DIFLUCAN

Main information

  • Trade name:
  • DIFLUCAN 2 Mg/ Ml Solution for Infusion
  • Dosage:
  • 2 Mg/ Ml
  • Pharmaceutical form:
  • Solution for Infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIFLUCAN 2 Mg/Ml Solution for Infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Triazole derivatives

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA0019/044/008
  • Authorization date:
  • 22-08-1989
  • Last update:
  • 20-10-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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Package leaflet: Information for the u

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D

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®

2

m

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solution for infu

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ucon

Read all of this leaflet carefully before you start u

s

i

ng

this medicine because it contains important info

r

m

a

t

i

on

for

y

ou

.

Keep this leaflet. You may need to read

- If

you have any further questions, ask your

pharmacist or nu

This medicine has been prescribed for you only.

not pass

on to others.

may harm them, even

if t

signs of illness are the same as

yours.

- If

you get any of the side effects, talk to your

doctor,

pharmacist or nurse. This includes any possible

effects not listed in this leaflet. See section

What is in this l

eafle

t:

1. What Diflucan is and what

is used

2. What you need to know before you take D

3. How to take

4. Possible side

5. How to store

6. Contents of the pack and other i

1

.

What Diflucan is and what it is used for

Diflucan

one of a group of medicines called

active substance is fluconazole. Diflucan is used

treat infections caused by fungi and may also be

to stop you from getting c

infection. The most common cause of fungal infections is a

yeast called

C

a

nd

i

d

a

A

du

l

t

s

You might be given this medicine by your doctor to tr

the following types of fungal in

ons:

Cryptococcal meningitis –

a fungal infection in the

Coccidioidomycosis –

a disease of t

bronchopulmonary sys

Infections caused by Candida and found in the

blood

stream, body organs (e.g. heart, lungs) or urinary tr

Mucosal thrush

infection affecting the lining of

mouth, throat and denture sore

mouth

You might also be given Diflucan

stop cryptococcal meningitis from coming b

stop mucosal thrush from coming b

stop you from getting an infection caused by Candida

your immune system is weak and not working

Children and adolescents (0 to 17 years o

l

d

)

You might be given this medicine by your doctor to tr

the following types of fungal in

ons:

Mucosal thrush

infection affecting the lining of

mouth, t

Infections caused by Candida and found in the

blood

stream, body organs (e.g. heart, lungs) or urinary tr

Cryptococcal meningitis –

a fungal infection in the

You might also be given Diflucan

stop you from getting an infection caused by Candida

your immune system is weak and not working

stop cryptococcal meningitis from coming b

2

.

What you need to know before you take

D

i

f

l

u

c

a

n

Do not take

D

i

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l

u

c

a

n

- if

you are allergic to fluconazole, to other

you have taken to treat fungal infections or to any of t

other ingredients of this medicine (listed in section

symptoms may include itching, reddening of

skin or difficulty in b

- if

you are taking astemizole, terfenadine (

medicines for

- if

you are taking cisapride (used for stomach

- if

you are taking pimozide (used for treating

- if

you are taking quinidine (used for treating

- if

you are

taking erythromycin (an antibiotic for tr

Warnings and p

r

e

c

a

ut

i

on

s

Talk to your doctor or nurse before taking

- if

you have liver or kidney

- if

you suffer from heart disease, including heart

rhythm

- if

you have abnormal levels of potassium, calcium

magnesium in your

blood

- if

you develop severe skin reactions (itching, r

of the skin or difficulty in b

- if

you develop signs of ‘adrenal insufficiency’ where t

adrenal glands do not produce adequate amounts

certain steroid hormones such as cortisol (chronic,

long lasting fatigue, muscle weakness, loss of

weight loss, abdominal p

Other medicines and

D

i

f

l

uc

a

n

Tell your doctor or pharmacist

you are taking,

recently taken or might take any other

Tell your doctor

immediately

you are taking

terfenadine (an antihistamine for treating allergies)

cisapride (used for stomach upsets) or pimozide (used

treating mental illness) or quinidine (used for treating h

arrhythmia) or erythromycin (an antibiotic for tr

infections) as these should not be taken with Diflucan (

section:

not take Diflucan

if you”).

