VORICONAZOL TEVA 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Voriconazole Teva 50 mg film-coated tablets EFG

Read the package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Voriconazole Teva and what is it used for.
2. What you need to know before you take Voriconazole Teva.
3. How to take Voriconazole Teva.
4. Possible side effects.
5. Storing Voriconazole Teva.

1. Contents of the pack and further information.

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

Voriconazole 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 for the treatment of patients (adults and children aged 2 years or older) with:

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

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

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

This medicine should only be used under medical supervision.

2. What you need to know before you take Voriconazole Teva

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

During treatment with Voriconazole Teva, do not takethe following medicines:

• Terfenadine (used for allergy).
• Astemizole (used for allergy).
• Cisapride (used for digestive problems).
• Pimozide (used for mental disorders).
• Quinidine (used for heart rhythm disorders).
  • Ivabradine (used for symptoms of chronic heart failure).

• Rifampicin (used for tuberculosis treatment).
• Efavirenz (used for HIV treatment) at doses of 400 mg and above 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 and above twice daily.
• St. John's Wort (hypericum, herbal remedy).
  • Naloxegol (used to treat constipation caused by opioid painkillers [e.g., morphine, oxycodone, fentanyl, tramadol, codeine]).
  • Tolvaptan (used to treat low sodium levels in the blood or to slow down kidney function decline in patients with polycystic kidney disease).
  • Lurasidone (used to treat depression).
  • Venetoclax (used to treat chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Voriconazole Teva if:

• you have had an allergic reaction to other azoles.
• you have or have had liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Teva. Your doctor should also monitor your liver function with blood tests while you are taking Voriconazole Teva.

you know that you have cardiomyopathy, irregular heartbeats, slow heart rate, or an abnormality in the electrocardiogram (ECG) called "QTc prolongation".

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

While taking Voriconazole Teva, inform your doctor if you experience:

• 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 necessary to examine you regularly. There is a small chance that you may develop skin cancer with long-term use of voriconazole.

If you develop signs of "adrenal insufficiency" where the adrenal glands do not produce enough of certain steroid hormones, such as cortisol, which can cause symptoms like: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, inform your doctor.

If you present signs of "Cushing's syndrome" where the body produces too much cortisol hormone, which can cause symptoms like: weight gain, hump of fat 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 your liver and kidney function with blood tests.

Children and adolescents

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

Taking Voriconazole Teva with other medicines

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

Some medicines, when used at the same time as Voriconazole Teva, can affect the action of Voriconazole Teva or Voriconazole Teva may affect the action of other medicines.

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

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

Inform your doctor if you are using any of the following medicines, as treatment at the same time as Voriconazole Teva should be avoided as much as possible, and a dose adjustment of voriconazole may be necessary:

• Rifabutin (used for tuberculosis treatment). If you are already being treated with rifabutin, your doctor will monitor your blood count and the side effects of rifabutin.
• Phenytoin (used to treat epilepsy). If you are already being treated with phenytoin, your doctor will monitor the concentration of phenytoin in your blood during treatment with Voriconazole Teva and may need to adjust your dose.

Tell your doctor if you are taking any of the following medicines, as you may need a dose adjustment or monitoring to check that these medicines and/or Voriconazole Teva are still working as they should:

• Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol; used to reduce blood clotting).
• Ciclosporin (used in transplant patients).
• Tacrolimus (used in transplant patients).
• Sulfonylureas (e.g., tolbutamide, glipizide, and gliburide) (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 stomach ulcer treatment).
• Oral contraceptives (if you take Voriconazole Teva while using oral contraceptives, you may experience side 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, and nevirapine) (used to treat HIV infection) (some doses of efavirenz should NOT be taken at the same time as Voriconazole Teva).
• Methadone (used to treat heroin addiction).
• Alfentanil, fentanyl, and other short-acting opiates such as sufentanil (painkillers used for operations).
• Oxycodone and other long-acting opiates such as hydrocodone (used to treat moderate to severe pain).
• Non-steroidal anti-inflammatory medicines (e.g., ibuprofen, diclofenac) (used to treat pain and inflammation).
• Fluconazole (used to treat fungal infections).
• Flucloxacillin (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 transplantation).
  • Ivacaftor: used to treat cystic fibrosis.

Pregnancy and breastfeeding

Do not take Voriconazole Teva during pregnancy unless your doctor has told you to. Women of childbearing age taking Voriconazole Teva should use effective contraception. Contact your doctor immediately if you become pregnant while taking Voriconazole Teva.

Breastfeeding should be stopped before starting to take Voriconazole Teva.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Voriconazole Teva may cause blurred vision or sensitivity to light. If this happens, do not drive or use tools or machines and tell your doctor.

Voriconazole Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Voriconazole Teva contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per film-coated tablet; this is essentially "sodium-free".

3. How to take Voriconazole Teva

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide 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 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.< p>

Your doctor may decide to reduce the dose if you have mild to moderate liver 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.

Tablets should only be given if the child is able to swallow whole tablets.

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

If you or your child are taking Voriconazole Teva to prevent fungal infections, your doctor may stop the administration of Voriconazole Teva if you or your child experience treatment-related side effects.

If you take more Voriconazole Teva than you should

If you take more tablets than you have been told to (or if someone else takes your tablets),

immediately seek medical help or go to the nearest hospital emergency department. Take the pack of Voriconazole Teva tablets with you. You may notice an abnormal sensitivity to light as a consequence of taking more Voriconazole Teva than you should.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service, telephone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Voriconazole Teva

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

If you stop taking Voriconazole Teva

It has been shown that correctly following the prescribed dosage, administering each dose at the right time, can significantly increase the effectiveness of this medicine. Therefore, unless your doctor tells you to stop treatment, it is important that you continue taking Voriconazole Teva as instructed above.

Continue taking Voriconazole Teva until your doctor tells you to stop. Do not stop treatment early, as the infection may not be fully treated. Patients with a weakened immune system or complicated infections may need longer treatment to prevent the infection from coming back.

When your doctor stops treatment with Voriconazole Teva, you should not experience any effects from stopping treatment.

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

If any appear, it is most likely to be mild and transient. However, some can be serious and require medical attention.

Severe Adverse Effects - Stop taking Voriconazol Teva and consult your doctor immediately

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

Other Adverse Effects

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

• Visual disturbance (change in vision, such as blurred vision, visual disturbances of colors, abnormal intolerance to visual perception of light, color blindness, eye disorder, visual halo, night blindness, oscillating vision, spark vision, visual aura, decreased visual acuity, visual clarity, partial loss of usual visual field, spots in the visual field).
• Fever.
• Skin rash.
• Nausea, vomiting, and diarrhea.
• Headache.
• Swelling of the limbs.
• Stomach pain.
  • Difficulty breathing.
  • Elevated liver enzymes.

Frequent: may affect up to 1 in 10 people:

• Irritation and inflammation of the gastrointestinal tract, sinusitis, inflammation of the gums, chills, weakness.
  • Low count, including severe, of some types of red blood cells (sometimes of an immune nature) and/or white blood cells (sometimes accompanied by fever) in the blood, low platelet count that helps blood clot.
  • Low blood sugar levels, low potassium levels in the blood, low sodium levels in the blood.

• Anxiety, depression, confusion, agitation, insomnia, hallucinations.
  • Seizures, tremors or uncontrolled muscle movements, tingling or abnormal sensations in the skin, increased muscle tone, somnolence, dizziness.
  • Ocular hemorrhage.

• Cardiac rhythm problems, including very fast or very slow heartbeat, fainting.

• Hypotension, inflammation of the veins (which may be associated with the formation of blood clots).
• Acute difficulty breathing, chest pain, swelling of the face (mouth, lips, and around the eyes), fluid retention in the lungs.
  • Constipation, indigestion, inflammation of the lips.

• Jaundice (yellowish skin color), liver inflammation, and liver damage.
  • Skin eruptions, which can be severe, with blisters and peeling, characterized by a flat and reddened area, covered with small bumps that converge, skin redness.

• Itching.
• Alopecia.
• Back pain.
• Kidney failure, presence of blood in urine, alterations 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, antibiotic-associated gastrointestinal tract inflammation that causes diarrhea, lymphatic vessel inflammation.

• Inflammation of the tissue that lines the inner wall of the abdomen and covers the abdominal organs.

• Enlargement (sometimes painful) of the lymph nodes, bone marrow failure, increased eosinophils.
  • Decreased adrenal gland function, underactive thyroid gland.

• Abnormal brain function, symptoms similar to Parkinson's disease, nerve damage causing numbness, pain, tingling, or burning in the 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 that causes vision changes, inflammation of the optic papilla.
• Decreased sensitivity to touch.
  • Alteration of taste.
  • Difficulty hearing, ringing in the ears, vertigo.

• Inflammation of certain internal organs, pancreas, and duodenum, swelling and inflammation of the tongue.

• Enlargement of the liver, liver failure, gallbladder disease, gallstones.
• Joint inflammation, inflammation of the veins under the skin (which may be associated with the formation of a blood clot).
• Kidney inflammation, protein in the urine, kidney damage.
  • Very high or extra heart rate, sometimes with erratic electrical impulses.

• Abnormal electrocardiogram (ECG).
  • High cholesterol in the blood, high urea in the blood.
  • Severe skin allergic reactions (sometimes life-threatening), such as a skin disease that causes painful blisters and ulcers on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, skin redness and irritation, reddish or purplish skin discoloration that can be caused by 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.
  • Worsening of brain activity as a serious complication of liver disease.

• Loss of most of the optic nerve fibers, corneal opacity, involuntary eye movement.
  • Blister formation due to photosensitivity.
  • Disorder in which the immune system attacks part of the peripheral nervous system.

• Cardiac rhythm or conduction problems (sometimes potentially fatal).
• Potentially fatal allergic reaction
• Blood coagulation disorders
• Severe skin allergic reactions (sometimes life-threatening), such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, pruritic and painful skin plaques with silvery scales, potentially life-threatening, causing large portions of the epidermis, the outermost layer of the skin, to peel off from the underlying skin layers; generalized eruption, high body temperature, and enlarged lymph nodes
• Small, scaly, and dry skin patches, sometimes thick and with tips or "horns"

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

• Pigmented spots and patches

Other important adverse effects whose frequency is unknown, but which should be reported to the doctor immediately:

• Red, scaly skin patches or ring-shaped lesions that can be a symptom of an autoimmune disease called cutaneous lupus erythematosus

Since it has been observed that Voriconazol Teva affects 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 a different consistency.

Cases of skin cancer have been reported in patients treated with voriconazole for long periods of time (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 have skin disorders, your doctor may refer you to a dermatologist who, after consultation, may decide that it is important for you or your child to undergo regular follow-up. 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 EffectsIf you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Voriconazol Teva

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

Do not use this medicine after the expiration date that appears on the blister or packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Voriconazol Teva

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

Appearance of the Product and Package Contents

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

Voriconazol Teva 50 mg film-coated tablets are available in packages of 2, 10, 14, 20, 28, 30, 50, 56, 98, and 100 tablets in PVC/Alu blisters in multidose and individual packaging.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid, España

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 medicine 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 Επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

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 plevele dengtos tabletes

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 last revision of this prospectus:July 2024

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

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