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FLUCONAZOLE 150MG HARD CAPSULES

Active substance(s): FLUCONAZOLE

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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FLUCONAZOLE 150 MG HARD CAPSULES
Do not take Fluconazole 150 mg Hard 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 150 mg Hard
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)

23/08/2016
Date

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Furosemide 150mg leaflet
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Wockhardt UK Limited

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 yeast
called Candida.
Fluconazole is used to treat a fungal infection called vaginal
thrush (in women), and associated candidal balanitis (in men).
What is vaginal thrush?
Vaginal thrush is caused by tiny yeast called Candida.
Many women have the yeast living quite happily and
problem-free within their bodies. However, the natural
balance that keeps Candida under control can be upset by
other factors, e.g. antibiotics, diabetes, poor general health,
the Pill, or damage to vaginal tissues. Then the levels of yeast
become too high and thrush develops. The most common
symptoms are:
• Itching around the outside of the vagina.
• Soreness which becomes worse with rubbing and
scratching. Also the salt in urine can sting the sore tissue.
• A white, non-smelling discharge from the vagina.
Not every woman who has thrush will have all of these
symptoms. Some general advice to help stop thrush coming
back:
• Wash regularly, but do not wash and dry yourself too harshly.
• Avoid tight clothing.
• Wear cotton underwear and stockings rather than tights.
• Avoid perfumed soaps, bath additives and vaginal
deodorants.
• Change your tampon frequently as a blood-soaked
tampon can provide ideal conditions for yeast growth.
Sexual intercourse can damage delicate tissue and aggravate
thrush. Vaginal thrush is not “VD”, but may be passed on to
your partner through intercourse. If your attack of thrush
was successfully treated, but keeps coming back, your
partner may need to take Fluconazole 150mg Hard Capsules
himself. If you are unsure why your thrush keeps coming
back, or are unsure if your partner has thrush, you or your
partner should see a doctor.
What is candidal balanitis?
Candidal balanitis (penile thrush) is caused by yeast called
Candida. Balanitis is the medical term used to describe
inflammation of the end of the penis. The foreskin may also
be inflamed.
Thrush can be passed on from your partner through sexual
intercourse.
(Thrush is not “VD” - see “What is vaginal thrush?”). The most
common symptoms are:
• Soreness, redness and irritation of the penis.
• Tightness of the foreskin.
• A white, non-smelling discharge from the penis.
• Not every man who has candidal balanitis will have all of
these symptoms.

Customer

1.WHAT FLUCONAZOLE 150 MG HARD CAPSULES ARE
AND WHAT THEY ARE USED FOR

• 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’)
Do not use Fluconazole 150mg Hard Capsules without
first consulting your doctor or pharmacist:
• If you are under 16 years or over 60 years of age.
• If you are allergic to any of the ingredients in Fluconazole
150mg Hard Capsules or other antifungals and other
thrush treatments.
• If you are taking any other medicine other than the Pill.
• If you are taking the antihistamine terfenadine or the
prescription medicine cisapride.
• If you have had thrush more than twice in the last six months.
• If you have any disease or illness affecting your liver or
kidneys or have had unexplained jaundice.
• If you have a condition that can affect the rhythm of your
heart beat.
• If you suffer from any other chronic disease or illness.
• If you or your partner have had exposure to a sexually
transmitted disease.
• If you are unsure about the cause of your symptoms.
Women only:
• If you are pregnant, suspect you might be pregnant or are
breastfeeding.
• 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 suffering from lower abdominal pain or burning
on passing urine.
Men only:
• If your sexual partner does not have 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.
The product should never be used again if you experience a
rash or an allergic reaction following use of the product.
Other medicines and Fluconazole 150mg Hard 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 150 mg Hard Capsules
(see section: “Do not take Fluconazole 150 mg Hard Capsules
if you”).
There are some medicines that may interact with
Fluconazole 150 mg Hard 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)
• nifedipine, isradipine, amlodipine, felodipine and losartan
(for hypertension- high 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 150 mg Hard 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
150 mg Hard Capsules while you are pregnant or

