FLUXOGARD
Fluxogard 150mg Capsules
Fluconazole
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, pharmacist or nurse.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this Leaflet. See section 4.
What is in this leaflet:
- What Fluxogard is and what it is used for
- What you need to know before you take Fluxogard
- How to take Fluxogard
- Possible side effects
- How to store Fluxogard
- Contents of the pack and other information
- What Fluxogard is and what it is used for
Fluconazol belongs to a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazol is used to treat infections caused by fungi and may also be used to stop you from getting a candida infection. The most common cause of fungal infection is a yeast called Candida.
Adults
You might be given this medicine by your doctor to treat the following types of fungal infections:
– Cryptococcal meningitis – a fungal infection in the brain
– Coccidioidomycosis – a disease of the bronchopulmonary system
– Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary
Tract
– Mucosal thrush – infection affecting the lining of the mouth, throat and denture sore mouth
– Genital thrush – infection of the vagina or penis
– Skin infections – e.g. athlete’s foot, ringworm, jock itch, nail infection
You might also be given Fluxogard to:
– stop cryptococcal meningitis from coming back
– stop mucosal thrush from coming back
– reduce recurrence of vaginal thrush
– stop you from getting an infection caused by Candida (if your immune system is weak and not working
properly).
Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat the following types of fungal infections:
– Mucosal thrush – infection affecting the lining of the mouth, throat
– Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract.
– Cryptococcal meningitis – a fungal infection in the brain.
You might also be given Fluconazol capsules to:
– stop you from getting an infection caused by Candida (if your immune system is weak and not working properly)
– stop cryptococcal meningitis from coming back.
- What you need to know before you take Fluxogard
If you have any doubts about whether you should take these capsules then discuss with your doctor before taking them.
Do not take Fluxogard
– If you are allergic to any of the ingredients of Fluxogard (listed in section 6 of leaflet)
– If you are allergic to any other medicines that you have taken to treat a fungal infection. The symptoms
may include itching, reddening of the skin or difficulty in breathing
– If you are taking terfenadine or astemizole (an antihistamine for allergies)
– If you are taking cisapride (used for stomach upsets)
– If you are taking quinidine (used for heart disease)
– If you are taking pimozide (for treating a mental disorder)
– If you are taking erythromycin (an antibiotic for treating infections)
– If you are taking amiodarone (used for treating heart arrhythmia).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluxogard if:
– you are suffering from liver or kidney problems
– you are suffering from heart disease, including heart rhythm problems
– you have abnormal levels of potassium, calcium or magnesium in your blood
– develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
– you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
Other medicines and Fluxogard
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluxogard (see section: “ Do not take Fluxogard”)
There are some other medicines that may interact with Fluconazol. Make sure your doctor knows if you are taking any of the following medicines: – rifampicin or rifabutin (antibiotics for infections)
– alfentanil, fentanyl (used as anaesthetic)
– amitriptyline, nortriptyline (used as anti-depressant)
– amphotericin B, voriconazole (anti-fungal)
– medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
– benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
– carbamazepine, phenytoin (used for treating fits)
– nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension- high blood pressure)
– ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
– cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating
cancer
– halofantrine (used for treating malaria) – statins (atorvastatin, simvastatin and fluvastatin or similar
medicines) used for reducing high cholesterol levels
– methadone (used for pain)
– celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-
Inflammatory Drugs (NSAID))
– Oral contraceptives
– prednisolone (steroid)
– zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
– medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or
– tolbutamide
– theophylline (used to control asthma)
– vitamin A (nutritional supplement)
– ivacaftor (used for treating cystic fibrosis)
– amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
– hydrochlorothiazide (a diuretic)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those medicines obtained without a prescription.
Fluxogard with food and drink
You can take your medicine with or without a meal.
Pregnancy, breast-feeding 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 can continue breast-feeding after taking a single dose of Fluxogard. You should not breast-feed if you are taking a repeated dose of Fluxogard. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Fluxogard occasionally causes dizziness or fits may occur which could affect your ability to drive or use machinery.
Important information about some of the ingredients
Fluxogard contains methyl p-hidroxybenzoate (E 218) and propyl p-hidroxybenzoate (E 216)
May cause allergic reactions (even delayed).
Fluxogard cantains Ponceau 4R (E 124) and Sunset Yellow (E 110). May cause allergic reactions.
- How to take Fluxogard 150mg capsules
Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.
