DIFLUCAN 50MG/5ML POWDER FOR ORAL SUSPENSION

Active substance: FLUCONAZOLE

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S1653 LEAFLET Diflucan 20121107

PACKAGE LEAFLET: INFORMATION FOR THE USER

DIFLUCAN 50mg/ 5ml
POWDER FOR ORAL SUSPENSION
(fluconazole)
The name of your medicine is “Diflucan 50mg/ 5ml Powder for Oral
Suspension” will be referred to as “Diflucan” throughout the
following leaflet.
Please note that information regarding other strength “Diflucan
200mg/ 5ml Powder for Oral Suspension” may also be present in
the below 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 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

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 antidepressant)

-

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)

-

lornoxicam, meloxicam, diclofenac (Non- Steroidal Anti 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

6. Further information
-

theophylline (used to control asthma)

1. WHAT DIFLUCAN IS AND WHAT IT IS USED FOR

-

vitamin A (nutritional supplement)

Diflucan is one of a group of medicines called “antifungals”. The
active substance is fluconazole.

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

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.

Taking Diflucan with food and drink
Diflucan can be taken with or without food.

Adults

Pregnancy and breast-feeding

You might be given this medicine by your doctor to treat the
following types of fungal infections:

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.

-

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

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
Diflucan powder for oral suspension contains sucrose (sugar).
-

If you have an intolerance to some sugars, please contact your
doctor before taking this medicine.

-

Doses of 10 ml contain 5.6 g or more of sugar.

You might also be given Diflucan to:
-

stop cryptococcal meningitis from coming back

-

stop mucosal thrush from coming back

This should be taken into account if you have diabetes.

-

reduce recurrence of vaginal thrush

-

-

stop you from getting an infection caused by Candida (if your
immune system is weak and not working properly)

3. HOW TO TAKE DIFLUCAN

Children and adolescents (0 to 17 years old)

May be harmful to teeth if used for periods of longer than 2
weeks.

You might be given this medicine by your doctor to treat the
following types of fungal infections:

Always take your medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.

-

It is best to take medicine at the same time each day.

-

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

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

Cryptococcal meningitis – a fungal infection in the brain

You might also be given Diflucan to:
-

Dose

To treat cryptococcal
meningitis

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

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 the
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 –
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 of
mouth and throat from
coming back

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

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)

To stop you from getting an
infection caused by Candida
(if your immune system is
weak and not working
properly)

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

stop you from getting an infection caused by Candida (if your
immune system is weak and not working properly)

-

Condition

To stop cryptococcal
meningitis from coming back

-

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”).

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children
posology).

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

The maximum dose for children is 400 mg daily. The dose will be
based on the child’s weight in kilograms.

-

red or purple discoloration of the skin which may be caused by
low platelet count, other blood cell changes

Condition

Daily dose

-

blood chemistry changes (high blood levels of cholesterol, fats)

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)

-

low blood potassium,

-

shaking

-

abnormal electrocardiogram (ECG), change in heart rate or
rhythm

-

liver failure

Cryptococcal meningitis or
internal fungal infections caused
by Candida

6 mg to 12 mg per kg of body
weight

-

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

Children to 11 years old

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.

Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:

5. HOW TO STORE DIFLUCAN

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.



Keep out of the sight and reach of children.



Do not store above 30°C.

Use in children less than 2 weeks old:



Do not freeze. Keep the bottle tightly closed.



Any remaining reconstituted suspension should be discarded
after 14 days.



Do not use Diflucan after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.



If the medicine becomes discoloured or shows 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.

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.
Instructions to make up the suspension:
It is recommended that your pharmacist makes up Diflucan powder
for oral suspension before giving it to you. Instructions are provided
in a section of this leaflet for healthcare professionals.

6. FURTHER INFORMATION

Instructions for use:



The active substance is fluconazole. Each 5 ml of reconstituted
oral suspension contains 50 mg fluconazole.



The other ingredients are sucrose, colloidal anhydrous silica,
titanium dioxide (E171), xanthan gum, sodium citrate dihydrate,
citric acid anhydrous, sodium benzoate (E211) and natural
orange flavour.

Shake the closed bottle of the suspension every time before using.
If you take more Diflucan than you should
Taking too much Diflucan 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

What Diflucan looks like and contents of the pack.


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.

Diflucan Powder for oral suspension is a white to off-white
powder for oral suspension providing a white to off-white
suspension. Your pharmacist will add 24ml of water to the
powder produce, an orange flavoured suspension containing
the equivalent of 50mg of fluconazole per 5 ml.



If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

In each bottle the mixture of powder and water makes 35 ml of
suspension.



A 5ml spoon is provided to measure the correct dose. A full
spoon provides quantity of 5ml and halfway line on spoon
should be ignored.

If you forget to take Diflucan

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:
-

loss of appetite

-

vomiting

-

yellowing of your skin or the whites of your eyes (jaundice)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Farma Sierra, Carretera De Irun,
km 26,200, San Sebastian de los Reyes, E-28700, Spain.
POM

PL No: 19488/1653

Leaflet revision date: 07 November 2012
Diflucan is a registered trademark of Pfizer Inc.
S1653 LEAFLET Diflucan 20121107

tiredness

-

Product Licence holder

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

Instructions to make up the suspension:
The reconstituted suspension will provide a white to off-white
orange-flavoured suspension after reconstitution.
For the 60 ml bottle:
1. Tap the bottle to release the powder.
2. Add a small quantity of still water and shake it vigorously. Add
water up to the level marked on the bottle (this corresponds to
adding 24 ml of water)
3. Shake well for one to two minutes to obtain a well mixed
suspension.
4. Write the expiry date of the reconstituted suspension on the
bottle label (the shelf life of the reconstituted suspension is 28
days). Any unused suspension should be not be used after this
date and should be returned to your pharmacist.

-

rifampicin or rifabutin (antibiotics for infections)

PACKAGE LEAFLET: INFORMATION FOR THE USER

-

alfentanil, fentanyl (used as anaesthetic)

FLUCONAZOLE 50mg/ 5ml
POWDER FOR ORAL SUSPENSION
(fluconazole)

-

amitriptyline, nortriptyline (used as antidepressant)

-

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

Please note that information regarding other strength “Fluconazole
200mg/ 5ml Powder for Oral Suspension” may also be present in
the below leaflet.

-

carbamazepine, phenytoin (used for treating fits)

-

nifedipine, isradipine, amlodipine, felodipine and losartan (for
hypertension- high blood pressure)

Read all of this leaflet carefully before you start taking this
medicine

-

ciclosporin, everolimus, sirolimus or tacrolimus (to prevent
transplant rejection)



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

-



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

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)

-

lornoxicam, meloxicam, diclofenac (Non- Steroidal Anti Inflammatory Drugs (NSAID))

S1653 LEAFLET Fluconazole 201211107

The name of your medicine is “Fluconazole 50mg/ 5ml Powder for
Oral Suspension” will be referred to as “Fluconazole Suspension”
throughout the following leaflet.



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.

-

oral contraceptives

In this leaflet:

-

prednisolone (steroid)

1. What Fluconazole Suspension is and what it is used for

-

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)

2. Before you take Fluconazole Suspension
3. How to take Fluconazole Suspension
4. Possible side effects
5. How to store Fluconazole Suspension
6. Further information
1. WHAT FLUCONAZOLE SUSPENSION IS AND WHAT IT IS
USED FOR

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Taking Fluconazole Suspension with food and drink

Fluconazole Suspension is one of a group of medicines called
“antifungals”. The active substance is fluconazole.

Fluconazole Suspension can be taken with or without food.

Fluconazole Suspension 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.

Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. You should not take Fluconazole Suspension while
you are pregnant or breast-feeding unless your doctor has told you
to.

Adults

Ask your doctor or pharmacist for advice before taking any
medicines.

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

-

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

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
Fluconazole Suspension
Fluconazole Suspension powder for oral suspension contains
sucrose (sugar).

Genital thrush - infection of the vagina or penis

-

Pregnancy and breast-feeding

You might also be given Fluconazole Suspension to:

-

If you have an intolerance to some sugars, please contact your
doctor before taking this medicine.

-

Doses of 10 ml contain 5.6 g or more of sugar.
This should be taken into account if you have diabetes.

-

May be harmful to teeth if used for periods of longer than 2
weeks.

-

stop cryptococcal meningitis from coming back

-

stop mucosal thrush from coming back

3. HOW TO TAKE FLUCONAZOLE SUSPENSION

-

reduce recurrence of vaginal thrush

-

stop you from getting an infection caused by Candida (if your
immune system is weak and not working properly)

Always take your medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not
sure.

Children and adolescents (0 to 17 years old)

It is best to take medicine at the same time each day.

You might be given this medicine by your doctor to treat the
following types of fungal infections:

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

-

Condition

Dose

To treat cryptococcal
meningitis

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

-

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

Adults

Cryptococcal meningitis – a fungal infection in the brain

You might also be given Fluconazole Suspension to:
-

stop you from getting an infection caused by Candida (if your
immune system is weak and not working properly)

To stop cryptococcal
meningitis from coming back

200 mg once daily until you are told
to stop

-

stop cryptococcal meningitis from coming back

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 the
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 –
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

Take special care with Fluconazole Suspension

To stop mucosal infections of
mouth and throat from
coming back

100 mg to 200 mg once daily, or
200 mg 3 times a week, while you
are at risk of getting an infection

Tell your doctor if you:

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

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)

To stop you from getting an
infection caused by Candida
(if your immune system is
weak and not working
properly)

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

2. BEFORE YOU TAKE FLUCONAZOLE SUSPENSION
Do not take Fluconazole Suspension 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 Fluconazole Suspension. 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)

-

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 Fluconazole Suspension (see section: “Do not
take Fluconazole Suspension if you”).
There are some medicines that may interact with Fluconazole
Suspension. Make sure your doctor knows if you are taking any of
the following medicines:

Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children
posology).

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

The maximum dose for children is 400 mg daily. The dose will be
based on the child’s weight in kilograms.

-

red or purple discoloration of the skin which may be caused by
low platelet count, other blood cell changes

Condition

Daily dose

-

blood chemistry changes (high blood levels of cholesterol, fats)

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)

-

low blood potassium,

-

shaking

-

abnormal electrocardiogram (ECG), change in heart rate or
rhythm

-

liver failure

Cryptococcal meningitis or
internal fungal infections caused
by Candida

6 mg to 12 mg per kg of body
weight

-

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

Children to 11 years old

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.

Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:

5. HOW TO STORE FLUCONAZOLE SUSPENSION

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.



Keep out of the sight and reach of children.



Do not store above 30°C.

Use in children less than 2 weeks old:



Do not freeze. Keep the bottle tightly closed.



Any remaining reconstituted suspension should be discarded
after 14 days.



Do not use Fluconazole Suspension after the expiry date which
is stated on the pack. The expiry date refers to the last day of
that month.



If the medicine becomes discoloured or shows 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.

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.
Instructions to make up the suspension:
It is recommended that your pharmacist makes up Fluconazole
Suspension powder for oral suspension before giving it to you.
Instructions are provided in a section of this leaflet for healthcare
professionals.

6. FURTHER INFORMATION

Instructions for use:



The active substance is fluconazole. Each 5 ml of reconstituted
oral suspension contains 50 mg fluconazole.

If you take more Fluconazole Suspension than you should



Taking too much Fluconazole Suspension 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.

The other ingredients are sucrose, colloidal anhydrous silica,
titanium dioxide (E171), xanthan gum, sodium citrate dihydrate,
citric acid anhydrous, sodium benzoate (E211) and natural
orange flavour.

What Fluconazole Suspension looks like and contents of the
pack.

If you forget to take Fluconazole Suspension



Fluconazole Powder for oral suspension is a white to off-white
powder for oral suspension providing a white to off-white
suspension. Your pharmacist will add 24ml of water to the
powder produce, an orange flavoured suspension containing
the equivalent of 50mg of fluconazole per 5 ml.



In each bottle the mixture of powder and water makes 35 ml of
suspension.



A 5ml spoon is provided to measure the correct dose. A full
spoon provides quantity of 5ml and halfway line on spoon
should be ignored.

Shake the closed bottle of the suspension every time before using.

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, Fluconazole Suspension 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.

What Fluconazole Suspension contains

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

-

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

Manufacturer

-

skin rash

-

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

This product is manufactured by Farma Sierra, Carretera De Irun,
km 26,200, San Sebastian de los Reyes, E-28700, Spain.

Fluconazole Suspension may affect your liver. The signs of liver
problems include:
-

loss of appetite

-

vomiting

-

yellowing of your skin or the whites of your eyes (jaundice)

PL No: 19488/1653

Leaflet revision date: 07 November 2012
S1653 LEAFLET Fluconazole 201211107

tiredness

-

POM

If any of these happen, stop taking Fluconazole Suspension 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

Instructions to make up the suspension:
The reconstituted suspension will provide a white to off-white
orange-flavoured suspension after reconstitution.
For the 60 ml bottle:
1. Tap the bottle to release the powder.
2. Add a small quantity of still water and shake it vigorously. Add
water up to the level marked on the bottle (this corresponds to
adding 24 ml of water)
3. Shake well for one to two minutes to obtain a well mixed
suspension.
4. Write the expiry date of the reconstituted suspension on the
bottle label (the shelf life of the reconstituted suspension is 28
days). Any unused suspension should be not be used after this
date and should be returned to your pharmacist.

Expand view ⇕

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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