Fluconazole 150 Mg Capsules
(Fluconazole)
Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.
• Keep this leaflet. You may need to read it again.
• It you have anyturther questions, ask your doctor or pharmacist.
• This medicine has been prescribed tor you only. Do not pass it on to others. It may harm them, even it their signs of illness are the same as yours.
• It 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 150 mg Capsules Is and what It Is used for
2. What you need to know before you take Fluconazole 150 mg Capsules
3. How to take Fluconazole 150 mg Capsules
4. Possible side effects
5. Howto store Fluconazole 150 mg Capsules
6. Contents of the packand other Information
1. What Fluconazole 150 mg Capsules is and what it is used tor_
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 afew days you should go backto yourdoctor.
Penis thrush Infection
Yourcondition should startto clear up within afew days but it may take up to a week.
If yourcondition has not cleared up afterone week, you should go back to yourdoctor.
If you take more Fluconazole 150mg 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 150mg Capsules
Do nottake a double dose to make up foraforgotten dose. If you forget to take a dose, take it as soon as you remember. If itisalmosttimeforyournextdose, do not take thedose that you missed.
Ifyouhaveanyfurtherquestionsontheuse of this medicine, askyourdoctoror pharmacist.
4. Possible side effects
Fluconazole 150 mg Capsules is one of a group of medicines called “antifungals”. The active substance is fluconazole.
Fluconazole 150 mg 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 yourdoctorto treat genital thrush, infection of the vagina or penis.
2. What you need to know before you take Fluconazole 150 mg
Do not take Fluconazole 150mg 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 fortreating mental illness)
- if you are taking amiodaroneorquinidine (used fortreating heart arrhythmia)
- if you are taking erythromycin, (an antibiotic fortreating infections)
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole 150 mg Capsules If you
- have liverorkidneyproblems
- sufferfrom heart disease, including heartrhythm problems
- have abnormal levels of potassium, calcium or magnesium in your blood
- develop severe skin reactions (itching, reddening of the skin ordifficulty in breathing).
- have adrenal insufficiency (although rarely seen fluconazole may reduce the ability of the adrenal glands to work properly)
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 betaken in the same way as foradults.
Other medicines and Fluconazole 150 mg 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 fortreating mental illness) orquinidine (used fortreating heart arrhythmia) or erythromycin (an antibiotic fortreating infections) as these should not be taken with Fluconazole 150 mg Capsules (see section: “Do nottake Fluconazole 150 mg Capsules if you”).
There are some medicines that may interact with Fluconazole 150 mg Capsules.
Make sure yourdoctor knows if you are taking any of the following medicines:
- rifampicin orrifabutin (antibioticsforinfections)
- alfentanil, fentanyl (used as anaesthetic)
- amiodarone (used fortreating heart arrhythmia)
- amitriptyline, nortriptyline (used as anti-depressant)
- amphotericin B, voriconazole (anti-fungal)
- medicines thatthin the blood to prevent blood clots (warfarin, indanedione or similar medicines)
- benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep orfor anxiety
- carbamazepine, phenytoin (used fortreating fits)
- nifedipine, isradipine, amlodipine felodipine, hydrochlorothiazide and losartan (for hypertension- high blood pressure)
- ciclosporin, everolimus, sirolimus ortacrolimus (to preventtransplantrejection)
- cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used fortreating cancer
- halofantrine (used fortreating 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 ortolbutamide
- 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.
Fluconazole 150mg Capsules with food, drink and alcohol
You can take your medicine with or without a meal.
Pregnancy, breast-feeding and fertility
Tell yourdoctor if you are pregnant, trying to become pregnant or breast-feeding. You should not take Fluconazole 150 mg Capsules while you are pregnant or breast-feeding unless yourdoctor has told you to.
Askyourdoctororpharmacistforadvice before taking any medicines.
Driving and using machines
When driving vehicles or using machines, it should be taken into accountthat occasionally dizziness or fits may occur. Fluconazole 150mg Capsules contains 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 yourdoctor before taking this medicine.
3. Howto take Fluconazole 150 mg Capsules
Always take this 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.
Adults
150 mg as a single dose.
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 will be given.
Patients with kidney problems
The usual adult dose should be given.
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 ortightness in the chest
- swelling of eyelids, face or lips
- itching all overthe body reddening of the skin or itchy red spots
- skin rash
- severe skin reactions such as a rash that causes blistering (this can affectthe mouth and tongue).
Fluconazole 150mg Capsules may affect your liver. The signs of liver problems include:
- tiredness
- loss of appetite
- vomiting
- yellowing of yourskin orthe whites of youreyes (jaundice)
If any of these happen, stop taking Fluconazole 150mg 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 yourdoctoror 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, difficultdigestion, wind, dry mouth
- muscle pain
- liverdamageand 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
- liverfailure
- allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips orface
- hairloss
Reporting of side effects
If you get any side effects, talk to yourdoctoror 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 150 mg
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 150mg Capsules contains
- The active substance is fluconazole.
- Each hard capsule contains fluconazole 150 mg.
- Theotheringredientsare:
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) as colouring agents.
Black printing ink contains: shellac, propylene glycol and black iron oxide (E172).
What Fluconazole 150mg Capsule looks like and contents of the pack
Fluconazole 150mg Capsules are a blue/ blue coloured capsules printed with 'RANBAXY'.
Fluconazole 150 mg Capsules are available in blister strip in packs of 1,2,4,6 or 12 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy(UK) Limited 5th floor, Hyde Park, Hayes 3 11 Millington Road Hayes, UB34AZ United Kingdom
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue87 2132 JH Hoofddorp The Netherlands
TerapiaS.A.
Str. FabriciiNr.124 Cluj-Napoca 400 632
Romania ^
r--
This leaflet was last revised in August 2016. £2
OO
LO