Fluconazole 50mg Capsules
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 furtherquestions, askyour doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Fluconazole Capsules Is and what It Is used for
2. What you need to know before you take Fluconazole Capsules
3. Howto take Fluconazole Capsules
4. Possible side effects
5. Howto store Fluconazole Capsules
6. Contents of the pack and other Information
1. What Fluconazole Capsules Is and what It Is used for
Fluconazole Capsules is one of agroup of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole Capsules is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is a yeast called Candida.
Adults
You might be given this medicine by your doctorto treat the following types of fungal infections:
- Cryptococcal meningitis—a fungal infection in the brain
- Coccidioidomycosis-adisease of the bronchopulmonary system
- Infections caused by Candida andfound 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 Fluconazole Capsules 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 doctorto treat the following types of fungal infections:
- Mucosal thrush - infection affecting the lining of the mouth, throat
- Infections caused by Candida andfound in the blood stream, body organs (e.g. heart, lungs) or urinary tract
- Cryptococcal meningitis —afungal infection in the brain
You might also be given Fluconazole 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
2. What you need to know before you take Fluconazole Capsules
Do not take Fluconazole Capsules:
- if you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing
- if you are taking astemizole, terfenadine (antihistamine medicines for allergies)
- if you are taking cisapride (used for stomach upsets)
- if you are taking pimozide (usedfortreating mental illness)
- if you are taking amiodarone orquinidine (usedfortreating heart arrhythmia)
- if you are taking erythromycin (an antibiotic fortreating infections)
Warnings and precautions
Tell your doctor if you
- have liveror kidney problems
- sufferfrom heart disease, including heartrhythm problems
- have abnormal levels of potassium, calcium or magnesium in your blood.
- develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
- have adrenal insufficiency (although rarely seen fluconazole may reduce the ability of the adrenal glands to work properly)
Other medicines and Fluconazole Capsules
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating allergies) or cisapride (used for stomach upsets) or pimozide (usedfortreating mental illness) orquinidine (usedfortreating heart arrhythmia) or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazole Capsules (see section: “Do nottake Fluconazole Capsules”).
There are some medicines that may interact with Fluconazole Capsules. 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)
- amiodarone (usedfortreating heart arrhythmia)
- amitriptyline, nortriptyline (used as anti-depressant)
- amphotericin B, voriconazole (anti-fungal)
- medicines that thin the blood to prevent blood clots (warfarin, indanedione or similar medicines)
- benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep orfor anxiety
- carbamazepine, phenytoin (used fortreating fits)
- nifedipine, isradipine, amlodipine felodipine, hydrochlorothiazide and losartan (for hypertension- high blood pressure)
- ciclosporin, everolimus, sirolimus ortacrolimus (to preventtransplantrejection)
- cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for treating cancer
- halofantrine(usedfortreatingmalaria)
- statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels
- methadone (used for pain)
- celecoxib, flurbiprofen, naproxen, ibuprofen, lomoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))
- oral contraceptives
- prednisone (steroid)
- zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
- medicines for diabetes such as chlorpropamide, glibenclamide, glipizide ortolbutamide
- theophylline (used to control asthma)
- vitamin A (nutritional supplement)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Fluconazole Capsules with food, drink and alcohol
You can take your medicine with or without a meal.
Pregnancy breast-feeding and fertility
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. You should not take Fluconazole Capsules while you are pregnant or breast-feeding unless your doctor has told you to.
Askyour doctororpharmacistforadvice before taking any medicines.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.
Fluconazole Capsules contains lactose
This medicine contains a small amount of lactose (milk sugar). If you have been told by yourdoctorthatyou have an intolerance to some sugars, please contact your doctor before taking this medicine.
3. Howto take Fluconazole Capsules
Adolescents from 12 to 17 years old
Followthe dose prescribed by your doctor (eitheradults 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 |
6mgto12mg per kg of body weight |
|
To stop children from getting an infection caused by Candida (if their immune system is not working properly) |
3mg to12mg 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.
Doctors sometimes prescribe different doses to these. Always take your medicine exactly as your doctor has told you. You should check with yourdoctoror pharmacist if you are not sure.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Yourdoctor may change yourdose, depending on your kidney function.
If you take more Fluconazole Capsules 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 behaviour). Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
If you forget to take Fluconazole Capsules
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 almosttime for your next dose, do nottake the dose that you missed.
If you have any further questions on the use of this medicine, askyour doctoror pharmacist.
4. Possible side effects
Like all medicines, Fluconazole Capsules 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.
- sudden wheezing, difficulty in breathing ortightness in the chest
- swelling of eyelids, face orlips
- 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).
Fluconazole Capsules may affect your liver. The signs of liver problems include:
- tiredness
- loss of appetite
- vomiting
- yellowing of your skin orthe whites of youreyes (jaundice)
If any of these happen, stop taking Fluconazole Capsules 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: (may affect up to 1 in 10 people)
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liverfunction
- rash
Uncommon: (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: (may affect up to 1 in 1,000 people)
- 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
- liverfailure
- allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips orface
- 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fluconazole Capsules
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallowthe capsule whole with aglass of water. It is best to take your capsules at the same time each day.
The usual doses of this medicine for different infections are below:
Adults
|
Condition |
Dose |
|
To treat cryptococcal meningitis |
400 mg on the first day then 200 mg to 400 mg once daily for 6to8 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 |
What Fluconazole Capsules contains
Your medicine is called Fluconazole 50 mg Capsules or Fluconazole 200 mg Capsules. The carton and blister foil will show the capsule strength.
- The active substance is fluconazole.
- Each hard capsule contains 50 mg or 200 mg of fluconazole.
- The other ingredients are:
Capsule content: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate and sodium lauryl sulphate.
Capsule shell composition:
50 mg capsules: gelatin, patent blue (E131) and titanium dioxide (E171) as colouring agents
200mg capsules: gelatin, patent blue (E131), titanium dioxide (E171) and erythrosine (E127) as colouring
agents.
Printing ink:
The black printing ink contains shellac, propylene glycol and black iron oxide (E172).
What Fluconazole Capsules look like and content of the pack
The 50mg capsules are blue/ white coloured capsules, printed with 'RANBAXY'.
The 200mg capsules are purple/white coloured capsules, printed with 'RANBAXY'.
Fluconazole Capsules are available in blister strips in packs of 7 or 28 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Ranbaxy (UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB34AZ United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132 JH Hoofddorp The Netherlands
TerapiaS.A.
Str. Fabricii Nr. 124 Cluj-Napoca 400 632 Romania
This leaflet was last revised in August 2016.
CM
co
co
LO