Voriconazole Teva 200 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voriconazole Teva 200 mg powder for solution for infusion EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Voriconazole Teva 200 mg powder for solution for infusion is and what it is used for
2. What you need to know before you use Voriconazole Teva 200 mg powder for solution for infusion
3. How to use Voriconazole Teva 200 mg powder for solution for infusion
4. Possible side effects
5. How to store Voriconazole Teva 200 mg powder for solution for infusion
6. Contents of the pack and other information

1. What Voriconazol Teva 200 mg powder for solution for infusion is and what it is used for

Voriconazol Teva contains the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing or preventing the growth of fungi that cause infections.

It is used to treat patients (adults and children aged 2 years and older) 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 (patients who do not have an abnormally low white blood cell count),
• serious invasive infections caused by Candida sp. when the fungus is resistant to fluconazole (another antifungal medicine),
• serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).

Voriconazole is used in patients with serious fungal infections that may be life-threatening.

Prevention of fungal infections in bone marrow transplant recipients at high risk.

This medicine should only be used under medical supervision.

2. What you need to know before using Voriconazol Teva 200 mg powder for solution for infusion

Do not use Voriconazol Teva

• 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 inform your doctor, pharmacist, or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription, or herbal remedies.

During treatment with voriconazole, you must not take the following medicines:

• Terfenadine (used for allergies)
• Astemizole (used for allergies)
• Cisapride (used for digestive problems)
• Pimozide (used for mental disorders)
• Quinidine (used for heart arrhythmias)
• Ivabradine (used for symptoms of chronic heart failure)
• Rifampicin (used for the treatment of tuberculosis)
• Efavirenz (used for HIV treatment) at doses of 400 mg or higher once daily
• Carbamazepine (used to treat seizures)
• Phenobarbital (used for severe insomnia and seizures)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
• Sirolimus (used in transplant patients)
• Ritonavir (used for HIV treatment) at doses of 400 mg or higher twice daily
• St. John’s wort (hypericum, herbal remedy)
• Naloxegol (used to treat constipation specifically caused by analgesics called opioids [e.g., morphine, oxycodone, fentanyl, tramadol, codeine])
• Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow down the decline in kidney function in patients with polycystic kidney disease)
• Lurasidone (used to treat depression)
• Finerenone (used to treat 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 starting voriconazole if:

• you have had an allergic reaction to other azoles.

• you have or have ever had liver disease. If you have liver disease, your doctor may prescribe a lower dose of voriconazole. Your doctor should also monitor your liver function during treatment with voriconazole by performing blood tests.

• you have kidney failure

• you know you have cardiomyopathy, irregular heartbeats, slow heart rate, or an abnormality on the electrocardiogram (ECG) known as "long QT syndrome".

You should avoid exposure to sunlight and solar radiation during treatment. It is important to cover exposed areas and use sunscreen with a high sun protection factor (SPF), as increased sensitivity of the skin to UV rays from the sun may occur. This sensitivity may be further increased by the use of other medicines that make the skin sensitive to sunlight, such as methotrexate. These precautions also apply to children.

Inform your doctor immediately if you develop the following symptoms while being treated with voriconazole:

• Sunburn
• Severe skin rash or blisters
• Bone pain

If you develop skin disorders such as those described above, your doctor may refer you to a dermatologist, who may consider it important for you to have regular check-ups. There is a small possibility that long-term use of voriconazole may lead to skin cancer.

If you develop signs of "adrenal insufficiency," in which the adrenal glands do not produce sufficient amounts of certain steroid hormones, such as cortisol, which may cause symptoms such as: prolonged or chronic 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 too much cortisol hormone, which may cause symptoms such as: weight gain, fatty hump between the shoulders, rounded face, darkening of the skin on the abdomen, thighs, breasts, and arms, thin skin, easy bruising, high blood sugar levels, excessive hair growth, or excessive sweating, inform your doctor.

Your doctor should monitor the function of your liver and kidneys by performing blood tests.

Children and adolescents

Voriconazole must not be given to children under 2 years of age.

Using Voriconazol Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines, when taken at the same time as this medicine, may affect the action of voriconazole, or voriconazole may affect the action of other medicines.

Inform your doctor if you are using the following medicines, as concomitant treatment with voriconazole should be avoided if possible:

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

Inform your doctor if you are using any of the following medicines, as concomitant treatment with this medicine should be avoided if possible, and a dose adjustment of voriconazole may be needed:

• Rifabutin (used for the treatment of tuberculosis). If you are already being treated with rifabutin, your blood count should be monitored and adverse effects of rifabutin should be watched for.
• Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin, the concentration of phenytoin in your blood should be monitored during treatment with this medicine, and your dose may need to be adjusted.

Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be needed to ensure these medicines and/or voriconazole continue to have the desired effect:

• Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol; used to reduce blood clotting).
• 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 reduce cholesterol levels).
• Benzodiazepines (e.g., midazolam, triazolam) (used for severe insomnia and stress).
• Omeprazole (used for the treatment of stomach ulcers).
• Oral contraceptives (if you use voriconazole while taking oral contraceptives, you may experience adverse effects such as nausea and menstrual disorders).
• Vinca alkaloids (e.g., vincristine and vinblastine) (used to treat cancer).
• Tyrosine kinase inhibitors (e.g., axitinib, bosutinib, cabozantinib, ceritinib, cobimetinib, dabrafenib, dasatinib, nilotinib, sunitinib, ibrutinib, ribociclib) (used to treat cancer).
• Tretinoin (used to treat leukemia).
• Saquinavir and other HIV protease inhibitors (used to treat HIV infection).
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used to treat HIV infection) (some doses of efavirenz cannot be taken at the same time as voriconazole).
• Methadone (used to treat heroin addiction).
• Alfentanil, fentanyl, and other short-acting opioids such as sufentanil (analgesics 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).
• Flucloxacillin (an antibiotic used against bacterial infections).
• Everolimus (used to treat advanced kidney cancer and in transplant patients).
• Letermovir (used to prevent cytomegalovirus [CMV] infection after bone marrow transplant).
• Ivacaftor: used to treat cystic fibrosis.

Pregnancy and breastfeeding

You must not use voriconazole during pregnancy unless specifically instructed by your doctor. Women of childbearing potential must use effective contraception. Contact your doctor immediately if you become pregnant while taking voriconazole.

Breastfeeding must be stopped before starting Voriconazol Teva 200 mg powder for solution for infusion.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Voriconazole may cause blurred vision or discomfort due to increased sensitivity to light. If this occurs, do not drive or operate tools or machinery. Inform your doctor if this happens.

Voriconazol Teva 200 mg powder for solution for infusion contains hydroxypropyl betadex

This medicine contains 2500 mg of cyclodextrin per vial, equivalent to 125 mg/ml when reconstituted in 20 ml.

Do not use in children under 2 years of age unless specifically recommended by your doctor.

If you have kidney failure, consult your doctor before taking this medicine.

3. How to use Voriconazole Teva 200 mg powder for concentrate for solution for infusion

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the dose depending on your body weight and the type of infection you have.

Your doctor may adjust your dose according to your condition.

The recommended dose in adults (including elderly patients) is as follows:

Depending on your response to treatment, your doctor may reduce the dose to 3 mg/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 in children and adolescents is as follows:

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

Voriconazole must be reconstituted and diluted to the correct concentration by hospital pharmacy or nursing staff (for further information, see section 5 and the end of this leaflet).

It will be administered by intravenous infusion (into a vein) at a maximum rate of 3 mg/kg per hour for 1 to 3 hours.

If you or your child are taking voriconazole for the prevention of fungal infections, your doctor may stop the administration of voriconazole if you or your child experience adverse effects related to treatment.

If you forget a dose of Voriconazol Teva

Since you will be receiving this medicine under close medical supervision, it is unlikely that you will miss a dose. However, inform your doctor, pharmacist, or nurse if you think a dose has been missed.

If you stop treatment with Voriconazol Teva

Treatment with voriconazole should be continued for as long as your doctor considers appropriate. However, the duration of treatment with voriconazole should not exceed 6 months.

Patients with weakened immune systems or those with complicated infections may require longer treatment courses to prevent the infection from recurring. Once your condition improves, the intravenous infusion may be replaced with tablets.

When your doctor discontinues treatment with voriconazole, you should not experience any effects due to stopping the treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any occur, they are most likely to be mild and temporary. However, some may be serious and require immediate medical attention.

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

• Skin rash
• Jaundice; abnormalities in blood tests monitoring liver function
• Pancreatitis

Other adverse effects

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

• Visual disturbances (changes in vision such as blurred vision, disturbances in color vision, abnormal intolerance to visual perception of light, color blindness, eye disorder, visual halo, night blindness, oscillating vision, seeing sparks, visual aura, decreased visual acuity, visual clarity, partial loss of normal visual field, spots in the visual field)
• Fever
• Skin rash
• Nausea, vomiting, and diarrhea
• Headache
• Swelling of the extremities
• Stomach pain
• Breathing difficulties
• Elevated liver enzymes

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

• Irritation and inflammation of the gastrointestinal tract, sinusitis, gum inflammation, chills, weakness
• Low blood counts, including severe cases, of certain types of red blood cells (sometimes immune-mediated) and/or white blood cells (sometimes accompanied by fever), low platelet count affecting blood clotting
• Low blood sugar levels, low blood potassium levels, low blood sodium levels
• Anxiety, depression, confusion, agitation, insomnia, hallucinations
• Seizures, tremors or uncontrolled muscle movements, tingling or abnormal sensations in the skin, increased muscle tone, drowsiness, dizziness
• Ocular hemorrhage
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting
• Hypotension, inflammation of veins (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 (yellowing of the skin), liver inflammation, and liver damage
• Skin rashes, which may become severe with blisters and peeling, characterized by flat, red areas covered with small merging bumps, skin redness
• Itching
• Alopecia (hair loss)
• Back pain
• Kidney failure, presence of blood in urine, abnormalities 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 causing antibiotic-associated diarrhea, inflammation of lymphatic vessels
• Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs
• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils
• Decreased adrenal gland function, underactive thyroid gland
• Abnormal brain function, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling, or burning in hands or feet
• Problems with balance or coordination
• Brain swelling
• Double vision, serious eye diseases such as eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage causing vision changes, optic disc inflammation
• Decreased sensitivity to touch
• Taste disturbances
• Hearing difficulty, tinnitus (ringing in the ears), vertigo
• Inflammation of certain internal organs, pancreas and duodenum, tongue swelling and inflammation
• Liver enlargement, liver failure, gallbladder disease, gallstones
• Joint inflammation, inflammation of veins under the skin (which may be associated with blood clot formation)
• Kidney inflammation, protein in urine, kidney damage
• Very high heart rate or extrasystoles, sometimes with erratic electrical impulses
• Abnormal electrocardiogram (ECG)
• Elevated blood cholesterol, elevated blood urea
• Allergic skin reactions (sometimes severe), such as skin disease, potentially life-threatening condition causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, skin redness and irritation, red or purple skin discoloration possibly 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):

• Overactive thyroid gland
• Deterioration of brain function as a serious complication of liver disease
• Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movements
• Blister formation due to photosensitivity
• Disorder in which the immune system attacks part of the peripheral nervous system
• Heart rhythm or conduction problems (sometimes potentially fatal)
• Potentially life-threatening allergic reaction
• Blood clotting abnormalities
• Allergic skin reactions (sometimes severe), such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, itchy and painful thickened red skin plaques with silvery scales, potentially life-threatening condition causing large areas of the epidermis (the outermost skin layer) to detach from underlying skin layers, generalized rash, high body temperature, and enlarged lymph nodes
• Small scaly, dry skin patches, sometimes thick with tips or "horns"

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Freckles and pigmented spots

• Other important adverse effects with unknown frequency, but which must be reported to your doctor immediately:
  Red, scaly plaques or ring-shaped skin lesions, which may be a symptom of an autoimmune disease called cutaneous lupus erythematosus

During infusion, infrequently, reactions to voriconazole have occurred (including flushing, fever, sweating, increased heart rate, breathing difficulty, nausea, itching, and skin rash). Your doctor may stop the infusion if this happens.

