Fluconazole genoptim
Poland
Table of Contents
- Package leaflet: Information for the user
- 1. What Fluconazole Genoptim is and what it is used for
- 2. Important information before using Fluconazole Genoptim
- 3. How to use Fluconazole Genoptim
- 4. Possible adverse reactions
- 5. How to store Fluconazole Genoptim
- 6. Contents of the pack and other information
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
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you personally. 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, tell your doctor, pharmacist, or nurse. See section 4.
Leaflet contents
- What Fluconazole Genoptim is and what it is used for
- What you need to know before taking Fluconazole Genoptim
- How to take Fluconazole Genoptim
- Possible side effects
- How to store Fluconazole Genoptim
- 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 antifungal medicines. The active substance is fluconazole.
Fluconazole Genoptim is used to treat infections caused by pathogenic fungi
and may also be used for the prevention of Candida infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
Adults
Your doctor may recommend using this medicine for the following fungal infections:
- cryptococcal meningitis – a fungal infection of the brain;
- coccidioidomycosis – a respiratory disease;
- infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
- mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and oral thrush associated with the use of dental prostheses;
- genital yeast infections – infections of the vagina or penis;
- skin fungal infections – e.g. athlete's foot, fungal infections of the trunk, groin, or nails.
Fluconazole Genoptim may also be used:
- to prevent recurrence of cryptococcal meningitis;
- to prevent recurrence of mucosal yeast infections;
- to prevent recurrence of vaginal yeast infections;
- to prevent yeast infections in patients with weakened or impaired immune systems.
Children and adolescents (aged 0 to 17 years)
Your doctor may recommend using this medicine to treat the following fungal infections:
- mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat;
- infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract;
- cryptococcal meningitis – a fungal infection of the brain.
Fluconazole Genoptim may also be used:
- to prevent yeast infections (in patients with a weakened or poorly functioning immune system);
- to prevent recurrence of cryptococcal meningitis.
2. Important information before using Fluconazole Genoptim
When not to take Fluconazole Genoptim:
- if the patient is allergic to fluconazole, to other antifungal medicines, or to any of the other ingredients of this medicine (listed in section 6); symptoms may include itching, skin redness or difficulty breathing;
- if the patient is taking astemizole, terfenadine (antihistamine medicines used to treat allergies);
- if the patient is taking cisapride (used to treat stomach disorders);
- if the patient is taking pimozide (used to treat mental disorders);
- if the patient is taking quinidine (used to treat heart rhythm disorders);
- if the patient is taking erythromycin (an antibiotic used to treat infections).
Warnings and precautions
Before starting treatment with Fluconazole Genoptim, discuss with your doctor or
pharmacist:
- if the patient has ever experienced severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Fluconazole Genoptim;
- if the patient has liver or kidney function disorders;
- if the patient has heart diseases, including heart rhythm disorders;
- if the patient has abnormal blood levels of potassium, calcium or magnesium;
- if the patient experiences severe skin reactions (itching, skin redness, difficulty breathing);
- if symptoms of "adrenal insufficiency" develop, when adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
- if fungal infection does not improve, alternative antifungal treatment may be necessary.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with Fluconazole Genoptim. If any of the symptoms of severe skin reactions described in section 4 occur, treatment with Fluconazole Genoptim must be discontinued immediately and medical help should be sought without delay.
Fluconazole Genoptim and other medicines
You must immediately inform your doctor if you are taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these should not be taken together with Fluconazole Genoptim (see section "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, ensure that the doctor is informed:
- rifampicin or rifabutin (antibiotics used to treat infections);
- alfentanil, fentanyl (anaesthetics);
- amitriptyline, nortriptyline (antidepressants);
- amphotericin B, voriconazole (antifungal medicines);
- anticoagulants (medicines that reduce blood clotting and prevent blood clots, such as warfarin or similar medicines);
- benzodiazepines (midazolam, triazolam or similar medicines) used to aid sleep or for calming;
- 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 similar medicines) used in cancer treatment;
- halofantrine (used to treat malaria);
- statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used to lower cholesterol levels;
- methadone (a painkiller);
- celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs);
- oral contraceptives;
- prednisone (a steroid);
- zidovudine, also known as AZT;
- saquinavir (used in patients with HIV virus);
- antidiabetic medicines such as chlorpropamide, glyburide, 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 – "arrhythmias");
- hydrochlorothiazide (a diuretic).
