0 mg, 100 mg, 150 mg, 200 mg capsules, hard
fluconazole

What Fluconazole Aurobindo is and what it is used for

Fluconazole Aurobindo belongs to a group of medicines used to treat fungal infections. 

The active substance is fluconazole.

Fluconazole Aurobindo is used to treat infections caused by fungi, and can also be used to prevent getting a fungal infection. 

The most common cause of fungal infections is a yeast called Candida.

Adults

You can get this medicine from a doctor to treat the following fungal infections:

  • Meningitis caused by cryptococcus – a fungal infection of the brain
  • Coccidioidomycosis is – a lung disease
  • Infections caused by Candida and found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
  • Fungal infection in the mouth affects the lining of the mouth, throat and can give inflammation of the oral mucosa when using a denture
  • Fungal infection of the vagina or penis (genital fungal infection)
  • Skin infections – e.g. athlete’s foot, ringworm, inguinal fungus, nail infection

You can also get Fluconazole Aurobindo to:

  • prevent recurrence of meningitis caused by cryptococci.
  • prevent the recurrence of fungal infections in the mouth.
  • prevent recurrent fungal infection in the vagina
  • prevent infection caused by Candida (if you have a weakened immune system)

Children and adolescents (0 to 17 years)

  • You can get this medicine from your doctor to treat these types of fungal infections:
  • Fungal infection in the mouth – an infection that affects the lining of the mouth and throat
  • Infections caused by Candida and found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
  • Meningitis caused by cryptococcus – a fungal infection of the brain

You can also get Fluconazole Aurobindo to:

  • prevent infection caused by Candida (if you have a weakened immune system)
  • prevent recurrence of meningitis caused by cryptococci

Fluconazole contained in Fluconazole Aurobindo may also be approved for treating 

other diseases not mentioned in this product information. Ask your doctor, pharmacist, or 

other healthcare professionals if you have further questions and always follow their instructions.

What you need to know before you take Fluconazole Aurobindo

Do not take Fluconazole Aurobindo if you:

  • is allergic to fluconazole, to other medicines you have taken to treat fungal infection or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.
  • taking astemizole or terfenadine ( antihistamine for the treatment of allergies)
  • taking cisapride (for stomach upset)
  • takes pimozide (used to treat mental illness)
  • takes quinidine (used to treat irregular heartbeat)
  • taking erythromycin ( antibiotic for treating infections).

Warnings and cautions

Talk to your doctor or pharmacist before taking Fluconazole Aurobindo

if you:

  • have liver or kidney problems
  • have any heart disease, e.g. irregular heartbeat
  • have abnormal levels of potassium, calcium, or magnesium in the blood
  • develops severe skin reactions ( itching, redness of the skin, or difficulty breathing).
  • if you develop signs of “adrenal insufficiency”, where the adrenal glands do not produce sufficient amounts of certain steroid hormones such as. cortisol (chronic or long-term fatigue, muscle weakness, decreased appetite, weight loss, abdominal pain).

Other medicines and Fluconazole Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take

other drugs.

Tell your doctor  immediately  if you are taking astemizole, terfenadine (an antihistamine for 

treatment of allergy) or cisapride (for stomach upset) or pimozide (used for 

treatment of mental disorders) or quinidine (used to treat irregular heartbeat) or erythromycin (an antibiotic used to treat infections)

as these should not be taken with Fluconazole Aurobindo (see section “Do not use Fluconazole Aurobindo if you”).

Some medications can be affected by or affect Fluconazole Aurobindo.

Tell your doctor if you are taking any of the following medicines:

  • rifampicin, rifabutin ( antibiotics for infections)
  • alfentanil, fentanyl (used as anesthetic)
  • amitriptyline, nortriptyline (used to treat depression)
  • amphotericin B, voriconazole (antifungal infection)
  • blood thinners (eg warfarin, indanedione, or similar medicines) to prevent blood clots
  • benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
  • carbamazepine, phenytoin (for epilepsy)
  • nifedipine, isradipine, amlodipine, felodipine or losartan (for high blood pressure)
  • ciclosporin, everolimus, sirolimus or tacrolimus (used after transplants)
  • cyclophosphamide, vinca alkaloids (eg vincristine, vinblastine) used to treat cancer
  • halofantrine (against malaria)
  • statins (atorvastatin, simvastatin, and fluvastatin) used to lower blood cholesterol
  • methadone (counter pain)
  • celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs, NSAIDs)
  • birth control pills
  • prednisone ( steroid )
  • zidovudine (also known as AZT) or saquinavir (used to treat HIV)
  • drugs against diabetes as chlorpropamide, glibenclamide, glipizide or tolbutamide
  • theophylline (for asthma)
  • Vitamin A (nutritional supplement)
  • amiodarone (used to treat irregular heart rhythms, so-called arrhythmias)
  • hydrochlorothiazide (used to treat fluid retention)

Fluconazole Aurobindo with food and drink

The drug can be taken regardless of the meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

When driving or using machines, keep in mind that you may experience dizziness

or seizures during treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or 

perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. 

