Fluconazole 2 mg Solution

FLUCONAZOLE FRESENIUS is a medicine for the treatment and prevention of infections with fungi. FLUCONAZOLE FRESENIUS belongs to a group of medicines active against infections with fungi, called imidazoles.

FLUCONAZOLE FRESENIUS should not be given to you:

• if you are allergic (hypersensitive) to fluconazole, or other similar medicines such as ketoconazole and itraconazole or to any of the other ingredients of FLUCONAZOLE FRESENIUS (listed in section 6)
• in multiple doses of 400 mg per day or higher if you are also taking terfenadine (an antihistamine for allergies)
• if you are taking medicines known to affect your heart and that affect the way your body handles FLUCONAZOLE FRESENIUS, such as:
• cisapride (used to treat heartburn and to lower stomach acid)
• astemizole (an antihistamine for allergies)
• erythromycin (an antibiotic)
• pimozide (a so-called neuroleptic used to treat mental illness)
• quinidine (used in the treatment of heart rhythm disorders)
• if you are pregnant or breastfeeding your infant.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection: Special care should be taken with FLUCONAZOLE FRESENIUS:

• if you have tinea capitis (ringworm, a fungal infection of the scalp)
• if you have cryptococcosis (a fungal injection of the lungs or skin)
• if you have kidney disease
• if you have problems with your adrenal glands which produce certain hormones in the body
• if you have currently, or have previously had, problems with your liver
• if you have AIDS or have an infection that affects your whole body. If you have this, you may be more prone to serious skin reactions. Tell your doctor immediately if you develop skin rashes, hives or skin peeling
• if you are taking other medicines that work similar to FLUCONAZOLE FRESENIUS in the body (see “Other medicines and FLUCONAZOLE FRESENIUS”)
• if you have porphyria (a rare hereditary disease in which the blood pigment haemoglobin is abnormally metabolised)
• if you have heart disease including heart rhythm problems and/or electrolyte abnormalities such as low potassium levels in your blood.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with fluconazole treatment. Stop using FLUCONAZOLE FRESENIUS and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

You will not be expected to give yourself FLUCONAZOLE FRESENIUS. It will be given to you by a person who is qualified to do so. FLUCONAZOLE FRESENIUS will be administered to you via a drip (slow injection into a vein). The dose will be determined by your doctor. Treatment will normally continue until the infection has gone.

Patients with kidney problems: Your doctor will adjust the dose based on your kidney function.

Children: Your doctor will determine the dose in children.

FLUCONAZOLE FRESENIUS can have side effects. Not all side effects reported for FLUCONAZOLE FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving FLUCONAZOLE FRESENIUS, please consult your healthcare provider for advice.

If any of the following happens, stop receiving FLUCONAZOLE FRESENIUS and tell your doctor immediately:

• A sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure.
• Swelling of the face, lips, tongue and windpipe with wheezing and difficulty in breathing.
• Severe, extensive, blistering skin rash, with peeling of skin.
• Seizures or fits (convulsions).
• Liver problems and toxicity causing abnormal weakness, loss of appetite, persistent nausea, vomiting and/or jaundice (where the skin, white of the eyes and inside of the mouth turn yellow).
• Decrease in the number of cells in the circulation that may lead to anaemia, increased susceptibility to infection, easy bruising or bleeding.
• Infection with symptoms of fever and a severe worsening of your general condition, or fever with local infection e.g. sore throat, pharynx (back of throat), mouth or urinary tract problems.
• Changes in heart rhythm.

These are all very serious side effects. If you have them, you may have had a serious reaction to FLUCONAZOLE FRESENIUS. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache.
• Skin rash.
• Feeling sick (nausea).
• Being sick (vomiting).
• Stomach ache or pain.
• Diarrhoea.
• Alterations in blood test results of liver function.

Less frequent side effects:

• Changes in how food tastes, dry mouth.
• Dizziness.
• Indigestion.
• Wind (flatulence).
• Loss of appetite.
• Itching or rash, wheals, swelling or blistering (hives).
• Increased sweating.
• Loss of appetite.
• Changes in blood test results of kidney function.
• Abnormal sleep (sleeplessness, drowsiness).
• Numbness, trembling.
• Pain in muscles.
• Feeling weak and tired.
• Fever.
• Increased levels of fats in the blood (cholesterol and triglycerides).
• Decreased levels of potassium leading to weakness and an irregular or fast heart beat.
• Hair loss (alopecia).

Side effects with an unknown frequency:

• Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of FLUCONAZOLE FRESENIUS. Patients are asked to report any suspected adverse drug reactions to their healthcare provider or Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed.

Store all medicines out of reach of children. Store at or below 25 °C. Do not freeze. Keep the product in the outer container until required for use. Do not use FLUCONAZOLE FRESENIUS after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month. The product must be used immediately after first opening the container. Use only if the solution is clear and free from visible particles. Do not use if the bottle is damaged. The bottles are for single use only. Once having been used, bottles and any remaining contents must be disposed of. 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.