Fluconazole 150 Mg Capsules
Package leaflet: Information for the user
Fluconazole 150 mg capsules
(Fluconazole)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.
What is in this leaflet
1. What Fluconazole Capsules is and what it is 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 is and what it is used for
Fluconazole Capsules is one of a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole Capsules is used in adults to treat infections caused by fungi. The most common cause of fungal infections is a yeast called Candida.
You might be given this medicine by your doctor to treat genital thrush, infection of the vagina or penis.
2. What you need to know before you take Fluconazole Capsules Do not take Fluconazole Capsules :
- if you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6). The symptoms may include itching, reddening of the skin or difficulty in breathing
- if you are taking astemizole, terfenadine (antihistamine medicines for allergies)
- if you are taking cisapride (used for stomach upsets)
- if you are taking pimozide (used for treating mental illness)
- if you are taking amiodarone or quinidine (used for treating heart arrhythmia)
- if you are taking erythromycin, (an antibiotic for treating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole Capsules
- if you have liver or kidney problems
- if you suffer from heart disease, including heart rhythm problems
- if you have abnormal levels of potassium, calcium or magnesium in your blood
- if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
Adrenal insufficiency
Fluconazole may rarely cause adrenal insufficiency.
Children and adolescents
Although this medicine is for adults it can be used in adolescents (from 12 to 17 years old) if treatment is essential and no suitable alternative exists, and should be taken in the same way as for adults.
Other medicines and Fluconazole 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 Capsules (see section: “Do not take Fluconazole Capsules ”).
There are some medicines that may interact with Fluconazole 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)
- amiodarone (used for treating heart arrhythmia)
- amitriptyline, nortriptyline (used as anti-depressant)
- amphotericin B, voriconazole (anti-fungal)
- medicines that thin the blood to prevent blood clots (warfarin, indanedione 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, hydrochlorothiazide 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 (NonSteroidal 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)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Fluconazole Capsules with food and drink
You can take your medicine with or without a meal.
Pregnancy and breast-feeding
You should not take Fluconazole Capsules while you are pregnant or breast-feeding unless your doctor has told you to.
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.
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 contains lactose monohydrate
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.
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.
Adults
150 mg as a single dose.
Doctors sometimes prescribe different doses to these. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure
Elderly
The usual adult dose should be given.
Patients with kidney problems
The usual adult dose should be given.
How quickly will the treatment start to work?
Vaginal thrush
Your condition should start to clear up within a few days - some women notice an improvement in one day.
If your condition does not clear up within a few days you should go back to your doctor.
Penis thrush infection
Your condition should start to clear up within a few days but it may take up to a week.
If your condition has not cleared up after one week, you should go back to your doctor.
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 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 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)
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: (may affect up to 1 in 10 people)
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
Uncommon: (may affect up to 1 in 100 people)
- 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: (may affect up to 1 in 1,000 people)
- 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
- low blood potassium
- blood chemistry changes (high blood levels of cholesterol, fats)
- 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 or pharmacist. 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 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 blister and 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 contains
- The active substance is fluconazole.
- Each hard capsule contains fluconazole 150 mg.
- The other ingredients are:
Capsule content: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate and sodium lauryl sulphate.
Capsule shell composition: gelatin, patent blue (E131) and titanium dioxide (E171)
Printing ink: shellac, black iron oxide (E 172) and propylene glycol What Fluconazole Capsules looks like and contents of the pack
Fluconazole Capsules is a blue/blue hard gelatin, self locked capsule of size '1' imprinted with 'RANBAXY' in black edible ink on both cap and body containing white to off-white powder.
Fluconazole Capsules is available in blister strip in packs of 1, 2, 4, 6, 7, 12 or 28 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Ranbaxy (UK) Limited Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE United Kingdom
Manufacturer
Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co-Tipperary, Republic of Ireland