There are some medicines that may interact with D

Make sure your doctor knows

you are taking any of t

following m

rifampicin or rifabutin (antibiotics for i

alfentanil, fentanyl (used as

amitriptyline, nortriptyline (used

amphotericin B, voriconazole (

ti-f

medicines that thin the blood to prevent blood

clots

(warfarin or similar m

benzodiazepines (midazolam, triazolam or

medicines) used to help you sleep or for

carbamazepine, phenytoin (used for treating

fits)

nifedipine, isradipine, amlodipine, verapamil, f

and losartan (for hypertension

high blood p

olaparib (used for treating ovarian

ciclosporin, everolimus, sirolimus or tacrolimus

prevent transplant rej

cyclosphosphamide, vinca alkaloids (

vinblastine or similar medicines) used for tr

halofantrine (used for treating

statins (atorvastatin, simvastatin and fluvastatin

similar medicines) used for reducing high

methadone (used for

celecoxib, flurbiprofen, naproxen, i

lornoxicam, meloxicam,

diclofenac (Non-Steroidal

Inflammatory Drugs (

oral con

prednisone (

zidovudine, also known as AZT; saquinavir (used in H

infected p

medicines for diabetes such as

glibenclamide, glipizide or to

theophylline (used to control

tofacitinib (used for treating rheumatoid

riti

vitamin A (nutritional

supp

ivacaftor (used for treating cystic

fibrosis)

amiodarone (used for treating uneven

’)

hydrochlorothiazide (a

P

r

e

gn

a

n

cy

,

breast-feeding and

f

e

r

ti

li

t

y

you are pregnant or breast-feeding, think you may

pregnant or are planning to have a baby, ask your doctor

pharmacist for advice before taking this

You should not take Diflucan while you are pregnant

your doctor has told you

You can continue breast-feeding after taking

a single

of 150 mg

You should not breast-feed

you are taking a r

dose of

Driving and using

m

a

c

h

i

n

e

s

When driving vehicles or using machines

should b

taken into account that occasionally dizziness or fits

occur.

Diflucan contains

s

od

i

u

m

Diflucan contains 0.154 mmol sodium per ml. To be t

into consideration by patients on

controlled sodium d

3

.

How to take

D

i

f

l

u

c

a

n

This medicine will be given by your doctor or nurse as a

slow injection (infusion) into your vein. Diflucan is

supp

as a solution.

will not be diluted further. There is

more

information for healthcare professionals in

a section at t

end of the l

The recommended doses of this medicine

for different

infections are below. Check with your doctor or nurse

you are not sure why you are being given D

A

du

l

t

s

C

ond

i

t

i

on

D

o

s

e

To treat

ococc

400 mg on the first d

then 200 mg to 400

once daily for 6 to 8

or longer

Sometimes doses

increased up to 800

To stop

ococc

meningitis from co

200 mg once daily until

are told to

stop

To tr

cocc

200 mg to 400 mg onc

daily from 11 months

up to 24 months or long

needed. S

doses are increased up

To treat internal f

infections caused

C

a

nd

i

d

a

800 mg on the first d

then 400 mg once

until you are told to

stop

To treat mucosal i

affecting the lining

mouth, throat and

sore

mouth

200 mg to 400 mg on th

first day then 100 mg

200 mg once daily until

are told to

stop

To treat mucosal thrush

dose depends on where t

infection is loc

50 mg to 400 mg once

for 7 to 30 days until

are told to

stop

To stop mucosal i

affecting the lining

mouth, throat from

100 mg to 200 mg onc

daily, or 200 mg 3 times a

week, while you are at

risk

of getting an i

To stop you from

an infection caused

Candida

your i

system is weak and

working

200 mg to 400 mg onc

daily while you are at risk

getting an i

Adolescents from 12 to 17 years o

ld

the dose prescribed by your doctor (either adults

children

posology).

Children to 11 years

ol

d

The maximum dose for children is 400 mg

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

C

ond

i

t

i

on

Daily

do

s

e

Mucosal thrush

throat infections c

by Candida – dose

duration depends on t

severity of the infection

on where the infection

3 mg per kg of body

once daily (6 mg per kg

body weight might be

on the first d

Cryptococcal meningitis

internal fungal in

caused by

C

a

nd

i

d

a

6 mg to 12 mg per kg

body weight once

To stop

ococc

meningitis from co

6 mg per kg of body

once

To stop children

from

getting an infection

by Candida

their i

system is not

working

3 mg to 12 mg per kg

body weight once

Use in children 0 to 4 weeks of

a

g

e

Use in children of 3 to 4 weeks of

The same dose as above but given once every 2

The maximum dose is 12 mg per kg of body

every 48

hours.

