50 mg, 100 mg, 150 mg and 200 mg hard capsules fluconazole
What Fluconazole Hexal is and what it is used for
Fluconazole Hexal belongs to a group of medicines used to treat fungal infections. The active substance is fluconazole.
Fluconazole Hexal 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
- 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 and 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 Hexal 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 Hexal to:
- prevent infection caused by Candida (if you have a weakened immune system)
- prevent recurrence of meningitis caused by cryptococci
Fluconazole contained in Fluconazole Hexal 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.
What you need to know before you use Fluconazole Hexal
Do not use Fluconazole Hexal:
Fluconazole Hexal 50 mg, 100 mg, 150 mg:
- if you are allergic to fluconazole, other medicines you have taken to treat the 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.
Fluconazole Hexal 200 mg:
- if you are allergic to fluconazole, other medicines you have taken to treat a fungal infection, nycockin, 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 Hexal:
- 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 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 Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or 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 Hexal (see section “Do not use Fluconazole Hexal”).
Some medications can be affected by or affect Fluconazole Hexal.
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 ) 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 )
- olaparib (used to treat ovarian cancer)
- ciclosporin, everolimus, sirolimus or tacrolimus (used to prevent interference of the graft )
- 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 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 )
- amiodarone (used to treat irregular heartbeat ( arrhythmias ))
- hydrochlorothiazide (diuretic)
Fluconazole Hexal 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 Hexal if you are pregnant unless your doctor tells you to. You can continue breastfeeding after taking a single dose of 150 mg Fluconazole Hexal. You should not breast-feed if you take repeated doses of Fluconazole Hexal.
Driving and using machines
When driving and when using machines, keep in mind that dizziness or seizures can sometimes occur during treatment.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 Hexal 50 mg, 100 mg, 150 mg and 200 mg hard capsules contain lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
Fluconazole Hexal 200 mg hard capsules contain the red dye nycockin (E124)
May cause allergic reactions.
3. How to use Fluconazole Hexal
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.
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 and 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 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 |
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 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 Hexal then you should
You may feel unwell if you take too many capsules at once.
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, 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 the symptoms (supportive measures and, if necessary, gastric lavage) may be needed in case of overdose.
If you forget to take Fluconazole Hexal
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 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 Hexal 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 Hexal and contact your doctor immediately.
Other side effects are
If any of the following 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):
- headache
- feeling uncomfortable in the stomach, diarrhea, nausea, vomiting
- elevated liver values
- rash
Uncommon side effects (may affect up to 1 in 100 people):
- 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, flatulence, 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):
- 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 (occurs 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 Hexal
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 and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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.
One hard capsule contains 50, 100, 150, or 200 mg of fluconazole. - The other ingredients are:
Capsule content: lactose monohydrate, maize starch, magnesium stearate, and sodium lauryl sulfate, colloidal anhydrous silica.Capsule contents: gelatin, titanium dioxide (E171). In addition to Fluconaxol Hexal 50 mg, 100 mg, and 200 mg: indigo carmine (E132).In addition to Fluconazole Hexal 200 mg: nycockine (E124).Ink: shellac, black iron oxide (E172), propylene glycol (E1520).
What the medicine looks like and the contents of the pack
Fluconazole Hexal 50 mg hard capsules have a white part (body) and a turquoise part (cap). “FC 50” is printed on the capsule.
The packages contain 3, 7, 10, 14, 20, 28, 30, 42, 50, 98, 98×1 and 100 hard capsules.
Fluconazole Hexal 100 mg hard capsules have a white part (body) and a blue part (cap). “FC 100” is printed on the capsule.
The packages contain 7, 10, 20, 28, 50, and 100 hard capsules.
Fluconazole Hexal 150 mg hard capsules have a white part (body) and a white part (cap). “FC 150” is printed on the capsule.
The packages contain 1, 2, 4, and 6 hard capsules.
Fluconazole Hexal 200 mg hard capsules have a white part (body) and a purple part (cap). “FC 200” is printed on the capsule.
The packages contain 7, 10, 20, 28, 50, and 100 hard capsules.
The hard capsules are packaged in PVC / aluminum foil blisters that are in a carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer :
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany