Fluconazole Genoptim

Package Leaflet: 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 all of this leaflet carefully before taking this medicine.

• Keep this 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. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Fluconazole Genoptim belongs to a group of medicines called antifungals. The active substance is fluconazole.
Fluconazole Genoptim is used to treat infections caused by fungi and can also be used to prevent fungal infections.

Adults

Your doctor may prescribe Fluconazole Genoptim for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain;
• Coccidioidomycosis - a disease of the lungs;
• Candida infections of the blood, internal organs (such as the heart, lungs) or urinary tract;
• Mucosal candidiasis (thrush) - infection of the membranes of the mouth, throat and denture-related stomatitis;
• Genital candidiasis - infections of the vagina or penis;
• Dermatomycoses (fungal infections of the skin) - such as athlete's foot, body ringworm, jock itch.

Fluconazole Genoptim can also be used to:

• prevent relapse of cryptococcal meningitis;
• prevent relapse of mucosal candidiasis;
• prevent relapse of vaginal candidiasis;
• prevent candidal infections in patients with impaired immune systems.

Children and adolescents (from 0 to 17 years old)

Your doctor may prescribe Fluconazole Genoptim for the following fungal infections:

• Mucosal candidiasis (thrush) - infection of the mouth or throat;
• Candida infections of the blood, internal organs (such as the heart, lungs) or urinary tract;
• Cryptococcal meningitis - a fungal infection of the brain.

Fluconazole Genoptim can also be used to:

• prevent candidal infections in patients with impaired immune systems;
• prevent relapse of cryptococcal meningitis.

2. Before taking Fluconazole Genoptim

Do not take Fluconazole Genoptim:

• if you are allergic to fluconazole or any of the other ingredients of this medicine;
• if you are taking astemizole, terfenadine (antihistamines used for allergy);
• if you are taking cisapride (for stomach problems);
• if you are taking pimozide (for psychiatric problems);
• if you are taking quinidine (for heart rhythm problems);
• if you are taking erythromycin (an antibiotic used for infections).

Warnings and precautions

Before taking Fluconazole Genoptim, tell your doctor or pharmacist:

• if you have ever had a severe skin rash or peeling, blistering and bleeding of the skin (Stevens-Johnson syndrome) after taking fluconazole;
• if you have liver or kidney problems;
• if you have heart problems, including heart rhythm problems;
• if you have abnormal levels of potassium, calcium or magnesium in your blood;
• if you have severe skin reactions (itching, redness, difficulty breathing).
• if you develop signs of adrenal insufficiency (chronic or long-lasting fatigue, weakness, loss of appetite, weight loss, abdominal pain).
• if the fungal infection does not improve, you may need to take a different antifungal medicine.

There have been reports of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS) in patients taking Fluconazole Genoptim. If you experience any symptoms of severe skin reactions, stop taking Fluconazole Genoptim and seek medical help immediately.

Fluconazole Genoptim with other medicines

Tell your doctor or pharmacist if you are taking:

• rifampicin or rifabutin (antibiotics used for infections);
• alfentanil, fentanyl (anaesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungals);
• blood thinners (warfarin or similar medicines);
• benzodiazepines (midazolam, triazolam or similar medicines) used for sedation or sleep;
• carbamazepine, phenytoin (used for epilepsy);
• nifedipine, isradipine, amlodipine, felodipine and losartan (used for high blood pressure);
• cyclosporin, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection);
• cyclophosphamide, vincristine (used for cancer);
• halofantrine (used for malaria);
• statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used to lower cholesterol;
• methadone (pain relief);
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines);
• oral contraceptives;
• prednisone (steroid);
• zidovudine, also known as AZT;
• saquinavir (used for HIV);
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide or tolbutamide;
• theophylline (used for asthma);
• vitamin A (dietary supplement);
• ivacaftor (used for cystic fibrosis);
• amiodarone (used for heart rhythm problems);
• hydrochlorothiazide (diuretic).

Tell your doctor or pharmacist if you are taking any other medicines.