Use in children less than 2 weeks

old:

The same dose as above but given once every 3

The maximum dose is 12 mg per kg of body

every 72

hours.

E

l

d

e

r

l

y

The usual adult dose should be given unless you

kidney

Patients with kidney p

r

ob

l

e

ms

Your doctor may change your dose, depending on

your

kidney

function.

If you take more Diflucan than you

s

hou

l

d

you are concerned that you may have been given

much Diflucan, tell your doctor or nurse immediately.

symptoms of

a possible overdose may include

seeing, feeling and thinking things that are not r

(hallucination and paranoid

If you forget to take

D

i

f

l

u

c

a

n

As you will be given this medicine under close

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supervision,

is unlikely that a dose would be

However tell your doctor or pharmacist

you think that a

dose has been f

you have any further questions on the use of

this

medicine, ask your doctor, pharmacist or

4

.

Possible side

e

ff

e

c

t

s

Like all medicines, this medicine can cause side

although not everybody gets t

A few people develop

allergic reactions

although

allergic reactions are rare.

you get any side effects, t

to your doctor or pharmacist. This includes any

poss

side effects not listed in this leaflet.

you get any of t

following symptoms,

tell

your doctor i

mm

e

d

ia

t

e

l

y

sudden wheezing, difficulty in breathing or tightness

swelling of eyelids, face or

lips

itching all over the body reddening of the skin or

itchy

spots

skin r

severe skin reactions such as a rash that

blistering (this can affect the mouth and t

ongu

Diflucan may affect your liver. The signs of liver

- tir

loss of

- vomiting

yellowing of your skin or the whites of your

(jaundice)

any of these happen, stop taking Diflucan and

tell

y

ou

r

doctor i

mm

e

d

i

a

t

e

ly

Other side

e

ff

e

c

t

s

:

Additionally,

any of the following side effects

serious, or

you notice any side effects not listed in

this

leaflet, please tell your doctor or

Common side effects (may affect up to 1 in 10 people)

stomach discomfort, diarrhoea, feeling sick,

vomiting

increases in blood tests of liver

function

- r

Uncommon side effects (may affect up to 1 in 100

reduction in red blood cells which can make skin

and cause weakness or

decreased

inability to sleep, feeling

drowsy

fit, dizziness, sensation of spinning, tingling, pricking

numbness, changes in sense of t

constipation, difficult digestion, wind, dry

mouth

muscle p

liver damage and yellowing of the skin and

(jaundice)

wheals, blistering (hives), itching, increased

tiredness, general feeling of being unwell, f

Rare side effects (may affect up to 1 in 1,000 people)

lower than normal white blood cells that help d

against infections and blood cells that help to

stop

red or purple discoloration of the skin which may b

caused by low platelet count, other blood cell

blood chemistry changes (high blood levels

cholesterol,

fats)

low blood po

abnormal electrocardiogram

(ECG), change in heart r

rhythm

liver f

allergic reactions (sometimes severe),

including

widespread blistering rash and skin peeling, severe

skin

reactions, swelling of the lips or f

hair

loss

Frequency not known, but may occur (cannot be

from the available

hypersensitivity reaction with skin rash, fever, s

glands, increase in a type of white blood

(eosinophilia) and inflammation of internal organs (li

lungs, heart, kidneys and large intestine) (Drug

or rash with Eosinophilia and Systemic

Reporting of side

e

ff

e

c

ts

you get any side effects, talk to your doctor,

or nurse. This includes any possible side effects not li

in this leaflet. You can also report side effects

(see details below). By reporting side effects you can

provide more information on the safety of this

United

K

i

ngdo

m

Yellow Card Scheme website: www

.gov.uk

yellowcard or search for MHRA Yellow Card in the

Play or Apple App

I

r

e

l

a

nd

HPRA Pharmacovigilance, Earlsfort Terrace, IRL

- Dublin

2; Tel: +353 1 6764971; Fax: +353 1

6762517.

Website: www.hpra.ie; E-mail: m

5

.

How to store

D

i

f

l

u

c

a

n

Keep this medicine out of the sight and reach of

Do not use this medicine after the expiry date which

stated on the pack after EXP. The expiry date refers

the last day of that

month.

Storage

conditions:

Glass vials: Do not fr

Plasticised PVC bags: Store below 30°C. Do not free

Once opened the product should be used i

Any unused infusion should be discarded.

This

medicinal product is for single use

only.

Do not use this medicine

you notice visible particles

the solution is unclear or

Do not throw away any medicines via wastewater

household waste. Ask your pharmacist how throw

medicines you no longer use. These measures will

protect the

6

.

Contents of the pack and other info

r

m

a

t

i

on

What Diflucan

c

ont

a

i

n

s

The active substance is fl

ucon

Each ml contains 2 mg of fl

ucon

1 vial with 25 ml solution for infusion contains 50

ucon

1 vial with 50 ml solution for infusion contains 100

ucon

1 vial with 100 ml solution for infusion contains 200

ucon

1 vial with 200 ml solution for infusion contains 400

ucon

solution for infusion contains 200

ucon

solution for infusion contains 400

ucon

The other ingredients are: sodium chloride, water

injections and sodium hydroxide (for pH

What Diflucan looks like and contents of the p

a

ck

Diflucan is a clear, colourless solution with no

- It

comes in either glass vials

plasticised

Pack

1 vial containing 25 ml solution for in

1, 48 vial(s) containing 50 ml solution for

infusion

1, 40 vial(s) containing 100 ml solution for

infusion

1 vial containing 200 ml solution for

infusion

1, 5, 10, 20 plasticised

bag(s) containing 100

solution for

infusion

1, 5, 10, 20 plasticised

bag(s) containing 200

solution for

infusion

Not all pack sizes may be

Marketing Authorisation Holder and

M

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nuf

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tu

r

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r

Marketing Authorisation Ho

ld

e

r

Pfizer

Ramsgate

CT13

United

ngdo

M

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tu

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Fareva

Ambo

Zone

Industrielle

29 route des I

ndus

37530

This medicinal product is authorised in the

M

e

m

b

e

r

States of the EEA

under the following n

a

m

e

s

:

Diflucan 2

mg/ml

Infusionslösung

Belgium,

Denmark, Finland,

Ireland, Italy, Lux

Norway, Portugal,

Sweden, United

ngdo

Cyprus,

ungus

Czech

Diflucan I

Diflucan

2mg/ml

Triflucan 2 mg/ml, so

injectable pour

Diflucan i.v. 2

mg/ml,

Infusionslösung

Diflucan 2 mg/ml o

Diflucan 2 mg/ml so

infusion

Diflucan I.V. 2

mg/ml,

oplossing voor in

Diflucan 2 mg/ml so

Diflucan 2 mg/ml r

za i

Diflucan 2mg/ml so

para

This leaflet was last revised in:

UK

04/2018

IE

MM

/

YYYY

13_0

---------------------------------------------------------------------

following information is intended for medical

healthcare professionals

only:

Intravenous infusion

should be administrated

a ra

not exceeding 10 ml/minute. Diflucan is formulated

sodium chloride 9 mg/ml (0.9%) solution for

infusion,

each 200 mg (100 ml bottle) containing 15 mmol

of Na+ and C1-. Because Diflucan is available as a

sodium chloride solution, in patients requiring sodium

fluid restriction, consideration should be given to the r

of fluid

Fluconazole intravenous infusion is compatible with t

following administration

fluids:

a) Dextrose 5% and

b) Ringer’s

solution

c) Hartmann’s

solution

d) Potassium chloride in d

e) Sodium bicarbonate 4.2% and

Aminosyn

3.5%

g) Sodium chloride 9 mg/ml

(0.9%)

h) Dialaflex (interperitoneal dialysis Soln

6.36%)

Fluconazole may be infused through an existing line

with

one of the above listed fluids. Although no

incompatibilities

have been noted, mixing with any

medicinal products prior to infusion is not r

The solution for infusion is for single use only.

microbiological point of view, the dilutions should b

used immediately.

not used i

in-use storage times and conditions prior to use are t

responsibility of the user and would normally not be l

than 24 hours at 2 to 8

unless dilution has taken

controlled and validated aseptic

conditions.

dilution is to be made under aseptic conditions.

solution is to be inspected visually for particulate

and discoloration prior to administration.

solution

should only be used

the solution is clear and free

from

Any unused medicinal product or waste material should

disposed of in accordance with local r

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