Flukonazol 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

Read all of 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Fluconazole Actavis is and what it is used for
• 2. Before you take 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 fungi and can also be used to prevent fungal infections.

Adults

Your doctor may prescribe this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the lungs
• Candida infections, which can affect the blood, internal organs (such as the heart, lungs), or the urinary tract
• Mucosal candidiasis (thrush) - infection of the mucous membranes of the mouth, throat, and the mouth sores associated with the use of dentures
• Vaginal candidiasis - infections of the vagina or penis
• Fungal skin infections - such as athlete's foot (tinea pedis), tinea corporis, tinea cruris, and onychomycosis (fungal infection of the nails)

Fluconazole Actavis can also be used to:

• prevent relapse of cryptococcal meningitis
• prevent relapse of mucosal candidiasis
• reduce the frequency of vaginal candidiasis
• prevent infections caused by Candida (if the patient's immune system is weakened and not functioning properly)

Children and adolescents (from 0 to 17 years old)

Your doctor may prescribe this medicine for the following fungal infections:

• Mucosal candidiasis (thrush) - infection of the mucous membranes of the mouth or throat
• Candida infections, which can affect the blood, internal organs (such as the heart, lungs), or the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Fluconazole Actavis can also be used to:

• prevent Candida infections (if the patient's immune system is weakened and not functioning properly)
• prevent relapse of cryptocococcal meningitis

2. Before you take Fluconazole Actavis

Do not take Fluconazole Actavis

• if you are allergic to fluconazole, other antifungal medicines, or any of the other ingredients of this medicine (listed in section 6)
• if you are taking astemizole, terfenadine (antihistamines used to treat allergies)
• if you are taking cisapride (used to treat stomach disorders)
• if you are taking pimozide (used to treat mental disorders)
• if you are taking quinidine (used to treat irregular heartbeat)
• if you are taking erythromycin (an antibiotic used to treat infections)

Warnings and precautions

Before taking Fluconazole Actavis, tell your doctor or pharmacist if:

• you have kidney or liver disease
• you have heart disease, including irregular heartbeat
• you have abnormal levels of potassium, calcium, or magnesium in your blood
• you have severe skin reactions (itching, redness, difficulty breathing)
• you have signs of "adrenal insufficiency", where the adrenal glands do not produce enough steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• you have ever had a severe skin rash or peeling of the skin after taking fluconazole

There have been reports of severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with fluconazole. If you experience any symptoms of severe skin reactions, stop taking Fluconazole Actavis and seek medical help immediately.

Fluconazole Actavis with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• rifampicin or rifabutin (antibiotics used to treat infections)
• abrocitinib (used to treat atopic dermatitis, also known as eczema)
• alfentanil, fentanyl (anesthetics)
• amitriptyline, nortriptyline (antidepressants)
• amphotericin B, voriconazole (antifungal medicines)
• blood thinners (warfarin or similar medicines)
• benzodiazepines (midazolam, triazolam, or other similar medicines) that help you sleep or relax
• 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, vincristine (used to treat cancer)
• halofantrine (used to treat malaria)
• statins (atorvastatin, simvastatin, and fluvastatin, and other similar medicines) used to lower cholesterol
• methadone (a pain reliever)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines)
• oral contraceptives
• prednisolone (a steroid)
• zidovudine, also known as AZT; saquinavir (used to treat 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 or to slow the worsening of kidney function)
• vitamin A (a dietary supplement)
• ivacaftor (used to treat cystic fibrosis)
• amiodarone (used to treat irregular heartbeat)
• hydrochlorothiazide (a diuretic)
• ibrutinib (used to treat blood cancer)
• luraxizumab (used to treat schizophrenia)

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

When driving or using machines, consider that dizziness or seizures may occasionally occur.

Fluconazole Actavis contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Fluconazole Actavis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the capsule whole with a glass of water. The capsules are best taken at the same time each day.

You can take the capsules with or without food.

Adults

Indication Dosage

Treatment of cryptococcal meningitis 400 mg on the first day, followed by 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed. The dose may be increased to 800 mg.