A description of these effects and side effects can be found in other sections. Therefore read all the information in this leaflet

guidance.

If you are not sure, talk to your doctor or pharmacist.

Fluconazole Aurobindo capsules contain lactose monohydrate

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

3. How to use Fluconazole Aurobindo

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Swallow the capsule whole with a glass of water. You should take the capsules at the same time each day.

Instructions for pushing the capsule out of the blister:

Pressing the center of the blister bubble may cause the capsule nails to derm 

than the canister breaks, as shown in Fig. A. To avoid such damage, p ss 

removes the capsule by pressing on the edge of the blister bubble, as shown in picture B.

Pressing on the center of the blister bubble may cause the capsule to malform or the capsule to rupture.
To avoid such damage, push out the capsule by pressing on the edge of the blister bubble

Picture A Picture B

The table below shows the recommended doses for different infections:

Adults

Infection Dose
To treat meningitis caused by cryptococci 400 mg on the first day, then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if necessary. Sometimes the dose is increased by up to 800 mg
To prevent meningitis caused by cryptococci 200 mg once daily until your doctor tells you to stop taking the cloth
To treat coccidioidomycosis 200 mg to 400 mg once daily from 11 months up to 24 months or longer if needed. Sometimes the dose is increased by up to 800 mg
To treat internal fungal infections caused by  Candida 800 mg on the first day, then 400 mg once daily until your doctor tells you to stop
Fungal infection of the mouth affects the lining of the mouth, throat and can cause inflammation of the oral mucosa when using a denture 200 mg to 400 mg on the first day, then 100 mg to 200 mg until your doctor tells you to stop
To treat fungal infection in the mouth- does one depends on where the infection is 50 mg to 400 mg once daily for 7 to 30 days until your doctor tells you to stop
To prevent fungal infections that affect the mucous membranes of the mouth and throat 100 mg to 200 mg once a day or 200 mg three times a week as long as you are at risk of getting an infection
To treat genital fungal infection 150 mg single dose
To prevent recurrent fungal infection in the vagina 150 mg every three days for a total of 3 doses (days 1, 4, and 7) and then once a week for 6 months as long as you are at risk of getting an infection
To treat fungal infections of the skin and nails Depending on the site of infection a 50 mg once daily, 150 mg once a week, 300 to 400 mg once a week for 1 to 4 weeks (up to 6 weeks for athlete’s foot, in the treatment of nail infection until the infected nail has been replaced )
To prevent infection caused by Candida (if you have a weakened immune system) 200 mg to 400 mg once daily as long as there is a risk of getting an infection

Use for children and adolescents

Young people between 12 and 17 years

Use dose one prescribed by your doctor (according to the recommendations for either adults or children).

Children up to 11 years

The maximum dose for children is 400 mg daily.

Dose one is based on the child’s weight in kg.

Infection Daily dose
Fungal infections of the mouth and throat infections caused by Candida – dose, and duration of treatment depends on how severe the infection is and where it is located 3 mg per kg body weight (6 mg per kg body weight can be given on the first day)

Meningitis caused by cryptococcus or internal fungal infections caused by  Candida 6 mg to 12 mg per kg body weight
To prevent the child from getting an infection caused by youCandida (if the child has a weakened immune system) 3 mg to 12 mg per kg body weight

Children between 0 and 4 weeks

The same dose as above is given every other day. The maximum dose is 12 mg per kg body weight 

every other day (48 hours).

Children younger than 2 weeks:

The same dose as above is given every three days. The maximum dose is 12 mg per kg body weight each 

the third day (72 hours).

Your doctor may prescribe different doses than those listed here. Always take Fluconazole Aurobindo exactly as your doctor has told you. Consult a physician or pharmacist 

if you are unsure.

Older

The usual dose for adults can be used unless you have kidney problems.

Patients with kidney problems

Your doctor may change the dose depending on your kidney function.

If you take more Fluconazole Aurobindo then you should

You may feel unwell if you take too many capsules at once. Contact a doctor or nearest hospital immediately. The symptoms of a possible overdose may be that you begin to hear, see, feel and think things that are not real (hallucinations and paranoid behaviors). Treatment of symptoms and gastric lavage may be required in case of overdose.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Fluconazole Aurobindo

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Some people develop allergic reactions, although severe allergic reactions are rare. If you get any of the following symptoms, contact your doctor immediately.

