Fluconazole Genoptim

Leaflet accompanying the packaging: information for the user

Fluconazole Genoptim, 50 mg, hard capsules

Fluconazole Genoptim, 100 mg, hard capsules

Fluconazole Genoptim, 150 mg, hard capsules

Fluconazole Genoptim, 200 mg, hard capsules

Fluconazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fluconazole Genoptim and what is it used for
• 2. Important information before taking Fluconazole Genoptim
• 3. How to take Fluconazole Genoptim
• 4. Possible side effects
• 5. How to store Fluconazole Genoptim
• 6. Contents of the packaging and other information

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

Fluconazole Genoptim belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluconazole Genoptim is used to treat infections caused by pathogenic fungi
and can also be used to prevent yeast infections. The most common cause of fungal infections
is yeast of the genus Candida.

Adults

The doctor may recommend taking this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain;
• Coccidioidomycosis - a respiratory system disease;
• Infections caused by Candida yeast detected in the blood, internal organs (e.g., heart, lungs), or urinary tract;
• Yeast infections of the mucous membranes - infection of the mucous membrane of the mouth, throat, and mouth ulcers related to the use of dental prostheses;
• Yeast infections of the genital organs - infections of the vagina or penis;
• Fungal skin infections - e.g., athlete's foot, fungal infections of the torso, groin, and fingernails.

Fluconazole Genoptim can also be used to:

• prevent relapses of cryptococcal meningitis;
• prevent relapses of yeast infections of the mucous membranes;
• prevent relapses of yeast infections of the vagina;
• prevent yeast infections (in patients with a weakened and improperly functioning immune system).

Children and adolescents (from 0 to 17 years old)

The doctor may recommend taking this medicine to treat the following fungal infections:

• Yeast infections of the mucous membranes - infections of the mucous membrane of the mouth or throat;
• Infections caused by Candida yeast detected in the blood, internal organs (e.g., heart, lungs), or urinary tract;
• Cryptococcal meningitis - a fungal infection of the brain.

Fluconazole Genoptim can also be used to:

• prevent yeast infections (if the patient's immune system is weak and does not function properly);
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Fluconazole Genoptim

When not to take Fluconazole Genoptim:

Warnings and precautions

Before starting to take Fluconazole Genoptim, the patient should discuss it with their doctor or
pharmacist:

In patients treated with Fluconazole Genoptim, there have been cases of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of the symptoms of severe skin reactions described in section 4, they should stop taking Fluconazole Genoptim and seek medical help immediately.

Fluconazole Genoptim and other medicines

The patient should immediatelytell their doctor about taking astemizole, terfenadine (antihistamines used to treat allergies) or cisapride (used to treat stomach disorders), or pimozide (used to treat mental disorders), or quinidine (used to treat heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as they should not be taken with Fluconazole Genoptim (see "When not to take Fluconazole Genoptim").
There are also other medicines that may interact with Fluconazole Genoptim.
If the patient is taking any of the following medicines, they should make sure their doctor is informed:

• rifampicin or rifabutin (antibiotics used to treat infections);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• blood thinners, medicines that prevent blood clots (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam, or other similar medicines) that help with sleep or sedation;
• carbamazepine, phenytoin (used to treat epilepsy);
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure);
• cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or other similar medicines) used to treat cancer;
• halofantrine (used to treat malaria);
• statins (atorvastatin, simvastatin, and fluvastatin or other similar medicines) used to lower cholesterol levels;
• methadone (a pain reliever);
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (nonsteroidal anti-inflammatory medicines - NSAIDs);
• oral contraceptives;
• prednisone (a steroid);
• zidovudine, also known as AZT;
• saquinavir (used in patients with HIV);
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide;
• theophylline (used to treat asthma);
• vitamin A (dietary supplement);
• ivacaftor (used to treat cystic fibrosis);
• amiodarone (used to treat heart rhythm disorders - "arrhythmia");
• hydrochlorothiazide (a diuretic).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Fluconazole Genoptim with food and drink

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should not take Fluconazole Genoptim unless their doctor has advised them to do so.
If the patient plans to become pregnant, it is recommended that they wait for a week after taking a single dose of fluconazole before becoming pregnant.
In the case of longer treatment cycles with fluconazole, the patient should discuss the need for appropriate contraception during treatment and for a week after the last dose with their doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk of congenital heart, bone, and (or) muscle defects in the newborn.
There have been reports of children with congenital defects of the skull, ears, and femur and humerus bones, born to mothers treated for coccidioidomycosis with high doses of fluconazole (400-800 mg per day) for at least 3 months. The relationship between fluconazole use and these cases is unclear.
Fluconazole should not be taken in high doses, especially for a long time, during pregnancy, except for life-threatening infections.
Breastfeeding can be continued after taking a single dose of Fluconazole Genoptim of 200 mg or less. The patient should not breastfeed after taking multiple doses of Fluconazole Genoptim or after taking a high dose.

Driving and using machines

When driving or operating machinery, the patient should take into account that dizziness or seizures may occasionally occur.

Fluconazole Genoptim contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Fluconazole Genoptim contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Fluconazole Genoptim

This medicine should always be taken as directed by the doctor.In case of doubts, the patient should consult their doctor or pharmacist.
The capsule should be swallowed whole, with a glass of water. The capsules are best taken at the same time every day.
The recommended dosage, depending on the type of infection, is presented below.

