Voriconazole Teva 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voriconazole Teva 50 mg film-coated tablets EFG

Read the entire 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 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, including any side effects not listed in this leaflet. See section 4.

Leaflet contents:

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 Voriconazol Teva 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).

Voriconazol Teva 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 taking Voriconazole Teva

Do not take 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 currently using, or have recently used, any other medicines, including those obtained without a prescription, or herbal remedies.

During treatment with Voriconazol Teva, 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 to treat tuberculosis).

• Efavirenz (used to treat HIV) 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 to treat HIV) at doses of 400 mg or higher twice daily.

• St. John’s wort (hypericum, herbal remedy).

  • Naloxegol (used to treat constipation specifically caused by opioid analgesics [e.g., morphine, oxycodone, fentanyl, tramadol, codeine]).
  • Tolvaptan (used to treat hyponatremia [low sodium levels in blood] or to slow 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 Voriconazol Teva 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 Voriconazol Teva. Your doctor should also monitor your liver function during treatment with Voriconazol Teva by performing blood tests.

• you know you have cardiomyopathy, irregular heartbeats, slow heart rate, or an abnormality on your electrocardiogram (ECG) called “prolonged QTc syndrome.”

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

While being treated with Voriconazol Teva, inform your doctor if you develop:

• 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 regular monitoring necessary after evaluation. There is a small risk of developing skin cancer with long-term use of voriconazole.

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 experience 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

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

Taking Voriconazol Teva with other medicines

Tell 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 Voriconazol Teva, may affect the action of Voriconazol Teva, or Voriconazol Teva may affect the action of other medicines.

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

• Ritonavir (used to treat HIV) at a dose of 100 mg twice daily.
  • Glasdegib (used to treat cancer); if you need to take 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 Voriconazol Teva should be avoided if possible, and a dose adjustment of voriconazole may be needed:

• Rifabutin (used to treat tuberculosis). If you are already being treated with rifabutin, your blood count and adverse effects of rifabutin should be monitored.
• 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 Voriconazol Teva, and your dose may need to be adjusted.

Tell your doctor if you are taking any of the following medicines, as you may need a dose adjustment or monitoring to ensure these medicines and/or Voriconazol Teva remain effective:

• 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 lower cholesterol levels).

• Benzodiazepines (e.g., midazolam, triazolam; used for severe insomnia and stress).

• Omeprazole (used to treat stomach ulcers).

• Oral contraceptives (if you take Voriconazol Teva while using 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 with Voriconazol Teva).

• 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 for 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

Do not take Voriconazol Teva during pregnancy unless specifically instructed by your doctor. Women of childbearing potential receiving Voriconazol Teva should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with Voriconazol Teva.

Breastfeeding must be stopped before starting Voriconazol Teva.

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

Voriconazol Teva may cause blurred vision or discomfort due to increased sensitivity to light. If this occurs, do not drive or operate tools or machinery, and inform your doctor.

Voriconazol Teva contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Voriconazol Teva contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per film-coated tablet; hence, it is essentially “sodium-free.”

3. How to take Voriconazole Teva

• Take this medicine exactly as prescribed by your doctor or pharmacist. Always follow the instructions in the leaflet, unless otherwise directed by your doctor.
• Swallow the tablets whole with a glass of water.
• Voriconazole Teva can be taken with or without food.
• The recommended dose depends on your body weight and the type of infection being treated. Your doctor will determine the appropriate dose for you.
• Do not stop taking this medicine unless instructed by your doctor, even if you start to feel better.
• If you have any doubts about how to take this medicine, ask your doctor or pharmacist.

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

*This also applies to patients 15 years of age 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 in children and adolescents is as follows:

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

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

Take the tablets at least one hour before or one hour after a meal. Swallow the tablet whole with some water.

If you or your child are taking Voriconazole Teva for the prevention of fungal infections, your doctor may discontinue treatment with Voriconazole Teva if you or your child experience treatment-related adverse effects.

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 immediately seek medical assistance or go to the nearest hospital emergency department.
Take the Voriconazole Teva tablet pack with you. You may experience abnormal sensitivity to light as a result of taking more Voriconazole Teva than recommended.

In case of overdose or accidental ingestion, contact your doctor immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount ingested.

