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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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

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

• Cryptococcal meningitis - a fungal infection of the brain;
• Coccidioidomycosis - a disease of the respiratory system;
• Infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• Candida mucosal infections - infection of the mucous membrane of the mouth, throat, and mouth ulcers related to the use of dental prostheses;
• Candida genital infections - 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 Candida mucosal infections;
• prevent relapses of vaginal Candida infections;
• prevent yeast infections (in patients with a weakened and improperly functioning immune system).

Children and adolescents (from 0 to 17 years old)

Your doctor may prescribe this medicine to treat the following fungal infections:

• Candida mucosal infections - 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 not functioning properly);
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Fluconazole Genoptim

When not to take Fluconazole Genoptim:

Warnings and precautions

Before starting treatment with Fluconazole Genoptim, you should discuss it with your 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 you experience any of the severe
skin reactions described in section 4, you should stop taking Fluconazole Genoptim and seek medical
help immediately.

Fluconazole Genoptim and other medicines

You should immediatelytell your 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 you are taking any of the following medicines, you should make sure your 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 you fall asleep or calm down;
• carbamazepine, phenytoin (used to treat epilepsy);
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure);
• cyclosporine, everolimus, sirolimus, or tacrolimus (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 (non-steroidal 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).

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently
taken, as well as any medicines you plan to take.

Fluconazole Genoptim with food and drink

The medicine can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should not
take Fluconazole Genoptim unless your doctor has told you to.
If you plan to become pregnant, it is recommended that you wait one week after taking a single dose of
fluconazole before becoming pregnant.
In the case of longer treatment cycles with fluconazole, you should discuss the need for appropriate
contraception during treatment and for one week after the last dose with your doctor.
Fluconazole taken in the first or second trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken in the first trimester of pregnancy may increase the risk of congenital heart, bone, and
(or) muscle defects in the newborn.
There have been cases of children with congenital skull, ear, and thigh bone defects 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, you should take into account that dizziness or seizures may occur
occasionally.

Fluconazole Genoptim contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking
the medicine.

Fluconazole Genoptim contains sodium.

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

3. How to take Fluconazole Genoptim

This medicine should always be taken exactly as prescribed by your doctor.If you are unsure,
you should ask your 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 dose depends on the type of infection and is described 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 in 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

Your doctor may prescribe a different dose, depending on your kidney function.

Taking more than the recommended dose of Fluconazole Genoptim

Taking too many capsules at once can cause discomfort. You should immediately contact the emergency department of your 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

You should not take a double dose to make up for a missed dose. If you miss a dose, you should take it as soon as you remember. If it is almost time for your next dose, you should not take the missed dose.
If you have any further questions about taking this medicine, you should ask your 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 you experience any side effects, you should tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet.
If you experience any of the following symptoms, you 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 you experience any of the following symptoms, you should tell your doctor immediately:

• 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;
• skin rash;
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue).

Fluconazole Genoptim may affect the liver. Liver-related symptoms include:

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

If you experience any of the above symptoms, you should stop taking Fluconazole Genoptim and contact your doctor immediately.

Other side effects

Additionally, if any of the side effects get worse or if you experience any side effects not listed in this leaflet, you should tell your 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;
• skin rash.

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

• reduced red blood cell count, causing pallor, weakness, and shortness of breath;
• reduced appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance disorders (feeling of spinning), sensory disturbances, 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 less than 1 in 1000 people):

• reduced white blood cell count and platelet count;
• red or purple discoloration of the skin, which may be a sign of reduced platelet count or changes in other blood cells;
• changes in blood biochemistry parameters (high cholesterol, lipid levels in the blood);
• reduced potassium levels in the blood;
• tremors;
• abnormalities in the 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor or
pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring
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.
By reporting side effects, you can help provide more information on the safety of this 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 that month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 silicon dioxide, 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 yellow
inscription "FL" on the capsule cap and "50" on the capsule body, filled with white or almost white powder.
Fluconazole Genoptim, 100 mg: white or almost white opaque hard gelatin capsule, size "2", with yellow
inscription "FL" on the capsule cap and "100" on the capsule body, filled with white or almost white powder.
Fluconazole Genoptim, 150 mg: white or almost white opaque hard gelatin capsule, size "1", with yellow
inscription "FL" on the capsule cap and "150" on the capsule body, filled with white or almost white powder.
Fluconazole Genoptim, 200 mg: white or almost white opaque hard gelatin capsule, size "0", with yellow
inscription "FL" on the capsule cap and "200" on the capsule body, filled with 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