FLUCONAZOLO 50 mg Hard Capsules

Зміст інструкції

1. Fluconazole Aurobindo 50 mg hard capsules, 100 mg hard capsules, 150 mg hard capsules, 200 mg hard capsules
   1. What Fluconazole Aurobindo is and what it is used for
   2. What you need to know before taking Fluconazolo Aurobindo
   3. How to take Fluconazole Aurobindo
   4. Possible side effects
   5. How to store Fluconazolo Aurobindo
   6. Package Contents and Other Information

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

Generic medicine

Read this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Fluconazole Aurobindo belongs to a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole Aurobindo is used for the treatment of fungal infections and can be used to
prevent Candida infections. The most common cause of fungal infections is a yeast called

Candida.

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

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

Fluconazole Aurobindo may 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
• preventing Candida infections (if your immune system is weak or not functioning properly)

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

• Candidiasis of the mucous membranes - infection of the oral mucosa, throat infection
• Infections caused by Candidaand found in the bloodstream, in organs (e.g. heart, lungs) or in the urinary tract
• Cryptococcal meningitis - a fungal infection of the brain

Fluconazole Aurobindo may also be prescribed for:

• preventing Candida infections (if your immune system is weak or not functioning properly).
• preventing the recurrence of cryptococcal meningitis

2. What you need to know before taking Fluconazolo Aurobindo

Do not take Fluconazolo Aurobindo:

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

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

Tell your doctor if

• you have problems with your liver or kidneys
• you suffer from heart diseases, including problems with cardiac arrhythmia
• you have abnormal levels of potassium, calcium or magnesium in your blood.
• severe skin reactions appear (itching, redness of the skin or difficulty in breathing).
• signs of “adrenal insufficiency” appear, in which the adrenal glands do not produce adequate amounts of some steroid hormones such as cortisol (chronic or long-lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

Other medicines and Fluconazolo Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor immediatelyif you are taking astemizole, terfenadine (antihistamine used
for the treatment of allergies) or cisapride (used for the treatment of stomach disorders) or
pimozide (used for the treatment of mental disorders) or quinidine (used for the treatment of
cardiac arrhythmias) or erythromycin (antibiotic used for the treatment of bacterial infections), because
they cannot be taken with Fluconazolo Aurobindo (see section: “Do not take Fluconazolo
Aurobindo”).
There are some medicines that can interact with Fluconazolo Aurobindo. Tell your doctor if you are
taking any of the following medicines:

• rifampicin or rifabutin (antibiotics for the treatment of bacterial infections)
• alfentanil, fentanyl (used as anesthetics)
• amitriptyline, nortriptyline (used as antidepressants)
• amphotericin B, voriconazole (antifungals)
• medicines that thin the blood to prevent the formation of 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)
• nifedipine, isradipine, amlodipine, felodipine and losartan (used for the treatment of hypertension
• high blood pressure)
• cyclosporine, everolimus, sirolimus or tacrolimus (used to prevent transplant rejection)
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for the treatment of cancer
• halofantrine (used for the treatment of malaria)
• statins (atorvastatin, simvastatin, fluvastatin and similar medicines) used to reduce high cholesterol levels
• methadone (used for the treatment of pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs))
• oral contraceptives
• prednisone (steroid)
• zidovudine, also known as AZT; saquinavir (used in patients with HIV)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used for asthma control)
• vitamin A (food supplement)
• amiodarone (used for the treatment of irregular heartbeats “arrhythmias”)
• hydrochlorothiazide (used to treat fluid retention)

Fluconazolo Aurobindo with food and drink and alcohol
You can take the medicine with or without food.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
You should be aware that dizziness or convulsions may occasionally occur while driving or operating
machinery.

Fluconazolo Aurobindo contains lactose monohydrate, a type of sugar. If you have been told by
your doctor that you have an intolerance to some sugars, contact your doctor before taking the
medicine.

3. How to take Fluconazole Aurobindo

Take this medicine following exactly the instructions of your doctor. 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 every day at the
same time.

Instructions for removing the capsule from the blister pocket:
Pushing the capsule pocket in its central portion may cause deformation/rupture of the
capsule as shown in Fig. A. To avoid such damage, remove the capsule by pushing on the edge of the
pocket as shown in Fig. B.

Fig. AFig. B
The recommended doses of this medicine to be taken depending on the infection are listed below:

Adults

Use in children and adolescents
Adolescents aged 12 to 17 years
Follow the dose prescribed by the doctor (dosage both for adults and children).

Children up to 11 years
The maximum dose in children is 400 mg per day.
The dose will be established based on the child's weight in kilograms

Use in infants aged 0 to 4 weeks
Use in infants aged 3 to 4 weeks:
The same dosage 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 under 2 weeks of age:
The same dosage as described above but administered once every 3 days. The maximum dose is 12
mg per kg of body weight every 72 hours.
The doctor may sometimes prescribe doses different from these. Always take the medicine as
indicated by the doctor. If you have any doubts, consult your doctor or pharmacist

Use in the elderly
The same dose as provided for adults should be used unless you have kidney problems

Use in patients with kidney problems
The doctor may modify the dosage based on kidney function.

If you take more Fluconazole Aurobindo than you should
Taking too many capsules all at once may cause you problems. Immediately warn your
doctor or go to the nearest hospital. In case of accidental overdose, symptoms may
include sensing, seeing, perceiving and thinking things that are not real (hallucinations and paranoid behavior).
Symptomatic treatment may be appropriate (with adequate supportive measures and possibly gastric lavage).

