FLUCONAZOLO 50 mg Hard Capsules

Содержание инструкции

1. Fluconazole Accord 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What is Fluconazolo Accord and what it is used for
   2. What you need to know before you take Fluconazolo Accord
2. Fluconazole Accord and immediately consult your doctor if you notice any of the symptoms
   1. How to take Fluconazole Accord
   2. Possible side effects
   3. How to store Fluconazolo Accord
   4. Package contents and other information

Fluconazole Capsules 50/100/150/200 mg

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

Generic medicine

Read this 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Fluconazolo Accord 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 for the treatment of fungal infections and can also be used to prevent Candidainfections. The most common cause of fungal infection is a yeast called Candida.

Adults
Your doctor may prescribe this medicine for the treatment of the following types of fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain
• Coccidioidomycosis - a disease of the bronchopulmonary system
• Infections caused by Candidaand detected in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract
• Candidiasis of the mucous membranes - infection affecting the lining of the mouth and throat, and inflammation of the mouth from dentures
• Genital candidiasis - infection of the vagina or penis
• Skin infections - e.g. athlete's foot, ringworm, groin mycosis, nail infection

Fluconazolo Accord can also be prescribed for:

• preventing the recurrence of cryptococcal meningitis
• preventing the recurrence of candidiasis of the mucous membranes
• reducing the recurrence of vaginal candidiasis

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Fluconazolo Capsules 50/100/150/200 mg

• preventing Candidainfections (if your immune system is weak and not functioning properly)

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

• Candidiasis of the mucous membranes - infection affecting the lining of the mouth and throat
• Infections caused by Candidaand detected in the bloodstream, in body organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Fluconazolo can also be prescribed for:

• preventing Candidainfections (if your immune system is weak and not functioning properly).
• preventing the recurrence of cryptococcal meningitis

2. What you need to know before you take Fluconazolo Accord

Do not take Fluconazolo Accord

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

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

• if you have problems with your liver or kidneys
• if you suffer from heart disease, including heart rhythm problems
• if you have abnormal levels of potassium, calcium or magnesium in your blood
• if you develop severe skin reactions (itching, redness of the skin or difficulty breathing)
• if you develop signs of “adrenal insufficiency”, when the adrenal glands do not produce adequate quantities 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 skin rash or exfoliation of the skin, blisters and/or mouth ulcers after taking fluconazole.

Severe skin reactions including drug reaction with eosinophilia and
systemic symptoms (DRESS) related to treatment with fluconazole have been reported. Stop taking
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Fluconazole Accord and immediately consult your doctor if you notice any of the symptoms

related to the serious skin reactions described in paragraph 4.
Consult your doctor or pharmacist if the fungal infection does not improve, a
different antifungal therapy may be necessary.

Other medicines and Fluconazole Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor immediatelyif you are currently taking astemizole, terfenadine (an
antihistamine for the treatment of allergies) or cisapride (used for stomach disorders) or
pimozide (used for the treatment of mental illnesses) or quinidine (used for the treatment
of cardiac arrhythmia) or erythromycin (an antibiotic for the treatment of infections), because these
medicines must not be taken with Fluconazole Accord (see paragraph: "Do not take
Fluconazole Accord if you are").
There are some medicines that can interact with Fluconazole Accord. Make sure to tell
your doctor if you are currently taking any of the following medicines, a dose adjustment or monitoring may be necessary to ensure that the medicines continue to have
the desired effect:

• rifampicin or rifabutin (antibiotics for infections)
• abrocitinib (used for the treatment of 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 for the treatment of seizures)
• amiodarone (used for the treatment of “arrhythmias” with irregular heartbeat)
• hydrochlorothiazide (used as a diuretic)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for hypertension, i.e. high blood pressure)
• olaparib (used for the treatment of ovarian cancer)
• cyclosporine, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer
• alofantrine (used for the treatment of malaria)
• statins (atorvastatin, simvastatin and 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 (steroid)
• zidovudine, also called AZT; saquinavir (used in patients with HIV)

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• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• tofacitinib (used for the treatment of 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 drugs used to treat cystic fibrosis)
• ibrutinib (used to treat leukemia)
• lurasidone (used for the treatment of schizophrenia)

Fluconazole Accord with food and drink
You can take the medicine with or without a meal.

