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FLUCONAZOLE 200 MG CAPSULES HARD

Active substance(s): FLUCONAZOLE

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Fluconazole
P15xxxxxx

Fluconazole
P15xxxxxx

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Package leaflet: Information for the user

Fluconazole 50 mg capsules, hard
Fluconazole 100 mg capsules, hard
Fluconazole 150 mg capsules, hard
Fluconazole 200 mg capsules, hard
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 or pharmacist.
• 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Fluconazole is and what it is used for
2. What you need to know before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Contents of the pack and other information
1. What Fluconazole is and what it is used for
Fluconazole is one of a group of medicines called “antifungals”. The active
substance is fluconazole.
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 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 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
2. What you need to know before you take Fluconazole
Do not take Fluconazole
- 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
- 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)
Warnings and precautions
Talk to your doctor or pharmacist before using Fluconazole
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).
- 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
Tell your doctor or pharmacist if you are taking have recently taken or might
take any 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 Fluconazole (see section: “Do not take Fluconazole if
you”).
There are some medicines that may interact with Fluconazole. 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)

Black

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amphotericin B, voriconazole (anti-fungal)
medicines that thin the blood to prevent blood clots (warfarin, indanedione
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 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')
hydrochlorothiazide (used to treat fluid retention)

Fluconazole with food and drink and alcohol
You can take your medicine with or without a meal.
Pregnancy and breast-feeding and fertility
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.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that
occasionally dizziness or fits may occur.
Fluconazole capsule contains lactose monohydrate, a type of sugar. If you
have been told by your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Fluconazole capsules
Always take this medicine exactly as your doctor has told you. 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.
Instructions to remove the capsule from blister pocket:
Pushing the capsule pocket in its middle portion may cause deformation/
breakage of capsule as shown in Fig. A. In order to avoid such damage
remove the capsule by pushing the capsule pocket at its edge as shown in
Fig. B.

Fig. A

Fig. B

The recommended doses of this medicine for different infections are below:
Adults
Condition
To treat cryptococcal meningitis

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
200 mg once daily until you are
from coming back
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
800 mg on the first day then 400 mg
caused by Candida
once daily until you are told to stop
To treat mucosal infections affecting 200 mg to 400 mg on the first day
the lining of mouth, throat and
then 100 mg to 200 mg until you are
denture sore mouth
told to stop
To treat mucosal thrush – dose
50 mg to 400 mg once daily for 7 to
depends on where the
30 days until you are told to stop
infection is located
To stop mucosal infections affecting 100 mg to 200 mg once daily, or
the lining of mouth, throat
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
150 mg every third day for a total of
thrush
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
Depending on the site of the infection
infections
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 200 mg to 400 mg once daily while
caused by Candida (if your immune you are at risk of getting an infection
system is weak and not working
properly)

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.
Daily dose
Condition
Mucosal thrush and throat infections 3 mg per kg of body weight (6 mg
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
6 mg to 12 mg per kg of body weight
fungal infections caused by Candida
To stop children from getting an
3 mg to 12 mg 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.
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 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
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, 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 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 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 Fluconazole 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 may affect up to 1 in 10 people are listed below:
• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash
Uncommon side effects which may affect up to 1 in 100 people 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 may affect up to 1 in 1,000 people 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects
directly via the national reporting system listed in Yellow Card Scheme.
Website: 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
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton
after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to dispose of medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Fluconazole contains
• The active substance is fluconazole.
• Each capsule contains 50 mg/ 100 mg/ 150 mg or 200 mg fluconazole.
• The other ingredients are lactose monohydrate, maize starch, sodium
lauril sulfate, colloidal anhydrous silica and magnesium stearate.
The capsule shell contains titanium dioxide (E171), sodium lauril sulfate and
gelatin.
The printing ink contains shellac, propylene glycol, yellow iron oxide.
What Fluconazole looks like and contents of the pack
Fluconazole 50 mg Capsules
Size '4' hard gelatin capsule filled with white to off-white powder and imprinted
with 'E' on white to off-white opaque cap and '95' on white to off-white opaque
body with yellow ink.
Fluconazole 100 mg Capsules
Size '2' hard gelatin capsule filled with white to off-white powder and imprinted
with 'E' on white to off-white opaque cap and '96' on white to off-white opaque
body with yellow ink.
Fluconazole 150 mg Capsules
Size '1' hard gelatin capsule filled with white to off-white powder and imprinted
with 'E' on white to off-white opaque cap and '97' on white to off-white opaque
body with yellow ink.
Fluconazole 200 mg Capsules
Size '0' hard gelatin capsule filled with white to off-white powder and imprinted
with 'E' on white to off-white opaque cap and '98' on white to off-white opaque
body with yellow ink.
Fluconazole capsules are available in
Clear PVC/PVDC-Aluminium blister
Fluconazole 50 mg/100 mg/150 mg/200 mg: 1, 2, 3, 4, 5, 6, 7, 10, 14, 20, 21,
28, 30, 50, 60, 90, 100 capsules
HDPE Bottle
Fluconazole 50 mg/100 mg: 30 and 1000 capsules
Fluconazole 200 mg: 30 and 500 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road, South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far
Brizubbugia BBG 3000
Malta
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria:
Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg
Hartkapseln
Czech Republic: Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg tvrdé tobolky
Denmark:
Fluconazol “Aurobindo”
Germany:
Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200mg
Hartkapseln
Greece:
Fluconazole Aurobindo 50 mg/ 100 mg/ 150 mg καψάκια,
σκληρά
Hungary:
Fluconazol Aurobindo 150 mg kemény kapszula
Ireland:
Fluconazole Aurobindo 50 mg/ 150 mg/ 200 mg capsules,
hard
Italy:
Fluconazolo Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg
capsule rigide
Netherlands:
Fluconazol Aurobindo 50 mg/ 150 mg/ 200 mg, capsules
Poland:
Fluconazole Aurobindo
Portugal:
Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg
cápsulas duras
Romania:
Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg capsule
Spain:
Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg
cápsulas duras
Sweden:
Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg
kapslar, hårda
United Kingdom: Fluconazole 50 mg/ 100 mg/ 150 mg/ 200 mg capsules, hard
This leaflet was last approved in 06/2016.
P15XXXXX

Use in children and adolescents
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children posology).

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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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