Package Insert: Information for the User

Fluconazole TecniGen 200 mg Hard Capsules EFG

Fluconazole

Read this package insert carefully before starting to take the medication.

• Keep this package insert as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Fluconazol TecniGen is one of the medications in the group called "antifungals". The active ingredient is fluconazol.

Fluconazol TecniGen is used to treat fungal infections, and it may also be used to prevent the onset of a fungal infection. The most common cause of fungal infections is a fungus calledCandida.

Adults

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Fungal infections caused byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth, throat, or associated with dental prostheses.
• Genital candidiasis – an infection of the vagina or penis.
• Skin infections – e.g. athlete's foot, ringworm, inguinal ringworm, nail infection.

Your doctor may also prescribe Fluconazol TecniGen for:

• To prevent the recurrence of cryptococcal meningitis.
• To prevent the recurrence of mucosal infections.
• To reduce the recurrence of vaginal infections caused byCandida.
• To prevent the transmission of fungal infections caused byCandida(if your immune system is weak and does not function properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medication to treat the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the mucous membrane of the mouth or throat.
• Fungal infections caused byCandidalocated in the bloodstream, in organs of the body (e.g. heart, lungs) or in the urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

Your doctor may also prescribe Fluconazol TecniGen for:

• To prevent the transmission of fungal infections caused byCandida(if your immune system is weak and does not function properly).
• To prevent the recurrence of cryptococcal meningitis.

Do not take Fluconazol TecniGen if

• You are allergic (hypersensitive) to fluconazole, to other medications you have taken to treat fungal infections, or to any of the other components of Fluconazol TecniGen. Symptoms may include itching, skin redness, or difficulty breathing.
• You are taking astemizole, terfenadine (allergy medications).
• You are taking cisaprida (used to treat stomach discomfort).
• You are taking pimozida (used to treat mental illnesses).
• You are taking quinidina (used to treat heart arrhythmias).
• You are taking eritromicina (an antibiotic to treat infections).

Be especially careful with Fluconazol TecniGen

Inform your doctor if

• You have liver or kidney problems.
• You have a heart disease, including heart rhythm problems.
• You have abnormal levels of potassium, calcium, or magnesium in your blood.
• You experience severe skin reactions (itching, skin redness, or difficulty breathing).
• You have ever had a severe skin rash or peeling, blisters, or mouth sores after taking fluconazole.
• The fungal infection does not improve, and an alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in relation to fluconazole treatment. Stop taking fluconazole and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Use of other medications

Inform your doctor immediately if you are taking astemizole, terfenadine (an allergy medication), cisaprida (used to treat stomach discomfort), pimozida (used to treat mental illnesses), quinidina (used to treat heart arrhythmias), or eritromicina (an antibiotic to treat infections), as these medications should not be taken with Fluconazol TecniGen (see section: “Do not take Fluconazol TecniGen if”).

There are some medications that may interact with Fluconazol TecniGen. Make sure your doctor knows if you are taking any of the following medications:

• Rifampicina or rifabutina (antibiotics for infections).
• Alfentanilo, fentanilo (used as anesthetics).
• Amitriptilina, nortriptilina (used as antidepressants).
• Anfotericina B, voriconazol (antifungals).
• Medications that make blood less viscous, to prevent blood clots (warfarina or similar medications).
• Benzodiazepinas (midazolam, triazolam or similar medications) used to help sleep or for anxiety.
• Carbamazepina, fenitoína (used to treat seizures).
• Nifedipino, isradipino, amlodipino, felodipino, and losartan (for hypertension).
• Ciclosporina, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection).
• Ciclofosfamida, alcaloides de la vinca (vincristina, vinblastina or similar medications) used to treat cancer.
• Halofantrina (used to treat malaria).
• Estatinas (atorvastatina, simvastatina, and fluvastatina or similar medications) used to reduce high cholesterol levels.
• Metadona (used for pain).
• Celecoxib, flurbiprofeno, naproxeno, ibuprofeno, lornoxicam, meloxicam, diclofenaco (Nonsteroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisona (steroid).
• Zidovudina, also known as AZT; saquinavir (used in patients infected with HIV).
• Medications for diabetes, such as clorpropamida, glibenclamida, glipizida, or tolbutamida.
• Theophylline (used to control asthma).
• Vitamin A (nutritional supplement).

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Taking Fluconazol TecniGen with food and drinks

You can take the medication with or without food.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, trying to become pregnant, or breastfeeding. Do not take fluconazole if you are pregnant, think you may be pregnant, or plan to become pregnant or breastfeed, unless your doctor has told you to.

If you are planning to become pregnant, it is recommended that you wait one week after a single dose of fluconazole before becoming pregnant.

