydrocodone (used for the treatment of moderate to severe pain)
• Non-steroidal anti-inflammatory drugs (for example ibuprofen, diclofenac) (used for the treatment of pain and inflammation)
• Fluconazole (used to treat fungal infections)
• Everolimus (used for the treatment of advanced kidney cancer and in patients undergoing transplantation).

Pregnancy and breastfeeding
Voriconazolo Sandoz should not be taken during pregnancy, unless specifically
indicated by your doctor. Women of childbearing potential must use effective contraception.
If you become pregnant during treatment with Voriconazolo Sandoz, inform your doctor immediately.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
Voriconazolo Sandoz can cause blurred vision or a bothersome sensitivity to light.
If this happens, you should not drive or use tools or machinery. If you experience these effects
consult your doctor.

Voriconazolo Sandoz contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Voriconazolo Sandoz

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The doctor will establish the appropriate dose for you based on your weight and the type of infection.
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, the 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 dose
daily.

• 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 water.
If you or your child are taking Voriconazolo Sandoz for the prevention of fungal
infections, the doctor may decide to discontinue the administration of Voriconazolo Sandoz if
you or your child should develop adverse effects related to treatment.

If you take more Voriconazolo Sandoz than you should
If you take a number of tablets greater than that prescribed to you (or if someone
else takes your tablets) you must seek immediate medical assistance or go immediately
to the nearest emergency room. Bring with you the package of Voriconazolo
Sandoz tablets. If you take more Voriconazolo Sandoz than you should, you may experience
an abnormal intolerance to light.

If you forget to take Voriconazolo Sandoz
It is important to take the Voriconazolo Sandoz 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 Sandoz
It has been shown that taking doses on schedule can significantly increase
the effectiveness of the medicine. Therefore, unless your doctor has told you to stop
treatment, it is important that you continue to take Voriconazolo Sandoz correctly,
as described above.
Continue to take Voriconazolo Sandoz until your doctor tells you to stop
treatment. Do not stop treatment prematurely, as the infection may not
resolve. Patients with a weakened immune system or those with infections
difficult to cure may require long-term treatment to prevent the return
of the infection.
When treatment with Voriconazolo Sandoz is discontinued as directed by your doctor, you
should not experience any effects.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If side effects occur, most of them will likely be mild
and transient in nature. However, some may be serious and require medical attention.

Serious side effects - Stop taking Voriconazolo Sandoz and consult a
doctor immediately

• Skin rash
• Jaundice; changes in liver function tests
• Pancreatitis

Other side effects
Very common(may affect more than 1 in 10 people):

• Impaired vision (changes in vision including blurred vision, altered color vision, abnormal intolerance to the perception of visual light, color blindness, eye disease, halo vision, night blindness, oscillating vision, seeing sparks, visual aura, reduced visual acuity, visual brightness, partial loss of visual field, spots in front of the eyes)
• Fever
• Skin rashes
• Nausea, vomiting, diarrhea
• Headache
• Swelling of the extremities
• Stomach pain
• Difficulty breathing
• Elevated liver enzymes

Common(may affect up to 1 in 10 people):

• Inflammation of the paranasal sinuses, inflammation of the gums, chills, fatigue
• Reduction, even severe, in the number of some types of red blood cells (sometimes immune-related) and/or white blood cells (sometimes accompanied by fever), reduction in the number of blood cells called platelets that help blood clotting
• Low blood sugar levels, low potassium levels in the blood, low sodium levels in the blood
• Anxiety, depression, confusion, agitation, sleep disorders, hallucinations
• Convulsions, tremor or uncontrolled muscle movements, tingling or abnormal skin sensations, increased muscle tone, drowsiness, dizziness
• Bleeding in the eye
• 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 around the eyes), fluid accumulation in the lungs
• Constipation, indigestion, inflammation of the lips
• Jaundice, inflammation of the liver and liver damage
• Skin rash that may involve blistering and severe skin peeling, characterized by a flat and reddened area of skin with small confluent bumps, skin redness
• Itching
• Hair loss
• Back pain
• Kidney failure, blood in the urine, changes in kidney function tests

Uncommon(may affect up to 1 in 100 people):

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, inflammation of the gastrointestinal tract that can cause 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
• Enlargement of the lymph nodes (sometimes painful), bone marrow failure, increased eosinophils
• Reduced function of the adrenal glands, reduced activity of the thyroid gland
• Changes in brain function, Parkinson-like symptoms, nerve damage resulting in numbness, pain, tingling or burning in the hands or feet
• Problems with balance and coordination
• Brain edema
• Double vision, serious eye conditions including: eye and eyelid pain and inflammation, involuntary eye movement, abnormal eye movement, damage to the optic nerve with impaired vision, swelling of the optic disc
• Reduced sensitivity to touch
• Changes in taste
• Hearing disorders, ringing in the ears, vertigo
• Inflammation of some internal organs - pancreas and duodenum, swelling and inflammation of the tongue
• Enlargement of the liver, liver failure, gallbladder disease, gallstones
• Inflammation of the joints, inflammation of the superficial veins (which may be associated with the formation of blood clots)
• Inflammation of the kidneys, presence of protein in the urine, kidney damage
• Fast heart rate or skipped heartbeat, sometimes with irregular electrical impulses
• Altered electrocardiogram (ECG)
• Increased blood cholesterol, increased blood urea
• Allergic skin reactions (sometimes severe) including a potentially life-threatening skin condition causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, sunburn or severe skin reaction following exposure to light or sun, skin redness and irritation, skin discoloration red or purple which may be caused by a low platelet count, eczema.
• Reaction at the infusion site
• Allergic reaction or exaggerated immune response

