FLUCONAZOLE STADA 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fluconazole Stada 100 mg Hard Capsules EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fluconazole Stada and what is it used for
2. What you need to know before you take Fluconazole Stada

1. How to take Fluconazole Stada
2. Possible side effects

1. Storage of Fluconazole Stada
2. Contents of the pack and other information

1. What is Fluconazole Stada and what is it used for

Fluconazole Stada is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazole is used to treat infections caused by fungi, and it can also be used to prevent fungal infections from occurring. The most common cause of fungal infections is a yeast called Candida.

Adults

Your doctor may prescribe this medicine for the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection in the brain.
• Coccidioidomycosis – a disease of the bronchopulmonary system.
• Candidainfections of the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Mucosal candidiasis – an infection that affects the lining 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, jock itch, nail infection.

It may also be prescribed for you to:

• Prevent cryptococcal meningitis from coming back.
• Prevent Candidamucosal infections from coming back.
• Reduce the repeated appearance of Candidavaginal infections.
• Prevent the spread of Candidainfections (if your immune system is weak and not working properly).

Children and adolescents (0 to 17 years)

Your doctor may prescribe this medicine for the following types of fungal infections:

• Mucosal candidiasis – an infection that affects the lining of the mouth or throat.
• Candidainfections of the bloodstream, organs (e.g. heart, lungs) or urinary tract.
• Cryptococcal meningitis – a fungal infection in the brain.

It may also be prescribed for you to:

• Prevent the spread of Candidainfections (if your immune system is weak and not working properly).
• Prevent cryptococcal meningitis from coming back.

2. What you need to know before you take Fluconazole Stada

Do not take Fluconazole Stada

• if you are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin rash or difficulty breathing.
• if you are taking astemizole, terfenadine (antihistamine medicines for allergies).
• if you are taking cisapride (used for stomach upset).
• if you are taking pimozide (used for mental health conditions).
• if you are taking quinidine (used for heart rhythm disorders).
• if you are taking erythromycin (an antibiotic for infections).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Fluconazole Stada

• if you have liver or kidney problems.
• if you have a heart condition, including heart rhythm problems.
• if you have abnormal levels of potassium, calcium or magnesium in your blood.
• if you experience severe skin reactions (itching, skin rash or difficulty breathing).
• if you have ever had a severe skin rash or peeling, blisters and/or sores in the mouth after taking fluconazole.

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 of the symptoms related to these severe skin reactions described in section 4.

• if you experience signs of “adrenal insufficiency”, where the adrenal glands do not produce enough of certain hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain).
• if the fungal infection does not improve, alternative antifungal treatment may be necessary.

Taking Fluconazole Stada with other medicines

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

Tell your doctor immediatelyif you are taking astemizole, terfenadine (an antihistamine for allergies), cisapride (used for stomach upset), pimozide (used for mental health conditions), quinidine (used for heart rhythm disorders) or erythromycin (an antibiotic for infections), as these medicines should not be taken with fluconazole (see section: “Do not take Fluconazole Stada”).

There are some medicines that may interact with fluconazole. Make sure your doctor knows if you are taking any of the following medicines, as a dose adjustment or monitoring may be necessary to ensure the medicines continue to have the desired effect:

• Rifampicin or rifabutin (antibiotics for infections).
• Abrocitinib (used to treat atopic dermatitis, also known as eczema).
• Alfentanil, fentanyl (used as anaesthetics).
• Amitriptyline, nortriptyline (used as antidepressants).
• Amphotericin B, voriconazole (antifungals).
• Medicines that make the blood less viscous, to prevent blood clots (warfarin or similar medicines).
• Benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety.
• Carbamazepine, phenytoin (used to treat seizures).
• Nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for high blood pressure).
• Olaparib (used to treat ovarian cancer).
• Ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection).
• Cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer.
• Halofantrine (used to treat malaria).
• Statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used to lower high cholesterol levels.
• Methadone (used for pain relief).
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs – NSAIDs).
• Oral contraceptives.
• Prednisone (steroid).
• Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients).
• Medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide or tolbutamide.
• Theophylline (used to control asthma).
• Tofacitinib (used to treat rheumatoid arthritis).
• Tolvaptan (used to treat hyponatraemia [low sodium levels in the blood] or to slow down kidney function deterioration).
• Vitamin A (nutritional supplement).
• Ivacaftor (alone or in combination with medicines used to treat cystic fibrosis).
• Amiodarone (used to treat irregular heartbeats “arrhythmias”)
• Hydrochlorothiazide (diuretic)
• Ibrutinib (used to treat blood cancer).
• Lurasidone (used to treat schizophrenia).

Taking Fluconazole Stada with food and drinks

You can take the medicine with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 adequate contraceptive methods during treatment, which should be continued for one week after the last dose.

Do not take fluconazole if you are pregnant, think you may be pregnant or are planning to become pregnant or breast-feed, unless your doctor has told you to do so. If you become pregnant while taking this medicine or within one week of the last dose, consult your doctor.

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

There have been reports of babies born with congenital anomalies affecting the skull, ears and bones of the thigh and elbow 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.

You can continue breast-feeding after taking a single dose of 150 mg of fluconazole. You should not continue breast-feeding if you are taking repeated doses of fluconazole.

Driving and using machines

When driving or operating machinery, you should be aware that fluconazole can occasionally cause dizziness or seizures.

Fluconazole Stada contains lactose and sodium

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

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

3. How to take Fluconazole Stada

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The following are the recommended doses of this medicine for the different types of infections:

Adults

Use in children and adolescents

Adolescents 12 to 17 years of age

Follow the dose prescribed by your doctor (adult posology or pediatric posology).

Children up to 11 years

The maximum daily dose for children is 400 mg per day.

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

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

Use in children under 2 weeks of age:

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

Elderly 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 working.

If you take more Fluconazole Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

Taking too many capsules at once can make you feel unwell. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucinations and paranoid behaviour). Symptomatic treatment (with supportive measures and stomach lavage if necessary) may be initiated.

If you forget to take Fluconazole Stada

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking fluconazole and seek medical attention immediatelyif you notice any of the following symptoms:

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

Some people develop allergic reactions,although severe allergic reactions are rare. If any adverse effect appears, talk to your doctor or pharmacist. This includes any possible adverse effect not mentioned in this leaflet. If you experience any of the following symptoms, inform your doctor immediately.

• Sudden wheezing, 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 a rash that causes blisters (this can affect the mouth and tongue).

Fluconazole may affect your liver. Signs that indicate liver problems include:

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

If you experience any of these symptoms, stop taking fluconazole and inform your doctor immediately.

Other Adverse Effects:

Additionally, if you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent adverse effects (may affect up to 1 in 10 people) are:

• Headache.
• Stomach upset, diarrhea, discomfort, vomiting.
• Elevated blood test results indicating liver function.
• Rash.

Uncommon adverse effects (may affect up to 1 in 100 people) are:

• Reduction of red blood cells, which can make your skin pale and cause weakness or difficulty breathing.
• Decreased appetite.
• Insomnia, feeling of numbness.
• Seizures, dizziness, feeling of spinning, tingling, pinching, or numbness, changes in taste sensation.
• Constipation, heavy digestion, gas, dry mouth.
• Muscle pain.

• Liver damage and yellowing of the skin and eyes (jaundice).
• Hives, blisters (hives), itching, increased sweating.
• Fatigue, general feeling of discomfort, fever.

Rare adverse effects (may affect up to 1 in 1,000 people) are:

• White blood cells in the blood that help defend against 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 cholesterol, fat levels).
• Low potassium levels 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.

Frequency not known, but may occur (cannot be estimated from available data):

• Hypersensitivity reaction with skin rash, fever, inflamed glands, increased eosinophils, and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or eruption with eosinophilia and systemic symptoms [DRESS]).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Fluconazol Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Fluconazol Stada

• The active ingredient is fluconazole. Each hard capsule contains 100 mg of fluconazole.
• The other ingredients (excipients) are:

• Capsule content: lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate, and sodium lauryl sulfate.
• Capsule composition: titanium dioxide (E171), water, and gelatin.

Appearance of the Product and Package Contents

Fluconazol Stada 100 mg hard capsules are presented in the form of hard gelatin capsules, with the cap and body white in color.

They are presented in packages of 7 or 100 (clinical packaging) hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

or

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Leaflet:March 2024

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