For longer treatment cycles with fluconazole, consult your doctor about the need to use suitable contraceptive methods during treatment, which should be maintained for one week after the last dose.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of spontaneous abortion. Fluconazole during the first trimester may increase the risk of a baby being born with congenital anomalies affecting the heart, bones, and/or muscles.

Cases of babies born with congenital anomalies affecting the skull, ears, and leg and elbow bones have been reported in women treated for three months or more with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. The relationship between fluconazole and these cases is unclear.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

When driving or operating machines, be aware that occasional dizziness or seizures may occur.

Important information about some of the components of Fluconazol TecniGen

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

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

Follow exactly the administration instructions for Fluconazol TecniGen indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The capsules should be swallowed whole with the help of a glass of water. It is best to take your medications at the same time every day.

The following is the usual dose of this medication for different types of infections:

Adults

Adolescents 12 to 17 years old

Follow the dose indicated by your doctor (the adult dose or the pediatric dose)

Children up to 11 years old

The maximum daily dose for children is 400 mg per day

The dose will be based on the child's weight in kilograms

Use in children 0 to 4 weeks old

Use in children 3 to 4 weeks old:

-The same dose as described in the table, but administered once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children under 2 weeks old:

-The same dose as described in the table, but administered once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.

In some cases, doctors may prescribe different doses than those described. Follow exactly the administration instructions indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Geriatric patients

The usual adult dose, unless you have kidney problems

Patients with kidney problems

Your doctor may change your dose, depending on how well your kidneys are functioning

If you take more Fluconazol TecniGen than you should

Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital immediately. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Symptoms of a possible overdose may include hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behavior). It may be necessary to initiate symptomatic treatment (with supportive measures and gastric lavage if necessary).

If you forget to take Fluconazol TecniGen

Do not take a double dose to make up for the missed doses. If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose.

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

Like all medicines, Fluconazol TecniGen may cause side effects, although not everyone will experience them.

Stop taking fluconazol and seek medical attention immediately if you notice any of the following symptoms:

• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Some people developallergic reactionsalthough severe allergic reactions are rare.If you experience any of the following symptoms,inform your doctor immediately.

• Sudden onset of hives, difficulty breathing, or chest tightness.
• Swelling of the eyelids, face, or lips.
• Itching all over the body, skin redness, or red spots with itching.
• Skin rash.
• Severe skin reactions, such as rash that causes blisters (this may affect the mouth and tongue).

Fluconazol TecniGen may affect your liver. Signs that indicate liver problems include:

• Fatigue.
• Loss of appetite.
• Vomiting.
• Yellowing of the skin or white of the eyes (jaundice).

If you experience any of these symptoms, stop takingFluconazol TecniGenand inform your doctor immediately.

Other side effects:

In addition, if you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Below are the common side effects that affect 1 to 10 of every 100 patients:

• Headache.
• Stomach discomfort, diarrhea, nausea, vomiting.
• Abnormal blood test results indicating liver function.
• Rash.

Below are the uncommon side effects that affect 1 to 10 patients of every 1,000:

• Reduction of red blood cells, which may cause pale skin and weakness or difficulty breathing.
• Loss of appetite.
• Inability to sleep, numbness.
• Convulsions, dizziness, sensation of spinning, tingling, pins and needles, changes in taste.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.
• Liver damage and yellowing of the skin and eyes (jaundice).
• Rashes, blisters (pustules), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

Below are the rare side effects, which affect 1 to 10 patients of every 10,000:

• White blood cells in the blood that help us fight infections and blood cells that help stop bleeding, lower than normal.
• Red or purple discoloration of the skin, which may be due to a low number of platelets, other changes in blood cells.
• Changes in blood tests (high levels of cholesterol, fats).
• Low levels of potassium in the blood.
• Tremors.
• Abnormal electrocardiogram (ECG), changes in heart rate or rhythm.
• Liver function failure.
• Allergic reactions (sometimes severe), including widespread rash with blisters and skin peeling, severe allergic reactions, swelling of the lips or face.
• Hair loss.

If you consider that some of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly through the Spanish System for 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.

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

No special storage conditions are required

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

Composition of Fluconazol TecniGen

The active ingredient is fluconazole.

Each hard capsule contains 200 mg of fluconazole.

The other components (excipients) are:

Content of the capsule: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch (cornstarch), cornstarch, sodium lauryl sulfate, and magnesium stearate

Composition of the capsule: titanium dioxide (E-171), gelatin

Appearance of Fluconazol TecniGen 200 mg hard capsules and content of the packaging

The capsules have a white body and a white cap. They are presented in packs of 7 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

Medinfar Manufacturing, S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro Da Armada, nº 5.

Condeixa-a-Nova, 3150-194. Portugal

or

Atlantic Pharma-Produçoes Farmaceuticas, S.A.

Rua da Tapada Grande, Nº2 – Abrunheira. Sintra - 2710-089 – Portugal

This leaflet was approved in January 2021

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