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FLUCONAZOLE 150MG HARD CAPSULES

Active substance(s): FLUCONAZOLE / FLUCONAZOLE / FLUCONAZOLE

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Package leaflet: Information for the user

Fluconazole 150mg Hard Capsules
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.
•  T he full name of this medicine is Fluconazole 150mg Hard
Capsules but within the leaflet it will be referred to as
Fluconazole Capsules.

What is in this leaflet
1 What Fluconazole Capsules are and what they are
used for
2 What you need to know before you take
Fluconazole Capsules
3 How to take Fluconazole Capsules
4 Possible side effects
5 How to store Fluconazole Capsules
6 Contents of the pack and other information
1  What Fluconazole Capsules are and what they are

used for

Fluconazole Capsules are one of a group of medicines called
“antifungals”. The active substance is fluconazole.
Fluconazole Capsules are used in adults to treat infections caused
by fungi. The most common cause of fungal infections is a yeast
called Candida.

You might be given this medicine by your doctor to treat genital
thrush, infection of the vagina or penis.

2 What you need to know before you take

Fluconazole Capsules

Do not take Fluconazole Capsules:

• if you are allergic to fluconazole or any of the other ingredients
of this medicine (listed in section 6), or if you are allergic to other
medicines you have taken to treat a fungal infection or thrush. The
symptoms may include itching, reddening of the skin or difficulty
in breathing
• if you are taking astemizole or 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 Fluconazole
Capsules.
This is particularly important if:
• you have liver or kidney problems
• you suffer from heart disease, including heart rhythm problems
• you have abnormal levels of potassium, calcium or magnesium in
your blood
• you develop severe skin reactions (itching, reddening of the skin
or difficulty in breathing)
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• you 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).

Children and adolescents

Although this medicine is for adults it can be used in adolescents
(from 12-17 years old) if treatment is essential and no suitable
alternative exists, and should be taken in the same way as for adults.

Other medicines and Fluconazole Capsules

Tell your doctor or pharmacist 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”).
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 or fentanyl (used as anaesthetic)
• amitriptyline or nortriptyline (used as anti-depressant)
• amphotericin B or 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 or 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 or 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, or 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)
• amiodarone (used for treating uneven heartbeats“arrhythmias”)
• hydrochlorothiazide (a diuretic).
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

Fluconazole Capsules with food and drink

You can take this medicine with or without a meal.

Pregnancy, breast-feeding and fertility

You should not take Fluconazole Capsules while you are pregnant
or breast-feeding unless your doctor has told you to.
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

Fluconazole Capsules may cause dizziness or fits. If affected, do not
drive or use machines.
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Fluconazole Capsules contain lactose

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, contact your doctor before taking this medicinal product.

3 How to take Fluconazole Capsules
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults
150mg as a single dose.
Swallow the capsule whole with a glass of water.
Elderly
The usual adult dose should be given.
Patients with kidney problems
The usual adult dose should be given.

How quickly will the treatment start to work?
Vaginal thrush:
Your condition should start to clear up within a few days - some
women notice an improvement in one day. If your condition does
not clear up within a few days you should talk to your doctor.
Thrush infection of the penis:
Your condition should start to clear up within a few days but it may
take up to a week. If your condition has not cleared up after one
week, you should talk to your doctor.

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 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 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, 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 (may affect up to 1 in 10 people):
• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash.

Uncommon (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1,000 people):
• 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
• low blood potassium
• blood chemistry changes (high blood levels of cholesterol, fats)
• 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 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 Capsules
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.
Do not store above 30°C.
Store in the original package to protect from moisture.
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.

6 Contents of the pack

and other information
What Fluconazole Capsules contain

• T he active substance is fluconazole. Each hard capsule contains
150mg fluconazole.
• T he other ingredients are:
Capsule contents: Lactose monohydrate, pregelatinised maize
starch, colloidal anhydrous silica, magnesium stearate.
Capsule shell: Gelatin, titanium dioxide (E171).

What Fluconazole Capsules look like and contents of the
pack
•W
 hite cap and white body, size 1 hard gelatine capsule, filled with
white powder.
• F luconazole Capsules come in a blister pack containing one
capsule.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78,
220 Hafnarfjörður, Iceland
Manufacturer
Specifar SA,1, 28 Octovriou str. 123 51 Ag. Varvara, Athens, Greece
This leaflet was last revised in March 2017.

If you would like a
leaflet with larger text,
please contact
01271 385257.

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Actavis, Barnstaple, EX32 8NS, UK

Fluconazole 150mg 1 Capsule PIL - UK
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Expand Transcript

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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