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DIFLUCAN 50MG HARD CAPSULES

Active substance(s): FLUCONAZOLE

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Service Développement Fareva Amboise
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DIFLUCAN CAPS 50mg/200mg UK

NOIR

Mock up from 8817063-2
Couleur:
na
Bobine double
Minimum font size: 8 pts
135 x 315 mm
Version: 1
Recto: 4a + spot / Verso: 4b
Préparé par : Karine Duverger
Date: 17/07/2015
Text only is subject to market approval.
6. Contents of the pack and other information
What Diflucan contains
- The active substance is fluconazole.
- Each hard capsule contains 50 mg or 200 mg of fluconazole.
- The other ingredients are:

Package leaflet: Information for the user

Capsule content: lactose monohydrate, maize starch, colloidal silica anhydrous, magnesium stearate and
sodium laurilsulfate.
Capsule shell composition:
50 mg hard capsules: gelatin, titanium dioxide (E171) and patent blue V (E131)
200 mg hard capsules: gelatin, titanium dioxide (E171), erythrosine (E127) and indigo carmine (E 132)
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 looks like and contents of the pack
- Diflucan 50 mg hard capsules have a white body and a turquoise blue cap. They have “FLU‑50” and “Pfizer”
with black ink printed on them.
- Diflucan 200 mg hard capsules have a white body and a purple cap. They have “FLU‑200” and “Pfizer” with
black ink printed on them.
Diflucan 50 mg and 200 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



Diflucan® 50 mg hard capsules
Diflucan® 200 mg hard capsules
fluconazole
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Diflucan is and what it is used for
2. What you need to know before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Contents of the pack and other information

1. What Diflucan is and what it is used for

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Manufacturer
Fareva Amboise
Zone Industrielle
29 route des Industries
37530 Pocé-sur-Cisse
France

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

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Diflucan 50 mg Kapseln
Hungary
Diflucan 50 mg hard capsules
Diflucan 100 mg Kapseln
Diflucan 100 mg hard capsules
Diflucan 150 mg Kapseln
Diflucan 150 mg hard capsules
Diflucan 200 mg Kapseln
Diflucan 200 mg hard capsules
Belgium, Bulgaria, Diflucan
Latvia
Diflucan 50 mg hard capsules
Denmark, Finland,
Diflucan 150 mg hard capsules
Iceland, Ireland,
Italy, Luxembourg,
Norway, Portugal,
Poland, Sweden,
United Kingdom
Lithuania
Diflucan 50 mg hard capsules
Netherlands Diflucan 50 mg, capsule, hard
Diflucan 100 mg hard capsules
Diflucan 100 mg, capsule, hard
Diflucan 150 mg hard capsules
Diflucan 150 mg, capsule, hard
Diflucan 200 mg, capsule, hard
Cyprus, Greece
Fungustatin
Romania
Diflucan 50 mg capsule
Diflucan 150 mg capsule
Czech Republic
Diflucan 50mg, Diflucan 100mg,
Slovakia
Diflucan 50mg
Diflucan 150mg
Diflucan 100mg
Diflucan 150mg
Estonia
Diflucan 150mg
Slovenia
Diflucan 50 mg trde kapsule
Diflucan 100 mg trde kapsule
Diflucan 150 mg trde kapsule
France
Triflucan 50 mg gélule
Spain
Diflucan 50 mg capsulas duras
Triflucan 100 mg, gélule
Diflucan 100 mg capsulas duras
Triflucan 200 mg, gélule
Diflucan 150 mg capsulas duras
Fluconazole Pfizer 150mg, gélule
Diflucan 200 mg capsulas duras
Germany
Diflucan 50mg
Diflucan 100mg
Fungata
Diflucan 200mg
This leaflet was last revised in:
UK 06/2015
IE MM/YYYY
Ref: DF 7_0

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. What you need to know before you take Diflucan
Do not take Diflucan
- if you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to
any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching,
reddening of the skin or difficulty in breathing
- if you are taking astemizole, terfenadine (antihistamine medicines for allergies)
- if you are taking cisapride (used for stomach upsets)
- if you are taking pimozide (used for treating mental illness)
- if you are taking quinidine (used for treating heart arrhythmia)
- if you are taking erythromycin (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking Diflucan
- if you have liver or kidney problems
- if you suffer from heart disease, including heart rhythm problems
- if you have abnormal levels of potassium, calcium or magnesium in your blood
- if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
Other medicines and Diflucan
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)

Mock up from 8817063-2

- 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)
- celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac
(Non-Steroidal Anti-Inflammatory Drugs (NSAID))
- oral contraceptives
- prednisone (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)
- ivacaftor (used for treating cystic fibrosis)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Diflucan with food and drink
You can take your medicine with or without a meal.
Pregnancy, breast-feeding and fertility

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.
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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
You should not take Diflucan while you are pregnant unless your doctor has told you to.
You can continue breast-feeding after taking a single dose of Diflucan up to 200 mg.
You should not breast-feed if you are taking a repeated dose of Diflucan.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may
occur.
Diflucan contains lactose (milk sugar)
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.

4. Possible side effects
Like all medicines, this medicine 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 side effects,
talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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)

Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time each day.

If any of these happen, stop taking Diflucan and tell your doctor immediately.
Other side effects:

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

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.

Condition
To treat cryptococcal meningitis

Common side effects (may affect up to 1 in 10 people) are:
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash

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
To stop cryptococcal meningitis from coming back
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 mouth, 200 mg to 400 mg on the first day then 100 mg to
throat and denture sore mouth
200 mg until you are told to stop
To treat mucosal thrush – dose depends on where the
50 mg to 400 mg once daily for 7 to 30 days until
infection is located
you are told to stop
To stop mucosal infections affecting the lining of mouth, 100 mg to 200 mg once daily, or 200 mg 3 times a
throat
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 200 mg to 400 mg once daily while you are at risk of
(if your immune system is weak and not working
getting an infection
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.

Uncommon side effects (may affect up to 1 in 100 people) are:
- 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 (may affect up to 1 in 1,000 people) are:
- 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 (see details below). By reporting side effects you
can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5. How to store Diflucan
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine 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
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

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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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