Diflucan 50mg/5ml Powder for Oral Suspension
Diflucan 200mg/5ml Powder for Oral Suspension
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 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
What Diflucan Suspension is and what it is used for
Diflucan is one of a group of medicines called “antifungals”. The active ingredient is fluconazole.
Diflucan is used to treat infections caused by fungi including yeasts and may also be used to stop you from getting a fungal infection. The most common cause of fungal infections is a yeast called Candida.
You may be given this medicine by your doctor to treat the following types of fungal infections.
- Genital thrush, infection of the vagina or penis.
- Mucosal thrush, infection of the mouth or throat.
- Skin infections - e.g. athlete's foot, ringworm, jock itch.
- Internal (systemic) fungal infections caused by:
- Candida and found in the blood stream, body organs (e.g.heart, lungs) or urinary tract
- Cryptococcus, e.g. meningitis and infections of other sites such as the lungs and skin
You may also be given Diflucan to:
- stop you from getting a fungal infection (if your immune system is not working properly).
- stop an infection caused by Cryptococcus from coming back (in AIDS patients).
Before you take Diflucan
Do not take Diflucan if you
- have ever had an allergic reaction to:
- any of the ingredients of Diflucan
- other medicines you have taken to treat a fungal infection.
The symptoms may include itching, reddening of the skin or difficulty in breathing.
- are taking terfenadine (an antihistamine for allergies)
- are taking cisapride (used for stomach upsets)
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
Taking other medicines
Tell your doctor, immediately if you are taking Terfenadine (an antihistamine for treating allergies) or Cisapride (used for stomach upsets) as these should not be taken with Diflucan.
There are some medicines that may interact with Diflucan. Make sure your doctor knows if you are taking any of the following medicines:
- warfarin (or similar drugs) that thin the blood to prevent blood clots
- medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
- water tablets, such as hydrochlorothiazide, used to treat fluid retention and high blood pressure
- midazolam used to help you sleep or for anxiety
- phenytoin (used to control epilepsy)
- rifampicin or rifabutin (antibiotics for infections)
- ciclosporin or tacrolimus (to prevent transplant rejection)
- theophylline (used to control asthma)
- astemizole (an antihistamine for treating allergies)
- zidovudine, also known as AZT (used in HIV-infected patients)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not take Diflucan while you are pregnant or if you are breast feeding.
Driving and using machines
Treatment with Diflucan is unlikely to affect your ability to drive or use machinery.
Important information about some of the ingredients
DIFLUCAN suspension contains sucrose (sugar).
- If you have an intolerance to some sugars, please contact your doctor before taking this medicine.
- Doses of 10ml contain 5.5g or greater of sugar. This should be taken into account if you have diabetes.
- May be harmful to teeth if used for prolonged periods (2 weeks or more).
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.
Diflucan oral suspension can be taken with or without food using the measuring spoon provided (see further information in Section 6).
The usual doses of this medicine for different infections are below.
Adults
Genital thrush – 150mg as a single dose.
Mucosal thrush (dose depends on where the infection is located) – 50mg once daily for 7-14 days or 14-30 days. Sometimes doses are increased to 100 mg.
Fungal skin infections – 50mg once daily for 2-4 weeks (Athlete’s foot may be up to 6 weeks).
Internal fungal infections – 400mg on the first day then 200-400mg once daily for 6-8 weeks or longer if needed.
To stop you from getting fungal infections – 50-400mg once daily while you are at risk of getting an infection.
To stop infection caused by Cryptococcus from coming back – 100-200mg once daily indefinitely.
Children
4 weeks to 15 years old –
Mucosal infections – 3mg/kg once daily.
Internal fungal infections – 6-12mg/kg once daily.
Prevention of fungal infection – 3-12mg/kg once daily while at risk of
getting an infection.
2-4 weeks old – Same dose as above but given once every 2 days. A maximum dose of 12mg/kg every 2 days.
Less than 2 weeks old – Same dose as above but given once every 3 days. A maximum dose of 12mg/kg every 3 days.
A maximum dosage of 400mg daily should not be exceeded in children.
Use of Diflucan for treating genital Candida infections in children under 16 years old is not recommended.
If your child needs doses of 10mg DIFLUCAN or less they are most likely to be treated in hospital. The nurse or doctor will measure the right amount of medicine for your child.
For other doses of the medicine the pharmacist should advise you whether to measure the medicine using the spoon provided or an oral dosing syringe. The pharmacist will give you a syringe if it is needed.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may modify your dose, depending on your kidney function.
Doctors sometimes prescribe different doses to those described in this leaflet. The label on the pack will tell you what dose you or your child should take. If you are still not sure, ask your doctor or pharmacist.
It is best to take your medicine at the same time each day. You may take it with or without meals.
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.
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, take this but do not take the dose that you missed.
Diflucan Suspension 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 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), which can be a sign of. Stevens Johnson syndrome or toxic epidermal necrosis.
- If you are an AIDS patient you are more likely to get severe skin reactions to drugs including DIFLUCAN.
Very common side effects which may affect more than 1 person in 10 are listed below:
- feeling sick
- stomach discomfort
- diarrhoea
- wind
- rash
- headache
These undesirable effects are usually mild. If they cause you discomfort or are long lasting, check with your doctor or pharmacist.
Other Side Effects
- itching
- being sick
- seizure
- lower than normal levels of white blood cells that help defend against infections and blood cells that help to stop bleeding
- high blood levels of cholesterol, fats or salt
- liver damage and yellowing of the skin and eyes (Jaundice)
- hair loss
- dizziness
- altered sense of taste
- change in heart rate or rhythm
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.
How To Store Diflucan
- Keep out of the reach and sight of children
- Store between 5°C and 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.
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.
Further Information
What DIFLUCAN contains
- The active substance is 50mg/5ml fluconazole and 200mg/5ml fluconazole respectively.
- The other ingredients are:
Colouring agent:
- Titanium dioxide (E171)
Other inactive ingredients:
- Citric acid
- Colloidal silicon dioxide
- Natural orange flavour
- Sodium benzoate
- Sodium citrate dihydrate
- Sucrose
- Xantham gum
What DIFLUCAN 50mg/5ml and 200mg/5ml Powder for oral suspension looks like and contents of the pack.
- DIFLUCAN 50mg/5ml and 200mg/5ml Powder for oral suspension is a dry white to off-white powder. Your pharmacist will add 24ml of water to the powder produce, an orange flavoured suspension containing the equivalent of 50mg or 200mg 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.
Marketing Authorisation Holder and Manufacturer
Manufacturer
Company contact address
This leaflet was last approved in 06/2008
Ref: DF12
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