DIFLUCAN 150MG CAPSULES

Active substance: FLUCONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET- INFORMATION FOR THE USER
DIFLUCAN® 150mg CAPSULES
(fluconazole)
This product will be referred to as Diflucan Capsules throughout
this 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.




lornoxicam, meloxicam, diclofenac (Non- Steroidal Anti-Inflammatory
Drugs (NSAID))
oral contraceptives
prednisolone (steroid)
zidovudine, also known as AZT; saquinavir (used in HIV-infected
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

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

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.

1. WHAT DIFLUCAN IS AND WHAT IT IS USED FOR

Driving and using machines
When driving vehicles or using machines, it should be taken into account
that occasionally dizziness or fits may occur.

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.

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.

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

3. HOW TO TAKE DIFLUCAN

Condition

Dose

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)

To treat Cryptococcal meningitis

400mg on the first day then 200mg
to 400mg once daily for 6 to 8
weeks or longer if needed.
Sometimes doses are increased up
to 800mg

To stop Cryptococcal meningitis
from coming back

200mg once daily until you are told
to stop

To treat coccidioidomycosis

200mg to 400mg once daily from
11 months for up to 24 months or
longer if needed. Sometimes doses
are increased up to 800mg

To treat internal fungal infections
caused by candida

800mg on the first day then 400mg
once daily until you are told to stop

To treat mucosal infections affecting the lining of mouth, throat and
denture sore mouth

200mg to 400mg on the first day
then 100mg to 200mg until you are
told to stop

To treat mucosal thrush—dose
depends on where the infection is
located

50mg to 400mg once daily for 7 to
30 days until you are told to stop

To treat genital thrush

150mg as a single dose



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)

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

To stop mucosal infections affecting 100mg to 200mg once daily, or
the lining of mouth, throat
200mg 3 times a week, while you
are at risk of getting an infection
To reduce recurrence of vaginal
thrush

150mg 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 50mg once daily, 150 mg
once weekly, 300 to 400mg once
weekly for 1 to 4 weeks (athletes
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)

200mg to 400mg 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

Dose

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

6mg to 12mg per kg of body weight

To stop children from getting an
3mg to 12mg per kg of body weight
infection caused by candida (if their
immune system is not working
properly)

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.



6. FURTHER INFORMATION
What Diflucan Capsules contains



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.

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 active substance is 150 mg fluconazole.
The other ingredients are: magnesium stearate, colloidal silicon
dioxide, maize starch, lactose and sodium lauryl sulphate and gelatin
(in the capsule shell only). Colouring agents contained in the capsule
shell are: patent blue V (E131) and titanium dioxide (E171).

What Diflucan 150 mg capsules looks like and contents of the pack.


Diflucan 150 mg capsules are light turquoise blue and they have “FLU
150” and “PFIZER” printed on them.
 Diflucan 150 comes in a blister pack containing one capsule.
Manufacturer
The manufacturer is PFIZER, PGM, Zone Industrielle de Poce-sur-Cisse,
37401 Amboise, Cedex, France. Procured from within the EU by the
Product Licence holder: G Pharma Ltd., Salford M50 2PU
PL 16369/0212

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 150mg
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

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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. HOW TO STORE DIFLUCAN CAPSULES




Store below 30°C.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the capsules, take any unused
medicine to your pharmacist for safe disposal. Only keep the
capsules if your doctor tells you to.
 If you notice the capsules become discoloured or show any other
signs of deterioration, you should seek the advice of your
pharmacist.

Leaflet revision date: 28/01/2014
‘DIFLUCAN’ is a registered trademark of Pfizer

POM

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.

Hide
(web2)