Adults:
| Condition | Dose |
| To treat cryptococcal meningitis | 400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed. Sometimes doses are increased up to 800 mg |
| To stop cryptococcal meningitis from coming back | 200 mg once daily until you are told to stop |
| To treat coccidioidomycosis | 200 mg to 400 mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg. |
| To treat internal fungal infections caused by Candida | 800 mg on the first day then 400 mg once daily until you are told to stop |
| To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth | 200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop |
| To treat mucosal thrush – dose depends on where the infection is located | 50 mg to 400 mg once daily for 7 to 30 days until you are told to stop |
| To stop mucosal infections affecting the lining of mouth, throat | 100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection |
| To treat genital thrush | 150 mg as a single dose |
| To reduce recurrence of vaginal thrush | 150 mg every third day for a total of 3 doses (day 1, 4 and 7) and then once a week for 6 months while you are at risk of getting an infection |
| To treat fungal skin and nail infections | Depending on the site of the infection 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (Athlete’s foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced) |
| To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) | 200 mg to 400 mg once daily while you are at risk of getting an infection |
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children posology).
Children to 11 years old
The maximum dose for children is 400 mg daily.
The dose will be based on the child’s weight in kilograms.
| Condition | Daily dose |
| Mucosal thrush and throat infections caused by Candida – dose and duration depends on the severity of the infection and on where the infection is located | 3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day) |
| Cryptococcal meningitis or internal fungal infections caused by Candida | 6 mg to 12 mg per kg of body weight |
| To stop children from getting an infection caused by Candida (if their immune system is not working properly) | 3 mg to 12 mg per kg of body weight |
Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may modify your dose, depending on your kidney function.
If you take more Fluxogard than you should
Taking too many capsules at once may make you unwell. Contact your doctor or your nearest hospital casualty department at once. The symptoms of a possible overdose may include hearing, seeing, feeling and thinking things that are not real (hallucination and paranoid behavior). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate
If you forget to take Fluxogard
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take the dose that you missed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
- Possible side effects
Like all medicines, Fluxogard can cause side effects, although not everybody gets them.
A few people develop allergic reactions although serious allergic reactions are rare. If you get any of the following symptoms, tell your doctor immediately. This includes any possible side effects not listed in this leaflet.
– Sudden wheezing, difficulty in breathing or tightness in the chest
– Swelling of eyelids, face or lips
– Itching all over the body, reddening of the skin or itchy red spots
– Skin rash – severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).
Fluxogard may affect your liver. The signs of liver problems include:
– Tiredness
– Loss of appetite
– Vomiting
– Yellowing of your skin or the whites of your eyes (jaundice)
Fluxogard may affect the adrenal glands and steroid hormones produced. Signs of adrenal gland problems include:
– Tiredness
– Muscle weakness
– Loss of appetite
– Weight loss
– Abdominal pain
If any of these happen, stop taking Fluxogard and tell your doctor immediately.
Other side effects:
Additionally, 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 to 10 people
– Headache
– Stomach discomfort, diarrhoea, feeling sick, vomiting
– Increases in blood tests of liver function
– Rash
Uncommon side effects: may affect up to 1 in 100 people
– Reduction in red blood cells which can make skin pale and cause weakness or breathlessness
– decreased appetite
– Inability to sleep, feeling drowsy
– Fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
– Constipation, difficult digestion, wind, dry mouth
– Muscle pain
– Liver damage and yellowing of the skin and eyes (jaundice)
– Wheals, blistering (hives), itching, increased sweating
– Tiredness, general feeling of being unwell, fever
Rare side effects: may affect up to 1 in 1,000
– Lower than normal white blood cells that help defend against infections and blood cells that help to stop
bleeding
– Red or purple discoloration of the skin which may be caused by low platelet count, other blood cell
changes
– Blood chemistry changes (high blood levels of cholesterol, fats)
– Low blood potassium
– Shaking
– Abnormal electrocardiogram (ECG), change in heart rate or rhythm
– Liver failure
– Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face
– Hair loss.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via National Agency for Medicines and Medical Devices. Website: www.anm.ro. By reporting side effects you can help provide more information on the safety of this medicine.
- How to store Fluxogard
Keep out of the reach and sight of children.
Store at temperatures below 25°C, in the original packaging.
Do not use this medicine after the expiry date which is stated on the carton label after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines of via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
- Contents of the pack and other information
What Fluxogard contains
The active substance is Fluconazol.
The other ingredients are: microcrystalline cellulose, talc, magnesium stearate
Capsule shell:
Cap: gelatin, titanium dioxide (El 71), Brilliant Blue (E133), methyl p-hidroxybenzoate (E218), propyl p-hidroxybenzoat (E216), Erythrosine (E127).
Body: gelatin, titanium dioxide (El 71), Ponceau 4R (E124), Sunset Yellow (E110), methyl p-hidroxybenzoate (E218), propyl p-hidroxybenzoate (E216).
What Fluxogard looks like and contents of the pack
Capsules are orange body /blue cap containing white crystalline powder.
Fluxogard is available in PVC/Al blister pack of 1 capsule.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Nextra Group Ltd
18 Irodion Evodishvili str.,
0154 Tbilisi, Georgia
Manufacturers
S.C Slavia Pharm S.R.L
B-dul Theodor Pallady nr. 44C
Sector 3, București, România
| Manufacturer |
Slavia Pharm |
|---|