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

• Hyperactive thyroid gland
• Deterioration of brain function as a serious complication of liver disease
• Loss of much of the optic nerve fibers, corneal opacity, involuntary eye movement
• Bullous photosensitivity
• Disorder in which the body's immune system attacks a part of the peripheral nervous system
• Heart rhythm or conduction problems (sometimes fatal)
• Potentially life-threatening allergic reaction
• Disorders of the blood coagulation system
• Allergic skin reactions (sometimes severe), including rapid swelling (edema) of the dermis, subcutaneous tissue, mucous membranes and submucosal tissues, itchy or painful patches of thickened and reddened skin with silvery scales, skin irritation and mucous membranes, a potentially life-threatening skin condition causing large portions of the epidermis (the outer layer of skin) to detach from the underlying skin layers
• Small patches of dry, scaly skin, sometimes thick with bumps or ‘horns’

Side effects with frequency not known:

• Freckles and pigmented spots

Other significant side effects, whose frequency is unknown but which should be reported
immediately to the doctor are:

• Skin cancer
• Inflammation of the tissues surrounding the bones
• Red, scaly or ring-shaped skin lesions that may be symptoms of an autoimmune disease called systemic lupus erythematosus

Because Voriconazolo Sandoz is known to have effects on the liver and kidneys, the doctor must
monitor liver and kidney function by performing blood tests. Inform your doctor if
you have stomach pain or if your stools have a different consistency than usual.
Cases of skin cancer have been reported in patients treated with Voriconazolo Sandoz for
prolonged periods.
A sunburn or a severe skin reaction following exposure to light or sun has
been reported more frequently in children. If you or your child develops skin disorders, the doctor may have you/him/her visit a dermatologist who can decide whether it is
important for you or your child to continue regular visits with the dermatologist. Elevated liver enzymes have also been observed more frequently in children.
If any of these side effects persist or become worrying, inform your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Voriconazolo 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, on the carton and on the
bottle after the wording EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater 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 Sandoz contains

• The active ingredient is voriconazole. Each tablet contains 50 mg of voriconazole (for Voriconazolo Sandoz 50 mg film-coated tablets) or 200 mg of voriconazole (for Voriconazolo Sandoz 200 mg film-coated tablets)
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, sodium croscarmellose, povidone, magnesium stearate (which constitute the core of the tablet) and hypromellose (E464), lactose monohydrate, titanium dioxide (E171) and triacetin (which constitute the coating of the tablet).

Description of the appearance of Voriconazolo Sandoz and package contents
Voriconazolo Sandoz 50 mg film-coated tablets
Tablet from white to off-white, round, biconvex, film-coated, bearing the inscription
“50” on one side and smooth on the other side.
Voriconazolo Sandoz 200 mg film-coated tablets
Tablet from white to off-white, biconvex, capsule-shaped, film-coated, bearing
the inscription “200” on one side and smooth on the other side.
Blister in PVC/PVDC/Al

Package size (blister):2, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 500 or 1000
film-coated tablets
HDPE bottle with child-resistant screw cap

Package size (bottle):30, 50, 56 or 100 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder
Sandoz SpA
Largo U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia
LEK S.A.
ul. Domaniewska 50 C, 02-672 Warszawa
Poland
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

This medicinal product is authorized in the member states of the EEA with the following
names:
Netherlands Voriconazole Hexal 50 mg, film-coated tablets
Voriconazole Hexal 200 mg, film-coated tablets
Austria Voriconazole Sandoz 50 mg – Filmtabletten
Voriconazole Sandoz 200 mg – Filmtabletten
Belgium Voriconazole Sandoz 50 mg film-coated tablets
Voriconazole Sandoz 200 mg film-coated tablets
Czech Republic Vorikonazole Sandoz 200 mg
Denmark Voriconazole Sandoz
Estonia Voriconazole Sandoz
Finland Voriconazole Sandoz 50 mg tablets, film-coated
Voriconazole Sandoz 200 mg tablets, film-coated
France Voriconazole Sandoz 50 mg, film-coated tablet
Voriconazole Sandoz 200 mg, film-coated tablet
Ireland Voriconazole Rowex 50 mg Film- Coated Tablets
Voriconazole Rowex 200 mg Film- Coated Tablets
Italy Voriconazolo Sandoz
Luxembourg Voriconazol Sandoz 50 mg film-coated tablets
Voriconazol Sandoz 200 mg film-coated tablets
Norway Voriconazole Sandoz
Poland Voriconazole Sandoz
Portugal Voriconazole Sandoz
Romania Voriconazol Sandoz 50 mg film-coated tablets
Voriconazol Sandoz 200 mg film-coated tablets
Slovak Republic Vorikonazol Sandoz 50 mg film-coated tablets
Vorikonazol Sandoz 200 mg film-coated tablets
Spain Voriconazole Sandoz 50 mg film-coated tablets
Voriconazole Sandoz 200 mg film-coated tablets
Sweden Voriconazole Sandoz