DIFLUCAN 40MG/ML POWDER FOR ORAL SUSPENSION

Active substance: FLUCONAZOLE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Diflucan 40mg/ml Powder for Oral Suspension
(fluconazole)
Your medicine is available by the above name, but will be
referred to as Diflucan throughout the remainder of this
leaflet.






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

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.

Do not take Diflucan if you

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

Take special care with Diflucan

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
 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
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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)

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 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 AntiInflammatory 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)

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
Diflucan can be taken with or without food.

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.

caused by Candida
To treat mucosal
infections affecting
the lining of the
mouth, throat and
denture sore mouth
To treat mucosal
thrush – dose
depends on where
the infection is
located
To stop mucosal
infections of mouth
and throat from
coming back
To treat genital
thrush
To reduce
recurrence of
vaginal thrush

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 and
glucose (sugar).
 If you have an intolerance to some sugars, please contact
your doctor before taking this medicine.
 Doses of 10ml contain 5.6g 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.

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.
It is best to take medicine 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

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

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)

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
Daily dose
Mucosal thrush and
3 mg per kg of body
throat infections
weight (6 mg per kg of
caused by Candida
body weight
– dose and duration
might be given on the
depends on the
first day)
severity of the
infection
and on where the
infection is located
Cryptococcal
6 mg to 12 mg per kg
meningitis or internal of body weight
fungal infections
caused by Candida

6.
To stop children
from getting an
infection caused by
Candida (if their
immune system is
not working
properly)

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

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.

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.

Instructions for use:
Shake the closed bottle of the suspension every time before
using.

Instructions to use the paediatric syringe:
Shake the prepared suspension well.
1. Open the bottle (safety cap);
2. Insert the adapter fitted onto the syringe into the bottle neck
(Figure 1);
3. Turn the bottle with the syringe upside down and withdraw
the quantity of suspension prescribed by the doctor (Figure 2).
The marks on the syringe are shown in ml.
The maximum dose for children is 400 mg daily (see section
“3. How to take Diflucan”).
4. Remove the syringe from the bottle;
5. For younger children, the medicinal product may be given
directly into the mouth from the syringe. The child should remain
upright during administration. Point the syringe at the inside of
the cheek; release the suspension slowly into the child’s mouth
(Figure 3). For older children, the suspension may be put in a
spoon and drunk by the child.
6. Rinse the syringe after use.
7. Close the bottle with the safety cap; the
adapter will remain on the bottle neck.

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.

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.

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
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.

5.


How to store Diflucan
Keep out of the sight and reach of children.

Powder for oral suspension:



Do not store above 25°C.
Keep the bottle tightly closed.

Reconstituted suspension:






Do not store above 30°C.
Do not freeze, shake before use.
The shelf life of the reconstituted suspension is 28 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.
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.

Further information

What Diflucan contains



1ml of reconstituted suspension contains 40mg fluconazole
The other ingredients are sucrose, colloidal silica anhydrous,
titanium dioxide (E171), xanthan gum, sodium citrate
dihydrate, citric acid anhydrous, sodium benzoate (E211) and
natural orange flavour (orange oil containing glucose and
maltodextrin).

What Diflucan looks like and contents of the pack





Diflucan is a white to off-white powder for oral suspension
providing a white to off-white orange flavoured suspension
after reconstitution.
In each bottle the mixture of powder and water makes 35 ml
of suspension.
A 5 ml graduated syringe with a press-in bottle adaptor might
also be provided to measure the correct dose.

Manufacturer:
Farmasierra Manufacturing, S.L. Ctra.N-1, km 26,200. 28700
San Sebastián de los Reyes (Madrid), Spain.
Procured from within the EU and repackaged by: Amimed
Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick
Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL: 33902/0378

Leaflet revision date: 17/09/2013
Diflucan® is a registered trademark of Pfizer Limited.
The following information is intended for medical or healthcare
professionals only:
Instructions to make up the suspension:
The reconstituted suspension will provide a white to off-white
orange-flavoured suspension after reconstitution.
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 not be used after this
date and should be returned to your pharmacist.
S0378-35-SP-PIL-17.09.2013

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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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