Leaflet: information for the user

Voriconazole Teva 50 mg film-coated tablets EFG

Read 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information.

Voriconazol Teva contains the active ingredient voriconazol. Voriconazol is an antifungal medication. It acts by eliminating 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 produced byAspergillussp),

-candidemia (another type of fungal infection produced byCandidasp) in non-neutropenic patients (patients with a normal white blood cell count)

-severe invasive infections produced byCandidasp, when the fungus is resistant to fluconazol (another antifungal medication),

-severe fungal infections produced byScedosporiumsp or byFusariumsp (two different species of fungi).

Voriconazol Teva is used in patients with severe fungal infections that can be life-threatening.

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

This medication must be used only under medical supervision.

Do not take Voriconazol Teva

-if you are allergic to voriconazole or any of the other ingredients of this medication (listed in section 6).

It is very important that you inform your doctor, pharmacist, or nurse if you are using or have used recently other medications, including those purchased without a prescription, or herbal remedies.

During treatment with Voriconazol Tevado not takethe following medications:

-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 tuberculosis treatment).

-Efavirenz (used for HIV treatment) at doses of 400 mg and above once a day.

-Carbamazepine (used to treat seizures).

-Fenobarbital (used for severe insomnia and seizures).

-Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraines).

-Sirolimus (used in patients who have received a transplant).

-Ritonavir (used for HIV treatment) at doses of 400 mg and above twice a day.

-St. John's Wort (Hypericum, herbal remedy).

• Naloxegol (used to treat constipation caused specifically by opioids [e.g., morphine, oxycodone, fentanyl, tramadol, codeine]).
• Tolvaptan (used to treat hyponatremia [low sodium levels in the blood] or to slow the deterioration of renal function in patients with polycystic kidney disease).
• Lurasidone (used to treat depression).
• Venetoclax (used for the treatment of patients with chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Voriconazol 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 Voriconazol Teva. Your doctor should also monitor your liver function while you are taking Voriconazol Teva by doing blood tests.

-you know that you have heart disease, irregular heartbeats, slow heart rate, or an abnormality in your electrocardiogram (ECG) called "prolonged QTc syndrome".

You should avoid any exposure to the sun and sunlight during treatment. It is important to cover exposed areas and use a high-factor sunscreen, as you may be more sensitive to UV rays from the sun. This sensitivity may be increased even more by the use of other medications that make your skin sensitive to sunlight, such as methotrexate. These precautions also apply to children.

While you are taking Voriconazol Teva

-inform your doctor if you experience:

• sunburn
• severe skin rash or blisters
• bone pain

If you develop skin problems such as those described above, your doctor may refer you to a dermatologist, who after consultation may consider it necessary to have you examined 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" in which the adrenal glands do not produce sufficient amounts of certain steroid hormones, such as cortisol, which may cause symptoms such as: chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain, inform your doctor.

If you present signs of "Cushing's syndrome" in which the body produces too much cortisol hormone, which may cause symptoms such as: weight gain, hump of fat between the shoulders, rounded face, darkening of the skin of the abdomen, thighs, breasts, and arms, thin skin, easy bruising, high blood sugar, excessive hair growth or excessive sweating, inform your doctor.

Your doctor should monitor your liver and kidney function by doing blood tests.

Children and adolescents

Voriconazol Teva should not be administered to children under 2 years old.

Taking Voriconazol Teva with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication, including those purchased without a prescription.

Some medications, when used at the same time as Voriconazol Teva, may affect the action of Voriconazol Teva or Voriconazol Teva may affect the action of other medications.

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

-Ritonavir (used for HIV treatment) at doses of 100 mg twice a day.

• Glasdegib (used for cancer treatment); if you need to use both medications, your doctor will monitor your heart rate frequently.

Inform your doctor if you are using any of the following medications, as simultaneous treatment with Voriconazol Teva should be avoided as much as possible, and you may need to adjust the dose of voriconazole:

-Rifabutin (used for tuberculosis treatment). If you are already being treated with rifabutin, your doctor will need to monitor your blood count and the side effects of rifabutin.

-Fenitoin (used to treat epilepsy). If you are already being treated with phenytoin, your doctor will need to monitor the concentration of phenytoin in your blood during your treatment with Voriconazol Teva and may need to adjust your dose.

Inform your doctor if you are taking any of the following medications, as you may need to adjust your dose or have your medications monitored to ensure they are still producing the desired effect:

-Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol; used to reduce blood clotting).

-Ciclosporin (used in patients who have received a transplant).

-Tacrolimus (used in patients who have received a transplant).

-Sulfonilureas (e.g., tolbutamide, glipizide, and glibenclamide) (used to treat diabetes).

-Estatins (e.g., atorvastatin, simvastatin) (used to reduce 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 side effects such as nausea and menstrual disorders).

-Vincristine and vinblastine alkaloids (used to treat cancer).

• Inhibitors of tyrosine kinase (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 CANNOT be taken at the same time as Voriconazol Teva).

-Methadone (used to treat heroin addiction).

-Opioids with short action such as alfentanil, fentanyl, and sufentanil (used for surgical procedures).

-Opioids with long action such as oxycodone and hydrocodone (used to treat moderate to severe pain).

-Nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac) (used to treat pain and inflammation).

-Fluconazole (used to treat fungal infections).

-Flucloxacillin (antibiotic used to treat bacterial infections).

-Everolimus (used to treat advanced kidney cancer and in patients who have received a transplant).

• Letermovir (used to prevent cytomegalovirus (CMV) infection after a bone marrow transplant).
• Ivacaftor: used to treat cystic fibrosis.

Pregnancy and breastfeeding

You should not take Voriconazol Teva during pregnancy unless your doctor tells you to. Women of childbearing age taking Voriconazol Teva should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with Voriconazol Teva.

You should stop breastfeeding before starting to take Voriconazol Teva.

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

Driving and operating machinery

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

Voriconazol Teva contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Voriconazol Teva contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication is indicated for the treatment of fungal infections.Consult your doctor or pharmacist if you are unsure about the administration of this medication.

Your doctor will determine the dose based 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.

Your doctor may increase the daily dose to 300 mg (≥40 kg) or 150 mg (<40 kg) depending on your response to treatment.

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:

Your doctor may increase or decrease the daily dose depending on your response to treatment.

Tablets should only be administered 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 for the prevention of fungal infections, your doctor may discontinue Voriconazole Teva if you or your child experience adverse effects related to treatment.

If you take more Voriconazole Teva than you should

If you take more tablets than prescribed (or if someone else takes your tablets),

immediately seek medical assistance or go to the nearest emergency hospital. Bring the box of Voriconazole Teva tablets with you. You may notice an abnormal sensitivity to light as a result of taking more Voriconazole Teva than you should.

In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Voriconazole Teva

It is essential to take Voriconazole Teva tablets regularly at the same time of day. If you forget to take a dose, take the next one when it is due. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Voriconazole Teva

It has been demonstrated that correctly following the recommended dosage, administering each dose at the right time, can significantly increase the effectiveness of this medication. Unless your doctor tells you to discontinue treatment, it is essential to continue taking Voriconazole Teva as indicated above.

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

When your doctor suspends treatment with Voriconazole Teva, you should not experience any effects resulting from the interruption.

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

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

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

Severe side effects - Stop taking Voriconazol Teva and seek medical attention immediately

-Skin rash.

-Jaundice; changes in liver function.

-Pancreatitis.

Other side effects

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

-Visual disturbances (change in vision, blurred vision, visual color disturbances, abnormal light perception intolerance, color blindness, eye disorders, halo vision, night blindness, oscillating vision, spark vision, visual aura, decreased visual acuity, visual clarity, partial loss of the usual visual field, visual field spots).

-Fever.

-Skin rash.

-Nausea, vomiting, and diarrhea.

-Headache.

-Swelling of the extremities.

-Abdominal pain.

• Difficulty breathing.
• Elevated liver enzymes.

Common: may affect up to 1 in 10 people:

-Gastrointestinal irritation and inflammation, sinusitis, gum inflammation, chills, weakness.

• Low count, including severe, of some types of red blood cells (occasionally of an immunological type) and/or white blood cells (occasionally accompanied by fever) in the blood, low platelet count that helps blood to 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.
• Eye hemorrhage.

• Cardiac rhythm problems that include very fast heart rate, very slow heart rate, fainting.

-Hypotension, inflammation of the veins (which may be associated with the formation of blood clots).

-Acute difficulty breathing, chest pain, facial swelling (lips, mouth, and around the eyes), pulmonary edema.

• Constipation, indigestion, inflammation of the lips.

-Jaundice (yellowish skin color), liver inflammation, and liver damage.

• Skin eruptions, potentially severe, with blisters and desquamation, characterized by a flat, red area covered with small protuberances that converge, skin redness.

-Itching.

-Alopecia.

-Back pain.

-Renal failure, presence of blood in urine, alterations in renal function tests.

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

Uncommon: may affect up to 1 in 100 people:

• Symptoms of a cold, gastrointestinal irritation and inflammation, antibiotic-associated diarrhea, lymphatic vessel inflammation.

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

-Enlargement (occasionally painful) of the lymph nodes, bone marrow insufficiency, eosinophilia.

• Adrenal gland dysfunction, hypothyroidism.

• Abnormal cerebral function, Parkinson's disease-like symptoms, nerve damage causing numbness, pain, tingling, or burning in the hands or feet.

-Balance or coordination problems.

-Cerebral edema.

-Dual vision, severe eye diseases, such as: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage causing vision disturbances, papillary optic inflammation.

-Decreased sensitivity to touch.

• Alteration of the sense of taste.
• Difficulty hearing, tinnitus, 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).

-Renal inflammation, proteins in urine, renal damage.

• Very high or extrasystolic heart rate, occasionally with erratic electrical impulses.

-Abnormal electrocardiogram (ECG).

• Elevated blood cholesterol, elevated blood urea.
• Severe skin reactions (occasionally life-threatening) such as: skin thickening and redness with scaly skin, potentially life-threatening that causes large areas of the epidermis, the outermost layer of the skin, to peel off from the layers of skin underneath; generalized eruption, high body temperature, and lymph node enlargement.

• Severe allergic reaction or excessive immune response.

• Inflammation of the tissue surrounding the bone.

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

-Hyperthyroidism.

• Severe cerebral dysfunction as a complication of severe liver disease.

-Optic nerve fiber loss, corneal opacity, involuntary eye movements.

• Phototoxicity with blister formation.
• Autoimmune disease that attacks part of the peripheral nervous system.

• Cardiac rhythm problems or conduction problems (occasionally life-threatening).
• Life-threatening allergic reaction
• Blood coagulation disorders
• Severe skin reactions (occasionally life-threatening), such as: rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, pruritic and painful skin plaques with thickened and reddened skin covered with plate-like scales that can be potentially life-threatening that causes large areas of the epidermis, the outermost layer of the skin, to peel off from the layers of skin underneath; generalized eruption, high body temperature, and lymph node enlargement.
• Small, scaly, and dry skin patches, occasionally thick and with points or "horns".

Unknown frequency: the frequency cannot be estimated from the available data

• Age spots and pigmented patches.

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

• Red, scaly, or ring-shaped skin patches that may be a symptom of a skin autoimmune disease called lupus erythematosus.

Since Voriconazol Teva has been observed to affect the liver and kidneys, your doctor should monitor liver and renal function through blood tests. Inform your doctor if you have abdominal pain or if your stools have a different consistency.

Cases of skin cancer have been reported in patients treated with voriconazol for long periods of time (see section 2).

The frequency of sunburns or severe skin reactions after exposure to light or the sun was higher in children. If you or your child experience skin problems, your doctor may refer you to a dermatologist who, after consultation, can decide that it is necessary for you or your child to undergo regular follow-up. Elevated liver enzymes were also observed more frequently in children.

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

Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister pack or containerafter CAD. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Voriconazole Teva

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

Appearance of the product and contents of the pack

Voriconazole Teva 50 mg tablets are presented as film-coated tablets, white in color, round, biconvex (diameter: 7.2 mm approx.) with a “V” engraved on one face and “50” on the other

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid, Spain

Manufacturer responsible

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:Voriconazole 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

Finland:Voriconazole Teva

France:Voriconazole Teva 50 mg, comprimé pelliculé

Voriconazole Teva 200 mg, comprimé pelliculé

Germany:Voriconazole-ratiopharm®50 mg Filmtabletten

Voriconazole-ratiopharm®200 mg Filmtabletten

Greece:Voriconazole Teva 200 mgΕπικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Hungary:Voriconazole Teva 200 mg filmtabletta

Iceland:Voriconazole Teva

Ireland:Voriconazole Teva 200mg Film-coated Tablets

Italy:VORICONAZOLO TEVA

Latvia:Voriconazole Teva 200 mg apvalkotas tabletes

Lithuania:VoriconazoleTeva 200 mg plevele dengtos tabletes

Luxembourg:Voriconazole Teva 50 mg comprimés pelliculés

Voriconazole Teva 200 mg comprimés pelliculés

Netherlands:Voriconazole 50 mg Teva, filmomhulde tabletten

Voriconazole 200 mg Teva, filmomhulde tabletten

Norway:Voriconazolee Teva

Portugal:Voriconazole Teva

Spain:Voriconazole Teva 50 mg comprimidos recubiertos con película EFG

Voriconazole Teva 200 mg comprimidos recubiertos con película EFG

Sweden:Voriconazole Teva

Last review date of this leaflet :July 2024

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

You can access detailed and updated information on this medicinal product by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/79206/P_79206.html