FLUCONAZOLE 150 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Fluconazole PPH, 150 mg, hard capsules
   1. It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Fluconazole PPH and what is it used for
   1. Adults
   2. Children and adolescents (from 0 to 17 years old)
4. Important information before taking Fluconazole PPH
   1. When not to take Fluconazole PPH
   2. Warnings and precautions
   3. Fluconazole PPH and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Fluconazole PPH, 150 mg, contains lactose monohydrate and sodium
5. How to take Fluconazole PPH
   1. For doses that cannot be achieved with the help of capsules of this strength, other medicines containing fluconazole in the appropriate strength are available on the market.
   2. For children who cannot swallow a capsule and for small children, for whom precise dosing based on body weight is necessary, fluconazole is available in a syrup form on the market.
   3. Adults
   4. Adolescents from 12 to 17 years old
   5. Children up to 11 years old
   6. Dosing in children up to 4 weeks old
   7. Elderly patients
   8. Patients with kidney function disorders
   9. Method of administration
   10. Taking more than the recommended dose of Fluconazole PPH
   11. Missing a dose of Fluconazole PPH
6. Possible side effects
   1. If the patient experiences any of the following symptoms, they should stop taking Fluconazole PPH and seek medical help immediately:
   2. Fluconazole PPH
   3. If any of the above symptoms occur, the patient should stop taking Fluconazole PPH and immediately contact their doctor.
   4. Other side effects
   5. Reporting side effects
7. How to store Fluconazole PPH
8. Contents of the packaging and other information
   1. What Fluconazole PPH contains
   2. What Fluconazole PPH looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last update of the leaflet:

Leaflet attached to the packaging: patient information

Fluconazole PPH, 150 mg, hard capsules

Fluconazole

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fluconazole PPH and what is it 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 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 - fungal infection of the brain,
• Coccidioidomycosis - a respiratory system disease,
• Candida yeast infections detected in the blood, internal organs (e.g., heart, lungs), or urinary tract,
• Mucosal candidiasis (thrush) - infection of the mucous membrane of the mouth, throat, and mouth ulcers related to the use of dental prostheses,
• Genital candidiasis - vaginal or penile infections,
• Skin fungi - e.g., athlete's foot, body fungus, groin fungus, nail fungus.

Fluconazole PPH can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of mucosal candidiasis,
• prevent relapses of vaginal candidiasis,
• prevent yeast infections (in patients with a weakened, 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:

• Mucosal candidiasis (thrush) - infection of the mucous membrane of the mouth or throat,
• Candida yeast infections detected in the blood, internal organs (e.g., heart, lungs), or urinary tract,
• Cryptococcal meningitis - fungal infection of the brain.

Fluconazole PPH 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 PPH

When not to take Fluconazole PPH

Warnings and precautions

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

• the patient has kidney or liver function disorders,
• the patient has heart disease, including heart rhythm disorders,
• the patient has blood potassium, calcium, or magnesium level disorders,
• the patient experiences severe skin reactions (itching, skin redness, difficulty breathing),
• the patient has ever had a severe skin rash or skin peeling after taking Fluconazole PPH,
• the patient develops symptoms of "adrenal insufficiency", where the adrenal glands do not produce enough certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
• the fungal infection does not improve, other antifungal treatment may be necessary.

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

Fluconazole PPH and other medicines

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

• rifampicin, rifabutin, azithromycin (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 have a calming effect,
• 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, vincristine (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 HIV patients),
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide, or tolbutamide,
• theophylline (used to treat 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 or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
If the patient plans to become pregnant, it is recommended to wait for a week after taking a single dose of fluconazole before becoming pregnant. In case of longer treatment cycles with fluconazole, the patient should discuss the need for proper contraception during treatment and for a week after the last dose with their doctor.
If the patient is pregnant, thinks they may be pregnant, or is trying to conceive, they should not take fluconazole unless their doctor recommends it. If the patient becomes pregnant or thinks they may be pregnant while taking this medicine or within a week of the last dose, they should contact 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 birth defects of the heart, bones, and/or muscles.
There have been cases of children with birth defects of the skull, ears, and femur or ulna, 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 PPH should not be taken by breastfeeding women unless their doctor recommends it. Breastfeeding can be continued after taking a single dose of Fluconazole PPH of 200 mg or less. Breastfeeding should not be done in case of taking multiple doses of Fluconazole PPH.

Driving and using machines

While driving or operating machines, the patient should consider that dizziness or seizures may occasionally occur.

Fluconazole PPH, 150 mg, contains lactose monohydrate and sodium

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

This medicine should always be taken as recommended by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dosing, depending on the type of infection, is presented below.

For doses that cannot be achieved with the help of capsules of this strength, other medicines containing fluconazole in the appropriate strength are available on the market.

For children who cannot swallow a capsule and for small children, for whom precise dosing based on body weight is necessary, fluconazole is available in a syrup form on the market.

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

The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Dosing in children up to 4 weeks old

Children from 3 to 4 weeks old
The same dose as above, but given every other day. The maximum dose is 12 mg/kg body weight every 48 hours.
Children under 2 weeks old
The same dose as above, given every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.
For children who cannot swallow a capsule and for small children, for whom precise dosing based on body weight is necessary, fluconazole is available in a syrup form on the market.

Elderly patients

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

Patients with kidney function disorders

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

Method of administration

The capsule should be swallowed whole, with a glass of water. Capsules are best taken at the same time every day.
The medicine can be taken regardless of meals.

Taking more than the recommended dose of Fluconazole PPH

Taking too many capsules at once can 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 behavior). Symptomatic treatment (life-supporting treatment and stomach flushing, if necessary) may be indicated.

Missing a dose of Fluconazole PPH

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 any of the following symptoms occur, the patient should immediatelytell their doctor:

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

If the patient experiences any of the following symptoms, they should stop taking Fluconazole PPH and seek medical help immediately:

Fluconazole PPH

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

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

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

Fluconazole PPH may affect the adrenal glands and the production of steroid hormones. Symptoms of adrenal disorders include:

• fatigue,
• muscle weakness,
• loss of appetite,
• weight loss,
• abdominal pain.

If any of the above symptoms occur, the patient should stop taking Fluconazole PPH and immediately contact their doctor.

Other side effects

Frequent(occurring in no more than 1 in 10 patients)

• headache,
• abdominal pain, diarrhea, nausea, vomiting,
• increased liver function test values,
• rash.

Infrequent(occurring in no more than 1 in 100 patients)

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

Rare(occurring in less than 1 in 1,000 patients)

• decreased white blood cell count and platelet count,
• red or purple skin discoloration, which may be a sign of decreased platelet count or changes in other blood cells,
• changes in blood biochemical parameters (high cholesterol, lipids in the blood),
• decreased potassium levels in the blood,
• tremors,
• ECG changes, 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 any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 PPH

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 PPH contains

• The active substance of the medicine is fluconazole. Each capsule contains 150 mg of fluconazole.
• Other ingredients are: capsule contents: lactose monohydrate, cornstarch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate; capsule shell: gelatin, titanium dioxide (E 171).

What Fluconazole PPH looks like and contents of the packaging

Fluconazole PPH, 150 mg, are hard capsules with a white body and cap, size ‘1’.
The packaging contains 1 capsule in a cardboard box.

Marketing authorization 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 Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Date of last update of the leaflet: