DIFLUCAN 150MG CAPSULES

Active substance: FLUCONAZOLE

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Diflucan® 150mg Capsules/
Fluconazole 150mg Capsules
(fluconazole)
Your medicine is known by any of the above names, but will be referred to
as Diflucan throughout this:
Patient Information Leaflet
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 get 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.

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1) What Diflucan is and what it is used for

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)

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.

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.

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
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)

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

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

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
- hair loss
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Diflucan
 Do not use after the expiry date printed on the carton, label or blister
strip.
 Do not store above 30°C.
 Keep out of the sight and reach of children.
 If your doctor tells you to stop taking the capsules, please take them
back to the pharmacist for safe disposal. Only keep them if your doctor
tells you to.
 If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.
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 150mg Fluconazole.
 The other ingredients are:
Capsule content: lactose, maize starch, colloidal silicon dioxide,
magnesium stearate and sodium laurilsulfate.
Capsule shell composition: gelatin, titanium dioxide (E171) and patent
blue V (E131).
Printing ink: Printing ink: shellac, black iron oxide (E172), butyl alcohol,
industrial methylated spirit, purified water, propylene glycol and isopropyl
alcohol or shellac, black iron oxide (E172), butyl alcohol, purified water,
propylene glycol, isopropyl alcohol, dehydrated alcohol, concentrated
ammonia solution and potassium hydroxide.
What Diflucan looks like and contents of the pack
Each hard gelatin capsule has a blue opaque cap marked with ‘PFIZER’
logo and a blue opaque body marked ‘FLU-150’ in black printing ink.
Diflucan 150mg Capsules/Fluconazole 150mg Capsules are available as
blister packs of 1 capsule.
PL 10383/1298

Diflucan 150mg Capsules/
Flucanozole 150mg Capsules

POM

Who makes and repackages your medicine?
Diflucan 150mg Capsules/Fluconazole 150mg Capsules are manufactured
by Pfizer, PGM, Zone Industrielle de Poce-sur-Cisse, 37401 Amboise
Cedex, France. Procured from within the EU and repackaged by Product
Licence Holder Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
Leaflet date: 25.09.2014.
Diflucan is a registered trademark of the Pfizer group of companies.

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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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