DIFLUCAN CAPSULE 150MG

Active substance: FLUCONAZOLE

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370 LEAFLET Diflucan 20130605

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFLUCAN CAPSULES 150mg
FLUCONAZOLE CAPSULES 150mg
(fluconazole)
Your medicine is known as the above names but will be referred to
as Diflucan throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine

-

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)

Keep this leaflet. You may need to read it again.



-

nifedipine, isradipine, amlodipine, felodipine and

If you have any further questions, please ask your doctor or
pharmacist.

-

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

1. What Diflucan is and what it is used for

-

methadone (used for pain)

2. Before you take Diflucan

-

lornoxicam, meloxicam, diclofenac
Inflammatory Drugs (NSAID))

-

oral contraceptives

-

prednisolone (steroid)

-

zidovudine, also known as AZT; saquinavir (used in HIVinfected
patients)

-

medicines for diabetes such as chlorpropamide, glibenclamide,
glipizide or tolbutamide

-

theophylline (used to control asthma)

-

vitamin A (nutritional supplement)





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:

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
candida 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:

(Non-Steroidal

Anti-

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 and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. You should not take Diflucan while you are pregnant
or breast-feeding unless your doctor has told you to.
Ask your doctor or pharmacist for advice 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.
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.

-

Mucosal thrush - infection affecting the lining of the mouth,
throat

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

-

Infections caused by Candida and found in the blood stream,
body organs (e.g. heart, lungs) or urinary tract

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

-

Cryptococcal meningitis – a fungal infection in the brain

Condition

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).

-

To treat
meningitis

Dose
cryptococcal

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

50 mg to 400 mg once daily for 7 to
30 days until you are told to stop

stop cryptococcal meningitis from coming back

2. BEFORE TAKING 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

– dose depends on where
the infection is located
To stop mucosal
infections affecting the

develop severe skin reactions (itching, reddening of the skin or
difficulty in breathing)
Taking other medicines

lining of mouth, throat

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”).

vaginal thrush

-

There are some medicines that may interact with Diflucan. Make
sure your doctor knows if you are taking any of the following
medicines:

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

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)

-

liver damage and yellowing of the skin and eyes (jaundice)

-

wheals, blistering (hives), itching, increased sweating

Candida (if your immune

-

tiredness, general feeling of being unwell, fever

system is weak and not

Rare side effects which affect 1 to 10 users in 10,000 are listed
below:

To stop you from getting
an infection caused by

200 mg to 400 mg once daily while
you are at risk of getting an infection

working properly)

-

lower than normal white blood cells that help defend against
infections and blood cells that help to stop bleeding

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

-

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)

The maximum dose for children is 400 mg daily.

-

low blood potassium

The dose will be based on the child’s weight in kilograms.

-

shaking

Condition

Daily dose

-

Mucosal thrush and throat
infections caused by Candida

3 mg per kg of body weight (6
mg per kg of body weight might
be given on the first day)

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

Cryptococcal
meningitis
or
internal fungal infections caused
by Candida

6 mg to 12 mg per kg of body
weight

-

hair loss

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

5. HOW TO STORE DIFLUCAN

Adolescents from 12 to 17 years old

– dose and duration depends on
the severity of the infection and
on where the infection is located

Use in children 0 to 4 weeks of age

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.


Do not store the medicine above 30°C.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister.



If the capsule becomes discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will advise you what to do.

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

6. FURTHER INFORMATION
What Diflucan contains


Each capsule contains 150mg of the active ingredient
fluconazole.



Diflucan capsules also contain lactose, maize starch, colloidal
silicon dioxide, magnesium stearate and sodium lauryl sulphate.
The capsule shell contains gelatin, titanium dioxide (E171) and
patent blue V(E131). The black printing ink is composed of
shellac, black iron oxide E172 and propylene glycol.

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

What Diflucan looks like and contents of the pack

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.

 Diflucan Capsules comes in pack containing 1 capsule.
Product Licence holder

If you forget to take Diflucan

Manufacturer

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.

The capsules are made by

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 150 mg 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



Diflucan capsules are turquoise blue and are marked Pfizer on
one end and FLU-150 on the other, in black printing ink.

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex HA0 1DX.



Pfizer SARL, BP 109, 37401 Amboise Cedex, France.



Pfizer, PGM, Zone Industrielle de Pocesur-Cisse, 37401
Amboise Cedex, France.

POM

PL No: 08747/0370

Leaflet revision date: 05 June 2013
Diflucan is a registered trade mark of Pfizer Ltd, UK.
370 LEAFLET Diflucan 20130605

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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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