Measure bar should be 150mm at 100% scale

PATIENT INFORMATION LEAFLET
Fluconazole 150mg Hard Capsules
Please read this carefully before you start taking this
medicine.
This medicine is available without prescription. Nevertheless,
you still need to use Fluconazole 150mg Hard Capsules
carefully to get the best results from them.
• 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 150 mg Hard Capsules are and what
they are used for
2. What You Need To Know before you take Fluconazole 150 mg
Hard Capsules
3. How to take Fluconazole 150 mg Hard Capsules
4. Possible side effects
5. How to store Fluconazole 150 mg Hard Capsules
6. Contents of the pack and other information

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 08/2016
104531/7

23/08/2016
Date

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Artwork No.

680374

1

English
Language

louise.heel

UK
Market

Proof No.

7pt (Main Body) / 7pt (Variables)
Min. Point Size

Proof By

148 x 260mm
Size

104531/7
Item Code

n-a

Furosemide 150mg leaflet
Description

Profile

Pharma
Code

n-a

Text free area (non-printing)

Process Black

Colours Used

Keyline (non-printing)

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

6. FURTHER INFORMATION
What Fluconazole 150 mg Hard Capsules contains
• The active substance is fluconazole.
• Each hard capsule contains 150 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: titanium dioxide (E171),
quinoline yellow (E104), sunset yellow (E110) and gelatin.
What Fluconazole 150 mg Hard Capsules look like and
contents of the pack
Fluconazole 150 mg Hard Capsules are yellow capsules.
Fluconazole 150 mg Hard Capsules are available in a blister
pack containing 1 capsule.
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:
Product name
Reference number
Fluconazole 150mg Hard
PL 29831/0318
Capsules

Clearly mark any amendments on one proof and return to MPS

Like all medicines, Fluconazole 150 mg Hard 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 150 mg Hard 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 150 mg Hard
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.

Keep this medicine out of the sight and reach of children.
Do not use Fluconazole 150 mg Hard 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.

artwork.leicester@multipkg.com

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE FLUCONAZOLE 150 MG HARD
CAPSULES

Wockhardt UK Limited

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 can be taken with or without food.
Adults and young people aged over 16 years
The whole course for the treatment of thrush in men or
women is one 150mg capsule.
Elderly
This product is not recommended for self-medication in the elderly.
If you are over 60 years old, please do not take this capsule. Instead
you should discuss your symptoms with your doctor.
Children under 16 years old
This product is not recommended for self-medication in
children under 16 years old. If you are under 16 years old,
please do not take this capsule. Instead you should discuss
your symptoms with your doctor.
If you take too many capsules
You only need to take one capsule. If you or someone else
swallows several of these capsules all together, contact
your doctor, pharmacist or hospital emergency department
immediately. Always take any capsules left over with you
and also the box, as this will allow easier identification of the
capsules.
When you should start to feel better
Your condition should start to improve within a few days.
If your symptoms do not clear up within a week or you think
that the capsule has not worked properly, please speak to
your doctor. If you experience another attack of thrush after
seven days you can use the capsule again. It might also be
worth getting your partner to use this medicine or to see
a doctor. Thrush is not a sexually transmitted disease but
both partners can suffer from it, even if they do not have
any symptoms. If you experience more than two attacks of
thrush within 6 months you should tell your doctor.

Customer

3. HOW TO TAKE FLUCONAZOLE 150 MG HARD
CAPSULES

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.

Measure bar should be 150mm at 100% scale

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 150 mg Hard Capsules.
You should not breast-feed if you are taking a repeated dose
of Fluconazole 150mg Hard Capsules.
Driving and using machines
When driving vehicles or using machines, it should be taken
into account that occasionally dizziness or fits may occur.
If affected do not drive or use machines.
Important information about some of the ingredients of
Fluconazole 150 mg Hard 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.
The capsule also 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.

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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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