Leaflet: information for the user

Voriconazole Aurovitas 200 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. Do 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.

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

2.What you need to know before you start taking Voriconazole Aurovitas

3.How to take Voriconazole Aurovitas

4.Possible side effects

5.Storage of Voriconazole Aurovitas

6.Contents of the pack and additional information

Voriconazol Aurovitas contains the active ingredient voriconazol. Voriconazol is an antifungal medication. It works by eliminating or preventing the growth of fungi that cause infections.

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

•Invasive aspergillosis (a type of fungal infection produced byAspergillussp).

•Candidemia (another type of fungal infection produced byCandida sp) in non-neutropenic patients (patients with a normal white blood cell count).

•Severe invasive infections produced byCandida sp, when the fungus is resistant to fluconazol (another antifungal medication).

•Severe fungal infections produced byScedosporium spor byFusarium sp(two different species of fungi).

Voriconazol is used in patients with severe fungal infections that may put their lives at risk.

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

This medication must be used only under medical supervision.

Do not take Voriconazol Aurovitas

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

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

During treatment with voriconazole, do not take the following medications:

•Terfenadine (used for allergies).

•Astemizol (used for allergies).

•Cisapride (used for digestive problems).

•Pimozide (used for mental disorders).

•Quinidine (used for arrhythmias).

•Ivabradine (used for symptoms of chronic heart failure).

•Rifampicin (used for the treatment of tuberculosis).

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

•Carbamazepine (used to treat seizures).

•Phenobarbital (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 the treatment of HIV) 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 opioid analgesics [e.g., morphine, oxycodone, fentanyl, tramadol, codeine]).

•Tolvaptan (used to treat hyponatremia [low sodium levels in the blood] or to slow the progression of renal disease 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 Aurovitas 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. Your doctor should also monitor your liver function while you are taking voriconazole by performing blood tests.

•You know you have heart disease, irregular heartbeats, slow heart rate, or an electrocardiogram (ECG) anomaly called "prolonged QTc syndrome."

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

While taking voriconazole:

•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 regular examination necessary. 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 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 develop signs of "Cushing's syndrome" where the body produces too much cortisol hormone, which may cause symptoms such as:

•Weight gain

•Buffalo hump

•Rounded face

•Darkening of skin on the abdomen, thighs, breasts, and arms

•Thin skin

•Easy bruising

•High blood sugar

•Excessive hair growth

•Excessive sweating

Inform your doctor.

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

Children and adolescents

Voriconazole should not be administered to children under 2 years old.

Other medications and Voriconazol Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some medications, when used at the same time as voriconazole, may affect the action of voriconazole or vice versa.

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

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

•Glasdegib (used for the treatment of cancer); 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 voriconazole should be avoided as much as possible, and may require adjustment of the voriconazole dose:

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

•Phenitoin (used to treat epilepsy). If you are already being treated with phenitoin, your doctor will need to monitor the concentration of phenitoin in your blood during your treatment with voriconazole 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 medication monitored to ensure it continues to produce 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).

•Sulfonylureas (e.g., tolbutamide, glipizide, and glibenclamide) (used to treat diabetes).

•Statins (e.g., atorvastatin, simvastatin) (used to reduce cholesterol levels).

•Benzodiazepines (e.g., midazolam, triazolam) (used to treat severe insomnia and stress).

•Omeprazole (used to treat stomach ulcers).

•Oral contraceptives (if you take voriconazole while using oral contraceptives, you may experience side effects such as nausea and menstrual disorders).

•Ergot 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).

•Indinavir and other HIV protease inhibitors (used to treat HIV infection).

•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 voriconazole).

•Methadone (used to treat heroin addiction).

•Alfentanil, fentanyl, and other short-acting opioids (e.g., sufentanil) (used as analgesics for surgery).

•Oxycodone and other long-acting opioids (e.g., 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).

•Letermovir (used to prevent cytomegalovirus (CMV) infection after a bone marrow transplant).

•Ivacaftor (used to treat cystic fibrosis).

•Flucloxacillin (antibiotic used to treat bacterial infections).

Pregnancy and breastfeeding

You should not take voriconazole during pregnancy unless your doctor indicates it. Women of childbearing age taking voriconazole should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with voriconazole.

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

Voriconazole 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 Aurovitas contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Voriconazol Aurovitas contains sodium

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

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

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:

Your doctor may increase the daily dose to 300 mg twice a day 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 for the prevention of fungal infections, your doctor may suspend voriconazole administration if you or your child experience adverse effects related to treatment.

If you take more Voriconazole Aurovitas 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 Aurovitas tablets with you. You may notice abnormal sensitivity to light as a result of taking more voriconazole than you should.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amountingested.

If you forgot to take Voriconazole Aurovitas

It is essential to take the voriconazole 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 Aurovitas

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

Continue taking voriconazole 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 voriconazole treatment, you should not experience any effects resulting from the interruption.

If you have any other doubts 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, it is likely to be mild and temporary. However, some may be serious and require medical attention.

Severe side effects - Stop taking voriconazole and seek medical attention immediately

•Skin rash.

•Jaundice, liver function test abnormalities.

•Pancreatitis.

Other side effects

Frequent: 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, spots in the visual field).

•Fever.

•Skin rash.

•Nausea, vomiting, and diarrhea.

•Headache.

•Swelling of the extremities.

•Abdominal pain.

•Dyspnea.

•Elevated liver enzymes.

Frequent: may affect up to 1 in 10 people

•Sinusitis, gingivitis, chills, weakness.

•Low white blood cell count, including severe cases, of certain types of red or white blood cells in the blood, low platelet count that helps blood to clot.

•Low blood sugar, 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 respiratory difficulty, chest pain, facial swelling (mouth, lips, and around the eyes), pulmonary edema.

•Constipation, indigestion, lip inflammation.

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

•Skin eruptions, which may be severe, with blisters and peeling, 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, renal function test abnormalities.

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

•Skin cancer.

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

•Hyperthyroidism.

•Cerebral deterioration as a serious complication of liver disease.

•Optic nerve fiber loss, corneal opacity, involuntary eye movement.

•Phototoxicity blistering.

•Demyelinating disease in which the immune system attacks part of the peripheral nervous system.

•Severe cardiac rhythm problems or conduction (which may be potentially fatal).

•Potentially fatal allergic reaction.

•Blood coagulation abnormalities.

•Severe skin allergic reactions, such as potentially fatal skin disease that causes painful blisters and sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, redness, and irritation, skin discoloration or purpura that may be caused by low platelet count, eczema.

•Reaction at the infusion site.

•Exaggerated immune response or allergic reaction.

•Periosteal inflammation.

Unknown frequency: may affect up to 1 in 1,000 people

•Moles and pigmented spots.

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

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

Since voriconazole 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 voriconazole for long periods of time.

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, may 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 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:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Voriconazol Aurovitas

-The active ingredient is voriconazole. Each film-coated tablet contains 200 mg of voriconazole.

-The other components are:

Tablet core:lactose monohydrate,cornstarch pregelatinized,cornstarch, croscarmellose sodium, povidone (K-30), anhydrous colloidal silica, magnesium stearate.

Tablet coating:hypromellose 2910 (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin (E 1518).

Appearance of the product and content of the container

White film-coated tablets, oval, biconvex, with the marks “CC” and “56” separated by a groove on one face, and smooth on the other. The tablet can be divided into equal doses.

Voriconazol Aurovitas film-coated tablets are available in PVC transparent/Aluminum blister packs. Each pack contains 14 or 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Last review date of this leaflet:December 2023

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