Flukonazol Actavis

Leaflet accompanying the packaging: 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Fluconazole Actavis and what is it 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 pathogenic fungi and can also be used to prevent yeast infections. The most common cause of fungal infections is yeast called Candida.

Adults

The doctor may recommend taking this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the respiratory system
• Infections caused by Candidayeast detected in the blood, internal organs (e.g., heart, lungs), or urinary tract
• Fungal infections (thrush) of the mucous membrane - infection of the mucous membrane of the mouth, throat, and mouth sores associated with the use of dental prostheses
• Fungal infections of the genital organs - infections of the vagina or penis
• Fungal skin infections - e.g., athlete's foot (foot fungus), fungal infection of the torso, groin, or nails.

Fluconazole Actavis can also be used to:

• prevent relapses of cryptococcal meningitis
• prevent relapses of fungal infections of the mucous membrane
• reduce the frequency of relapses of vaginal yeast infections
• prevent infections caused by Candida(if the patient's immune system is weak and not functioning properly).

Children and adolescents (from 0 to 17 years old)

The doctor may recommend taking this medicine to treat the following fungal infections:

• Fungal infections (thrush) of the mucous membrane - infections of the mucous membrane of the mouth or throat
• Infections caused by Candidayeast detected in the blood, internal organs (e.g., heart, lungs), or urinary tract
• Cryptococcal meningitis - a fungal infection of the brain.

Fluconazole Actavis can also be used to:

• prevent fungal infections (if the patient's immune system is weak and not functioning properly)
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Fluconazole Actavis

When not to take Fluconazole Actavis

• if the patient is allergic to fluconazole, other medicines used to treat fungal infections, 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, terfenadine (antihistamines 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 to take Fluconazole Actavis, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver function disorders
• if the patient has heart disease, including heart rhythm disorders
• if the patient has abnormal levels of potassium, calcium, or magnesium in the blood
• if the patient has severe skin reactions (itching, skin redness, difficulty breathing)
• if the patient experiences symptoms of "adrenal insufficiency", in which the adrenal glands do not produce enough of certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if the patient has ever experienced a severe skin rash or skin peeling after taking fluconazole.

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

Fluconazole Actavis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• rifampicin or rifabutin (antibiotics used to treat infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• 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, 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 other similar medicines) used to treat cancer
• halofantrine (used to treat malaria)
• statins (atorvastatin, simvastatin, and fluvastatin, as well as 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
• 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 (a dietary supplement)
• ivacaftor (given 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)
• lurasydon (used to treat schizophrenia).

Pregnancy, breastfeeding, and fertility

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 that they wait for a week after taking a single dose of fluconazole before becoming pregnant.

In the case of longer treatment cycles with fluconazole, the patient should discuss with their doctor the need for adequate contraception during treatment and for a week after the last dose.

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should not take Fluconazole Actavis unless their doctor has told them to do so. If the patient becomes pregnant while taking this medicine or within a week of taking 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 congenital heart, bone, and/or muscle defects in the newborn.

There have been reports of children with congenital defects of the skull, ears, and thigh or forearm bones born to mothers treated with fluconazole for coccidioidomycosis for at least 3 months with high doses (400-800 mg per day). The relationship between fluconazole use and these cases is unclear.

Breastfeeding can be continued after taking a single dose of up to 150 mg.

The patient should not breastfeed if they are taking multiple doses of fluconazole.

Driving and using machines

While driving or operating machinery, the patient should take into account that dizziness or seizures may occasionally occur.

Fluconazole Actavis contains lactose

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

3. How to take Fluconazole Actavis

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

The capsule should be swallowed whole, with a glass of water. The capsules are best taken at the same time every day.

The medicine can be taken with or without food.

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

Adult dosage

Indication Dosage

Treatment of cryptococcal meningitis 400 mg on the first day, then 200 mg to 400 mg once a day for 6 to 8 weeks or longer if necessary. Sometimes the dose is increased to 800 mg.

Prevention of relapses of cryptococcal meningitis 200 mg once a day until the doctor recommends stopping treatment.

Treatment of coccidioidomycosis 200 mg to 400 mg once a day for 11 months to 24 months or longer if necessary. Sometimes the dose may be increased to 800 mg.

Treatment of internal organ infections caused by Candidayeast 800 mg on the first day, then 400 mg once a day until the doctor recommends stopping treatment.

Treatment of fungal infections of the mouth, throat, and mouth sores associated with the use of dental prostheses 200 mg to 400 mg on the first day, then 100 mg to 200 mg once a day until the doctor recommends stopping treatment.

Fungal infections of the mucous membrane - the dose depends on the location 50 mg to 400 mg once a day for 7 to 30 days, until the doctor recommends stopping treatment.

Prevention of relapses of fungal infections of the mouth and throat 100 mg to 200 mg once a day, or 200 mg 3 times a week, if the patient is at increased risk of relapse.

Treatment of fungal infections of the genital organs Single dose of 150 mg.

Prevention of relapses of vaginal yeast infections 150 mg every third day, for a total of 3 doses (days 1, 4, and 7), and then once a week for 6 months, if the patient is at increased risk of relapse.