Adults

Adolescents from 12 to 17 years old
The dose prescribed by the doctor should be taken (as for adult patients or as for children).
Children up to 11 years old
For children who cannot swallow capsules and for young children who require precise dosing based on body weight, fluconazole is available in a syrup form.
The maximum dose for children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Children from 0 to 4 weeks old

Dosing in children from 3 to 4 weeks old
The same dose as above, but given every other day. The maximum dose is 12 mg per kilogram of body weight every 48 hours.
Dosing in children under 2 weeks old
The same dose as above, given every 3 days. The maximum dose is 12 mg per kilogram of body weight every 72 hours.

Elderly patients

The usual adult dose is given, unless the patient has kidney problems.

Patients with kidney problems

The doctor may recommend changing the dose, depending on kidney function.

Taking more than the recommended dose of Fluconazole Genoptim

Taking too many capsules at once may cause discomfort. The patient should immediately contact the emergency department of the nearest hospital. Symptoms of possible overdose may include hearing, vision, or sensation disorders, thinking about untrue things (hallucinations and paranoid behaviors). Symptomatic treatment (life-supporting treatment and stomach lavage, if necessary) may be indicated.

Missing a dose of Fluconazole Genoptim

The patient should not take a double dose to make up for a missed dose. If a dose is missed, it should be taken as soon as remembered. If it is almost time for the next dose, the missed dose should not be taken.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, but severe allergic reactions are rare. If the patient experiences any side effects, they should consult their doctor or pharmacist. This also applies to side effects not listed in this leaflet.
If the patient experiences any of the following symptoms, they should stop taking Fluconazole Genoptim and seek medical help immediately:

• widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity to the medicine).

If the patient experiences any of the following symptoms, they should immediately tell their doctor:

• sudden wheezing, difficulty breathing, or chest tightness;
• swelling of the eyelids, face, or lips;
• itching all over the body, redness of the skin, or red, itchy blisters;
• rash on the skin;
• severe skin reactions, such as a rash with blisters (may also affect the mouth and tongue).

Fluconazole Genoptim may affect the liver. Symptoms of liver problems include:

• feeling tired;
• loss of appetite;
• vomiting;
• yellowing of the skin or whites of the eyes (jaundice).

If the patient experiences any of the above symptoms, they should stop taking Fluconazole Genoptim and immediately contact their doctor.

Other side effects

Additionally, if any side effects worsen or if any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.
Common side effects(may occur in up to 1 in 10 people):

• headache;
• abdominal pain, diarrhea, nausea, vomiting;
• increased liver enzyme values;
• rash.

Uncommon side effects(may occur in up to 1 in 100 people):

• decrease in the number of red blood cells, causing paleness, weakness, and shortness of breath;
• decrease in appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, numbness, or prickling, changes in taste;
• constipation, indigestion, bloating, dry mouth;
• muscle pain;
• liver damage or yellowing of the skin and eyes (jaundice);
• blisters, hives, itching, increased sweating;
• feeling tired, malaise, fever.

Rare side effects(may occur in up to 1 in 1000 people):

• decrease in the number of white blood cells involved in the body's defense against infections and cells that help stop bleeding;
• red or purple discoloration of the skin, which may be a sign of a decrease in platelet count or changes in other blood cells;
• changes in blood biochemical parameters (high cholesterol, lipid levels in the blood);
• decrease in potassium levels in the blood;
• tremors;
• abnormalities in ECG, heart rhythm disorders;
• liver failure;
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face;
• hair loss.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fluconazole Genoptim

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP: (expiry date). The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazole Genoptim contains

• The active substance of the medicine is fluconazole. The hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• Other ingredients:
• capsule contents: lactose monohydrate, cornstarch, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.
• gelatin capsule: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water.
• ink contains: shellac, iron oxide yellow (E 172).

What Fluconazole Genoptim looks like and contents of the pack

Fluconazole Genoptim, 50 mg: white or almost white opaque hard gelatin capsule, size "4", with a yellow inscription "FL" on the capsule cap and "50" on the capsule body, filled with a white or almost white powder.
Fluconazole Genoptim, 100 mg: white or almost white opaque hard gelatin capsule, size "2", with a yellow inscription "FL" on the capsule cap and "100" on the capsule body, filled with a white or almost white powder.
Fluconazole Genoptim, 150 mg: white or almost white opaque hard gelatin capsule, size "1", with a yellow inscription "FL" on the capsule cap and "150" on the capsule body, filled with a white or almost white powder.
Fluconazole Genoptim, 200 mg: white or almost white opaque hard gelatin capsule, size "0", with a yellow inscription "FL" on the capsule cap and "200" on the capsule body, filled with a white or almost white powder.

Pack sizes

Fluconazole Genoptim hard capsules are available in the following packs:
PVC/PVDC/Aluminum blisters, in a cardboard box.
The pack contains 1, 2, 4, 6, 7, 10, 12, 14, 20, 21, 28, 30, 50, 60, 90, or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

Generis Farmacȇutica, S.A.
Rua João de Deus, n. 19, Venda Nova,
2700-487 Amadora, Portugal
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far Birzebbugia, BBG 3000
Malta
Date of last revision of the leaflet:01.2024