Voriconazole Kern Pharma 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Voriconazole Kern Pharma 50 mg film-coated tablets EFG

Voriconazole Kern Pharma 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; do not pass it on 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 these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Voriconazol Kern Pharma is and what it is used for

Voriconazol Kern Pharma contains the active substance voriconazol. Voriconazol Kern Pharma 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 Fusarium sp (two different species of fungi).

Voriconazol Kern Pharma is used in patients with serious fungal infections that may be life-threatening.

Prevention of fungal infections in high-risk bone marrow transplant recipients. This medicine should only be used under medical supervision.

2. What you need to know before taking Voriconazol Kern Pharma

Do not take Voriconazol Kern Pharma

• if you are allergic to voriconazol or to any of the other ingredients of Voriconazol Kern Pharma (listed in section 6).

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

During treatment with this medicine, 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 heart arrhythmias)
• Ivabradine (used for symptoms of chronic heart failure)
• Rifampicin (used to treat tuberculosis)
• Efavirenz (used to treat 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 patients who have received a transplant)
• Ritonavir (used to treat 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 pain medicines (e.g., morphine, oxycodone, fentanyl, tramadol, codeine))
• Tolvaptan (used to treat hyponatremia (low sodium levels in blood) or to slow 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 this medicine if:

• you have had an allergic reaction to other azoles;
• you have or have ever 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 Kern Pharma by performing blood tests;
• you know you have cardiomyopathy, irregular heartbeat, slow heart rate, or an abnormality on electrocardiogram (ECG) known as “prolonged QTc syndrome”.

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

While being treated with voriconazol:

• inform your doctor if you experience:
• sunburn
• severe skin rash or blistering
• 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 to monitor you regularly. There is a small possibility that you may develop skin cancer with long-term use of voriconazol.

If you experience 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 develop signs of “Cushing's syndrome”, in which the body produces too much cortisol hormone, which may cause symptoms such as: weight gain, fatty hump between the shoulders, rounded face, darkening of the skin on the stomach, thighs, breasts, and arms, thinning of the skin, easy bruising, increased blood sugar, excessive hair growth, and excessive sweating, inform your doctor.

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

Children and adolescents

Voriconazol Kern Pharma must not be given to children under 2 years of age.

Other medicines and Voriconazol Kern Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those not requiring a prescription.

Some medicines, when taken at the same time as this medicine, 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 to treat HIV) at a dose of 100 mg twice daily.
• Glasdegib (used to treat cancer): if you need to take both medicines, your doctor will monitor your heart rhythm frequently.

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 to treat 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 continue to have the desired effect:

• Warfarin and other anticoagulants (e.g.: phenprocoumon, acenocoumarol; used to reduce blood clotting)
• Cyclosporine (used in patients who have received a transplant)
• Tacrolimus (used in patients who have received a transplant)
• Sulfonylureas (e.g.: tolbutamide, glipizide, glyburide) (used for diabetes)
• Statins (e.g.: atorvastatin, simvastatin) (used to lower 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 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 at the same time as 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

Do not take this medicine 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 Kern Pharma 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 Kern Pharma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Voriconazol Kern Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg tablet; this is essentially “sodium-free”.

This medicine contains less than 1 mmol of sodium (23 mg) per 200 mg tablet; this is essentially “sodium-free”.

3. How to take Voriconazol Kern Pharma

Follow exactly the instructions for use of this medicine given by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Your doctor will determine the dose depending on your body 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 this medicine to prevent fungal infections, your doctor may stop treatment with voriconazol if you or your child experience treatment-related adverse effects.

If you take more Voriconazol Kern Pharma 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 hospital emergency department. Take the pack of Voriconazol Kern Pharma tablets with you. You may experience abnormal sensitivity to light as a result of taking more Voriconazol Kern Pharma than recommended.

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 Kern Pharma

It is important to take Voriconazol Kern Pharma 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 Kern Pharma

It has been shown that correctly following the prescribed dosing schedule, taking each dose at the correct 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 this medicine until your doctor tells you otherwise. Do not stop treatment prematurely, as the infection may not be cured. Patients with weakened immune systems or complicated infections may require longer treatment courses to prevent the infection from returning.

When your doctor stops treatment with Voriconazol Kern Pharma, 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 experiences them.

If any adverse effects 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 Kern Pharma and contact your doctor immediately

• Skin rash.
• Jaundice or abnormalities 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 intolerance to visual perception of light, color blindness, eye disorder, visual halos, night blindness, oscillating vision, seeing 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 extremities.
• 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.
• Ocular hemorrhage.
• Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting.
• Hypotension, vein inflammation (which may be associated with blood clot formation).
• Acute breathing difficulty, chest pain, facial swelling (mouth, lips, and around the eyes), fluid accumulation in the lungs.
• Constipation, indigestion, lip inflammation.
• Jaundice (yellowing of the skin), liver inflammation, and liver damage.
• Skin rashes, which may become severe, with blisters 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 following 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, gastrointestinal inflammation causing antibiotic-associated diarrhea, inflammation of lymphatic vessels.
• Inflammation of the thin tissue lining the abdominal wall and covering abdominal organs (peritonitis).
• Enlargement (sometimes painful) of lymph nodes, bone marrow failure, increased eosinophils.
• Decreased adrenal gland function, underactive thyroid gland.
• Abnormal brain function, Parkinson-like symptoms, nerve damage causing numbness, pain, tingling, or burning sensations 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, optic disc inflammation.
• Decreased sensitivity to touch.
• Altered sense of taste.
• Hearing difficulty, ringing in the ears (tinnitus), vertigo.
• Inflammation of certain internal organs, including 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 high 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 skin disorders, potentially life-threatening conditions 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 (periostitis).

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 abnormalities.
• Skin allergic reactions (sometimes severe), such as rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal layers, itchy and painful thickened red skin plaques with silvery scales, skin and mucous membrane irritation, potentially life-threatening skin disorder causing large sections 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: (cannot be estimated from available data)

• Freckles and pigmented spots.

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

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

Since Voriconazole Kern Pharma 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 experience 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 following exposure to light or sun was higher in children. If you or your child develop skin disorders, your doctor may refer you to a dermatologist who, after evaluation, may determine 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Voriconazole Kern Pharma

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

Do not use this medicine after the expiry date stated on the carton, blister, and vial after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Vials: use within 30 days after first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Voriconazol Kern Pharma

• The active substance is voriconazole.

Each Voriconazol Kern Pharma 50 mg film-coated tablet contains 50 mg of voriconazole.

Each Voriconazol Kern Pharma 200 mg film-coated tablet contains 200 mg of voriconazole.

• The other components are: tablet core (monohydrate lactose, pregelatinized corn starch, sodium croscarmellose, povidone K30, anhydrous colloidal silica, magnesium stearate) and tablet coating (Opadry II white OY-LS 28908).

The Opadry II white film coating OY-LS 28908 contains: hypromellose, titanium dioxide (E171), monohydrate lactose and macrogol 4000/PEG.

Appearance of the product and contents of the container

Voriconazol Kern Pharma 50 mg tablets are presented as film-coated tablets, white to off-white in colour, round-shaped, with "V50" engraved on one side, 7.1 ± 0.2 mm in diameter.

Voriconazol Kern Pharma 200 mg tablets are presented as film-coated tablets, white to off-white in colour, oval-shaped, with "V200" engraved on one side, 15.7 ± 0.2 mm in length and 7.9 ± 0.2 mm in width.

Voriconazol Kern Pharma 50 mg film-coated tablets and 200 mg film-coated tablets are supplied in PVC/aluminum blisters and are available in pack sizes of 2, 10, 14, 20, 28, 30, 50, 56 or 100 tablets, or in white opaque HDPE bottles with a child-resistant screw cap containing 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Pharmathen S.A.

6, Dervenakion Str.

15351 Pallini Attikis

Greece

or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

69300 Rodopi

Greece

or

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50, Nürnberg

90449 Germany

This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Date of the last review of this leaflet: March 2026

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