Fluconazole Genoptim with food and drink

Fluconazole Genoptim can be taken with or without food.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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, your doctor may recommend using a contraceptive method during treatment with Fluconazole Genoptim and for one week after the last dose.
Fluconazole may increase the risk of miscarriage and birth defects if taken during the first trimester of pregnancy. If you take Fluconazole Genoptim during the first trimester of pregnancy, your doctor will monitor your baby's development.
There have been reports of birth defects in babies born to mothers who took high doses of fluconazole (400-800 mg per day) for a long time (more than 3 months) during pregnancy. The relationship between fluconazole and these birth defects is not clear.
Fluconazole should not be taken during pregnancy unless absolutely necessary.
You can breastfeed after taking a single dose of Fluconazole Genoptim 200 mg or less. You should not breastfeed if you are taking multiple doses of Fluconazole Genoptim or high doses.

Driving and using machines

Fluconazole Genoptim may cause dizziness or seizures. Be careful when driving or operating machinery.

Fluconazole Genoptim contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Fluconazole Genoptim contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially 'sodium-free'.

3. How to take Fluconazole Genoptim

Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. Try to take the capsule at the same time each day.
The recommended dose depends on the type of infection. The following doses are recommended:

Adults

Adolescents from 12 to 17 years old
Take the dose prescribed by your doctor (as for adults or children).
Children under 11 years old
For children who cannot swallow capsules and for young children who need precise dosing based on body weight, fluconazole is available as a syrup.
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
Same dose as above, but given every other day. Maximum dose is 12 mg per kilogram of body weight every 48 hours.
Dosing in children under 2 weeks old
Same dose as above, given every 3 days. Maximum dose is 12 mg per kilogram of body weight every 72 hours.

Elderly patients

Take the usual adult dose, unless you have kidney problems.

Patients with kidney problems

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

Overdose

If you take too many capsules, contact your doctor or the nearest hospital emergency department immediately. Symptoms of overdose may include hearing, vision or feeling disturbances, and hallucinations or paranoid behaviour. Treatment may include supportive therapy and gastric lavage if necessary.

Missed dose

Do not take a double dose to make up for a forgotten dose. Take the missed dose as soon as you remember, unless it is almost time for your next dose. If you have any further questions, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluconazole Genoptim can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, although severe allergic reactions are rare. If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
If you experience any of the following symptoms, stop taking Fluconazole Genoptim and seek medical help immediately:

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

If you experience any of the following symptoms, tell your doctor immediately:

• sudden wheezing, difficulty breathing or tightness in the chest;
• swelling of the eyelids, face or lips;
• itching all over the body, redness, difficulty breathing;
• skin rash;
• severe skin reactions, including blistering of the skin (Stevens-Johnson syndrome).

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

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

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

Other side effects

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common side effects(may affect up to 1 in 10 people):

• headache;
• abdominal pain, diarrhoea, nausea, vomiting;
• increased liver enzymes;
• skin rash.

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

• reduced red blood cell count, which can cause pale skin, weakness and shortness of breath;
• reduced appetite;
• insomnia, drowsiness;
• seizures, dizziness, balance problems (feeling of spinning), changes in sensation, usually as tingling, numbness or altered sense of touch;
• constipation, indigestion, bloating, dry mouth;
• muscle pain;
• liver damage or yellowing of the skin and eyes (jaundice);
• blisters, hives, itching, increased sweating;
• feeling tired, unwell, fever.

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

• reduced white blood cell count, which can increase the risk of infection;
• red or purple discoloration of the skin, which can be a sign of reduced platelet count or other blood disorders;
• changes in blood tests (high cholesterol, lipids);
• reduced potassium levels in the blood;
• tremors;
• abnormal heart rhythm, changes in ECG;
• 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 of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluconazole Genoptim

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fluconazole Genoptim contains

• The active substance is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are:
• capsule content: lactose monohydrate, maize starch, sodium lauryl sulfate, colloidal silicon dioxide and magnesium stearate.
• capsule shell: 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 printing "FL" on the cap and "50" on the body, filled with white or almost white powder.
Fluconazole Genoptim 100 mg: white or almost white opaque hard gelatin capsule, size 2, with yellow printing "FL" on the cap and "100" on the body, filled with white or almost white powder.
Fluconazole Genoptim 150 mg: white or almost white opaque hard gelatin capsule, size 1, with yellow printing "FL" on the cap and "150" on the body, filled with white or almost white powder.
Fluconazole Genoptim 200 mg: white or almost white opaque hard gelatin capsule, size 0, with yellow printing "FL" on the cap and "200" on the body, filled with white or almost white powder.

Pack sizes

Fluconazole Genoptim hard capsules are available in the following pack sizes:

PVC/PVDC/Aluminium blisters in a cardboard box.
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 authorisation holder

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

Manufacturer

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