Voriconazole Teva

Package leaflet: Information for the user

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

Equivalent medicinal product
Read all of this leaflet carefully before you start taking this medicine because 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 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 Teva is and what it is used for
2. What you need to know before taking Voriconazole Teva
3. How to take Voriconazole Teva
4. Possible side effects
5. How to store Voriconazole Teva
6. Contents of the pack and other information

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

Voriconazole Teva film-coated tablets contain the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing or inhibiting the growth of fungi that cause infections.

It is used to treat patients (adults and children over 2 years of age) with:

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

Voriconazole Teva film-coated tablets are indicated for patients with worsening fungal infections and potentially life-threatening conditions.
Prevention of fungal infections in high-risk bone marrow transplant patients.
This product should only be used under the supervision of a doctor.

2. What you must know before taking Voriconazole Teva

Do not take Voriconazole Teva

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

It is very important that you inform your doctor, pharmacist, or nurse if you are taking or have taken any other medicines, including those without a prescription and herbal products.
The following medicines must not be taken during treatment with Voriconazole Teva film-coated tablets.

• Terfenadine (used for allergies)
• Astemizole (used for allergies)
• Cisapride (used for stomach problems)
• Pimozide (used to treat mental illnesses)
• Quinidine (used for irregular heartbeat)
• Ivabradine (used for symptoms of chronic heart failure)
• Rifampicin (used to treat tuberculosis)
• Efavirenz (used to treat HIV) at doses of 400 mg or more, once daily
• Carbamazepine (used to treat epileptic seizures)
• Phenobarbital (used for insomnia and severe epileptic seizures)
• Ergot alkaloids (e.g., ergotamine and dihydroergotamine, used for migraine)
• Sirolimus (used in organ transplant patients)
• Ritonavir (used to treat HIV) at doses of 400 mg or more, twice daily
• St. John’s Wort (a 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 (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)
• Venetoclax (used for the treatment of patients with chronic lymphocytic leukemia-CLL)

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Voriconazole Teva film-coated tablets if:

• you have had an allergic reaction to other azole medicines;
• you have or have had liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Teva film-coated tablets. Your doctor will also need to monitor your liver function during treatment with Voriconazole Teva by performing blood tests;
• you have cardiomyopathy, irregular heartbeat, slow heart rate, or an electrocardiogram (ECG) abnormality known as “long QTc syndrome”.

During treatment, you must avoid any exposure to sunlight and solar radiation. It is important to cover sun-exposed skin areas and use high sun protection factor (SPF) sunscreen, as increased sensitivity of the skin to UV radiation from sunlight may develop. This sensitivity may be further increased by other medicines that make the skin more sensitive to sunlight, such as methotrexate. These precautions also apply to children.
During treatment with Voriconazole Teva film-coated tablets, inform your doctor immediately if you develop:

• sunburn
• 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 to schedule regular follow-up visits. Long-term use of voriconazole may be associated with a small risk of skin cancer.

Inform your doctor 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 may lead to symptoms such as: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, and abdominal pain.
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, and excessive sweating.
Your doctor will need to monitor liver and kidney function by performing blood tests.
Children and adolescents
Voriconazole Teva film-coated tablets must not be administered to children under 2 years of age.
Other medicines and Voriconazole Teva
Inform your doctor or pharmacist if you are taking, using, have recently taken or used, or might take or use any other medicines, including those obtained without a prescription.
Some medicines, if taken together with Voriconazole Teva film-coated tablets, may alter the effect of Voriconazole Teva, or Voriconazole Teva may alter the effect of these medicines.
Inform your doctor if you are taking the following medicine because taking this medicine together with Voriconazole Teva is permitted but should be avoided if possible:

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

Inform your doctor if you are taking any of the following medicines because taking these medicines together with Voriconazole Teva film-coated tablets should be avoided if possible, and dose adjustment of voriconazole may be required:

• Rifabutin (used to treat tuberculosis). If you are already taking rifabutin, blood counts and rifabutin side effects should be monitored.
• Phenytoin (used to treat epilepsy). If you are already taking phenytoin, blood phenytoin levels should be monitored during treatment with Voriconazole Teva, and dose adjustment may be necessary.

Inform your doctor if you are taking any of the following medicines, as dose adjustment or monitoring may be needed to ensure that the medicines and/or Voriconazole Teva continue to have the desired effect:

• Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol; used to slow blood clotting)
• Cyclosporine (used in organ transplant patients)
• Tacrolimus (used in organ 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 Teva while using oral contraceptives, you may experience side effects such as nausea and menstrual disturbances)
• 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)
• Saquinavir 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 with Voriconazole Teva)
• 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 for moderate to severe pain)
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used to treat pain and inflammation)
• Fluconazole (used for fungal infections)
• Flucloxacillin (an antibiotic indicated for bacterial infections)
• Everolimus (used for the treatment of advanced renal cell carcinoma and in organ transplant patients)
• Letermovir (used to prevent cytomegalovirus (CMV) disease after bone marrow transplantation)
• Ivacaftor: used to treat cystic fibrosis

Pregnancy and breastfeeding
Voriconazole Teva film-coated tablets must not be taken during pregnancy unless specifically indicated by your doctor. Women of childbearing potential must use an effective method of contraception.
Contact your doctor immediately if you become pregnant while taking Voriconazole Teva.
Breastfeeding must be discontinued before starting Voriconazole film-coated tablets.
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and use of machines
Voriconazole Teva film-coated tablets may cause blurred vision or uncomfortable sensitivity to light. If you experience these symptoms, do not drive vehicles or operate tools or machinery. In such cases, contact your doctor.
Voriconazole Teva film-coated tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Voriconazole Teva film-coated tablets contain sodium
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 Teva

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

* This also applies to patients aged 15 years and older.
Depending on your response to treatment, your doctor may increase the daily dose to 300 mg (≥ 40 kg)
or 150 mg (< 40 kg) twice daily.
Your doctor may decide to reduce the dose if you have mild to moderate cirrhosis.
Use in children and adolescents
The recommended dose for children and adolescents is as follows

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

• The tablets should only be administered if the child is able to swallow them.

Take the tablet at least one hour before or one hour after a meal. The tablet must be swallowed whole with water.
If you or your child are taking Voriconazole Teva to prevent fungal infections, your doctor may decide to discontinue treatment with Voriconazole Teva if treatment-related adverse effects occur.

If you take more Voriconazole Teva than you should
If you take more tablets than prescribed (or if someone else takes your tablets), you must contact your doctor or go immediately to the nearest hospital emergency department. Take the pack of Voriconazole Teva film-coated tablets with you. If you take more Voriconazole Teva than recommended, you may develop an abnormal intolerance to light.

If you forget to take Voriconazole Teva
It is important to take Voriconazole Teva film-coated tablets regularly at the same time every 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 a forgotten dose.

If you stop taking Voriconazole Teva
It has been shown that taking all doses at the correct time can significantly increase the effectiveness of the medicine. Therefore, unless your doctor tells you otherwise, it is important that you continue to take Voriconazole Teva correctly, as described above.
Continue taking Voriconazole Teva until your doctor tells you to stop. Do not stop treatment prematurely, as the infection may not be cured. For patients with a weakened immune system or those with difficult-to-treat infections, long-term treatment may be necessary to prevent the infection from recurring.
If treatment with Voriconazole Teva is stopped by your doctor, no withdrawal effects should occur.

If you have further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Voriconazole Teva can cause side effects, although not everyone gets them.
If side effects occur, they are mostly mild and temporary.
However, some may be serious and require immediate medical attention.

Serious side effects – Stop taking Voriconazole Teva and contact your doctor immediately

• Rash
• Jaundice; abnormal blood tests indicating liver function abnormalities
• Pancreatitis

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

• Visual disturbances (including blurred vision, altered colour vision, abnormal tolerance to light perception, colour blindness, eye disorders, seeing halos, 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
• Rash
• Nausea, vomiting, diarrhoea
• Headache
• Swelling of the extremities
• Stomach pain
• Difficulty breathing
• Elevated liver enzymes

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

• Inflammation of the sinuses, gums, chills, weakness
• Reduction, sometimes severe, in the number of certain types of red blood cells (sometimes immune-mediated) and/or white blood cells (sometimes with 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, sleep disorders, 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 injury
• Rash that may lead to severe blistering and peeling of the skin, characterized by a flat, red area of skin with small merging bumps, skin redness
• Itching
• Hair loss
• Back pain
• Kidney failure, presence of blood in urine, changes in kidney function tests
• Sunburn or severe skin reaction following exposure to light or sunlight
• Skin cancer

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

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation that may cause antibiotic-associated diarrhoea, inflammation of the lymphatic vessels
• Inflammation of the thin tissue lining the inner wall of the abdomen and covering abdominal organs
• Swollen lymph nodes (sometimes painful), bone marrow failure (increased eosinophils)
• Reduced adrenal gland function, reduced thyroid gland activity
• Changes in brain function, Parkinson-like symptoms, nerve damage leading to numbness, pain, tingling or burning in hands or feet
• Problems with coordination or balance
• Brain swelling
• Double vision, severe eye disorders including: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage with visual impairment, swelling of the optic disc
• Decreased sensitivity to touch
• Altered taste
• 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 irregular heartbeat, sometimes with irregular electrical impulses
• Abnormal electrocardiogram (ECG)
• Increased cholesterol, increased blood urea
• Allergic skin reactions (sometimes severe), including potentially life-threatening skin condition causing blisters and painful sores of the skin and mucous membranes, especially in the mouth, skin inflammation, hives, redness and irritation of the skin, skin discoloration (red or purplish) possibly due to low platelet count, eczema
• Allergic reactions 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 optic nerve fibres, corneal clouding, 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 fatal)
• Potentially life-threatening allergic reaction
• Coagulation disorders
• 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, scaly 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 the skin, from underlying skin layers; widespread rash, high body temperature, and swollen lymph nodes
• Small patches of dry, scaly skin, sometimes thickened with tips or 'horns'

