DIFLUCAN 10MG/ML POWDER FOR ORAL SUSPENSION

Active substance: FLUCONAZOLE

View full screen / Print PDF » Download PDF ⇩

Transcript
Diflucan® 10mg/ml
Powder for Oral Suspension
Fluconazole 10mg/ml
Powder for Oral Suspension

2342
29.08.13[5]

(fluconazole)
PATIENT INFORMATION LEAFLET
Your medicine is available using any one of the above names but will be
referred to as Diflucan throughout the following leaflet.
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 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 Diflucan Suspension is and what it is used for
2. Before you take Diflucan
3. How to take Diflucan
4. Possible side effects
5. How to store Diflucan
6. Further information
1. WHAT DIFLUCAN IS AND WHAT IT IS USED FOR
Diflucan is one of a group of medicines called “antifungals”. The active
substance is fluconazole.
Diflucan 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 Diflucan 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 Diflucan 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 DIFLUCAN
Do not take Diflucan 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
Diflucan. 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 Diflucan
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 Diflucan (see section: “Do not take Diflucan if you”).
There are some medicines that may interact with Diflucan. 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)
- lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti -Inflammatory
Drugs (NSAID))
- oral contraceptives
- prednisolone (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)

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Taking Diflucan with food and drink
Diflucan can be taken with or without food.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breastfeeding. You should not take Diflucan while you are pregnant or breastfeeding unless your doctor has told you to.
Ask your doctor or pharmacist for advice before taking any medicines.
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 Diflucan
Diflucan powder for oral suspension contains sucrose (sugar).
- If you have an intolerance to some sugars, please contact your doctor
before taking this medicine.
- Doses of 10 ml contain 5.6 g or more of sugar. This should be taken into
account if you have diabetes.
- May be harmful to teeth if used for periods of longer than 2 weeks.
3. HOW TO TAKE DIFLUCAN
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
It is best to take medicine at the same time each day.
The usual doses of this medicine for different infections are below:
Adults
Condition
Dose
To treat cryptococcal
meningitis

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
200 mg once daily until you are told to
meningitis from coming back 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
800 mg on the first day then 400 mg once
infections caused by Candida daily until you are told to stop
To treat mucosal
infections affecting the
lining of the mouth, throat
and denture sore mouth
To treat mucosal thrush –
dose depends on where the
infection is located
To stop mucosal infections
of mouth and throat from
coming back
To treat genital thrush

200 mg to 400 mg on the first day then
100 mg to 200 mg until you are told to
stop
50 mg to 400 mg once daily for 7 to 30
days until you are told to stop
100 mg to 200 mg once daily, or 200 mg 3
times a week, while you are at risk of
getting an infection
150 mg as a single dose

To reduce recurrence of
vaginal thrush

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
of getting an infection
To treat fungal skin and
Depending on the site of the infection 50
nail infections
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
200 mg to 400 mg once daily while you
infection caused by Candida (if are at risk of getting an infection
your immune system is weak
and not working properly)
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
Daily Dose
Mucosal thrush and throat infections
3 mg per kg of body weight
caused by Candida – dose and duration
(6 mg per kg of body weight
depends on the severity of the infection
might be given on the first
and on where the infection is located
day)
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)

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.
Instructions to make up the suspension:
It is recommended that your pharmacist makes up Diflucan powder for oral
suspension before giving it to you. Instructions are provided in a section of
this leaflet for healthcare professionals.
Instructions for use:
Shake the closed bottle of the suspension every time before using.
If you take more Diflucan than you should
Taking too much Diflucan 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 Diflucan
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.

The following information is intended for medical or healthcare
professionals only:

4. POSSIBLE SIDE EFFECTS
Like all medicines, Diflucan 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).

1. Tap the bottle to release the powder.
2. Add 24ml of water to the powder and shake it vigorously to produce, an
orange flavoured suspension containing the equivalent of 50mg of
fluconazole per 5 ml.
3. Shake well for one to two minutes to obtain a well mixed suspension.
4. Write the expiry date of the reconstituted suspension on the bottle label
(the shelf life of the reconstituted suspension is 14 days). Any unused
suspension should be not be used after this date and should be returned
to your pharmacist.

Diflucan 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 Diflucan 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 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
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.
5. HOW TO STORE DIFLUCAN
- Keep out of the sight and reach of children.
- Keep the bottle tightly closed. Do not store above 25°C.
- Once reconstituted, do not store the suspension above 30°C, do not
freeze.
- Do not use Diflucan after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.
- Any remaining reconstituted suspension should be discarded after 28
days.
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 Diflucan contains
- The active substance is fluconazole
Each 5 ml of suspension contains 50 mg fluconazole (10 mg/ml)
- The other ingredients are: sucrose, citric acid anhydrous, colloidal
anhydrous silica, sodium benzoate, sodium citrate, xanthan gum,
titanium dioxide (E171) and natural orange flavour (containing orange oil
and maltodextrin).
What Diflucan looks like and contents of the pack.
- Diflucan is a dry white to off-white powder with an aroma of orange
flavour. Your pharmacist will add 24ml of water to the powder produce,
an orange flavoured suspension containing the equivalent of 50mg of
fluconazole per 5 ml.
- In each bottle the mixture of powder and water makes 35 ml of
suspension.
- A 5ml spoon is provided to measure the correct dose.
Manufacturer and Product Licence holder
Manufactured by FarmaSierra Manufacturing S.L., Carretera De Irun, km
26,200, San Sebastian de los Reyes, E-28700, Spain and is procured from
the EU by Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge
Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL No: 20636/2342

Leaflet revision and issue date (Ref) 29.08.13[5]
Diflucan is a trademark of the Pfizer Products Inc.

Instructions to make up the suspension:
The reconstituted suspension will provide a white to off-white orangeflavoured suspension after reconstitution.

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
(web5)