Voriconazole Sandoz

Patient Information Leaflet

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

Equivalent medicinal product
Please read all of 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 give it to other people, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Voriconazole Sandoz contains the active substance voriconazole. Voriconazole Sandoz is an antifungal medicine. It works by killing the fungi that cause infections or by stopping their growth. It is used to treat patients (adults and children over 2 years of age) who have:

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

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

2. What you should know before taking Voriconazole Sandoz

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

• Terfenadine (used for allergies)
• Astemizole (used for allergies)
• Cisapride (used for stomach disorders)
• Pimozide (used to treat mental illnesses)
• Quinidine (used to treat irregular heartbeat)
• Ivabradine (used for symptoms of chronic heart failure)
• Rifampicin (used to treat tuberculosis)
• Efavirenz (used to treat HIV) at doses equal to or greater than 400 mg once daily
• Carbamazepine (used to treat seizures)
• Phenobarbital (used for severe insomnia and seizures)
• Ergot alkaloids (e.g. ergotamine, dihydroergotamine; used to treat migraine)
• Sirolimus (used in transplant patients)
• Ritonavir (used to treat HIV) at doses equal to or greater than 400 mg twice daily
• St. John’s Wort (herbal supplement)
• Naloxegol (for the treatment of constipation specifically caused by opioid pain medicines [e.g. morphine, oxycodone, fentanyl, tramadol, codeine])
• Tolvaptan (for the treatment of hyponatremia, i.e. low sodium levels in the blood, or to slow the decline in kidney function in patients with polycystic kidney disease)
• Lurasidone (for the treatment of depression)
• Finerenone (for the treatment of chronic kidney disease)
• Eplerenone (for the treatment of heart and/or blood vessel problems)
• Voclosporin (for the treatment of immune system disorders)
• Venetoclax (used to treat patients with chronic lymphocytic leukemia - CLL).

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

• you have had an allergic reaction to other azoles
• you have or have had liver disease. If you have liver problems, your doctor may prescribe a lower dose of Voriconazole Sandoz. Your doctor should also monitor your liver function during treatment with Voriconazole Sandoz through blood tests
• you have cardiomyopathy, irregular heartbeat, slow heartbeat, or an abnormality on the electrocardiogram (ECG) called "long QT syndrome".

You must avoid any exposure to sunlight and UV light during treatment. It is important to cover sun-exposed skin areas and use high-protection sunscreens (SPF), as increased sensitivity of the skin to UV rays may occur. This sensitivity may be further increased by other medicines that make the skin sensitive to sunlight, such as methotrexate.
These precautions also apply to children.
During treatment with Voriconazole Sandoz, inform your doctor immediately if you develop:

• sunburn FI VORICONAZOLE SZ

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• 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 regular check-ups are necessary. With long-term use of voriconazole, there is a small risk of developing skin cancer.
If you develop signs of "adrenal insufficiency", where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol, which may lead to symptoms such as: chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, tell your doctor.
Inform your doctor if you develop signs of "Cushing's syndrome", in which the body produces excessive amounts of the hormone cortisol, which may cause symptoms such as weight gain, fat accumulation between the shoulders, rounded face, darkening of the skin on the abdomen, thinning of legs, breasts and arms, thinning of the skin, easy bruising, increased blood sugar levels, excessive body hair growth, excessive sweating.
Your doctor should monitor the function of your liver and kidneys through blood tests.
Children and adolescents
Voriconazole Sandoz must not be given to children under 2 years of age.
Other medicines and Voriconazole Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those obtained without a prescription.
Some medicines, when taken together with Voriconazole Sandoz, may affect the activity of Voriconazole Sandoz or Voriconazole Sandoz may affect the activity of these medicines.
Inform your doctor if you are taking the following medicine, as concomitant treatment with Voriconazole Sandoz should be avoided if possible:

• Ritonavir (for the treatment of HIV) at doses of 100 mg twice daily.
• Glasdegib (for the treatment of cancer): if you need to use both medicines, your doctor will frequently monitor your heart rhythm.

Inform your doctor if you are taking either of the following medicines, as concomitant treatment with Voriconazole Sandoz should be avoided if possible, and dose adjustment of voriconazole may be necessary:

• Rifabutin (used to treat tuberculosis). If you are already being treated with rifabutin, blood cell counts and rifabutin side effects should be monitored.
• Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin, blood levels of phenytoin should be monitored during treatment with Voriconazole Sandoz, and dose adjustment may be required.

Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be necessary to ensure these medicines and/or Voriconazole Sandoz continue to have the desired effect:
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• Warfarin and other anticoagulants (e.g. phenprocoumon, acenocoumarol; used to slow down the blood clotting process)
• Cyclosporine (used in transplant patients)
• Tacrolimus (used in transplant patients)
• Sulfonylureas (e.g. tolbutamide, glipizide, glyburide) (used for diabetes)
• Statins (e.g. atorvastatin, simvastatin) (used to lower cholesterol)
• Benzodiazepines (e.g. midazolam, triazolam) (used for severe insomnia and stress)
• Omeprazole (used to treat ulcers)
• Oral contraceptives (if you take Voriconazole Sandoz while using oral contraceptives, you may experience side effects such as nausea and menstrual disorders)
• Vinca alkaloids (e.g. vincristine, vinblastine) (used to treat cancer)
• Tyrosine kinase inhibitors (e.g. axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (for cancer treatment)
• Tretinoin (for the treatment of 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 cannot be taken concomitantly with Voriconazole Sandoz)
• Methadone (used to treat heroin addiction)
• Alfentanil and fentanyl and other short-acting opioids such as sufentanil (painkillers used during surgery)
• 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 transplant patients)
• Letermovir (used to prevent cytomegalovirus (CMV) disease after bone marrow transplant)
• Ivacaftor: used to treat cystic fibrosis
• Flucloxacillin (antibiotic used against bacterial infections).

Pregnancy and breastfeeding
Voriconazole Sandoz must not be taken during pregnancy unless specifically prescribed by your doctor. In women of childbearing age, an effective contraceptive method must be used. If you become pregnant while being treated with Voriconazole Sandoz, inform your doctor immediately.
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Voriconazole Sandoz may cause blurred vision or increased sensitivity to light. In such cases, you must not drive or operate tools or machinery. If you experience these effects, consult your doctor.
Voriconazole Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
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This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Voriconazole Sandoz

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will determine the dose appropriate for you based on your body weight and the type of infection.
The recommended dose for adults (including elderly patients) is as follows:

Depending on the response to treatment, your doctor may increase the daily dose to 300 mg twice daily.
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:

Depending on the response to treatment, your doctor may increase or decrease the daily dose.

• Tablets should only be given if the child is able to swallow 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 is taking Voriconazole Sandoz to prevent fungal infections, your doctor may decide to discontinue treatment with Voriconazole Sandoz if you or your child develops treatment-related side effects.
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If you take more Voriconazole Sandoz than you should
If you take more tablets than prescribed (or if someone else takes your tablets), you must seek immediate medical assistance or go straight to the nearest emergency department. Take the pack of Voriconazole Sandoz tablets with you. If you take more Voriconazole Sandoz than you should, you may experience unusual sensitivity to light.
If you forget to take Voriconazole Sandoz
It is important to take Voriconazole Sandoz tablets regularly every day, at the same time each day. 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 the missed dose.
If you stop taking Voriconazole Sandoz
It has been shown that taking doses at the scheduled times 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 Voriconazole Sandoz correctly, as described above.
Continue taking Voriconazole Sandoz until your doctor tells you to stop. Do not stop treatment prematurely, as the infection may not resolve. Patients with a weakened immune system or those with difficult-to-treat infections may require long-term treatment to prevent the infection from returning.
When treatment with Voriconazole Sandoz is stopped on the advice of your doctor, you should not experience any effects.
If you have any questions 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 are likely to be mild and transient. However, some may be serious and require immediate medical attention.
Serious side effects – Stop taking Voriconazole Sandoz and contact a doctor immediately

• Skin rash
• Jaundice; abnormal liver function tests
• Pancreatitis

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

• Visual disturbances (including blurred vision, altered colour vision, abnormal sensitivity to light, colour blindness, eye disorders, seeing halos, night blindness, fluctuating vision, seeing sparks, visual aura, reduced visual acuity, increased brightness perception, partial loss of visual field, spots in front of the eyes)
• Fever
• Skin rashes
• Nausea, vomiting, diarrhoea
• Headache
• Swelling of extremities
• Stomach pain
• Breathing difficulties
• Elevated liver enzymes

Common – may affect up to 1 in 10 people:

• Sinus inflammation, gum inflammation, chills, fatigue
• Reduction, sometimes severe, in the number of certain types of red blood cells (sometimes immune-mediated) 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 blood potassium levels, low blood sodium levels
• Anxiety, depression, confusion, agitation, difficulty sleeping, hallucinations
• Seizures, 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 blood clot formation)
• Acute breathing difficulty, chest pain, facial swelling (mouth, lips and around the eyes), fluid accumulation in the lungs
• Constipation, indigestion, inflammation of the lips
• Jaundice, liver inflammation and liver damage
• Skin rash which may lead to severe blistering and peeling of the skin, characterised by a flat, red area of skin with small merging bumps, skin redness
• Itching
• Hair loss
• Back pain
• Kidney failure, blood in urine, altered kidney function tests
• Sunburn or severe skin reaction following 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, gastrointestinal inflammation which may cause antibiotic-associated diarrhoea, inflammation of the lymphatic vessels
• Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs
• Enlarged lymph nodes (sometimes painful), bone marrow failure, increased eosinophils
• Reduced adrenal gland function, reduced thyroid gland activity FI VORICONAZOLE SZ