If you forget to take Fluconazole Aurobindo
Do not take a double dose to make up for missed doses. If you forget to take a
dose, take it as soon as possible. If it is time to take the next dose, do not take the dose
you forgot.
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.
Some people experience allergic reactionsalthough severe allergic reactions are rare. If you experience any of the following symptoms inform your doctor immediately.

• sudden shortness of breath, difficulty breathing or a 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 spots
• skin rashes
• severe skin reactions, for example, rashes that cause blisters (can affect the mouth and tongue).

Fluconazolo Aurobindo may have effects on the liver. Symptoms of liver problems include:

• fatigue
• loss of appetite
• vomiting
• yellowing of the skin and the white of the eyes (jaundice) If you experience any of these symptoms, stop taking Fluconazolo Aurobindo and inform your doctor immediately.

Other side effects:
Also, if any side effect gets worse, or if you notice any side effect not listed here, tell your doctor or pharmacist.
Common side effects, which may affect up to 1 in 10 people, are as follows:

• headache
• stomach discomfort, diarrhoea, nausea, vomiting
• increases in liver function values in blood tests
• skin rashes

Uncommon side effects, which may affect up to 1 in 100 people, are as follows:

• reduction in red blood cells which can cause paleness, weakness or shortness of breath
• decreased appetite
• insomnia, drowsiness
• convulsions, dizziness, feeling of spinning, 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 being unwell, fever.

Rare side effects, which may affect up to 1 in 1,000 people, are as follows:

• lower than normal levels of white blood cells, which help you fight infections, and platelets, which help your blood clot
• altered skin colour (red or purple) which may be caused by a reduction in platelets, other changes in blood cells
• changes in the chemical composition of the blood (high levels of cholesterol, fats)
• low levels of potassium in the blood
• shivering
• altered electrocardiogram (ECG), changes in heart rate and rhythm
• liver failure
• allergic reactions (sometimes severe), including skin rashes with widespread blistering and peeling of the skin, severe skin reactions, swelling of the lips and face
• hair loss

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Fluconazolo Aurobindo

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 package after EXP.
The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
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 Aurobindo contains

• The active ingredient is fluconazole
• Each capsule contains 50 mg/ 100 mg/ 150 mg or 200 mg of fluconazole
• The excipients are: lactose monohydrate, corn starch, sodium lauryl sulfate, anhydrous colloidal silica and magnesium stearate.

The capsule shell contains titanium dioxide (E171), sodium lauryl sulfate and gelatin.
The printing ink contains shellac, propylene glycol, yellow iron oxide.

Description of the appearance of Fluconazolo Aurobindo and package contents
Fluconazolo 50 mg capsules
Hard gelatin capsules size ‘4’ filled with powder from white to off-white and imprinted with ‘E’
on the opaque cap from white to off-white and ‘95’ on the body from white to off-white with yellow
ink.

Fluconazolo Aurobindo 100 mg
Hard gelatin capsules size ‘2’ filled with powder from white to off-white and imprinted with ‘E’
on the opaque cap from white to off-white and ‘96’ on the body from white to off-white with yellow
ink.

Fluconazolo Aurobindo 150 mg hard capsules
Hard gelatin capsules size ‘1’ filled with powder from white to off-white and imprinted with ‘E’
on the opaque cap from white to off-white and ‘97’ on the body from white to off-white with yellow
ink.

Fluconazolo Aurobindo 200 mg
Hard gelatin capsules size ‘0’ filled with powder from white to off-white and imprinted with ‘E’
on the opaque cap from white to off-white and ‘98’ on the body from white to off-white with yellow
ink.
Fluconazolo Aurobindo capsules are available in:
Transparent PVC/PVDC-aluminum blister:
Fluconazolo 50mg/100mg/150mg/200mg: 1, 2, 3, 4, 5, 6, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 100 capsules.
HDPE container:
Fluconazolo 50mg/100mg: 30 and 1000 capsules
Fluconazolo 200mg: 30 and 500 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg Hartkapseln
Czech Republic: Fluconazol Aurobindo 50mg/ 100mg/ 150mg hard capsules
Denmark: Fluconazol “Aurobindo”
Germany: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg Hartkapseln
Greece: Fluconazole Aurobindo 50mg/ 100mg/ 150mg mg capsules, hard
Hungary: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg kemény kapszula
Ireland: Fluconazole Aurobindo 50mg/ 150mg/ 200mg capsules, hard
Italy: Fluconazolo Aurobindo 50mg/ 100mg/ 150mg/ 200mg capsule rigide
Netherlands: Fluconazol Aurobindo 50mg/ 150mg/ 200mg, capsules
Poland: Fluconazole Aurobindo
Portugal: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg hard capsules
Romania: Fluconazol Aurobindo 50mg/ 100mg/ 150mg capsules
Slovakia: Fluconazole Aurobindo 50mg/ 100mg/ 150mg/ 200mg hard capsules
Spain: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg cápsulas duras
Sweden: Fluconazol Aurobindo 50mg/ 100mg/ 150mg/ 200mg capsules, hard
United Kingdom: Fluconazole 50mg/ 100mg/ 150mg/ 200mg capsules, hard