Fluconazole pph
Poland
Table of Contents
Package leaflet: Information for the patient
Fluconazole PPH, 150 mg, hard capsules
Fluconazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Fluconazole PPH is and what it is used for
- Important information before taking Fluconazole PPH
- How to take Fluconazole PPH
- Possible side effects
- How to store Fluconazole PPH
- Contents of the pack and other information
1. What Fluconazole PPH is and what it is used for
Fluconazole PPH belongs to a group of antifungal medicines. The active substance is fluconazole.
Fluconazole PPH is used to treat infections caused by pathogenic fungi
and can also be used to prevent Candida yeast infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
Adults
Your doctor may prescribe this medicine for the following fungal infections:
- cryptococcal meningitis – a fungal infection of the brain,
- coccidioidomycosis – a respiratory disease,
- Candida yeast infections 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 denture-related stomatitis,
- 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 PPH may also be used to:
- prevent recurrence of cryptococcal meningitis,
- prevent recurrence of mucosal yeast infections,
- prevent recurrence of vaginal yeast infections,
- prevent yeast infections (in patients with weakened or impaired immune systems).
Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:
- mucosal yeast infections (thrush) – infections of the mucous membranes of the mouth or throat,
- Candida yeast infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
- cryptococcal meningitis – a fungal infection of the brain.
Fluconazole PPH may also be used to:
- prevent yeast infections (in patients with a weakened or improperly functioning immune system),
- prevent recurrence of cryptococcal meningitis.
2. Important information before using Fluconazole PPH
When not to use Fluconazole PPH
- if the patient is allergic to fluconazole, to other azole compounds, 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 or 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 PPH, discuss this with your doctor or pharmacist if:
- the patient has impaired kidney or liver function,
- the patient has heart conditions, including heart rhythm disorders,
- the patient has abnormal blood levels of potassium, calcium, or magnesium,
- the patient experiences severe skin reactions (itching, skin redness, difficulty breathing),
- the patient has previously experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking Fluconazole PPH,
- the patient develops symptoms of "adrenal insufficiency", where the 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 PPH. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Fluconazole PPH must be discontinued immediately and medical help should be sought without delay.
Fluconazole PPH and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
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 used together with Fluconazole PPH (see section "When not to use Fluconazole PPH").
There are also other medicines that may interact with Fluconazole PPH. If the patient is taking any of the following medicines, ensure that the doctor is aware:
- rifampicin, rifabutin, azithromycin (antibiotics used to treat infections),
- alfentanil, fentanyl (anaesthetic medicines),
- 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 the treatment of cancer,
- halofantrine (used to treat malaria),
- statins (atorvastatin, simvastatin, fluvastatin or similar medicines) used to lower cholesterol levels,
- methadone (a pain-relieving medicine),
- 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 HIV patients),
- antidiabetic medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
- theophylline (used in asthma),
- vitamin A (dietary supplement),
- ivacaftor (used to treat cystic fibrosis),
- hydrochlorothiazide (a diuretic),
- amiodarone (used to treat heart rhythm disorders).
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
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.
If the patient is pregnant, suspects she may be pregnant, or is trying to conceive, she should not take fluconazole unless otherwise directed by a doctor. If the patient becomes pregnant or suspects she may be pregnant while taking this medicine or within one week after the last dose, she should contact her doctor immediately.
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 malformations in the baby.
Cases of babies born with congenital skull, ear, femur, and/or humerus abnormalities have been reported in mothers treated for coccidioidomycosis with high doses of fluconazole (400–800 mg daily) for at least three months. The causal relationship between fluconazole use and these cases is not fully established.
Fluconazole PPH should not be used in breastfeeding women unless otherwise advised by a doctor. Breastfeeding may be continued after a single dose of Fluconazole PPH of 200 mg or less. Breastfeeding should be avoided if the patient is taking multiple doses of Fluconazole PPH.
Driving and operating machinery
When driving or operating machinery, bear in mind that dizziness or seizures may occur rarely.
Fluconazole PPH, 150 mg, contains lactose monohydrate and sodium
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".
3. How to use Fluconazole PPH
This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
The recommended dosage, depending on the type of infection, is given below.
For doses that cannot be achieved using capsules of this strength, other fluconazole medicines
of appropriate strengths are available on the market.
For children who cannot swallow capsules and for young children requiring precise dosing
according to body weight, fluconazole in syrup form is available on the market.