Side effects with unknown frequency: frequency cannot be estimated from available data

• Freckles and pigmented spots

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

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

Since it is known that Voriconazole Teva affects the liver and kidneys, your doctor will need to monitor liver and kidney function through blood tests. Inform your doctor if you have stomach pain or if your stools have an unusual consistency.
Cases of skin carcinoma have been reported in patients treated with voriconazole for prolonged periods (see section 2).
Sunburn or severe skin reaction following exposure to light or sunlight has been reported more frequently in children. If you or your child develops skin problems, your doctor may refer you to a dermatologist, who may decide whether it is important for you or your child to continue regular visits with a dermatologist. Elevated liver enzymes have also been observed more frequently in children.
Inform your doctor if any of these side effects persist or are bothersome.

Reporting of side effects
If you experience any side effects, 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 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 Teva

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 or the carton 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 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 Voriconazolo Teva contains

• The active substance is voriconazole. Each tablet contains 50 mg of voriconazole (Voriconazolo Teva 50 mg film-coated tablets) or 200 mg of voriconazole (Voriconazolo Teva 200 mg film-coated tablets).
• The other components are: lactose monohydrate (see section 2 “Voriconazolo Teva film-coated tablets contain lactose”), croscarmellose sodium, povidone K25, pregelatinized maize starch, magnesium stearate, hypromellose 5 mPa ∙ s, glycerol 85 %, titanium dioxide (E 171).

Description of the appearance of Voriconazolo Teva and package contents
Voriconazolo Teva 50 mg is a white, round, biconvex film-coated tablet (diameter: approximately 7.2 millimetres) with “V” engraved on one side and “50” on the other side.
Voriconazolo Teva 200 mg is a white, oval-shaped film-coated tablet (dimensions: approximately 17.2 millimetres x 7.2 millimetres) with “V” engraved on one side and “200” on the other side.
Voriconazolo Teva 50 mg film-coated tablets are available in packs of 2, 10, 14, 20, 28, 30, 50, 56, 98 and 100 in PVC/Alu blisters.
Voriconazolo Teva 200 mg film-coated tablets are available in packs of 2, 10, 14, 20, 28, 30, 50, 56, 98 and 100 in PVC/Alu blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturers
Merckle GmbH - Ludwig-Merckle-Str. 3, 89143 Blaubeuren – Germany
TEVA Pharmaceutical Works Private Limited Company - Pallagi út 13, 4042 Debrecen – Hungary
TEVA PHARMA S.L.U. - C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza – Spain
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd) - Prilaz Baruna Filipovica 25, Zagreb 10000 – Croatia
TEVA Operations Poland Sp. z o.o. - Mogilska 80 Str., 31-546 Krakow – Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Voriconazol ratiopharm 200 mg Filmtabletten
Belgium: Voriconazole Teva 50 mg filmomhulde tabletten
Voriconazole Teva 200 mg filmomhulde tabletten
Czech Republic: Voriconazole Teva 200 mg
Estonia: Voriconazole Teva
France: Voriconazole Teva 50 mg, comprimé pelliculé
Voriconazole Teva 200 mg, comprimé pelliculé
Germany: Voriconazol-ratiopharm 50 mg Filmtabletten
Voriconazol-ratiopharm 200 mg Filmtabletten
Greece: Voriconazole Teva 200 mg Επικαλυμμένα με λεπτό υμένιο δισκία
Hungary: Voriconazole Teva 200 mg filmtabletta
Ireland: Voriconazole Teva 200mg Film-coated Tablets
Italy: Voriconazolo Teva
Latvia: Voriconazole Teva 200 mg apvalkotās tabletes
Lithuania: Voriconazole Teva 200 mg plėvele dengtos tabletės
Luxembourg: Voriconazole Teva 50 mg comprimés pelliculés
Voriconazole Teva 200 mg comprimés pelliculés
Netherlands: Voriconazol 50 mg Teva, filmomhulde tabletten
Voriconazol 200 mg Teva, filmomhulde tabletten
Portugal: Voriconazol Teva
Spain: Voriconazol Teva 50 mg comprimidos recubiertos con película EFG
Voriconazol Teva 200 mg comprimidos recubiertos con película EFG
Sweden: Voriconazole Teva