DIFLUCAN 150MG CAPSULE

Active substance: FLUCONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
Diflucan® 150mg Capsule
(fluconazole)
This medicine is known by the above name but will be referred to as Diflucan
Capsule throughout this leaflet.
Patient Information 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 Capsule is and what it is used for
2. Before you take Diflucan Capsule
3. How to take Diflucan Capsule
4. Possible side effects
5. How to store Diflucan Capsule
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 bloodstream, 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 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.
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

To
treat
internal
fungal
infections caused by Candida
To treat mucosal infections
affecting the lining of mouth,
throat and denture sore mouth
To treat mucosal thrush – dose
depends on where the infection
is located
To stop mucosal infections
affecting the lining of mouth,
throat

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 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

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
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

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)

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.

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 CAPSULE
Keep out of the sight and reach of children.
Store between 15-30°C.
Do not use after the date shown as ‘EXP’ which is printed on the carton label or the
blister label.
If your Diflucan Capsule becomes discoloured or shows any other signs of
deterioration consult your pharmacist.
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 Capsule contains
The name of your medicine is Diflucan 150mg Capsule. It contains 150mg of the
active ingredient fluconazole. The capsule contains: lactose, maize starch, colloidal
silicon dioxide, magnesium stearate and sodium lauryl sulphate. The capsule shell
contains: gelatin, patent blue V (E131) and titanium dioxide (E171).
The black printing ink used on the capsule shell contains: shellac, black iron oxide,
butyl alcohol, industrial methylated spirit, purified water, propylene glycol and
isopropyl alcohol or alternatively printing ink contains: shellac, black iron oxide, butyl
alcohol, purified water, propylene glycol, isopropyl alcohol, dehydrated alcohol,
strong ammonia solution and potassium hydroxide.
What Diflucan Capsule looks like and contents of the pack
The capsule is light turquoise blue and is marked ‘Pfizer’ and ‘FLU-150’ in black
printing ink.
Each pack contains 1 capsule.

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.

Diflucan Capsule is manufactured by Pfizer, PGM, F-37401, Amboise, Cedex,
France and is procured from within the EU by the Product Licence holder: Caseview
(PL) Ltd, 20 Alliance Court, Alliance Road, London W3 0RB and repackaged by OPD
Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

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

PL No: 13826/0127

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.
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

POM
Diflucan® 150mg Capsule
Leaflet revision date (ref): 11/10/2012

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)