DIFLUCAN 150MG HARD CAPSULES

Active substance: FLUCONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Diflucan® 150 mg
hard capsules
fluconazole
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
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 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
- 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
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”).
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 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)
- 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
- 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
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.
Swallow the capsule whole with a glass of water. It is best
to take your capsules 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

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
To treat internal fungal
800 mg on the first day then
infections caused by
400 mg once daily until you
Candida
are told to stop
To treat mucosal
200 mg to 400 mg on the first
infections affecting the
day then 100 mg to 200 mg
lining of mouth, throat and until you are told to stop
denture sore mouth
To treat mucosal thrush 50 mg to 400 mg once daily
– dose depends on where for 7 to 30 days until you are
the infection is located
told to stop

To stop mucosal
infections affecting the
lining of mouth, throat
To treat genital thrush
To reduce recurrence of
vaginal thrush

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)

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
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
Cryptococcal meningitis or
internal fungal infections
caused by Candida
To stop children from getting
an infection caused by Candida
(if their immune system is not
working properly)

Daily dose
3 mg per kg of body weight
(6 mg per kg of body weight
might be given on the first
day)
6 mg to 12 mg per kg of body
weight
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.
If you take more Diflucan than you should
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.
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 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
- 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 reach and sight of children.
- Do not use Diflucan after the expiry date which is stated on
the pack after EXP. The expiry date refers to the last day of the
month.
- Store below 30°C
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.

6. FURTHER INFORMATION
What Diflucan contains
- The active substance is fluconazole.
- Each hard capsule contains 150 mg of fluconazole.
- The other ingredients are:
Capsule content: lactose monohydrate, maize starch, colloidal
silica anhydrous, magnesium stearate and sodium laurilsulfate.
Capsule shell composition:
150 mg hard capsules: gelatin, titanium dioxide (E171) and
patent blue V (E131)
Printing ink: shellac (glaze), black iron oxide, N-Butyl alcohol,
dehydrated alcohol, purified water, propylene glycol, industrial
methylated spirit, isopropyl alcohol, strong ammonia solution,
potassium hydroxide
What Diflucan 150 mg hard capsules look like and
contents of the pack
- Diflucan 150 mg hard capsules have a turquoise blue body
and a turquoise blue cap. They have “FLU_150” and “Pfizer”
with black ink printed on them.
Diflucan 150 mg come in packs of 1, 2, 3, 4, 6, 7, 10, 12, 14, 20,
28, 30, 42, 50, 60, 100 or 500 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road
Sandwich, Kent
CT13 9NJ. United Kingdom.
Manufacturer
Pfizer PGM, Zone Industrielle, 29 route des Industries,
37530 Pocé sur Cisse, France.
This leaflet was last approved in: 11/2011
Ref: DF 1_0 UK/IE

8817050

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.

Advanced Breast Cancer: Learn about treatments to improve quality of life. Click Here

Close
Hide
(web4)