Fluconazole actavis

Package leaflet: Information for the user

Fluconazole Actavis, 50 mg, hard capsules
Fluconazole Actavis, 100 mg, hard capsules
Fluconazole Actavis, 150 mg, hard capsules
Fluconazole Actavis, 200 mg, hard capsules
Fluconazolum
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, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Fluconazole Actavis is and what it is used for
2. What you need to know before taking Fluconazole Actavis
3. How to take Fluconazole Actavis
4. Possible side effects
5. How to store Fluconazole Actavis
6. Contents of the pack and other information

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

Fluconazole Actavis belongs to a group of medicines called antifungals. The active substance is
fluconazole.
Fluconazole Actavis is used to treat infections caused by disease-causing fungi and may also be used to prevent Candida infections. The most common cause of fungal infections are yeasts called 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 system 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 denture-related stomatitis
• genital yeast infections – infections of the vagina or penis
• skin fungal infections – e.g. athlete's foot (tinea pedis), tinea corporis, tinea cruris, fungal nail infections.

Fluconazole Actavis may also be used:

• to prevent recurrence of cryptococcal meningitis
• to prevent recurrence of mucosal yeast infections
• to reduce the frequency of recurrent vaginal Candida infections
• to prevent Candida infections (if the patient's immune system is weakened or not functioning properly).

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 Actavis may also be used:

• to prevent yeast infections (if the patient's immune system is weakened or not functioning properly)
• to prevent recurrence of cryptococcal meningitis.

2. Important information before taking Flukonazol Actavis

When not to take Flukonazol Actavis

• if the patient is allergic to fluconazole, other antifungal medicines, or 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 Flukonazol Actavis, discuss the following with your doctor or
pharmacist:

• if the patient has kidney or liver problems
• if the patient has heart disease, including heart rhythm disorders
• if the patient has abnormal blood levels of potassium, calcium, or magnesium
• if the patient has had severe skin reactions (itching, skin redness, difficulty breathing)
• if symptoms of "adrenal insufficiency" occur, in which 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 the patient has previously experienced severe skin rash, skin peeling, blisters, and/or oral ulcers after taking fluconazole.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with fluconazole. If any of the symptoms of severe skin reactions described in section 4 occur, treatment with Flukonazol Actavis must be discontinued immediately and medical help should be sought without delay.
Contact your doctor or pharmacist if the fungal infection does not improve, as alternative antifungal treatment may be necessary.
Flukonazol Actavis and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
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 Flukonazol Actavis (see section "When not to take Flukonazol Actavis").
There are also other medicines that may interact with Flukonazol Actavis. If the patient is taking any of the following medicines, ensure that the doctor is informed, as dose adjustment or monitoring may be necessary to ensure the continued effectiveness of the medicines:

• rifampicin or rifabutin (antibiotics used to treat infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• 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 help sleep or for calming
• carbamazepine, phenytoin (used to treat epilepsy)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (used to treat high blood pressure)
• olaparib (used to treat ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used to treat cancer
• halofantrine (used to treat malaria)
• statins (atorvastatin, simvastatin and fluvastatin, and 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
• prednisolone (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)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan used to treat hyponatremia (low sodium levels in the blood) or to slow the worsening of kidney function
• vitamin A (dietary supplement)
• ivacaftor (administered alone or in combination with other medicines used to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeat, i.e. arrhythmia)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• lurasidone (used to treat schizophrenia).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should not take Flukonazol Actavis unless specifically advised by a doctor. If pregnancy occurs during treatment or within one week after the last dose, contact your 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 abnormalities in the newborn.
Cases of infants born with congenital malformations of the skull, ears, and femur and elbow bones 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 clear.
Breastfeeding may be continued after a single dose of up to 150 mg.
Breastfeeding should be avoided if the patient is taking multiple doses of fluconazole.
Driving and operating machinery
When driving or operating machinery, bear in mind that dizziness or seizures may rarely occur.
Flukonazol Actavis contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to use Flukonazol Actavis

This medicine should always be used as directed by a physician or pharmacist. If in doubt, consult a 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.
This medicine may be taken with or without food.

The recommended dosage, depending on the type of infection, is given below:

Use in 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 recurrence of 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, pharyngeal and denture-related mucosal candidiasis | 200 mg to 400 mg on the first day, then 100 mg to 200 mg once daily until the physician advises stopping treatment. | | Mucosal candidiasis (thrush) – dosage depends on site of infection | 50 mg to 400 mg once daily for 7 to 30 days, or until the physician advises stopping treatment. | | Prevention of recurrence 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 recurrence. | | Treatment of genital yeast infections | Single dose of 150 mg. | | Prevention of recurrence of vaginal infections | 150 mg every third day, for a total of 3 doses (on days 1, 4, and 7), then once weekly for 6 months, if the patient is at increased risk of 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 need to continue for up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by healthy, uninfected nail). | | Prophylaxis of Candida 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. |

Use in adolescents aged 12 to 17 years
The dose prescribed by the physician should be administered (as for adult patients or as for children).

