TEVA FLUCONAZOLE 100 MG CAPSULES

Active substance: FLUCONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUCONAZOLE 50 mg, 100 mg, 150 mg and 200 mg CAPSULES
(fluconazole)

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or your 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 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.
IN THIS LEAFLET:
1. What Fluconazole is and what it is used for
2. Before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Further information

1. WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
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 trush from coming back
reduce recurrence of vaginal trush
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
*

Only marketed pack sizes will be included in the printed version of the PIL

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. BEFORE YOU TAKE FLUCONAZOLE
Do NOT take Fluconazole 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. 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)
Take special care with 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).
Taking 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)
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 AntiInflammatory 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)
*

Only marketed pack sizes will be included in the printed version of the PIL

vitamin A (nutritional supplement)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Taking Fluconazole 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 while you are pregnant or breast-feeding unless your doctor has told you to.
Ask your doctor or pharmacist for advice before taking any medicine.
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
Fluconazole capsules contain 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.
The 200 mg capsules also contain E122 (Azorubine), which can cause an allergic-type reaction,
including asthma. This reaction is more common in those people who are allergic to aspirin.
3. HOW TO TAKE FLUCONAZOLE
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 capsules may be taken with or without a meal.
The usual doses of this medicine for different indications 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 from 200 mg once daily until you are told to stop
coming back
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 caused 800 mg on the first day then 400 mg once daily until you
by Candida
are told to stop
To treat mucosal infections affecting the 200 mg to 400 mg on the first day then 100 mg to 200 mg
lining of mouth, throat and denture sore until you are told to stop
mouth
To treat mucosal thrush – dose depends on 50 mg to 400 mg once daily for 7 to 30 days until you are
where the infection is located
told to stop
To stop mucosal infections affecting the 100 mg to 200 mg once daily, or 200 mg 3 times a week,
lining of mouth, throat
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

*

Only marketed pack sizes will be included in the printed version of the PIL

of getting an infection
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 200 mg to 400 mg once daily while you are at risk of
caused by Candida (if your immune system getting an infection
is weak and not working properly)
To treat fungal skin and nail infections

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
Mucosal thrush and throat infections caused by
Candida – dose and duration depends on the severity
of the infection and on where the infection is located
Cryptococcal meningitis or internal fungal infections
caused by Candida
To stop children from getting an infection caused by
Candida (if their immune system is not working
properly)

Daily dose
3 mg per kg of body weight (6 mg per kg of
body weight might be given on the first day)
6 mg to 12 mg per kg of body weight
3 mg to 12 mg per kg of body weight

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 nearly time to take the next dose, do not take the dose that you missed.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
*

Only marketed pack sizes will be included in the printed version of the PIL

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluconazole 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 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 affecti 1 to 10 users in 100 are listed below):
Headache
Rash
Stomach discomfort, feeling sick, vomiting, diarrhoea
Increases in blood tests of liver function.
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
*

Only marketed pack sizes will be included in the printed version of the PIL

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
Keep out of the reach and sight of children.
Do not store above 30 C. Do not transfer the capsules to another container.
Do not use Fluconazole after the expiry date that is stated on the outer packaging. 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. FURTHER INFORMATION
What Fluconazole capsules contain:
The active substance is fluconazole 50 mg, 100 mg, 150 mg and 200 mg.
Other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, sodium laurilsulfate
and magnesium stearate. The capsule shell contains gelatin and the following colours:
50, 100 and 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133)
200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133).
What Fluconazole capsules look like and contents of the pack:
Fluconazole 50 mg are hard gelatine capsules with a light blue opaque cap and white opaque body.
Fluconazole 100 mg are hard gelatine capsules with a blue opaque cap and white opaque body.
Fluconazole 150 mg are hard gelatine capsules with a light blue opaque cap and light blue opaque body.
Fluconazole 200 mg are hard gelatine capsules with a purple opaque cap and white opaque body.
The 50 mg capsules are available in pack sizes of 1, 7, 10, 20, 28, 30, 50, 100 and 500 capsules.
The 100 mg capsules are available in pack sizes of 7, 10, 28, 30, 50 (1x50), 60 and 100 capsules.
The 150 mg capsules are available in pack sizes of 1, 2, 4 and 12 capsules.
The 200 mg capsules are available in pack sizes of 1, 4, 7, 10, 12, 20, 30, 50 and 100 capsules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company responsible for manufacture is Teva UK Limited,
Eastbourne, BN22 9AG England.
This leaflet was last revised: May 2014
PL 00289/0403-0406

*

Only marketed pack sizes will be included in the printed version of the PIL

Expand view ⇕

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.

Hide
(web1)