Fluconazole Accord

Fluconazole Capsules 50/100/150/200 mg

Package leaflet: Information for the user

Fluconazole Accord 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules

Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What Fluconazolo Accord is and what it is used for

Fluconazolo Accord belongs to a group of medicines called "antifungals". The active substance is fluconazole. Fluconazolo Accord is used to treat fungal infections and may also be used to prevent Candida infections. The most common cause of fungal infection is a yeast called Candida.
Adults
Your doctor may prescribe this medicine to treat the following types of fungal infections:

• Cryptococcal meningitis – a fungal infection of the brain
• Coccidioidomycosis – a disease affecting the bronchopulmonary system
• Candida infections found in the bloodstream, internal organs (e.g. heart, lungs), or urinary tract
• Mucosal candidiasis – infection affecting the lining of the mouth and throat, and denture-related stomatitis
• Genital candidiasis – infection of the vagina or penis
• Skin infections – e.g. athlete’s foot, ringworm, groin fungal infection, nail infection

Fluconazolo Accord may also be prescribed to:

• prevent recurrence of cryptococcal meningitis
• prevent recurrence of mucosal candidiasis
• reduce recurrences of vaginal candidiasis
• prevent Candida infections (if your immune system is weakened and not functioning properly)

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Fluconazolo Capsules 50/100/150/200 mg

Children and adolescents (0 to 17 years of age)
Your doctor may prescribe this medicine to treat the following types of fungal infections:

• Mucosal candidiasis – infection affecting the lining of the mouth and throat
• Candida infections found in the bloodstream, internal organs (e.g. heart, lungs), or urinary tract
• Cryptococcal meningitis – a fungal infection of the brain

Fluconazolo Accord may also be prescribed to:

• prevent Candida infections (if your immune system is weakened and not functioning properly)
• prevent recurrence of cryptococcal meningitis

2. What you need to know before taking Fluconazole Accord

Do not take Fluconazole Accord

• if you are allergic to fluconazole, to other medicines used to treat fungal infections, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness, or difficulty breathing
• if you are currently taking astemizole or terfenadine (antihistamine medicines for allergies)
• if you are currently taking cisapride (used for stomach disorders)
• if you are currently taking pimozide (used to treat mental illnesses)
• if you are currently taking quinidine (used to treat cardiac arrhythmia)
• if you are currently taking erythromycin (an antibiotic used to treat infections)

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole Accord

• if you have liver or kidney problems
• if you suffer from heart disease, including problems with heart rhythm
• if you have abnormal levels of potassium, calcium, or magnesium in your blood
• if you develop severe skin reactions (itching, skin redness, or difficulty breathing)
• if you develop signs of "adrenal insufficiency", where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
• if you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking fluconazole.

Severe skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported with fluconazole treatment. Stop taking Fluconazole Accord and contact your doctor immediately if you notice any of the symptoms related to severe skin reactions described in section 4.
Contact your doctor or pharmacist if the fungal infection does not improve, as alternative antifungal therapy may be needed.

Other medicines and Fluconazole Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor immediately if you are currently taking astemizole, terfenadine (an antihistamine used to treat allergies), cisapride (used for stomach disorders), pimozide (used to treat mental illnesses), quinidine (used to treat cardiac arrhythmia), or erythromycin (an antibiotic used to treat infections), as these medicines must not be taken with Fluconazole Accord (see section: "Do not take Fluconazole Accord if you").

Some medicines may interact with Fluconazole Accord. Make sure to inform your doctor if you are currently taking any of the following medicines, as dose adjustment or monitoring may be needed to ensure these medicines continue to have the desired effect:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that thin the blood to prevent blood clots (warfarin, indanedione, or similar medicines)
• benzodiazepines (midazolam, triazolam, or similar medicines) used to help you sleep or for anxiety
• carbamazepine, phenytoin (used to treat seizures)
• amiodarone (used to treat irregular heartbeat "arrhythmias")
• hydrochlorothiazide (used as a diuretic)
• nifedipine, isradipine, amlodipine, verapamil, felodipine, and losartan (for hypertension, i.e., high blood pressure)
• olaparib (used to treat ovarian cancer)
• ciclosporin, everolimus, sirolimus, or tacrolimus (to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used to treat cancer
• halofantrine (used to treat malaria)
• statins (atorvastatin, simvastatin, fluvastatin, or similar medicines) used to reduce high cholesterol levels
• methadone (used for pain)
• 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)

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• diabetes medicines such as chlorpropamide, glibenclamide, glipizide, or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used to treat rheumatoid arthritis)
• tolvaptan, used to treat hyponatremia (low sodium levels in the blood) or to slow the decline in kidney function
• vitamin A (dietary supplement)
• ivacaftor (alone or in combination with other medicines used to treat cystic fibrosis)
• ibrutinib (used to treat leukemia)
• lurasidone (used to treat schizophrenia)

Fluconazole Accord with food and drink
You may take this medicine with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are planning a pregnancy, it is recommended to wait one week after a single dose of fluconazole before attempting to conceive.
For longer-term fluconazole treatment, it is advisable to consult your doctor about the need for adequate contraception during treatment, which should continue for one week after the last dose.
Do not take Fluconazole Accord if you are pregnant, think you may be pregnant, or are planning to become pregnant, unless your doctor specifically tells you to. If you become pregnant while taking this medicine or within one week of your most recent dose, contact your doctor.
Taking fluconazole during the first or second trimester of pregnancy may increase the risk of spontaneous abortion.
Taking low-dose fluconazole during the first trimester may slightly increase the risk of the baby being born with heart, bone, and/or muscle malformations.
Cases of babies born with birth defects affecting the skull, ears, and thigh and elbow bones have been reported in women treated for three months or more with high doses (400–800 mg per day) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not clear.
You may continue breastfeeding after taking a single 150 mg dose of Fluconazole Accord. You must not breastfeed if you are taking repeated doses of Fluconazole Accord.

