Leaflet: information for the user

Voriconazole Normon 200 mg film-coated tablets EFG

Voriconazole

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, consult 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.

Content of the leaflet

1. What is Voriconazole Normon and for what it is used.
2. What you need to know before starting to take Voriconazole Normon.
3. How to take Voriconazole Normon.
4. Possible side effects.
5. Storage of Voriconazole Normon.
6. Contents of the pack and additional information.

This medication 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 to treat patients (adults and children 2 years of age or older) with:

• invasive aspergillosis (a type of fungal infection produced byAspergillus sp),
• candidemia (another type of fungal infection produced byCandida sp) in non-neutropenic patients (patients who do not have an abnormally low count of white blood cells),
• serious invasive infections produced byCandida sp, when the fungus is resistant to fluconazol (another antifungal medication),
• serious fungal infections produced byScedosporium spor byFusarium sp(two different species of fungi).

Voriconazol is used in patients with serious fungal infections that can 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 Normon

• 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 or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, or herbal remedies.

Do not take the following medicines during treatment with Voriconazol Normon:

• Terfenadine (used for allergies).
• Astemizol (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).
• 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 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 opioid analgesics [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 to treat patients with chronic lymphocytic leukemia [CLL]).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take voriconazole 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 doing blood tests.
• you know that you have heart disease, irregular heartbeats, slow heart rate, or an abnormality in the electrocardiogram (ECG) 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 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:

• 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 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" 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 experience signs of the "Cushing's syndrome" where 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 sweating, inform your doctor.

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

Children and adolescents

Voriconazol Normon should not be administered to children under 2 years.

Other medicines and Voriconazol Normon

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

• Some medicines, 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 medicines, as simultaneous treatment with voriconazole 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 medicines, your doctor will monitor your heart rate frequently.

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

• 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.
• 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 Voriconazol and may need to adjust your dose.

Inform your doctor if you are taking any of the following medicines, as you may need to adjust your dose or have your blood monitored to ensure that these medicines and/or Voriconazol Normon continue 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).
• Sulfonilureas (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 Voriconazol Normon 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).
• 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 Voriconazol Normon).
• 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).
• 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.
• Flucloxacillin (antibiotic used to treat bacterial infections).

Pregnancy and breastfeeding

You should not take this medicine during pregnancy unless your doctor tells you to. Women of childbearing age taking Voriconazol 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Voriconazol Normon contains lactose

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

Voriconazol Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which 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. For patients weighing less than 40 kg, the oral dose may be increased to 150 mg twice a day.

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 Normon for the prevention of fungal infections, your doctor may suspend the administration of Voriconazole if you or your child experience adverse effects related to treatment.

If you take more Voriconazole Normon than you should

If you take more tablets than prescribed (or if someone else takes your tablets), seek immediate medical assistance or go to the nearest emergency hospital. Bring the box of Voriconazole Normon tablets with you. You may notice an abnormal sensitivity to light as a result of taking more Voriconazole Normon 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 amount ingested.

If you forget to take Voriconazole Normon

It is essential to take 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 Normon

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. Unless your doctor tells you to stop treatment, it is essential to continue taking Voriconazole as indicated above.

Continue taking Voriconazole Normon 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, 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 Voriconazol Normon and seek medical attention immediately

• Skin rash.
• Jaundice, liver function test abnormalities.
• Pancreatitis.

Other side effects

Very common: may affect more than 1 in 10 people

• Visual disturbance (change in vision, such as blurred vision, visual colour changes, abnormal light perception intolerance, colour blindness, eye disorder, 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

• Sinusitis, gum inflammation, chills, weakness.
• Low count, including severe, of some 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, drowsiness, 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 blood clot formation).
• Difficulty breathing, chest pain, facial swelling (mouth, lips, and around the eyes), fluid retention in the lungs.
• Constipation, indigestion, lip inflammation.
• Jaundice (yellow skin discoloration), 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, blood in the urine, renal function test abnormalities.
• Sunburn or severe skin reaction after exposure to light or the sun.
• Skin cancer.

Uncommon: may affect up to 1 in 100 people

• Flu-like symptoms, gastrointestinal tract irritation and inflammation, gastrointestinal tract inflammation that causes diarrhea associated with antibiotics, lymphatic vessel inflammation.
• Peritoneal inflammation, which is the thin tissue that lines the abdominal wall and covers the abdominal organs.
• Enlargement (sometimes painful) of the lymph nodes, bone marrow insufficiency, eosinophil increase.
• Adrenal gland dysfunction, hypothyroidism.
• Abnormal brain function, Parkinson's disease-like symptoms, nerve damage causing numbness, pain, tingling, or burning in the hands or feet.
• Balance or coordination problems.
• Brain swelling.
• Dual vision, severe eye diseases, such as: eye and eyelid pain and inflammation, abnormal eye movements, optic nerve damage that causes vision changes, 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.
• Enlarged liver, liver failure, gallbladder disease, gallstones.
• Joint inflammation, inflammation of the veins under the skin (which may be associated with blood clot formation).
• Kidney inflammation, protein in the urine,kidney damage.
• Very high or extrasystolic heart rate, sometimes with erratic electrical impulses.
• Abnormal electrocardiogram (ECG).
• Elevated cholesterol levels in the blood, elevated urea levels in the blood.
• Severe skin allergic reactions, such as skin disease, potentially fatal that causes blisters and painful 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.
• Severe allergic reaction or excessive immune response.
• Inflammation of the tissue surrounding the bone.

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

• Hyperactive thyroid gland.
• Cerebral activity deterioration as a severe complication of liver disease.
• Optic nerve fibre loss, corneal opacity, involuntary eye movement.
• Blister formation due to photosensitivity.
• Condition in which the immune system attacks part of the peripheral nervous system.
• Cardiac rhythm problems or conduction (sometimes potentially fatal).
• Severe allergic reaction.
• Blood coagulation abnormalities.
• Severe skin allergic reactions, such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, pruritic and painful skin plaques with thickened and scaly skin, skin irritation and mucous membranes, potentially fatal skin disease that causes large areas of the epidermis, the skin's outermost layer, to peel off from the layers of skin beneath it.
• Small, scaly, and dry skin patches, sometimes thick and with points or "horns".

Side effects of unknown frequency:

• 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 prospectus. You can also report them directly through the Spanish System for 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.

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Voriconazole Normon

• The active ingredient is voriconazole.

Voriconazole Normon 50 mg film-coated tablets: each tablet contains 50 mg of voriconazole

Voriconazole Normon 200 mg film-coated tablets: each tablet contains 200 mg of voriconazole

• The other components are:

Tablet core: lactose monohydrate, sodium croscarmellose, povidone, pregelatinized maize starch, and magnesium stearate (E-572).

Tablet coating: hypromellose (E-464), titanium dioxide (E-171), macrogol 6000, and talc.

Appearance of the product and contents of the packaging

Voriconazole Normon 50 mg film-coated tablets are presented as white, round, biconvex, and marked with V50 on one side.

Voriconazole Normon 50 mg film-coated tablets are available in packs of 30, 56, and 100.

Voriconazole Normon 200 mg film-coated tablets are presented as white, elongated, biconvex, and marked with V200 on one side.

Voriconazole Normon 200 mg film-coated tablets are available in packs of 30, 56, and 100.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain.

Responsible manufacturer

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain.

This medicinal product is authorized in the Member States of the EEA under the following names:

Spain: Voriconazole Normon 50 mg film-coated tablets EFG

Voriconazole Normon 200 mg film-coated tablets EFG

Portugal: Voriconazole Normon

Last review date of this leaflet: September 2024

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