Use in children under 11 years of age
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 | |----------------|----------------| | Mucosal candidiasis of the mouth and throat caused by Candida | 3 mg per kg of body weight once daily (on the first day, a dose of 6 mg/kg body weight may be given) – dose and duration depend on severity and site of infection | | Cryptococcal meningitis or systemic Candida infections | 6 mg to 12 mg per kg of body weight once daily | | Prevention of recurrence of cryptococcal meningitis | 6 mg/kg body weight once daily | | Prophylaxis of Candida infections in children (in patients with impaired immune function) | 3 mg to 12 mg per kg of body weight once daily |

Use in children aged 0 to 4 weeks
Use in children aged 3 to 4 weeks:

• Same dose as above, but administered every other day. Maximum dose is 12 mg per kg of body weight every 48 hours.

Use in children under 2 weeks of age:

• Same dose as above, administered every 3 days. Maximum dose is 12 mg per kg of body weight every 72 hours.

Elderly patients
The usual adult dose is administered, unless the patient has impaired renal function.

Patients with renal impairment
The physician may adjust the dosage depending on renal function.

Use of more than the recommended dose of Flukonazol Actavis
Taking too many capsules at once may cause adverse effects. Seek immediate medical attention at the nearest hospital emergency department. Symptoms of overdose may include disturbances in hearing, vision and sensation, and thinking about things that are not true (hallucinations and paranoid behavior). Symptomatic treatment may be required (supportive care to maintain vital functions and gastric lavage if necessary).

Missed dose of Flukonazol Actavis
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following symptoms, treatment with
Fluconazole Actavis must be discontinued and immediate medical help must be sought:

• extensive rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, frequency cannot be estimated from available data). Some patients may experience allergic reactions, although severe allergic reactions are rare. If any adverse reaction occurs, consult a doctor or pharmacist. This also applies to any other adverse reactions not listed in this leaflet. If any of the following symptoms occur, inform the doctor immediately:
• sudden wheezing, difficulty breathing or tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, skin redness or red or itchy blisters
• skin rash
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue).

Fluconazole Actavis 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 Actavis and contact a doctor immediately.
Other adverse reactions
Additionally, if any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Common adverse reactions (may affect up to 1 in 10 people):

• headache
• stomach pain, diarrhoea, nausea, vomiting
• increased liver enzyme activity (liver function tests)
• rash.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• reduction in red blood cells, which may cause paleness, weakness and breathlessness
• loss of appetite
• insomnia, drowsiness
• seizures, dizziness, sensation of spinning, sensory disturbances, tingling or prickling, taste changes
• constipation, indigestion, flatulence, dry mouth
• muscle pain
• liver damage or yellowing of the skin or eyes (jaundice)
• blisters, urticaria, increased sweating
• fatigue, general malaise, fever.

Rare adverse reactions (may affect up to 1 in 1,000 people):

• reduction in white blood cells involved in the body's defence against infections and in 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 (high cholesterol levels, blood lipids)
• decreased potassium levels in blood
• tremor
• abnormalities in ECG, heart rhythm disturbances
• liver failure
• allergic reactions (sometimes severe), including extensive blistering rash and 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 a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Flukonazol Actavis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Flukonazol Actavis contains

• The active substance is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• Other components are:
  Capsule contents: lactose monohydrate, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.
  Capsule shell: gelatin, titanium dioxide (E 171).
  Capsule cap:
  Flukonazol Actavis, 50 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132)
  Flukonazol Actavis, 100 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132)
  Flukonazol Actavis, 150 mg: gelatin, titanium dioxide (E 171)
  Flukonazol Actavis, 200 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow iron oxide (E 172), black iron oxide (E 172)

What Flukonazol Actavis looks like and contents of the pack
Hard capsules.
Appearance
Flukonazol Actavis, 50 mg: A hard, gelatin capsule, size "3", with a pale blue cap and a white body, filled with white powder.
Flukonazol Actavis, 100 mg: A hard, gelatin capsule, size "2", with a light blue cap and a white body, filled with white powder.
Flukonazol Actavis, 150 mg: A hard, gelatin capsule, size "1", with a white cap and a white body, filled with white powder.
Flukonazol Actavis, 200 mg: A hard, gelatin capsule, size "0", with a blue cap and a white body, filled with white powder.

Pack sizes
Flukonazol Actavis, 50 mg, 100 mg, and 200 mg: 7, 14, or 28 capsules in blister packs, in a cardboard box.
Flukonazol Actavis, 150 mg: 1 or 7 capsules in a blister pack, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
PharmaPath S.A.
28is Oktovriou 1
Agia Varvara,
123 51,
Greece

For more detailed information about the medicinal product and its trade names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.