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FLUCONAZOLE 150MG CAPSULES

Active substance(s): FLUCONAZOLE / FLUCONAZOLE / FLUCONAZOLE

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PATIENT INFORMATION LEAFLET

CP.FLC.150C.P.IS.V6P1

FLUCONAZOLE 150mg CAPSULE
Read all of this leaflet carefully before you start taking this medicine. This medicine is available without prescription.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• You should contact your doctor if your symptoms worsen or do not improve in 7 days
• If you have any unusual effects after taking this product, tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Fluconazole 150mg Capsule is and what it is used for
2. Before you take Fluconazole 150mg Capsule
3. How to take Fluconazole 150mg Capsule
4. Possible side effects
5. How to store Fluconazole 150mg Capsule
6. Contents of the pack and other information

1.

WHAT FLUCONAZOLE 150mg CAPSULE IS AND WHAT IT IS
USED FOR

Fluconazole 150mg Capsule is a full course of treatment for thrush.
Only use this product if you have been previously diagnosed by
your doctor as having thrush.
The active substance is Fluconazole. It belongs to a group of medicines
called azoles and is an antifungal agent. It fights the cause of infections
such as thrush.

2.

BEFORE YOU TAKE FLUCONAZOLE 150mg CAPSULE

Do not take Fluconazole 150mg Capsule if you:
• are allergic (hypersensitive) to fluconazole, or another drug from the
same group of antifungal drugs (i.e. imidazoles), or any of the other
ingredients of Fluconazole 150mg Capsule (See section 6, Contents of
the pack and other information)
• are taking another drug called terfenadine or astemizole
(antihistamines), cisapride (a drug used to treat acid reflux, indigestion
or decreased gastric motility), pimozide (a psychiatric medicine) or
quinidine (for heart disease)
• suffer from porphyria
Take special care with Fluconazole 150mg Capsule
Before taking Fluconazole 150mg Capsule, you should see your doctor if:
• You are unsure about the cause of your symptoms
• You have had thrush more than twice in the last six months
• You or your partner have ever been exposed to a sexually transmitted
disease
• You are taking any medicine other than the contraceptive pill
• You are aged under 16 or over 60 years
• You have had any disease or illness affecting the liver or kidneys, or
have had any unexplained jaundice (yellowing of the skin and eyes)
• You suffer from any other chronic disease or illness
• if 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)
Women only:
• If you are pregnant, suspect you might be pregnant or are
breast-feeding.
• If you have any abnormal or irregular vaginal bleeding or a blood
stained discharge.
• If you have vulval or vaginal sores, ulcers or blisters.
• If you are experiencing lower abdominal pain or burning on passing
urine.
Men only:
• If your sexual partner does not have vaginal thrush.
• If you have penile sores, ulcers or blisters.
• If you have an abnormal penile discharge (leakage).
• If your penis has started to smell.
• If you have pain on passing urine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Inform your doctor if you are taking:
• Amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
• Cisapride (for stomach upsets)
• Terfenadine or astemizole (antihistamines)
• Pimozide (a psychiatric medicine)
• Quinidine or calcium channel blockers (for heart disease).

Customer: IS

Originated by: TC (AWG)

• Rifampicin, rifabutin, azithromycin or erythromycin (antibiotics).
• Diuretics e.g. hydrochlorothiazide (used to treat fluid retention and high
blood pressure).
• Losartan (used to treat high blood pressure)
• Warfarin or coumarin-type anticoagulant medicines (used to prevent
blood clots)
• Benzodiazepines e.g. midazolam (used as tranquilisers)
• Oral sulphonylureas e.g. chlorpropamide, glibenclamide, glipizide or
tolbutamide (used to control diabetes).
• Phenytoin or carbamazepine (used to control epilepsy)
• Ciclosporin, everolimus, sirolimus or tacrolimus (used to affect the
immune response)
• Theophylline (used to control asthma)
• Zidovudine, also known as AZT, or saquinavir (used in HIV-infected
patients)
• Prednisone (used to treat allergies)
• Oral contraceptives
• Opioids such as alfentanil, fentanyl and methadone (used for pain relief
or anaesthesia)
• Non-steroidal anti-inflammatory medicines such as aspirin, celecoxib
• The anti-depressants amitriptyline and nortriptyline
• Amphotericin B, voriconazole (used to treat fungal infections)
• Cyclophosphamide and vinca alkaloids (used in chemotherapy)
• Halofantrine (used to treat malaria)
• HMG-CoA reductase inhibitors (statins (atorvastatin, simvastatin and
fluvastatin or similar medicines) used for reducing high cholesterol
levels)
• Hydrochlorothiazide (a diuretic)
• Vitamin A
Pregnancy and breast-feeding
Do not use Fluconazole 150mg Capsule if you are pregnant, trying to get
pregnant or are breast-feeding.
Driving and using machines
Fluconazole Capsules are unlikely to affect your ability to drive or use
machinery, however, when driving or operating machines it should be
taken into account that occasionally dizziness or seizures may occur.
Important information about some of the ingredients of Fluconazole
150mg Capsule
Fluconazole 150mg Capsule contains lactose monohydrate, a type of
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.
Fluconazole 150mg Capsule contains sunset yellow (E110) which may
cause allergic reactions.

3.

HOW TO TAKE FLUCONAZOLE 150mg CAPSULE

If this product was prescribed for you by a doctor, you should take
Fluconazole 150mg Capsule exactly as he/she has told you. If you
purchased this product without a prescription, follow these directions
closely:
Adults: 16 - 60 years
The full course of treatment consists of a single Fluconazole 150mg
Capsule. The capsule is to treat thrush at the site of infection and should
be swallowed whole with a glass of water.
The symptoms of thrush should disappear within two days of treatment. If
no improvement is seen after seven days, you must tell your doctor. If the
infection returns after seven days another capsule may be taken but if you
have more than two infections within 6 months you should see your
doctor.
If you take more Fluconazole 150mg Capsule than you should
If you or someone else swallows more than one capsule at once, contact
your doctor, pharmacist or hospital emergency department immediately.

Colours

Product: Fluconazole 150mg Capsule P
Dimensions: 210mm x 297mm
Item Code: CP.FLC.150C.P.IS.V6P1
Proof and Date: 1 17/01/2017
Revision:
ARTWORK FOR SUBMISSION
Supersedes:

Pantone Blue
280 C

Always take any capsules left over with you and also the box, as this will
allow easier identification of the capsules.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Fluconazole Capsules can cause side effects,
although not everybody gets them.
STOP taking Fluconazole 150mg Capsule straight away and contact
your doctor immediately if you experience:
• a serious allergic reaction (anaphylaxis) or hypersensitivity including
an itchy rash (hives), itching, sore mouth or eyes, fever, swelling of the
face, lips, throat or tongue
• a sudden wheeziness or tightness of the chest
• liver problems such as yellowing of the skin or whites of the eyes
(jaundice), dark coloured urine, or changes in the way your liver works
(that may show up in blood tests)
• a severe skin rash with flushing, fever, blisters or ulcers
(Stevens-Johnson syndrome)
• a severe rash with reddening, peeling and swelling of the skin that
looks like a burn (toxic epidermal necrolysis).
The following side-effects are usually mild. However, if you suffer
from any of these and they are severe or prolonged, please inform
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
• anaemia, reduction in red blood cells which can make skin pale and
cause weakness or breathlessness
• decreased appetite
• inability to sleep, feeling drowsy
• fits, dizziness, sensation of spinning, tingling, pricking or numbness,
changes in sense of taste
• indigestion, wind, dry mouth
• muscle pain
• low blood potassium, which may cause muscle cramps or weakness,
nausea and changes in heart rhythm
• 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 (you may have more infections
than usual such as sore throats, fever or flu-like symptoms)
• lower than normal blood cells that help to stop bleeding (you may
have unexplained bruising or bleeding)
• red or purple discoloration of the skin which may be caused by low
platelet count
• blood chemistry changes (high blood levels of cholesterol, fats)
• shaking
• abnormal electrocardiogram (ECG), change in heart rate or rhythm
• hair loss
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 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.

The capsule shell contains:
Titanium dioxide (E171), Quinoline yellow (E104), sunset yellow (E110)
and gelatin.
What Fluconazole 150mg Capsule looks like and contents of the
pack
Fluconazole 150mg capsule is a yellow capsule.
Each pack contains a blister pack of 1 capsule.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
Company responsible for release of this product to market
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent,
TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
PL 30464/0147
Further information about thrush
Vaginal thrush (candidiasis) is a common infection that most women
suffer from at some stage in their lives and is not caused by lack of
personal hygiene.
Thrush is caused by a yeast (fungus) called Candida, which lives
harmlessly in the vagina and other parts of the body without ever being
noticed.
However, the natural balance that keeps Candida under control can be
upset by many factors such as hormonal changes (menstruation,
contraceptive pill, pregnancy, menopause), poor health, antibiotics,
perfumed soaps, bath additives and tight clothing.
If the natural pH balance is altered, the level of yeast increases and can
develop into a thrush infection causing any of the following symptoms:
persistent burning and/or itching around the vagina and vulva, redness,
swelling and soreness of the tissues of the vagina and the vulva and a
whitish, odourless discharge from the vagina.
Not everybody who has thrush has all these symptoms; you may have
only one of them.
In men, Candida can also cause thrush - a condition called balanitis
(inflammation of the end of the penis). It causes any of the following
symptoms:
soreness and redness of the penis, tightness of the foreskin and a white,
odourless discharge from the penis.
How to avoid future recurrences
• Wear cotton underwear and avoid tight clothing
• Wash daily
• After going to the toilet, wipe yourself from front to back as a thrush
infection may be transferred from the bowel
• Change your sanitary protection regularly
• Try to avoid washing with perfumed soaps and using vaginal
deodorants
• Do not wash or rub yourself hard with sponges or flannels
If you are still worried or have any questions about the symptoms or the
treatment of thrush, contact your doctor or pharmacist for advice.
The leaflet was last revised January 2017.

HOW TO STORE FLUCONAZOLE 150mg CAPSULE

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not use Fluconazole 150mg Capsule after the expiry date, which is
stated on the carton. The expiry date refers to the last day of that 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.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluconazole 150mg Capsule contains
The active substance is fluconazole. Each capsule contains 150mg
fluconazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose,
maize starch, sodium laurilsulfate, colloidal anhydrous silica and
magnesium stearate.
CP.FLC.150C.P.IS.V6P1

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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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