Driving and using machines
When driving or operating machinery, consider that dizziness or seizures may occasionally occur.

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Fluconazole Capsules 50/100/150/200 mg

Fluconazole Accord contains lactose monohydrate
This medicine contains lactose monohydrate (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, talk to your doctor before taking this medicine.
Fluconazole Accord contains less than 1 mmol of sodium (23 mg) per capsule, i.e., essentially 'sodium-free'.

3. How to take Fluconazole Accord

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Swallow the capsule whole with a glass of water. It is best to take the capsules at the same time each day.
The recommended doses of this medicine for different infections are provided below:
Adults

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Fluconazole Capsules 50/100/150/200 mg

Adolescents aged 12 to 17 years
Follow the dose prescribed by your doctor (adult or pediatric dosage).
Children up to 11 years of age
The maximum dose for children is 400 mg per day.
The dose will be based on the child's weight in kilograms.

Use in children aged between 0 and 4 weeks
Use in children aged 3–4 weeks:
The same dose as described above, but administered once every 2 days. The maximum dose is 12 mg
per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as described above, but administered once every 3 days. The maximum dose is 12 mg
per kg of body weight every 72 hours.
Elderly
The usual adult dose should be administered, unless you have renal problems.
Patients with renal impairment
Your doctor will adjust your dose according to your renal function.
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If you take more Fluconazolo Accord than you should
Taking too many capsules at once may make you feel unwell. Contact your doctor or the nearest hospital emergency department immediately. Symptoms of a possible overdose may include sensing, seeing, feeling, and thinking about things that are not actually present (hallucinations and paranoid behaviour). Symptomatic treatment (with supportive measures and gastric lavage, if necessary) may be appropriate.
If you forget to take Fluconazolo Accord
Do not take a double dose to make up for the missed tablet. If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Fluconazole Accord and contact your doctor immediately if you notice any of the following symptoms:

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

Some people may develop allergic reactions, although serious allergic reactions are rare. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. If you have any of the following symptoms, tell your doctor immediately.

• sudden breathlessness, difficulty breathing, or tightness in the chest
• swelling of the eyelids, face, or lips
• itching all over the body, skin redness, or itchy red patches
• rash
• severe skin reactions, such as a rash causing blistering (which may affect the mouth and tongue). Fluconazole Accord may affect the liver. Signs of liver problems include:
• fatigue
• loss of appetite
• vomiting
• yellowing of the skin or whites of the eyes (jaundice).

If any of these effects occur, stop taking Fluconazole Accord and tell your doctor immediately.
Other side effects:
Additionally, if any of the following side effects become severe, or if you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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Fluconazole Capsules 50/100/150/200 mg
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach upset, diarrhoea, nausea, vomiting
• increased liver function test values in blood tests
• rash

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

• reduction in red blood cells, which may cause paleness, weakness, or breathlessness
• loss of appetite
• inability to sleep, drowsiness
• seizures, dizziness, vertigo, tingling, prickling, or numbness, altered taste
• constipation, indigestion, flatulence, dry mouth
• muscle pain
• liver damage and yellowing of the skin and eyes (jaundice)
• swellings, blisters (urticaria), itching, increased sweating
• fatigue, general feeling of being unwell, fever

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

• lower than normal numbers of white blood cells, which help defend against infections, and of blood cells that help stop bleeding
• red or purple skin discolouration, which may be caused by low platelet count, other changes in blood cells
• changes in blood test parameters (high levels of cholesterol in the blood, fats)
• low potassium levels in the blood
• tremor
• abnormal electrocardiogram (ECG), changes in heart rate or rhythm
• liver failure
• allergic reactions (sometimes severe), including rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips or face
• hair loss

Frequency not known, but possible (frequency cannot be estimated from the available data):

• hypersensitivity reaction with rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia), and inflammation of internal organs (liver, lungs, heart, kidneys, and large intestine) (drug reaction or drug-induced rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects via
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Fluconazole Capsules 50/100/150/200 mg
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluconazole Accord

• 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 label or the carton after Exp. The expiry date refers to the last day of that month.
• Store below 30 °C. Keep in the original packaging to protect the medicine from moisture.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Fluconazolo Accord 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 monohydrate lactose, maize starch, sodium lauryl sulfate, colloidal anhydrous silica, and magnesium stearate.
Capsule shell:
For 50 mg:
Gelatin
Titanium dioxide (E171)
Indigo carmine (E132)
Yellow iron oxide (E172)
For 100 mg and 150 mg:
Gelatin
Titanium dioxide (E171)
Patent Blue V (E131)
For 200 mg:
Gelatin
Titanium dioxide (E171)

Description of the Appearance of Fluconazolo Accord and Contents of the Package
50 mg: Capsule shell: Size 4, white body and green cap.
100 mg: Capsule shell: Size 2, white body and blue cap.
150 mg: Capsule shell: Size 1, blue body and blue cap.
200 mg: Capsule shell: Size 0, white body and white cap.
Fluconazolo Accord Capsules are available in PVC-aluminum blister packs.
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Fluconazole Capsules 50/100/150/200 mg
Capsules of 50 mg and 200 mg
Pack sizes of 7, 14, 20, 28, 50, and 100 hard capsules
Capsules of 100 mg
Pack sizes of 7, 10, 20, 28, 50, 60, and 100 hard capsules
Capsules of 150 mg
Pack sizes of 1, 2, 4, 6, and 10 hard capsules
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009,
Greece

This medicinal product is authorized in the European Economic Area Member States under the following names:

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