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

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

Fluconazole Accord belongs to a group of medicines used to treat fungal infections. The active substance is fluconazole. Fluconazole Accord is used in adults to treat fungal infections. 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
  • Infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
  • Fungal infection of the mouth affects the lining of the mouth, throat and can cause 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 Accord 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
  • Infection is caused by Candida and is found in the bloodstream, internal organs (eg heart, lungs), or urinary tract.
  • Meningitis caused by a cryptococcal fungal infection of the brain

You can also get Fluconazole Accord to:

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

Fluconazole contained in Fluconazole Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

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

Do not take Fluconazole Accord:

  • if you are allergic to fluconazole, 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.
  • if you are taking astemizole or terfenadine ( antihistamine for the treatment of allergies )
  • if you are taking cisapride (for stomach upset)
  • if you are taking pimozide (used to treat mental illness)
  • if you are taking quinidine (used to treat irregular heartbeat)
  • if you are taking erythromycin ( antibiotic to treat infections ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Fluconazole Accord

  • if you have liver or kidney problems
  • if you have any heart disease, e.g. irregular heartbeat
  • 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” which means that the adrenal glands do not produce enough of certain steroid hormones, e.g. cortisol ( chronic or prolonged fatigue, muscle weakness, decreased appetite, weight loss, abdominal pain).

Other medicines and Fluconazole Accord

Tell your doctor or pharmacist if you are taking, have recently taken, nor might take any other medicines.

Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for the treatment of allergies ) or cisapride (for stomach upset) or pimozide (used to treat mental disorders) or quinidine (used to treat irregular heartbeat), or erythromycin (an antibiotic for the treatment of infections ) as these should not be taken with Fluconazole Accord (see section “Do not use Fluconazole Accord if you”).

Some medications can be affected by or affect the Fluconazole Accord. 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 (for fungal infections)
  • blood-thinning drugs (eg warfarin or similar drugs) to prevent blood clots
  • benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
  • carbamazepine, phenytoin (for epilepsy )
  • amiodarone (used to treat irregular heartbeats, “arrhythmias”)
  • hydrochlorothiazide (used as a diuretic [diuretic])
  • nifedipine, isradipine, amlodipine, verapamil, felodipine or losartan (for high blood pressure )
  • olaparib (used to treat ovarian cancer)
  • 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 (for pain)
  • celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs, NSAIDs )
  • on 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 )
  • tofacitinib (for rheumatoid arthritis )
  • A vitamin (nutritional supplements)
  • ivacaftor (used to treat cystic fibrosis )

Fluconazole Accord with food and drink

The drug can be taken regardless of the meal.

Pregnancy, breastfeeding, and fertility

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

You should not take Fluconazole Accord if you are pregnant unless your doctor tells you to. You can continue breastfeeding after taking a single dose of 150 mg fluconazole.

You should not breast-feed if you are taking repeated doses of fluconazole.

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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fluconazole Accord contains lactose monohydrate

This medicine 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 this medicine.

3. How to take Fluconazole Accord

Always take your 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.

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 as needed. 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
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 once daily until your doctor tells you to stop
To treat a 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 recurrent fungal infections that affect the mucous membranes of the mouth and throat 100 mg to 200 mg once daily 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 as 1 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 you are at risk of getting an infection.

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 – the dose and duration of treatment depends on how severe the infection is and where it is located. 3 mg per kg body weight once daily (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 once daily
To prevent recurrent meningitis caused by cryptococci 6 mg per kg body weight once daily
To prevent the child from getting an infection caused by Candida (if the child has a weakened immune system) 3 mg to 12 mg per kg body weight once daily

Children between 0 and 4 weeks

Children between 3 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 every three days (72 hours).

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 Accord then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. The symptoms of a possible overdose may be that you start hearing, seeing, feeling, and thinking things that are not real (hallucinations and paranoid behaviors). Treatment of symptoms and gastric lavage may be required in case of overdose.

If you take more doses than your doctor prescribes, you may feel drowsy, dizzy, and have an abnormal heartbeat.

If you forget to take Fluconazole Accord

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 rareIf you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. 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 Accord 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 Accord 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
  • rash.

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

  • decreased 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 infection 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
  • decreased 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.

Has been reported (may occur in an unknown number of users):

  • hypersensitivity reaction with skin rash, fever, swollen glands, increased amount of a white blood cell type ( eosinophilia ), and inflammation of internal organs (liver, lungs, heart, kidneys, and colon) (so-called “drug reaction with eosinophilia and systemic symptoms”, (DRESS )).

5. How to store Fluconazole Accord

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiration date is the last day of the specified month.
  • Store below 30 ° C. Store in the original package. Moisture sensitive.
  • 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.

Capsule shell:

For 50 mg:

Gelatine

Titanium dioxide (E171)

Indigotine (E132)

Yellow iron oxide (E172)

Capsule shell:

For 100 mg and 150 mg:

Gelatine

Titanium dioxide (E171)

Patent Blue V (E131)

Capsule shell:

For 200 mg:

Gelatine

Titanium dioxide (E171)

What the medicine looks like and the contents of the pack

50 mg: capsule cover: Size 4, white bottom and green top.

100 mg: capsule cover: Size 2, white base, and blue top.

150 mg: capsule shell: Size 1, blue.

200 mg: capsule shell: Strolek 0, white.

Fluconazole Accord capsules are packaged in PVC-aluminum blisters.

50 mg and 200 mg capsules

The pack sizes are 7, 14, 20, 28, 50, and 100 capsules, hard

100 mg capsules

Pack sizes are 7, 10, 20, 28, 50, 60, 100 capsules, hard

150 mg capsules

Pack sizes of 1, 2, 4, 6, and 10 capsules, hard

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice

Poland

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Muhammad Nadeem

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