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FLUCONAZOLE CAPSULE 150MG

Active substance(s): FLUCONAZOLE

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370 LEAFLET Diflucan 20160419

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIFLUCAN CAPSULES 150mg
FLUCONAZOLE CAPSULES 150mg
(fluconazole)

Other medicines and Diflucan

Your medicine is known as the above names but will be referred to
as Diflucan throughout the following leaflet.

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”).

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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

-

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

-

rifampicin or rifabutin (antibiotics for infections)

-

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

-

alfentanil, fentanyl (used as anaesthetic)

-

amitriptyline, nortriptyline (used as anti-depressant)

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.

-

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

5. How to store Diflucan

-

halofantrine (used for treating malaria)

6. Contents of the pack and other information

-

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 HIVinfected patients)

-

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

-

theophylline (used to control asthma)

-

vitamin A (nutritional supplement)

-

ivacaftor (used for treating cystic fibrosis)

-

-

If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet:
1. What Diflucan is and what it is used for
2. What you need to know before you take Diflucan
3. How to take Diflucan
4. Possible side effects

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

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Diflucan with food and drink

-

Genital thrush – infection of the vagina or penis

You can take your medicine with or without a meal.

-

Skin infections - e.g. athlete’s foot, ringworm, jock itch, nail
infection

Pregnancy, breast-feeding and fertility

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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIFLUCAN
Do not take Diflucan

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.
Diflucan contains lactose (milk sugar)
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.

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

The recommended doses of this medicine for different infections
are below:
Condition

Dose

-

if you are taking astemizole, terfenadine (antihistamine
medicines for allergies)

To treat cryptococcal
meningitis

-

if you are taking cisapride (used for stomach upsets)

-

if you are taking pimozide (used for treating mental illness)

-

if you are taking quinidine (used for treating heart arrhythmia)

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

-

if you are taking erythromycin (an antibiotic for treating
infections)

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

-

Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan
-

if you have liver or kidney problems

-

if you suffer from heart disease, including heart rhythm
problems

-

if you have abnormal levels of potassium, calcium or
magnesium in your blood

-

if you develop severe skin reactions (itching, reddening of the
skin or difficulty in breathing)

Adults

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

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:

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)

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.

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 (may affect up to 1 in 10 people) are:
-

headache

-

stomach discomfort, diarrhoea, feeling sick, vomiting

-

increases in blood tests of liver function

-

rash

Uncommon side effects (may affect up to 1 in 100 people) are:
-

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 (may affect up to 1 in 1,000 people) are:
-

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

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

6 mg to 12 mg per kg of body
weight

-

liver failure

-

allergic reactions (sometimes severe), including widespread
blistering rash and skin peeling, severe skin reactions, swelling
of the lips or face

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

-

hair loss

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:

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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.
5. HOW TO STORE DIFLUCAN


Do not store the medicine above 30°C.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Elderly



The usual adult dose should be given unless you have kidney
problems.

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.

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.

Patients with kidney problems
Your doctor may change your dose, depending on your kidney
function.
If you take more Diflucan than you should

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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.

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), N-Butyl alcohol, dehydrated
alcohol, purified water, propylene glycol, industrial methylated
spirit, isopropyl alcohol, strong ammonia solution and
potassium hydroxide.

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.

What Diflucan looks like and contents of the pack

4. POSSIBLE SIDE EFFECTS

 Diflucan Capsules comes in pack containing 1 capsule.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex HA0 1DX.

Like all medicines, this medicine 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 side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in this
leaflet. If you get any of the following symptoms, tell your doctor
immediately.



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

Manufacturer

-

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

The capsules are made by
 Pfizer SARL, BP 109, 37401 Amboise Cedex, France.
 Pfizer, PGM, Zone Industrielle de Pocesur-Cisse, 37401
Amboise Cedex, France.
 Fareva Amboise, zone industrielle, 29 route des industries,
37530 poce sur cisse, France.

-

severe skin reactions such as a rash that causes blistering (this
can affect the mouth and tongue).

POM

PL: 08747/0370

Leaflet revision date: 19 April 2016
Diflucan is a registered trade mark of Pfizer Ltd, UK.
370 LEAFLET Diflucan 20160419

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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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