Pregnancy, breastfeeding and fertility
If you are pregnant or suspect you may be pregnant, or if you are breastfeeding with
breast milk, 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 becoming pregnant.
In case of longer treatments with fluconazole, it is advisable to consult your doctor about the need
for adequate contraception during treatment, which must continue for one week after
the last dose.
Do not take Fluconazole Accord if you are pregnant, suspect you are pregnant, or are planning a
pregnancy, unless your doctor tells you to. If you become pregnant while taking
the medicine or within one week of the most recent dose, contact your doctor.
Fluconazole taken during the first or second trimester of pregnancy may increase
the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase
the risk that the baby is born with malformations of the heart, bones and/or muscles.
Cases of children born with birth defects affecting the skull, ears
and bones of the thigh and elbow 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 can continue to breastfeed after taking a single dose of Fluconazole Accord150 mg. Do not
breastfeed if you are taking repeated doses of Fluconazole Accord.

Driving and operating machinery
When driving vehicles or operating machinery, you need to consider that dizziness or seizures may 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 suffer from intolerance to certain sugars, consult your doctor before taking this
medicine.
Fluconazole Accord contains less than 1mmol of sodium (23 mg) per capsule, i.e. essentially
‘sodium-free’.

3. How to take Fluconazole Accord

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have 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
every day.
The recommended doses of this medicine for different infections are provided below:

Adults

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Adolescents from 12 to 17 years of age
Follow the dose prescribed by the doctor (adult or children's 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 infants aged 0 to 4 weeks
Use in infants 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 infants less than 2 weeks of age:
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 dose for adults should be administered, unless you have
kidney problems.

Patients with kidney problems
The doctor will modify your dose, depending on your kidney function.
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If you take more Fluconazole Accord than you should
Taking too many capsules at once may make you feel unwell. Seek immediate
medical attention or go to the nearest hospital emergency room. Symptoms of a possible overdose
may include seeing, hearing, feeling and thinking about things that do not actually exist
(hallucinations and paranoid behavior). Symptomatic treatment (with supportive measures and
gastric lavage, if necessary) may be appropriate.

If you forget to take Fluconazole Accord
Do not take a double dose to make up for the missed tablet. If you have forgotten
a dose, take it as soon as you remember. However, if it is almost time to take the next dose,
skip the missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• sudden shortness of breath, difficulty breathing or feeling of tightness in the chest
• swelling of the eyelids, face or lips
• itching all over the body, redness of the skin or itchy red patches
• rash
• severe skin reactions, such as a rash that causes blistering (may affect the mouth and tongue). Fluconazolo Accord can have effects on the liver. Signs of liver problems include:
• fatigue
• loss of appetite
• vomiting
• yellowing of the skin or the white of the eyes (jaundice).

If any of these effects occur, stop taking Fluconazolo Accord and inform your doctor immediately.

Other side effects:
Also, if any of the following side effects becomes serious, or if you experience any side effect, including
those not listed in this leaflet, contact your doctor or pharmacist.
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Fluconazolo Capsules 50/100/150/200 mg
Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhea, nausea, vomiting
• increased liver function values in blood tests
• rash

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

• reduction in red blood cells which can make the skin pale and cause weakness or shortness of breath
• decreased appetite
• inability to sleep, feeling sleepy
• convulsions, dizziness, feeling giddy, tingling, prickling or numbness, altered taste
• constipation, difficulty digesting, 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 unwellness, fever

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

• lower than normal number of white blood cells, which help fight infections, and blood cells that help stop bleeding
• red or purple discoloration of the skin, which may be caused by a low number of platelets, other changes in blood cells
• changes in blood parameters (high levels of cholesterol in the blood, fats)
• low level of potassium in the blood
• tremor
• altered electrocardiogram (ECG), change in heart rate or rhythm
• liver failure
• allergic reactions (sometimes severe), including skin rashes with widespread blisters and peeling of the skin, severe skin reactions, swelling of the lips or face
• hair loss

Frequency not known, but may occur (frequency cannot be estimated on the basis of the available
data):

• hypersensitivity reaction with rash, fever, swollen glands, increased type of white blood cells (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (drug reaction or rash with eosinophilia and systemic symptoms (DRESS))

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
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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 Fluconazolo 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 packaging after Scad. The expiry date refers to the last day of that month.
• Store at a temperature below 30  C. Store in the original packaging to protect the medicine from moisture.
• Do not dispose of any medicine in 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 ingredient is fluconazole. Each hard capsule contains 50 mg, 100 mg, 150 mg or 200 mg of
fluconazole.
The other ingredients are lactose monohydrate, corn 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 package contents
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 blister packs made of PVC-aluminum.
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Fluconazole Capsules 50/100/150/200 mg
50 mg and 200 mg Capsules
Pack sizes of 7, 14, 20, 28, 50 and 100 hard capsules
100 mg Capsules
Pack sizes of 7, 10, 20, 28, 50, 60, 100 hard capsules
150 mg Capsules
Pack sizes of 1, 2, 4, 6, 10 hard capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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,
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:

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