Prevention of relapse of cryptococcal meningitis 200 mg once daily until the doctor recommends stopping treatment.

Treatment of coccidioidomycosis 200 mg to 400 mg once daily for 11 months to 24 months or longer if needed. The dose may be increased to 800 mg.

Treatment of Candida infections 800 mg on the first day, followed by 400 mg once daily until the doctor recommends stopping treatment.

Treatment of mucosal candidiasis 200 mg to 400 mg on the first day, followed by 100 mg to 200 mg once daily until the doctor recommends stopping treatment.

Candida mucosal infections - the dose depends on the location 50 mg to 400 mg once daily for 7 to 30 days, until the doctor recommends stopping treatment.

Prevention of relapse of mucosal candidiasis 100 mg to 200 mg once daily, or 200 mg 3 times a week, if the patient is at high risk of relapse.

Treatment of vaginal candidiasis A single dose of 150 mg.

Prevention of relapse of vaginal candidiasis 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 high risk of relapse.

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

Prevention of Candida infections (if the patient's immune system is weakened and not functioning properly) 200 mg to 400 mg once daily, if the patient is at high risk of relapse.

Children and adolescents (from 12 to 17 years old)

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

Children (from 0 to 11 years old)

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

Indication Daily dose

Candida mucosal infections of the mouth and throat - the dose and duration of treatment depend on the severity and location of the infection 3 mg/kg body weight once daily (on the first day, a dose of 6 mg/kg body weight may be given)

Cryptococcal meningitis or Candida infections 6 mg to 12 mg/kg body weight once daily

Prevention of relapse of cryptococcal meningitis 6 mg/kg body weight once daily

Prevention of Candida infections in children (if the immune system is not functioning properly) 3 mg to 12 mg/kg body weight once daily

Children (from 0 to 4 weeks old)

For 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.

For 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.

Elderly patients

The usual adult dose should be taken, unless the patient has kidney disease.

Patients with kidney disease

The doctor may recommend a change in dosage, depending on kidney function.

Overdose

Taking too many capsules at once may cause discomfort. Contact the emergency department of your nearest hospital immediately. Symptoms of overdose may include hearing, vision, or feeling disturbances, and thinking about things that are not true (hallucinations and paranoid behavior). Symptomatic treatment (life-supporting measures and gastric lavage, if necessary) may be indicated.

Missed dose

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose.

4. Possible side effects

Like all medicines, Fluconazole Actavis can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking Fluconazole Actavis and contact a doctor immediately

Fluconazole Actavis and seek medical help immediately:

• extensive rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome, frequency cannot be estimated from the available data)
• sudden wheezing, difficulty breathing, or chest tightness
• swelling of the eyelids, face, or lips
• itching all over the body, redness, or red or itchy blisters
• skin rash
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue)

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

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

If you experience any of these symptoms, stop takingFluconazole Actavis and contact a doctor immediately.

Other side effects

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

• headache
• stomach pain, diarrhea, nausea, vomiting
• increased liver enzymes (liver function tests)
• rash

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

• reduced red blood cell count, which can cause pale skin, weakness, and shortness of breath
• loss of appetite
• insomnia, drowsiness
• seizures, dizziness, feeling of spinning, disturbances in sensation, 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 feeling of being unwell, fever

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

• reduced white blood cell count or platelet count
• red or purple discoloration of the skin, which can be a sign of reduced platelet count or changes in other blood cells
• changes in blood biochemistry (high cholesterol, lipids in the blood)
• reduced potassium levels in the blood
• tremors
• abnormal ECG, irregular heartbeat
• 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 of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Fluconazole Actavis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fluconazole Actavis contains

• The active substance is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole.
• The other ingredients are: Capsule content: lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate. Capsule shell: 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), yellow iron oxide (E 172), black iron oxide (E 172)

What Fluconazole Actavis looks like and contents of the pack

Hard capsules.

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

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

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

Fluconazole Actavis, 200 mg:hard gelatin capsule, size 0, with 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 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 information about this medicine, including its other names, please contact the Marketing Authorisation Holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

Date of last revision of the leaflet:February 2024