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FLUCONAZOLE 50MG HARD CAPSULES

Active substance(s): FLUCONAZOLE

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PATIENT INFORMATION LEAFLET
Fluconazole 50mg, 200mg Hard Capsules
Please read this 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 Fluconazole Capsules are and what they are used for
2. Before you take Fluconazole Capsules
3. How to take Fluconazole Capsules
4. Possible side effects
5. How to store Fluconazole Capsules
6. Further information

1. WHAT FLUCONAZOLE CAPSULES ARE AND WHAT THEY ARE USED FOR
The active substance is fluconazole. Fluconazole is one of a group of medicines called
“antifungals”.
Fluconazole 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 Fluconazole 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 may 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 Fluconazole 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

• nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertensionhigh 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)
• 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)
• amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Taking Fluconazole Capsules 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 Fluconazole Capsules 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.
You can continue breast-feeding after taking a single dose of Fluconazole Capsules up to 200 mg.
You should not breast-feed if you are taking a repeated dose of Fluconazole Capsules.
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 Fluconazole Capsules
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.
Fluconazole 150mg Capsules contains sunset yellow (E110), which may cause allergic
reactions, including asthma, in some people. This is more common in people who are allergic
to aspirin.

3. HOW TO TAKE FLUCONAZOLE CAPSULES
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

Dose

To treat cryptococcal meningitis

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

2. BEFORE YOU TAKE FLUCONAZOLE CAPSULES
Do not take Fluconazole Capsules 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 Fluconazole Capsules. 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)
• if you are taking amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole Capsules 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).
• develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate
amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue,
muscle weakness, loss of appetite, weight loss, abdominal pain)
Other medicines and Fluconazole Capsules
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 Fluconazole Capsules (see section:
“Do not take Fluconazole Capsules if you”).
There are some medicines that may interact with Fluconazole Capsules. 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)

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

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 trush
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 200 mg to 400 mg once daily while you are
by Candida (if your immune system is weak at risk of getting an infection
and not working properly)

Measure bar should be 150mm at 100% scale

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Fluconazole common leaflet

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Date

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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 throat infections caused
3 mg per kg of body weight (6 mg per kg
by Candida – dose and duration depends on
of body weight might be given on the
the severity of the infection and on where the first day)
infection is located
Cryptococcal meningitis or internal fungal
6 mg to 12 mg per kg of body weight
infections caused by Candida
To stop children from getting an infection
3 mg to 12 mg per kg of body weight
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.
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 Fluconazole Capsules 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 Fluconazole Capsules
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, Fluconazole Capsules 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).
Fluconazole Capsules 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)
Fluconazole Capsules may affect your adrenal glands and the levels of steroid hormones
produced. The signs of adrenal problems include:
• tiredness
• muscle weakness
• loss of appetite
• weight loss
• abdominal pain
If any of these happen, stop taking Fluconazole Capsules 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 FLUCONAZOLE CAPSULES
Keep this medicine out of the sight and reach of children.
Do not use Fluconazole Capsules after the expiry date which is stated on the pack after EXP.
The expiry date refers to the last day of the 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.

6. FURTHER INFORMATION
What Fluconazole Capsules contains
• The active substance is fluconazole.
• Each hard capsule contains 50 mg or 200 mg of fluconazole.
• The other ingredients are:
Capsule content: lactose monohydrate, microcrystalline cellulose, pregelatinised maize
starch, colloidal anhydrous silica, magnesium stearate and sodium lauryl sulphate.
Capsule shell composition:
50mg hard capsules: titanium dioxide (E171), quinoline yellow (E104), yellow iron oxide (E172),
patent blue V (E131) and gelatin.
200mg hard capsules: titanium dioxide (E171) and gelatin.
What Fluconazole Capsules look like and contents of the pack
50mg hard capsules: green and white capsules.
200mg hard capsules: white capsules.
Fluconazole Capsules are available in blister packs of:
50mg hard capsules: 7 capsules
200mg hard capsules: 7 capsules.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of
charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
Reference number

Product name
Fluconazole 50mg Hard Capsules

PL 29831/0294

Fluconazole 200mg Hard Capsules

PL 29831/0305

This is a service provided by the Royal National Institute of Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was last revised in 12/2015

104528/6

Measure bar should be 150mm at 100% scale

artwork.leicester@multipkg.com
Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
DWDOOWLPHVWRHQVXUHDFFXUDF\WRRXUFOLHQW·VEULHI
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

Wockhardt UK Limited

Colours Used

Description

Fluconazole common leaflet

Process Black

Item Code

104528-6

Text Free (Does not print)

Profile

n-a

Size

200 x 300mm

Min. Point Size

8pt (main body) / 6pt (variables)

Market

UK

Language

English

Proof By

louise.heel

Proof No.

1

Date

08/01/2016

Artwork No.

622962

Keylines (does not print)

Pharma
Code

N/A

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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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