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Fluconazole Genoptim with food and drink
This medicine can be taken during or independently of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should not take Fluconazole Genoptim unless specifically advised by a doctor.
If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.
For longer treatment courses with fluconazole, discuss with your doctor the need for appropriate contraception during treatment and for one week after the last dose.
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 abnormalities in the newborn.
Cases of infants born with congenital malformations of the skull, ears, femur and elbow bones have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least 3 months. The causal relationship between fluconazole use and these cases is not fully established.
High-dose fluconazole, particularly when used long-term, should not be used during pregnancy except for the treatment of life-threatening infections.
Breastfeeding may continue after a single dose of Fluconazole Genoptim of 200 mg or less. The patient should not breastfeed after receiving multiple doses of Fluconazole Genoptim or after administration of a high dose.
Driving and using machines
When driving or operating machinery, bear in mind that dizziness or seizures may occasionally occur.
Fluconazole Genoptim contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Fluconazole Genoptim contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning this medicine is considered "sodium-free".
3. How to use Fluconazole Genoptim
This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The capsule should be swallowed whole with a glass of water. It is best to take the capsules
at the same time each day.
The recommended dosage, depending on the type of infection, is given below.
Adults
| Indication | Dosage |
|---|---|
| Treatment of cryptococcal meningitis | 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks, or longer if necessary. Sometimes the dose may be increased to 800 mg |
| Prevention of recurrence of cryptococcal meningitis | 200 mg once daily until the physician decides to discontinue treatment |
| Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. Sometimes the dose may be increased to 800 mg |
| Treatment of systemic Candida infections | 800 mg on the first day, then 400 mg once daily until the physician decides to discontinue treatment |
| Treatment of fungal infections of the oral mucosa, throat and denture-related stomatitis | 200 mg to 400 mg on the first day, then 100 mg to 200 mg until the physician decides to discontinue treatment |
| Mucosal fungal infections (mycoses) – dosage depends on the site of infection | 50 mg to 400 mg once daily for 7 to 30 days, until the physician decides to discontinue treatment |
| Prevention of oral and pharyngeal mucosal infections | 100 mg to 200 mg once daily or 200 mg three times weekly, if the patient is at increased risk of infection recurrence |
| Treatment of genital fungal infections | Single 150 mg dose |
| Prevention of vaginal infection recurrence | 150 mg every third day, for a total of 3 doses (days 1, 4, and 7), then once weekly for 6 months, if the patient is at increased risk of infection recurrence |
| Treatment of fungal skin and nail infections | Depending on the site of infection: 50 mg once daily, 150 mg once weekly, or 300 mg to 400 mg once weekly for 1 to 4 weeks (in tinea pedis, treatment may require up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by a new, uninfected one) |
| Prevention of fungal infections (in patients with weakened or impaired immune system) | 200 mg to 400 mg once daily, if the patient is at increased risk of infection recurrence |
Adolescents aged 12 to 17 years
The dose prescribed by the physician should be administered (the same as for adult patients or as for children).
Children up to 11 years of age
For children who cannot swallow capsules and for young children requiring precise dosing based on body weight, fluconazole is available in the form of syrup.
The maximum daily dose in children is 400 mg.
The dose will be determined based on the child's body weight in kilograms.
| Indication | Daily dose |
|---|---|
| Oral and pharyngeal mucosal candidiasis caused by Candida − dose and duration of treatment depend on severity and site of infection | 3 mg per kg of body weight (on the first day, a dose of 6 mg/kg body weight may be given) |
| Cryptococcal meningitis or systemic fungal infections | 6 mg to 12 mg per kg of body weight |
| Prevention of fungal infections in children (when the immune system is not functioning properly) | 3 mg to 12 mg per kg of body weight |
Children aged 0 to 4 weeks
Dosing in children aged 3 to 4 weeks
The same dose as above, but administered every other day. The maximum dose is 12 mg per kg
of body weight every 48 hours.
Dosing in children under 2 weeks of age
The same dose as above, administered every 3 days. The maximum dose is 12 mg per kg of body weight
every 72 hours.
Elderly patients
The usual adult dose should be given, unless the patient has impaired kidney function.
Patients with renal impairment
The physician may adjust the dosage depending on kidney function.
Use of a higher than recommended dose of Fluconazole Genoptim
Taking too many capsules at once may cause malaise. Immediate contact should be made with
the emergency department of the nearest hospital. Symptoms of overdose may include disturbances
of hearing, vision, and sensation, thinking about untrue things (hallucinations and paranoid behavior).
Symptomatic treatment may be indicated (supportive treatment of vital functions and gastric
lavage, if necessary).
Missed dose of Fluconazole Genoptim
Do not take a double dose to make up for a missed dose. If a dose is missed, 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 further doubts regarding the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any adverse reaction occurs, consult a doctor or pharmacist. This also applies to any adverse reactions not listed in this leaflet.
If any of the following symptoms occur, stop taking Fluconazole Genoptim immediately and seek medical help without delay:
- extensive rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity).
If any of the following symptoms occur, tell 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, itchy blisters;
- skin rash;
- severe skin reactions, such as blistering rash (may also affect the mouth and tongue).
Fluconazole Genoptim may affect the liver. Liver-related symptoms include:
- feeling tired;
- loss of appetite;
- vomiting;
- yellowing of the skin or whites of the eyes (jaundice).
If any of the above symptoms occur, stop taking Fluconazole Genoptim and contact your doctor immediately.
Other adverse reactions
Additionally, if any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Common adverse reactions (may occur in up to 1 in 10 people):
- headache;
- abdominal pain, diarrhoea, nausea, vomiting;
- increased liver function test values;
- rash.
Uncommon adverse reactions (may occur in up to 1 in 100 people):
- decreased number of red blood cells causing paleness, weakness, and shortness of breath;
- decreased appetite;
- insomnia, drowsiness;
- seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly tingling, prickling, or numbness, taste changes;
- constipation, indigestion, bloating, dry mouth;
- muscle pain;
- liver damage or yellowing of the skin and eyes (jaundice);
- blisters, urticaria, itching, increased sweating;
- feeling of fatigue, malaise, fever.
Rare adverse reactions (may occur in up to 1 in 1,000 people):
- decreased number of white blood cells involved in defending the body against infections and blood cells that help stop bleeding;
- red or purple skin discolouration, which may result from reduced platelet count or changes in other blood cells;
- changes in blood biochemical parameters (elevated cholesterol, blood lipids);
- decreased potassium levels in the blood;
- tremor;
- abnormalities in ECG, heart rhythm disorders;
- liver failure;
- allergic reactions (sometimes severe), including extensive blistering rash, skin peeling, severe skin reactions, swelling of the lips or face;
- hair loss.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 stated on the packaging following:
EXP: (expiry date). The expiry date refers to the last day of the specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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.
- Other ingredients:
- Capsule contents: lactose monohydrate, maize starch, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.
- Gelatin capsule shell: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, purified water.
- Printing ink contains: shellac, yellow iron oxide (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 "FL" printed 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 a yellow "FL" printed 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 a yellow "FL" printed 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 a yellow "FL" printed 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 types:
PVC/PVDC/Aluminium blisters in cardboard outer packaging.
Each 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
Poland
Manufacturer/Importer
Generis Farmacêutica, 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