If you forget to take Voriconazole Teva

It is important to take Voriconazole Teva tablets regularly at the same time each day. If you forget to take a dose, take the next one at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Voriconazole Teva

It has been shown that correctly following the prescribed dosing schedule, taking each dose at the appropriate time, can significantly increase the effectiveness of this medicine. Therefore, unless your doctor tells you otherwise, it is important to continue taking Voriconazole Teva exactly as indicated above.

Continue taking Voriconazole Teva until your doctor tells you otherwise. Do not stop treatment prematurely, as the infection may not be cured. Patients with weakened immune systems or with complicated infections may require longer treatment courses to prevent the infection from recurring.

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

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; changes in liver function.
• Pancreatitis.

Other adverse effects

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

• Visual disturbance (changes in vision such as blurred vision, colour vision disturbances, abnormal intolerance to visual perception of light, colour blindness, eye disorder, visual halos, night blindness, oscillating vision, seeing sparks, visual aura, decreased visual acuity, reduced visual clarity, partial loss of normal visual field, spots in the visual field).
• Fever.
• Skin rash.
• Nausea, vomiting and diarrhoea.
• Headache.
• Swelling of the limbs.
• Stomach pain.
  • Difficulty breathing.
  • 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 cell 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 haemorrhage.

• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting.

• Hypotension, inflammation of veins (which may be associated with blood clot formation).

• Acute difficulty breathing, chest pain, facial swelling (mouth, lips and around the eyes), fluid accumulation in the lungs.

  • Constipation, indigestion, lip swelling.

• 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.

• Hair loss.

• Back pain.

• Kidney failure, presence of blood in urine, abnormalities in kidney function tests.

  • Sunburn or severe skin reaction after exposure to light or sun.
  • Skin cancer.

Uncommon: may affect up to 1 in 100 people:

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation causing antibiotic-associated diarrhoea, inflammation of lymphatic vessels.

• Inflammation of the thin tissue lining the inner wall of the abdomen and covering abdominal organs.

• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils.

  • Reduced adrenal gland function, underactive thyroid gland.

• Abnormal brain function, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling or burning sensations in hands or feet.

• Problems with balance or coordination.

• Brain swelling.

• Double vision, serious eye disorders such as eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage causing vision disturbances, optic disc inflammation.

• Reduced sensitivity to touch.

  • Altered sense of taste.
  • 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.
  • Skin allergic reactions (sometimes severe), such as skin disorders, potentially life-threatening conditions 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 discolouration possibly due to low platelet count, eczema.

• 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 fibres, 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 disorders.

• Skin allergic 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 portions of the epidermis, the outermost skin layer, to detach from underlying skin layers; widespread 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 patches or ring-shaped skin lesions which may be symptoms of an autoimmune disease called cutaneous lupus erythematosus.

Since Voriconazole Teva 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 have 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 (see section 2).

The frequency of sunburn or severe skin reactions after exposure to light or sun was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after consultation, may decide that regular follow-up 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, consult your doctor, pharmacist or nurse, 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

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to your local pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Voriconazol Teva

• The active substance is voriconazole. Each tablet contains 50 mg of voriconazole.
• The other components are lactose monohydrate (see section 2 "Voriconazol Teva contains lactose"), sodium croscarmellose, povidone K25, pregelatinized maize starch, magnesium stearate, hypromellose 5 mPa·s, glycerol 85%, and titanium dioxide (E171).

Appearance of the product and contents of the container

Voriconazol Teva 50 mg film-coated tablets are white, round, biconvex tablets (diameter: approx. 7.2 mm) with "V" engraved on one side and "50" on the other.

Voriconazol Teva 50 mg film-coated tablets are available in packs containing 2, 10, 14, 20, 28, 30, 50, 56, 98, and 100 tablets in PVC/Alu blisters in multi-dose and individual packs.

Only certain pack sizes may be commercially available.

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

Pliva Hrvatska d.o.o.
(Pliva Croatia Ltd.)
Prilaz baruna Filipovica, 25
10000 Zagreb
Croatia

Merckle GmbH
Ludwig-Merckle-Straße 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, Polígono Industrial Malpica
50016 Zaragoza
Spain

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
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
Denmark: Voriconazole Teva
Estonia: Voriconazole Teva 200 mg
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 apvalkotas 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

Date of the most recent review of this leaflet: March 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79206/P_79206.html