Active ingredient
- fluconazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0146 .
Fluconazole 50 mg, 200 mg Capsules
Package leaflet: Information for the user
Fluconazole 50 mg, 200 mg Capsules
(fluconazole)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Fluconazole Capsules are and what they are used for
2. What you need to know before you take Fluconazole Capsules
3. How to take Fluconazole Capsules
4. Possible side effects
5. How to store Fluconazole Capsules
6. Contents of the pack and other information
1. What Fluconazole Capsules are and what they are used for
Fluconazole Capsules are one of a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole Capsules are 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:
You might also be given Fluconazole Capsules to:
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:
You might also be given Fluconazole Capsules to:
2. What you need to know before you take Fluconazole Capsules
Do not take Fluconazole Capsules
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole Capsules
Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Fluconazole Capsules treatment. Stop taking Fluconazole Capsules and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Other medicines and Fluconazole Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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 Capsules (see section: “Do not take Fluconazole Capsules if you”).
There are some medicines that may interact with Fluconazole Capsules. Make sure your doctor knows if you are taking any of the following medicines:
Fluconazole Capsules with food
You can take your medicine with or without a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Fluconazole Capsules if you are pregnant, think you may be pregnant, are trying to become pregnant or breast-feeding, unless your doctor has told you so. You can continue breast-feeding after taking a single dose of Fluconazole Capsules up to 150 mg. You should not breast-feed if you are taking a repeated dose of Fluconazole Capsules.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken at low doses during the first trimester may slightly increase the risk of a baby being born with birth defects affecting the bones and/or muscles.
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.
Fluconazole Capsules contain lactose
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.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to take Fluconazole Capsules
Always take this medicine exactly as your doctor has told you. 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 recommended doses of this medicine for different infections are below:
Adults
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.
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.
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 Capsules 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 Capsules
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.
4. Possible side effects
Like all medicines, this medicine 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. If you get any of the following symptoms, tell your doctor immediately.
Fluconazole Capsules may affect your liver. The signs of liver problems include:
If any of these happen, stop taking Fluconazole Capsules and tell your doctor immediately.
Stop taking Fluconazole Capsules and seek medical attention immediately if you notice any of the following symptoms:
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 (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Frequency not known, but may occur (cannot be estimated from the available data):
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Fluconazole Capsules
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fluconazole Capsules contain
Your medicine is called Fluconazole 50 mg Capsules or Fluconazole 200 mg Capsules. The carton and blister foil will show the capsule strength.
Capsule content: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate and sodium lauryl sulphate.
Capsule shell composition:
50 mg capsules: gelatin, patent blue (E131) and titanium dioxide (E171) as colouring agents
200 mg capsules: gelatin, patent blue (E131), titanium dioxide (E171) and erythrosine (E127) as colouring agents.
Printing ink: The black printing ink contains shellac, propylene glycol and black iron oxide (E172).
What Fluconazole Capsules look like and content of the pack
The 50 mg capsules are blue/ white coloured capsules, printed with ‘RANBAXY’.
The 200 mg capsules are purple/ white coloured capsules, printed with ‘RANBAXY’.
Fluconazole Capsules are available in blister strips in packs of 7 or 28 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturers
This leaflet was last revised in February 2021.
V029
6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK
+44 (0) 208 848 8688
+44 (0) 208 848 5052