2mg / ml Infusion solution
fluconazole

What Fluconazole Villerton is and what it is used for

Fluconazole Villerton is a medicine used to treat fungal infections. The active substance is fluconazole.

Fluconazole Want Chesterton is used to treat the infection caused by fungi and may also be used to prevent that you get a yeast 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.
  • A fungal infection that affects the lining of the mouth, throat and can cause mouth soreness when using a denture

You can also get Fluconazole Villerton to:

  • prevent recurrence of meningitis caused by cryptococci.
  • prevent the recurrence of fungal infections in the mouth.
  • 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 Villerton to:

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

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

What you need to know before you use Fluconazole Villerton

You should not be treated with Fluconazole Villerton if you

  • is allergic (hypersensitive) to fluconazole, to any other medicines you have taken to treat fungal infection, or to any of the other ingredients of Fluconazole Villerton (sodium chloride, sodium hydroxide). 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 to treat infections ).

Take special care with Fluconazole Villerton

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).

Use of other medicines

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

Tell your doctor immediately if you are taking astemizole or terfenadine (an antihistamine to treat allergies ) or cisapride (used to treat 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 Villerton (see section “You should not be treated with Fluconazole Villerton if you”).

Some medications can be affected by or affect Fluconazole Villerton. Tell your doctor if you are taking any of the following medicines:

  • rifampicin or 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 ) to prevent blood clots
  • benzodiazepines (eg midazolam, triazolam) used for insomnia or anxiety
  • carbamazepine, phenytoin (for epilepsy )
  • nifedipine, isradipine, amlodipine, felopidine, and 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 (eg 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 )
  • birth control pills
  • prednisone ( steroid )
  • zidovudine (also called AZT) or saquinavir (used to treat HIV )
  • drugs against diabetes as chlorpropamide, glibenclamide, glipizide or tolbutamide
  • theophylline (for asthma )
  • vitamin A (nutritional supplement).

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.

Tell your doctor if you are pregnant, trying to become pregnant, or breast-feeding. You should not take Fluconazole Villerton while you are pregnant or breast-feeding unless your doctor tells you to.

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

Driving and using machines

Fluconazole Villerton normally has little or no effect on the ability to drive or use machines. However, when driving or using machines, you may experience dizziness or seizures.

You are always 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.

Important information about some of the ingredients of Fluconazole Villerton

Fluconazole Villerton contains 15 mmol sodium per 100 ml solution. This should be considered by patients on a low-salt diet.

How to use Fluconazole Villerton

Always use this medicine exactly as your doctor has told you. Your doctor has adjusted the dose specifically for you. Fluconazole Villerton solution for infusion will be given as a slow injection ( infusion ) into a vein. This will be done by a doctor or other healthcare professional.

The dose and duration of treatment depend on your infection.

The table below shows the usual doses for different infections  Consult your doctor or nurse if you are not sure why you are receiving Fluconazole Villerton.

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 recurrence of 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 (cod) – dose one depends on exactly 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 lining of the mouth and throat 100 mg to 200 mg once daily or 200 mg 3 times a week as long as you are at risk of getting an infection
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 from 12 to 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 0 to 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 Villerton 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 Villerton then you should

If you are concerned about taking too much fluconazole, tell your doctor or nurse immediately. 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).

If a dose of Fluconazole Villerton is missed

As you will receive this medicine under close medical supervision, it is unlikely that a dose will be missed. Talk to your doctor or pharmacist if you think a dose has been missed.

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

4. Possible side effects

Like all medicines, Fluconazole Villerton 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 Villerton 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 Villerton and contact your doctor immediately.

Other side effects:

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 affect between 1 to 10 users in 100:

  • headache
  • feeling uncomfortable in the stomach, diarrhea, nausea, vomiting
  • elevated liver values
  • rash

Uncommon side effects affecting 1 to 10 users in 1,000:

  • 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 or eyes (jaundice)
  • streaks in the skin, blistering ( hives ), itching, sweating
  • fatigue, general malaise, fever.

Rare side effects affecting 1 to 10 users in 10,000:

  • 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

5. How to store Fluconazole Villerton

Keep out of 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.

Store in the original package. Do not freeze

Do not use this medicine if you notice visible deterioration.

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 ml of solution for infusion contains 2 mg of fluconazole.

The other ingredients are sodium chloride, sodium hydroxide, and water for injections.

What the medicine looks like and the contents of the pack

Fluconazole Villerton is a clear, colorless solution for infusion. Fluconazole Villerton is delivered in plastic bags with a door with twistable protection. Each bag of Fluconazole Villerton is packed in an outer bag of aluminum foil.

Carton sizes: 10 × 50 ml, 10 × 100 ml and 10 × 200 ml.

Marketing Authorisation Holder

Villerton Invest SA

Rue Edward Steichen 14

2540 Luxembourg

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Mylan Hospital AS

PO Box 194, 1371 ASKER

Norway

Manufacturer

Facta Pharmaceuticals SPA

TERAMO – ITALY

Muhammad Nadeem

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