DIFLUCAN 200MG HARD CAPSULES

Active substance: FLUCONAZOLE

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- hair loss
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5. HOW TO STORE DIFLUCAN
- Keep out of the reach and sight of children.
- Do not use Diflucan after the expiry date which is stated on the pack after EXP. The expiry date refers
to the last day of the month.
- Store below 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. FURTHER INFORMATION
What Diflucan contains
- 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 silica anhydrous, magnesium stearate
and sodium laurilsulfate.
Capsule shell composition:
50 mg hard capsules: gelatin, titanium dioxide (E171) and patent blue V (E131)
200 mg hard capsules: gelatin, titanium dioxide (E171), erythrosine (E127) and indigo carmine (E 132)
Printing ink: shellac (glaze), black iron oxide, N-Butyl alcohol, dehydrated alcohol, purified water,
propylene glycol, industrial methylated spirit, isopropyl alcohol, strong ammonia solution, potassium
hydroxide
What Diflucan 50 mg and 200 mg hard capsules look like and contents of the pack
- Diflucan 50 mg hard capsules have a white body and a turquoise blue cap. They have “FLU‑50” and
“Pfizer” with black ink printed on them.
- Diflucan 200 mg hard capsules have a white body and a purple cap. They have “FLU‑200” and “Pfizer”
with black ink printed on them.
Diflucan 50 mg and 200 mg come in packs of 1, 2, 3, 4, 6, 7, 10, 12, 14, 20, 28, 30, 42, 50, 60, 100 or
500 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Pfizer PGM
Zone Industrielle
29 route des Industries
37530 Poce sur Cisse
France
This leaflet was last approved in: 11/2013
Ref: DF 2_1 UK/IE

PACKAGE LEAFLET: INFORMATION FOR THE USER



Diflucan® 50 mg hard capsules

Diflucan® 200 mg hard capsules
fluconazole

Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Diflucan is and what it is used for
2. Before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Further information

1. WHAT DIFLUCAN IS AND WHAT IT IS USED FOR
Diflucan is one of a group of medicines called “antifungals”. The active substance is
fluconazole.
Diflucan 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 Diflucan 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 Diflucan 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. BEFORE YOU TAKE DIFLUCAN
Do not take Diflucan if you
- are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat
fungal infections or to any of the other ingredients of Diflucan. The symptoms may
include itching, reddening of the skin or difficulty in breathing
- are taking astemizole, terfenadine (antihistamine medicines for allergies)
- are taking cisapride (used for stomach upsets)
- are taking pimozide (used for treating mental illness)
- are taking quinidine (used for treating heart arrhythmia)
- are taking erythromycin (an antibiotic for treating infections)
Take special care with Diflucan
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)
Taking other medicines

MOCK-UP FROM 8817060

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 Diflucan (see
section: “Do not take Diflucan if you”).
There are some medicines that may interact with Diflucan. 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)
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Taking Diflucan 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 should
not take Diflucan while you are pregnant unless your doctor has told you to.
You can continue breast-feeding after taking a single dose of Diflucan up to 200 mg.
You should not breast-feed if you are taking a repeated dose of Diflucan.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that
occasionally dizziness or fits may occur.
Important information about some of the ingredients of Diflucan
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 DIFLUCAN
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.
The usual doses of this medicine for different infections are below:
Adults
Condition
To treat cryptococcal
meningitis
To stop cryptococcal
meningitis from
coming back
To treat
coccidioidomycosis

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
To treat internal fungal 800 mg on the first day then 400 mg once daily until you are
infections caused by told to stop
Candida
To treat mucosal
200 mg to 400 mg on the first day then 100 mg to 200 mg until
infections affecting the you are told to stop
lining of mouth, throat
and denture sore
mouth
To treat mucosal
50 mg to 400 mg once daily for 7 to 30 days until you are told
thrush – dose depends to stop
on where the infection
is located
To stop mucosal
100 mg to 200 mg once daily, or 200 mg 3 times a week, while
infections affecting the you are at risk of getting an infection
lining of mouth, throat
To treat genital thrush 150 mg as a single dose
To reduce recurrence 150 mg every third day for a total of 3 doses (day 1, 4 and 7)
of vaginal thrush
and then once a week for 6 months while you are at risk of
getting an infection
To treat fungal skin
Depending on the site of the infection 50 mg once daily,
and nail infections
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
200 mg to 400 mg once daily while you are at risk of getting an
getting an infection
infection
caused by Candida (if
your immune system
is weak and not
working properly)
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
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.
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 Diflucan 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 Diflucan
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, Diflucan 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).
Diflucan 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 Diflucan 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 which affect 1 to 10 users in 100 are listed below:
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
Uncommon side effects which affect 1 to 10 users in 1,000 are listed below:
- 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 which affect 1 to 10 users in 10,000 are listed below:
- 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

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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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