Voriconazole Aurovitas 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voriconazole Aurovitas 200 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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Voriconazole Aurovitas is and what it is used for
2. What you need to know before taking Voriconazole Aurovitas
3. How to take Voriconazole Aurovitas
4. Possible side effects
5. How to store Voriconazole Aurovitas
6. Contents of the pack and other information

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

Voriconazol Aurovitas contains the active substance voriconazole. Voriconazole is an antifungal medicine. It works by killing or stopping 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 by Fusarium sp (two different species of fungi).

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

Prevention of fungal infections in high-risk recipients of allogeneic hematopoietic stem cell transplantation.

This medicine should only be used under medical supervision.

2. What you need to know before taking Voriconazol Aurovitas

Do not take Voriconazol Aurovitas

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

It is very important that you inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, or herbal medicines.

During treatment with voriconazol, 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 cardiac 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 or higher once daily.
• Carbamazepine (used to treat seizures).
• Phenobarbital (used for severe insomnia and seizures).
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine).
• Sirolimus (used in transplant patients).
• Ritonavir (used for the treatment of HIV) at doses of 400 mg or higher twice daily.
• St. John’s wort (hypericum, herbal medicine).
• 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 down the decline in kidney function in patients with polycystic kidney disease).
• Lurasidone (used to treat depression).
• Finerenone (used to treat chronic kidney disease).
• Venetoclax (used for the treatment of patients with chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Voriconazol Aurovitas if:

• You have had an allergic reaction to other azoles.
• You have or have previously had liver disease. If you have liver disease, your doctor may prescribe a lower dose of voriconazol. Your doctor should also monitor your liver function during treatment with voriconazol by performing blood tests.
• You know you have cardiomyopathy, irregular heartbeat, slow heart rate, or an abnormality on the 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 radiation from sunlight. This sensitivity may be further increased by the use of other medicines that make the skin more sensitive to sunlight, such as methotrexate. These precautions also apply to children.

While you are being treated with voriconazol:

• 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 important for you to have regular check-ups. There is a small risk of developing skin cancer with long-term use of voriconazol.

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

Other medicines and Voriconazol Aurovitas

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

• Some medicines, when used at the same time as voriconazol, may affect the action of voriconazol or voriconazol may affect the action of other medicines.

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

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

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

• Rifabutin (used for the treatment of 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, 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 are still 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 reduce cholesterol levels).
• Benzodiazepines (e.g., midazolam, triazolam) (used for severe insomnia and stress).
• Omeprazole (used for the treatment of stomach ulcers).
• Oral contraceptives (if you take voriconazol while using oral contraceptives, you may experience adverse effects such as nausea and menstrual disorders).
• Vinca alkaloids (e.g., vincristine, 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).
• Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used to treat HIV infection) (some doses of efavirenz must NOT be taken with voriconazol).
• 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).
• Everolimus (used to treat advanced renal cell carcinoma and in transplant patients).
• Letermovir (used to prevent cytomegalovirus (CMV) infection after bone marrow transplant).
• Ivacaftor (used to treat cystic fibrosis).
• Flucloxacillin (an antibiotic used to treat bacterial infections).

Pregnancy and breastfeeding

You must not take voriconazol during pregnancy unless instructed by your doctor. Women of childbearing age being treated with voriconazol should use effective contraception. Contact your doctor immediately if you become pregnant while taking voriconazol.

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 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 him before taking this medicine.

Voriconazol Aurovitas contains sodium

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

3. How to take Voriconazole Aurovitas

Always follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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:

Depending on your response to treatment, your doctor may increase the daily dose to 300 mg 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 whole tablets.

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 voriconazol for the prevention of fungal infections, your doctor may discontinue voriconazol administration if you or your child experience treatment-related adverse effects.