  • sudden wheezing, difficulty breathing, or a tight feeling in the chest
  • swelling of the eyelids, face, or lips
  • itching all over the body, reddening of the skin or itchy, red spots
  • rash
  • severe skin reactions, e.g. a rash with blistering (this can affect the mouth and tongue).

Fluconazole Aurobindo may affect your liver. Signs of hepatic impairment include:

  • fatigue
  • decreased appetite
  • vomiting
  • yellowish skin or yellowish whites of the eyes (jaundice).

If any of these occur, stop taking Fluconazole Aurobindo and contact your doctor immediately.

Other side effects are

If any of the side effects gets 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) are:

– headache

– feeling uncomfortable in the stomach, diarrhea, nausea, vomiting

elevated liver values

– skin rash

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

– reduced amount of red blood cells which can lead to pale skin and cause weakness and shortness of breath

– decreased appetite

– difficulty sleeping, drowsiness

– seizures, dizziness, tingling sensation, and crawling, tingling or numbness, taste changes

– constipation, indigestion, gas tension, dry mouth

– muscle pain

– liver damage and yellowing of the skin and eyes (jaundice)

streaks in the skin, blistering ( hives ), itching, sweating

– fatigue, general malaise, fever

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

– reduced number of white blood cells that help defend the body against infections and reduced number of blood cells that help stop bleeding

– red or purple discoloration of the skin that may be caused by decreased platelet count or other changes in the blood

elevated blood cholesterol and blood fat levels

– reduced level of potassium in the blood

shaking

– abnormal ECG, changes in heart rate or heart rate

– liver failure

– allergic reactions (sometimes severe), including widespread rash with blistering and flaky skin, severe skin reactions, and swelling of the lips or face

– Hair loss

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

Läkemedelsverket
Box 26
751 03 Uppsala 

5. How to store Fluconazole 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 carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fluconazole 
  • Each 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.

The capsule shell contains titanium dioxide (E171), sodium lauryl sulfate, and gelatin.

The printing ink contains shellac, propylene glycol, and yellow iron oxide.

What the medicine looks like and the contents of the pack

What the medicine looks like and the contents of the pack

Fluconazole Aurobindo 50 mg capsules

Hard gelatin capsule of size 4 filled with white to off-white powder and marked with “E” on white to off-white opaque top and “95” on white to off-white opaque bottom in yellow ink.

Fluconazole Aurobindo 100 mg capsules

Hard gelatin capsule of size 2 filled with white to off-white powder and marked with “E” on white to off-white opaque top and “96” on white to off-white opaque bottom in yellow ink.

Fluconazole Aurobindo 150 mg capsules

Hard gelatin capsule of size 1 filled with white to off-white powder and marked with “E” on white to off-white opaque top and “97” on white to off-white opaque bottom in yellow ink.

Fluconazole Aurobindo 200 mg capsules

Hard gelatin capsule of size 0 filled with white to off-white powder and marked with “E” on white to off-white opaque top and “98” on white to off-white opaque bottom in yellow ink.

Fluconazole Aurobindo capsules are available in

Transparent PVC / PVDC aluminum blister

Fluconazole Aurobindo 50 mg / 100 mg / 150 mg / 200 mg: 1, 2, 3, 4, 5, 6, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 100 capsules

HDPE bottle

Fluconazole Aurobindo 50 mg / 100 mg: 30 and 1000 capsules

Fluconazole Aurobindo 200 mg: 30 and 500 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

APL Swift Services (Malta) Limited,

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000,

Malta

Local representative:

APL Swift Services (Malta) Limited,

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000,

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

This medicinal product is authorized under the European Economic Area under the names:

Czech Republic: Fluconazole Aurovitas

Denmark: Fluconazole “Aurobindo”

Germany: Fluconazole Aurobindo 50mg / 100mg / 150mg / 200mg Hard Capsules

Italy: Fluconazolo Aurobindo 50mg / 100mg / 150mg / 200mg capsule rigid

Netherlands: Fluconazole Aurobindo 50mg / 150mg / 200mg, capsules

Poland: Fluconazole Aurobindo

Portugal: Fluconazole Aurobindo 50mg / 100mg / 150mg / 200mg Durable Capsules

Romania: Fluconazole Aurobindo 50mg / 100mg / 150mg capsule

Spain: Fluconazole Aurobindo 50mg / 100mg / 150mg / 200mg capsules duras

United Kingdom: Fluconazole 50mg / 100mg / 150mg / 200mg capsules, hard

Muhammad Nadeem

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