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• Changes in brain function, Parkinson-like symptoms, nerve damage leading to numbness, pain, tingling or burning in hands or feet
• Balance or coordination problems
• Brain swelling
• Double vision, serious eye conditions including: eye and eyelid pain and inflammation, involuntary eye movements, abnormal eye movements, optic nerve damage with visual impairment, swelling of the optic disc
• Reduced sensitivity to touch
• Taste disturbances
• Hearing disorders, ringing in the ears, dizziness
• Inflammation of certain internal organs – pancreas and duodenum, swelling and inflammation of the tongue
• Enlarged liver, liver failure, gallbladder disease, gallstones
• Joint inflammation, inflammation of subcutaneous veins (which may be associated with blood clot formation)
• Kidney inflammation, presence of protein in urine, kidney damage
• Increased heart rate or skipped heartbeats, sometimes with irregular electrical impulses
• Abnormal 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 of the skin and mucous membranes, especially in the mouth, skin inflammation, urticaria, skin redness and irritation, red or purplish skin rash which may be caused by low platelet count, eczema
• Infusion site reaction
• Allergic reaction or exaggerated immune response
• Inflammation of tissues surrounding the bones

Rare – may affect up to 1 in 1,000 people:

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

Side effects with unknown frequency:

• Freckles and pigmented spots. FI VORICONAZOLE SZ

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

• Red, scaly patches or ring-shaped skin lesions which could be symptoms of an autoimmune disease called systemic lupus erythematosus.

Since Voriconazole Sandoz is known to affect the liver and kidneys, your doctor should monitor liver and kidney function through blood tests. Inform your doctor if you have stomach pain or if your stools are different from normal.
Cases of skin cancer have been reported in patients treated with Voriconazole Sandoz for prolonged periods.
Sunburn or severe skin reactions following exposure to light or sun have been reported more frequently in children. If you or your child develops skin disorders, your doctor may refer you to a dermatologist who, after evaluation, may decide it is important for you or your child to have regular check-ups. Elevated liver enzymes have also been observed more frequently in children.
If any of these side effects persist or become concerning, inform your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 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 pack, the carton and the vial after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via 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 Voriconazole Sandoz contains

• The active substance is voriconazole. Each film-coated tablet contains 50 mg of voriconazole. Each film-coated tablet contains 200 mg of voriconazole.

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• The other components are: monohydrate lactose, pregelatinized maize starch, croscarmellose sodium, povidone, magnesium stearate (in the tablet core), and hypromellose (E 464), monohydrate lactose, titanium dioxide (E 171), and triacetin (in the tablet coating).

Description of the appearance of Voriconazole Sandoz and package contents
50 mg film-coated tablets:
White to off-white, round, biconvex, film-coated tablets, marked with the inscription "50" on one side and smooth on the other side.
200 mg film-coated tablets:
White to off-white, biconvex, capsule-shaped, film-coated tablets, marked with the inscription "200" on one side and smooth on the other side.
The film-coated tablets are packaged in PVC/PVDC/Alu blisters and placed in a box.
Pack sizes: 2, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 500, 1000 film-coated tablets.
The film-coated tablets are packaged in HDPE bottles with child-resistant screw caps and placed in a box.
Pack sizes: 30, 50, 56, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57, 1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava
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 has been authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Netherlands Voriconazole Hexal 50 mg, filmomhulde tabletten
Voriconazole Hexal 200 mg, filmomhulde tabletten
Austria Voriconazole Sandoz 50 mg – Filmtabletten
Voriconazole Sandoz 200 mg – Filmtabletten
Belgium Voriconazole Sandoz 50 mg filmomhulde tabletten
Voriconazole Sandoz 200 mg filmomhulde tabletten
Czech Republic Voriconazole Sandoz 200 mg
Denmark Voriconazole Sandoz
Finland Voriconazole Sandoz 50 mg tabletti, kalvopäällysteinen
Voriconazole Sandoz 200 mg tabletti, kalvopäällysteinen
France Voriconazole Sandoz 50 mg, comprimé pelliculé
Voriconazole Sandoz 200 mg, comprimé pelliculé
Italy Voriconazole Sandoz
Norway Voriconazole Sandoz
Poland Voriconazole Sandoz
Slovak Republic Vorikonazol Sandoz 50 mg filmom obalené tablety
Vorikonazol Sandoz 200 mg filmom obalené tablety
Sweden Voriconazole Sandoz

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