Since voriconazole has been observed to affect the liver and kidneys, your doctor should monitor liver and kidney function through blood tests. Inform your doctor if you experience stomach pain or if your stools have an unusual consistency.

Cases of skin cancer have been reported in patients treated with voriconazole over long periods.

The frequency of sunburns or severe skin reactions following exposure to light or sunlight was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after evaluation, may determine that regular monitoring is necessary. Elevated liver enzymes were also observed more frequently in children.

If any of these adverse effects persist or are bothersome, inform your doctor.

Reporting of adverse effects: If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voriconazole Teva 200 mg powder for solution for infusion

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label or packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

After reconstitution, this medicine must be used immediately; however, if necessary, it may be stored for up to 24 hours at 2 °C – 8 °C (in a refrigerator). Reconstituted Voriconazole Teva 200 mg powder for solution for infusion must first be diluted with a compatible infusion diluent before administration. (For further information, see the end of this leaflet.)

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a designated collection point such as a SIGRE point. If you have any doubts, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voriconazole Teva 200 mg powder for solution for infusion

• The active substance is voriconazole.
• The other components (excipients) are hydroxypropyl betadex and hydrochloric acid (for pH adjustment).

Each vial contains 200 mg of voriconazole, which corresponds to a 10 mg/ml concentrated solution once reconstituted according to the instructions provided by hospital pharmacy or nursing staff (see information at the end of this leaflet).

Appearance of the product and contents of the pack

Voriconazole Teva 200 mg powder for solution for infusion is presented as a single-use glass vial containing a white to off-white powder for infusion solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TEVA PHARMA, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid, Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren, 89143

Germany

or

PLIVA HRVATSKA D.O.O.

Prilaz Baruna Filipovica 25

10000 Zagreb, Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: March 2026.

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

The following information is intended for healthcare professionals only:

Information on reconstitution and dilution

• Voriconazole must be reconstituted with 19 ml of water for injection or 19 ml of sodium chloride 9 mg/ml (0.9%) for infusion to obtain an extractable volume of 20 ml of a clear concentrate containing 10 mg/ml of voriconazole.
• The use of a standard 20 ml syringe (non-automatic) is recommended to ensure the exact amount (19.0 ml) of water for injection or sodium chloride 9 mg/ml (0.9%) is dispensed.
• The required volume of the reconstituted concentrate is then added to a compatible infusion solution listed below, to obtain a final voriconazole solution containing 0.5 to 5 mg/ml of voriconazole.
• This medicinal product is for single use only, and any unused solution must be discarded. Only clear solutions free of particles should be used.
• Must not be administered as a rapid intravenous injection.
• For information on storage, see section 5 “Storage of Voriconazole Teva 200 mg powder for concentrate for infusion”.

Required volumes of voriconazole 200 mg powder for concentrate for infusion (10 mg/ml)

Voriconazole is a sterile, single-dose lyophilisate without preservatives. Therefore, from a microbiological standpoint, the solution should be used immediately after reconstitution. If not used immediately, the time and storage conditions prior to use are the responsibility of the user, and the solution should be stored between 2 and 8 °C (in a refrigerator) for a maximum of 24 hours.

Compatible infusion solutions:

The reconstituted solution may be diluted with:

• Sodium chloride 9 mg/ml (0.9%) injection solution
• Compound sodium lactate intravenous infusion
• 5% glucose and sodium chloride 0.45% for intravenous infusion
• 5% glucose and Ringer's lactate for intravenous infusion
• 5% glucose for intravenous infusion
• 5% glucose with 20 mEq potassium chloride for intravenous infusion
• 0.45% sodium chloride for intravenous infusion
• 5% glucose and sodium chloride 0.9% for intravenous infusion

The compatibility of voriconazole with diluents other than those specifically listed above (or those listed below under "Incompatibilities") is unknown.

Incompatibilities:

Voriconazole must not be infused through the same line or cannula simultaneously with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).

Blood product infusions and short-term infusions of concentrated electrolyte solutions must not be administered simultaneously with voriconazole.

Total parenteral nutrition may be administered simultaneously with voriconazole, but not through the same line or cannula.

Voriconazole must not be diluted with 4.2% sodium bicarbonate solution.