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. The dose may sometimes be increased to 800 mg. |
| Prevention of recurrent cryptococcal meningitis | 200 mg once daily until the physician advises stopping treatment. |
| Treatment of coccidioidomycosis | 200 mg to 400 mg once daily for 11 to 24 months, or longer if necessary. The dose may sometimes be increased to 800 mg. |
| Treatment of systemic Candida infections | 800 mg on the first day, then 400 mg once daily until the physician advises stopping treatment. |
| Treatment of oral mucosal candidiasis, pharyngeal candidiasis, and denture-related stomatitis | 200 mg to 400 mg on the first day, then 100 mg to 200 mg until the physician advises stopping treatment. |
Yeast (mucosal) infections
| 50 mg to 400 mg once daily for 7 to 30 days, or until the physician advises stopping 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 recurrent infection. |
| Treatment of genital yeast infections | Single dose of 150 mg. |
| Prevention of recurrent vaginal infections | 150 mg every third day, for a total of 3 doses (days 1, 4, and 7), followed by once weekly for 6 months (if the patient is at increased risk of recurrent infection). |
| 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 (for tinea pedis, treatment may be required for up to 6 weeks; for nail infections, treatment should continue until the infected nail is completely replaced by a new, uninfected nail). |
| Prevention of yeast infections (in patients with weakened or impaired immune systems) | 200 mg to 400 mg once daily, if the patient is at increased risk of recurrent infection. |
Adolescents aged 12 to 17 years
The dose prescribed by the doctor should be administered (as in adult patients or as in children).
Children up to 11 years of age
The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.
| Indication | Daily dose |
| Yeast infections of the mucous membranes of the oral cavity and pharynx – dose and duration of treatment depend on the severity and location of the infection | 3 mg/kg body weight (on the first day, a dose of 6 mg/kg body weight may be administered) |
| Cryptococcal meningitis or systemic yeast infections of internal organs | 6 to 12 mg/kg body weight |
| Prophylaxis of yeast infections in children (when the immune system is not functioning properly) | 3 to 12 mg/kg body weight |
Dosage in children up to 4 weeks of age
Children aged 3 to 4 weeks
The same dose as above, but administered every other day. The maximum dose is 12 mg/kg body weight
every 48 hours.
Children under 2 weeks of age
The same dose as above administered every 3 days. The maximum dose is 12 mg/kg body weight
every 72 hours.
For children who cannot swallow capsules and for young children requiring precise dosing according to body weight, fluconazole in syrup form is available on the market.
Elderly patients
The usual adult dose should be administered, unless the patient has renal impairment.
Patients with renal impairment
The physician may adjust the dosage depending on renal function.
Method of administration
The capsule should be swallowed whole with a glass of water. Capsules are best taken daily at the same time.
The medicine may be taken independently of meals.
Overdose of Fluconazole PPH
Taking too many capsules at once may cause discomfort. Immediate contact should be made with the emergency department of the nearest hospital. Symptoms of overdose may include disturbances in hearing, vision, and sensation, thinking about unreal things (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive treatment maintaining vital functions and gastric lavage, if necessary).
Missed dose of Fluconazole PPH
Do not take a double dose to make up for a missed dose. If a dose has been missed, take it as soon as remembered. If it is almost time for the next dose, do not take the missed dose.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
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).
If any of the following symptoms occur, stop taking Fluconazole PPH and seek immediate medical help:
- widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Fluconazole PPH may affect the liver. Liver-related symptoms include:
- feeling tired,
- loss of appetite,
- vomiting,
- yellowing of the skin or whites of the eyes (jaundice).
Fluconazole PPH may affect the adrenal cortex and the levels of steroid hormones produced. Symptoms of adrenal cortex disorders include:
- fatigue,
- muscle weakness,
- loss of appetite,
- weight loss,
- abdominal pain.
If any of the above symptoms occur, stop taking Fluconazole PPH and contact your doctor immediately.
Other adverse effects
Common (occur in up to 1 in 10 patients)
- headache,
- abdominal pain, diarrhoea, nausea, vomiting,
- increased liver function test values,
- rash.
Uncommon (occur in up to 1 in 100 patients)
- reduced number of red blood cells causing paleness, weakness and breathlessness,
- decreased appetite,
- insomnia, drowsiness,
- seizures, dizziness, loss of balance (spinning sensation), sensory disturbances, most commonly tingling, pricking or numbness, taste changes,
- constipation, indigestion, bloating, dry mouth,
- muscle pain,
- liver damage and yellowing of the skin and eyes (jaundice),
- blisters, urticaria, itching, increased sweating,
- feeling tired, malaise, fever.
Rare (occur in less than 1 in 1,000 patients)
- reduced number of white blood cells involved in defending the body against infections and blood cells involved in stopping bleeding,
- red or purple skin discolouration, possibly due to reduced platelet count or changes in other blood cells,
- changes in blood biochemical parameters (elevated cholesterol, blood lipids),
- decreased blood potassium levels,
- tremor,
- abnormalities in ECG, heart rhythm disorders,
- liver failure,
- allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of lips or face,
- hair loss.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.
5. How to store Fluconazole PPH
Store below 25°C.
Keep in the original packaging to protect from light.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and that following "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
6. Contents of the pack and other information
What Fluconazole PPH contains
- The active substance is fluconazole. Each capsule contains 150 mg of fluconazole.
- The other ingredients are: capsule contents: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; capsule shell: gelatin, titanium dioxide (E 171).
What Fluconazole PPH looks like and contents of the pack
Fluconazole PPH, 150 mg, are hard capsules with a white body and cap, size '1'.
The pack contains 1 capsule in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba