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FLUCONAZOLE 50MG CAPSULES

Active substance(s): FLUCONAZOLE / FLUCONAZOLE / FLUCONAZOLE

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Package leaflet: Information for the user

Fluconazole 50mg, 200mg Capsules

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children posology).
Children to 11 years old

(Fluconazole)
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 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. How to take Fluconazole Capsules
4. Possible side effects
5. How to store Fluconazole Capsules
6. Contents of the pack and other information

The maximum dose for children is 400 mg daily.
The dose will be based on the child's weight in kilograms.
Condition
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
Cryptococcal meningitis or internal fungal infections
caused by Candida
To stop children from getting an infection caused by
Candida (if their immune system is not working
properly)

Daily dose
3 mg per kg of body weight (6 mg per kg of body
weight might be given on the first day)
6 mg to 12 mg per kg of body weight
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.

1. What Fluconazole Capsules is and what it is used for
Fluconazole Capsules is one of a group 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 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 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 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 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:

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 your doctor or pharmacist if you are not sure.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dose, 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 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.
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 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).

- 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 (used for treating mental illness)
- if you are taking amiodarone or quinidine (used for treating heart arrhythmia)
- if you are taking erythromycin (an antibiotic for treating infections)

Fluconazole Capsules 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)
If any of these happen, stop taking Fluconazole Capsules and tell your doctor immediately.

Warnings and precautions

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.

Tell your doctor if you
- have liver or kidney problems
- suffer from heart disease, including heart rhythm 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 (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
Fluconazole Capsules (see section: “Do not take 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:

-

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.

headache
stomach discomfort, diarrhoea, feeling sick, vomiting
increases in blood tests of liver function
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
- 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 repor t 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.

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.

6. Contents of the pack and other information
What Fluconazole Capsules contains

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

Your medicine is called Fluconazole 50 mg Capsules or Fluconazole 200 mg Capsules. The carton and blister
foil will show the capsule strength.

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 your doctor that you
have an intolerance to some sugars, please contact your doctor before taking this medicine.
3. How to take Fluconazole 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.

- 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.

Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.

Printing ink:
The black printing ink contains shellac, propylene glycol and black iron oxide (E 172).

The usual doses of this medicine for different infections are below:

What Fluconazole Capsules look like and content of the pack

Adults

The 50mg capsules are blue/ white coloured capsules, printed with 'RANBAXY'.
The 200mg capsules are purple/ white coloured capsules, printed with 'RANBAXY'.

Condition
To treat cryptococcal meningitis

To stop cryptococcal meningitis from coming back
To treat coccidioidomycosis

To treat internal fungal infections caused by Candida
To treat mucosal infections affecting the lining of
mouth, throat and denture sore mouth
To treat mucosal thrush – dose depends on where the
infection is located
To stop mucosal infections affecting the lining of
mouth, throat
To treat genital thrush
To reduce recurrence of vaginal thrush.

To treat fungal skin and nail infections

To stop you from getting an infection caused by
Candida (if your immune system is weak and not
working properly)

Dose
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
200 mg once daily until you are told to stop
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
800 mg on the first day then 400 mg once daily until
you are told to stop
200 mg to 400 mg on the first day then 100 mg to
200 mg until you are told to stop
50 mg to 400 mg once daily for 7 to 30 days until you
are told to stop
100 mg to 200 mg once daily, or 200 mg 3 times a
week, while you are at risk of getting an infection
150 mg as a single dose
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
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)
200 mg to 400 mg once daily while you are at risk of
getting an infection

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, UB3 4AZ
United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii Nr. 124
Cluj-Napoca 400 632
Romania
This leaflet was last revised in August 2016.

5131372 - LIT FLUCONAZOLE CAP (50/200MG), MARKET : UK-R, Size : 140 x 550 MM SPIL-DWS : 05.08.16VS, 21.07.16vs, OLD CODE : 5120211, ITF CODE : 05131372

(Ref-Blue U / Black U)

Font Size : 8pt

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rifampicin or rifabutin (antibiotics for infections)
alfentanil, fentanyl (used as anaesthetic)
amiodarone (used for treating 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 or for
anxiety
carbamazepine, phenytoin (used for treating fits)
nifedipine, isradipine, amlodipine felodipine, hydrochlorothiazide 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
prednisone (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)

-

5131372

-

Common: (may affect up to 1 in 10 people)

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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