0 mg, 150 mg, 200 mg hard capsules
fluconazole

What Fluconazole Bluefish is and what it is used for

Fluconazole Bluefish belongs to a group of medicines used to treat fungal infections. The active substance is fluconazole.

Fluconazole Bluefish is used to treat infections caused by fungi, and can also be used to prevent 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
  • 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 Bluefish 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 cryptococcus – a fungal infection of the brain

You can also get Fluconazole Bluefish to:

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

Fluconazole contained in Fluconazole Bluefish may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Bluefish

Do not take Fluconazole Bluefish

  • if you are allergic to fluconazole or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, redness of the skin, or difficulty breathing.

While taking any of the following medicines:

  • cisapride (for stomach upset) 
  • astemizole (for allergies )
  • pimozide (used to treat mental disorders)
  • quinidine (used to treat irregular heartbeat)
  • terfenadine (for allergies )
  • erythromycin ( antibiotic for the treatment of infections ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Fluconazole Bluefish

Tell your doctor 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 prolonged fatigue, muscle weakness, decreased appetite, weight loss, abdominal pain).

Other medicines and Fluconazole Bluefish

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 Bluefish (see section “Do not take Fluconazole Bluefish”).

Some medications can be affected by or affect Fluconazole Bluefish.

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

  • amiodarone (used to treat irregular heartbeat ( arrhythmias ))
  • hydrochlorothiazide (diuretic)
  • cisapride (for stomach problems)
  • astemizole (for allergies )
  • pimozide (for mental disorders)
  • quinidine (for the treatment of irregular heartbeat)
  • terfenadine (for allergies )
  • erythromycin
  • halofantrine (against malaria )
  • amphotericin B, voriconazole (for fungal infections)
  • rifampicin, rifabutin (for tuberculosis and other infections )
  • alfentanil, fentanyl (used as anesthetic)
  • amitriptyline, nortriptyline (used to treat depression)
  • warfarin (blood thinner)
  • certain benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
  • calcium channel blockers
  • losartan
  • methadone (for pain)
  • celecoxib (analgesic)
  • ciclosporin, tacrolimus, sirolimus and everolimus (prevents organ rejection after transplantation)
  • cyclophosphamide, vinca alkaloids (eg vincristine, vinblastine, or similar medicines) used to treat cancer
  • HMG CoA Reductase Inhibitor
  • Statins such as atorvastatin, simvastatin, and fluvastatin (cholesterol-lowering agents)
  • carbamazepine, phenytoin (for epilepsy )
  • prednisone ( steroid )
  • saquinavir (used to treat HIV )
  • sulfonureider
  • azithromycin
  • theophylline (for asthma )
  • zidovudine, also called AZT
  • oral contraceptives
  • celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs) ( NSAIDs )
  • A vitamin (nutritional supplements)

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Fluconazole Bluefish with food and drink

The drug can be taken with or without a meal.

Pregnancy, breastfeeding, and fertility

Fluconazole Bluefish should not be used during pregnancy unless clearly necessary. 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.

Women of childbearing potential should use reliable contraception in long-term treatment with Fluconazole Bluefish.

Fluconazole Bluefish passes into breast milk and high or repeated doses should not be used during breast-feeding. Breast-feeding may be continued after a single dose of no more than 200 mg.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Fluconazole Bluefish is not expected to affect your ability to drive or use machines. However, you should be aware of how you react, as dizziness and seizures may occur in isolated cases.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Bluefish contains lactose and nycockin

Fluconazole Bluefish contains a small amount of lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Fluconazole Bluefish 200 mg capsules also contain the dye nycockin (E124) which may cause allergic reactions.

Fluconazole Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 50 mg, 150 mg, and 200 mg capsules, ie essentially ‘sodium-free’.

3. How to take Fluconazole Bluefish

Always take Fluconazole Bluefish exactly as your doctor or pharmacist 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 usual 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 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 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 a 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

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 Candida (if the child has a weakened immune system) 3 mg to 12 mg per kg body weight

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).

Your doctor may prescribe you other doses than those listed here. Always use Fluconazole Bluefish exactly as your doctor has told you. Ask your doctor 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 Bluefish than you should

You may feel unwell if you take too many capsules at once. If you have ingested too much or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center in Finland) for risk assessment and advice. 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 forget to take Fluconazole Bluefish

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 Bluefish can 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 Bluefish 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 that may affect up to 1 in 10 people:

headache, skin rash, vomiting, stomach discomfort, diarrhea, elevated liver values

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

fever, dizziness, decreased red blood cells which can lead to pale skin and cause weakness and shortness of breath, decreased appetite, insomnia, drowsiness, seizures, spinning sensation, prickling, tingling or numbness, change in taste, constipation, indigestion, muscle pain, flatulence, dry mouth, liver damage and yellowing of the skin and eyes (jaundice), streaks in the skin, blistering ( hives ), itching, sweating, fatigue, general malaise

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

decreased white blood cell count that helps defend the body against infections and decreased blood cell count that helps stop bleeding, red or purple discoloration of the skin that can be caused by decreased platelet counts or other changes in the blood, elevated blood cholesterol, and blood fat levels, decreased potassium levels in the blood, tremors, abnormal ECG, changes in heart rate or heart rate, twists of the nails on an ECG, QT prolongation, 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.

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.

5. How to store Fluconazole Bluefish

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. The expiration date is the last day of the specified month.

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, 150 mg or 200 mg of fluconazole .

The other ingredients are lactose monohydrate (37.32 mg, 111.96 mg, and 149.28 mg per capsule, respectively), corn starch, colloidal anhydrous silica, talc, sodium lauryl sulfate. The capsule cover contains gelatin and dyes: titanium dioxide (E171), patent blue (E131). Fluconazole Bluefish 200 mg also contains nycockin (E124) and indigo carmine (E132).

What the medicine looks like and the contents of the pack

Blister (PVC / PVDC / Al).

50 mg: white / clear blue capsule

Packages: 5, 7, 10, 14, 20, 28, 30, 60, 98, 100 and 100×1 capsules

150 mg: clear blue / clear blue capsule

Packaging: 1, 2, 4, 5, 6, 10 and 12 capsules

200 mg: white / dark blue capsule

Packaging: 5, 7, 10, 14, 20, 28, 30, 98 and 100 capsules

Not all pack sizes may be marketed.

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

Denmark, Norway: Fluconazole Bluefish

Muhammad Nadeem

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