Treatment of fungal skin and nail infections Depending on the location of the infection, 50 mg once a day, 150 mg once a week, 300 mg to 400 mg once a week for 1 to 4 weeks (in athlete's foot, treatment may be necessary for up to 6 weeks, in nail infections, treatment should be continued until the old, infected nail is replaced by a new, healthy one).

Prevention of infections caused by Candida(if the patient's immune system is weak and not functioning properly) 200 mg to 400 mg once a day, if the patient is at increased risk of relapse.

Dosage in adolescents from 12 to 17 years old

The dose prescribed by the doctor should be taken (as for adult patients or as for children).

Dosage in 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.

Indication Daily dose

Fungal infections of the mucous membrane of the mouth and throat caused by Candida- the dose and duration of treatment depend on the severity and location of the infection 3 mg per kilogram of body weight once a day (on the first day, a dose of 6 mg/kg can be given)

Cryptococcal meningitis or internal organ infections caused by Candida6 mg to 12 mg per kilogram of body weight once a day

Prevention of relapses of cryptococcal meningitis 6 mg/kg once a day

Prevention of Candidainfections in children (if the immune system is not functioning properly) 3 mg to 12 mg per kilogram of body weight once a day

Dosage in children from 0 to 4 weeks old

Dosage in children from 3 to 4 weeks old:

• The same dose as above, but given every other day. The maximum dose is 12 mg per kilogram of body weight every 48 hours.

Dosage in children under 2 weeks old:

• The same dose as above, given every 3 days. The maximum dose is 12 mg per kilogram of body weight every 72 hours.

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 dosage, depending on kidney function.

Taking more than the recommended dose of Fluconazole Actavis

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 lavage, if necessary) may be indicated.

Missing a dose of Fluconazole Actavis

The patient should not take a double dose to make up for a missed dose. If they miss a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should not take the missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Fluconazole Actavis and seek medical help immediately:

• widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome, frequency cannot be estimated from available data). In some patients, allergic reactionsmay occur, but severe allergic reactions are rare. If the patient experiences any side effect, they should consult their doctor or pharmacist. This also applies to other side effects not listed in this leaflet. If the patient experiences any of the following symptoms, they should immediately tell 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
• skin rash
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue).

Fluconazole Actavis may affect the liver. Symptoms of liver disorders include:

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

If the patient experiences any of the above symptoms, they should stop takingFluconazole Actavis and immediately contact their doctor.

Other side effects

Additionally, if any of the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people):

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

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

• reduced red blood cell count, which can cause pallor, weakness, and shortness of breath
• loss of appetite
• insomnia, drowsiness
• seizures, dizziness, feeling of spinning, sensation disorders, changes in taste
• constipation, indigestion, gas, dry mouth
• muscle pain
• liver damage or yellowing of the skin or eyes (jaundice)
• blisters, hives, increased sweating
• fatigue, general malaise, fever.

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

• reduced white blood cell count and platelet count
• red or purple skin discoloration, which can be a sign of reduced platelet count or changes in other blood cells
• changes in blood biochemistry parameters (high cholesterol, lipid levels in the blood)
• reduced 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Fluconazole Actavis

The medicine should be stored out of 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 month stated.

Do not store above 25°C.

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 Actavis contains

• The active substance of the medicine is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• Other ingredients are: Capsule contents: lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate. Capsule body: gelatin, titanium dioxide (E 171). Capsule cap: Fluconazole Actavis, 50 mg:gelatin, titanium dioxide (E 171), indigo carmine (E 132) Fluconazole Actavis, 100 mg:gelatin, titanium dioxide (E 171), indigo carmine (E 132) Fluconazole Actavis, 150 mg:gelatin, titanium dioxide (E 171) Fluconazole Actavis, 200 mg:gelatin, titanium dioxide (E 171), indigo carmine (E 132), iron oxide yellow (E 172), iron oxide black (E 172)

What Fluconazole Actavis looks like and contents of the pack

Hard capsules.

Appearance

Fluconazole Actavis, 50 mg:hard gelatin capsule, size "3", consisting of a light blue cap and a white body, filled with a white powder.

Fluconazole Actavis, 100 mg:hard gelatin capsule, size "2", consisting of a light blue cap and a white body, filled with a white powder.

Fluconazole Actavis, 150 mg:hard gelatin capsule, size "1", consisting of a white cap and a white body, filled with a white powder.

Fluconazole Actavis, 200 mg:hard gelatin capsule, size "0", consisting of a blue cap and a white body, filled with a white powder.

Pack sizes

Fluconazole Actavis, 50 mg, 100 mg, and 200 mg: 7, 14, or 28 capsules in blisters, in a cardboard box.

Fluconazole Actavis, 150 mg: 1 or 7 capsules in a blister, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Actavis Group PTC ehf.

Dalshraun 1

220 Hafnarfjörður

Iceland

Manufacturer

PharmaPath S.A.

28is Oktovriou 1

Agia Varvara,

123 51,

Greece