If you take more Voriconazol Aurovitas than you should

If you take more tablets than prescribed (or if someone else takes your tablets), seek immediate medical help or go to the nearest hospital emergency department. Take the Voriconazol Aurovitas tablet pack with you. You may experience abnormal sensitivity to light as a result of taking more voriconazol than you should.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Voriconazol Aurovitas

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

If you stop taking Voriconazol Aurovitas

It has been shown that correctly following the prescribed dosing schedule, by 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 voriconazol correctly as indicated above.

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

When your doctor discontinues treatment with voriconazol, 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 of these 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 and contact your doctor immediately

• Skin rash.
• Jaundice, changes in blood tests monitoring 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, color vision disturbances, abnormal tolerance to visual perception of light, color blindness, eye disorder, visual halos, night blindness, oscillating vision, perception of 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 diarrhea.
• Headache.
• Swelling of the limbs.
• Stomach pain.
• Difficulty breathing.
• Elevated liver enzymes.

Common: may affect up to 1 in 10 people

• Sinusitis, gum inflammation, chills, weakness.
• Low blood counts, including severe cases, of certain types of red blood cells (sometimes immune-mediated) 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.
• Eye hemorrhage.
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting.
• Hypotension, inflammation of veins (which may be associated with blood clot formation).
• Acute difficulty breathing, chest pain, facial swelling (mouth, lips, and around the eyes), fluid retention in the lungs.
• Constipation, indigestion, inflammation of the lips.
• Jaundice (yellowing of the skin), liver inflammation, and liver damage.
• Skin rashes, which may become severe with blistering and peeling, characterized by flat, red areas covered with small merging bumps, skin redness.
• Itching.
• Alopecia.
• Back pain.
• Kidney failure, presence of blood in urine, abnormalities in kidney function tests.
• Sunburn or severe skin reaction after exposure to light or sunlight.
• Skin cancer.

Uncommon: may affect up to 1 in 100 people

• Flu-like symptoms, irritation and inflammation of the gastrointestinal tract, gastrointestinal inflammation causing antibiotic-associated diarrhea, inflammation of lymphatic vessels.
• Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs.
• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils.
• Reduced adrenal gland function, underactive thyroid gland.
• Abnormal brain function, symptoms resembling Parkinson's disease, nerve damage causing numbness, pain, tingling, or burning 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, inflammation of the optic disc.
• Decreased sensitivity to touch.
• Disturbance of taste sensation.
• Hearing difficulty, ringing in the ears, vertigo.
• Inflammation of certain internal organs, pancreas and duodenum, swelling and inflammation of the tongue.
• Enlarged liver, 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 rapid 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 potentially life-threatening skin disease causing blisters and painful sores on the skin and mucous membranes, especially in the mouth, skin inflammation, hives, skin redness and irritation, reddish or purplish skin discoloration possibly due to low platelet count, eczema.
• Infusion site reaction.
• Allergic reaction or exaggerated immune response.
• Inflammation of the tissue surrounding the bone.

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

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

Adverse effects with unknown frequency:

• Freckles and pigmented spots.

Other important adverse effects with unknown frequency, but which must be reported to your doctor immediately:

• Scaly red patches or ring-shaped skin lesions, which may be a sign of an autoimmune disease called cutaneous lupus erythematosus.

Since voriconazole has been observed to affect the liver and kidneys, your doctor should monitor liver and kidney function through blood tests. Inform your doctor if you 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.

The frequency of sunburn or severe skin reactions after exposure to light or sunlight was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voriconazole Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister pack following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voriconazole Aurovitas

• The active substance is voriconazole. Each film-coated tablet contains 200 mg of voriconazole.
• The other components are:

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

Tablet coating: hypromellose 2910 (E464), lactose monohydrate, titanium dioxide (E171), triacetin (E1518).

Appearance of the product and contents of the pack

White, oval, biconvex film-coated tablets, marked with "CC" and "56" separated by a score line on one side, and smooth on the other. The tablet can be divided into equal doses.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Date of the most recent review of this leaflet: December 2025

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