Fluconazole 150mg Capsules
CP.FLC.150C.RIS.V5P3 PATIENT INFORMATION LEAFLET
CP.FLC.150C.RIS.V5P3 PATIENT INFORMATION LEAFLET
FLUCONAZOLE 150mg CAPSULE
Read all of this leaflet carefully before you start taking this medicine. This medicine is available without prescription.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• You should contact your doctor if your symptoms worsen or do not improve in 7 days
• If you have any unusual effects after taking this product, tell your doctor or pharmacist.
IN THIS LEAFLET
1. What Fluconazole 150mg Capsule is and what it is used for
2. Before you take Fluconazole 150mg Capsule
3. Flow to take Fluconazole 150mg Capsule
4. Possible side effects
5. Flow to store Fluconazole 150mg Capsule
6. Contents of the pack and other information
1WHAT FLUCONAZOLE 150mg CAPSULE IS AND WHAT IT IS ■ USED FOR
2 ■ BEFORE YOU TAKE FLUCONAZOLE 150mg CAPSULE
3 ■ HOW TO TAKE FLUCONAZOLE 150mg CAPSULE
Fluconazole 150mg Capsule is a full course of treatment for thrush. Only use this product if you have been previously diagnosed by your doctor as having thrush.
The active substance is Fluconazole. It belongs to a group of medicines called azoles and is an antifungal agent. It fights the cause of infections such as thrush.
Do not take Fluconazole 150mg Capsule if you:
• are allergic (hypersensitive) to fluconazole, or another drug from the same group of antifungal drugs (i.e. imidazoles), or any of the other ingredients of Fluconazole 150mg Capsule (See section 6, Contents of the pack and other information)
• are taking another drug called terfenadine or astemizole (antihistamines), cisapride (a drug used to treat acid reflux, indigestion or decreased gastric motility), pimozide (a psychiatric medicine) or quinidine (for heart disease)
• suffer from porphyria
Take special care with Fluconazole 150mg Capsule
Before taking Fluconazole 150mg Capsule, you should see your doctor if:
• You are unsure about the cause of your symptoms
• You have had thrush more than twice in the last six months
• You or your partner have ever been exposed to a sexually transmitted disease
• You are taking any medicine other than the contraceptive pill
• You are aged under 16 or over 60 years
• You have had any disease or illness affecting the liver or kidneys, or have had any unexplained jaundice (yellowing of the skin and eyes)
• You suffer from any other chronic disease or illness
Women only:
• If you are pregnant, suspect you might be pregnant or are breast feeding.
• If you have any abnormal or irregular vaginal bleeding or a blood stained discharge.
• If you have vulval or vaginal sores, ulcers or blisters.
• If you are experiencing lower abdominal pain or burning on passing urine.
Men only:
• If your sexual partner does not have vaginal thrush.
• If you have penile sores, ulcers or blisters.
• If you have an abnormal penile discharge (leakage).
• If your penis has started to smell.
• If you have pain on passing urine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Inform your doctor if you are taking:
• Cisapride (for stomach upsets)
• Terfenadine or astemizole (antihistamines)
• Pimozide (a psychiatric medicine)
• Quinidine or calcium channel blockers (for heart disease).
• Rifampicin, rifabutin, azithromycin or erythromycin (antibiotics).
• Diuretics e.g. hydrochlorothiazide (used to treat fluid retention and high blood pressure).
• Losartan (used to treat high blood pressure)
• Warfarin or coumarin-type anticoagulant medicines (used to prevent blood clots)
• Benzodiazepines e.g. midazolam (used as tranquilisers)
• Oral sulphonylureas e.g. chlorpropamide, glibenclamide, glipizide or tolbutamide (used to control diabetes).
• Phenytoin or carbamazepine (used to control epilepsy)
• Ciclosporin, everolimus, sirolimus or tacrolimus (used to affect the immune response)
• Theophylline (used to control asthma)
•Zidovudine, also known asAZT, or saquinavir (used in HIV-infected patients)
• Prednisone (used to treat allergies)
• Oral contraceptives
• Opioids such as alfentanil, fentanyl and methadone (used for pain relief or anaesthesia)
• Non-steroidal anti-inflammatory medicines such as aspirin, celecoxib
• The anti-depressants amitriptyline and nortriptyline •Amphotericin B, voriconazole (used to treat fungal infections)
• Cyclophosphamide and vinca alkaloids (used in chemotherapy)
• Halofantrine (used to treat malaria)
• HMG-CoA reductase inhibitors (statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels)
• Vitamin A
Pregnancy and breast-feeding
Do not use Fluconazole 150mg Capsule if you are pregnant, trying to get pregnant or are breast-feeding.
Driving and using machines
Fluconazole Capsules are unlikely to affect your ability to drive or use machinery, however, when driving or operating machines it should be taken into account that occasionally dizziness or seizures may occur.
Important information about some of the ingredients of Fluconazole 150mg Capsule
Fluconazole 150mg Capsule contains lactose monohydrate, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Fluconazole 150mg Capsule contains sunset yellow (E110) which may cause allergic reactions.
If this product was prescribed for you by a doctor, you should take Fluconazole 150mg Capsule exactly as he/she has told you. If you purchased this product without a prescription, follow these directions closely:
Adults: 16 - 60 years
The full course of treatment consists of a single Fluconazole 150mg Capsule. The capsule is to treat thrush at the site of infection and should be swallowed whole with a glass of water.
The symptoms of thrush should disappear within two days of treatment. If no improvement is seen after seven days, you must tell your doctor. If the infection returns after seven days another capsule may be taken but if you have more than two infections within 6 months you should see your doctor.
If you take more Fluconazole 150mg Capsule than you should
If you or someone else swallows more than one capsule at once, contact your doctor, pharmacist or hospital emergency department immediately. Always take any capsules left over with you and also the box, as this will allow easier identification of the capsules.
Customer: | Originated by:
Product: Fluconazole 150mg Capsule P Dimensions: 210mm x 297mm Item Code: CP.FLC.150C.P.IS.V5P3 Proof and Date: 3 20/07/2016
Pantone Blue 280 C
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluconazole Capsules can cause side effects, although not everybody gets them.
STOP taking Fluconazole 150mg Capsule straight away and contact your doctor immediately if you experience:
• a serious allergic reaction (anaphylaxis) or hypersensitivity including an itchy rash (hives), itching, sore mouth or eyes, fever, swelling of the face, lips, throat or tongue
• a sudden wheeziness or tightness of the chest
• liver problems such as yellowing of the skin or whites of the eyes (jaundice), dark coloured urine, or changes in the way your liver works (that may show up in blood tests)
• a severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome)
• a severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis).
The following side-effects are usually mild. However, if you suffer from any of these and they are severe or prolonged, please inform 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
• anaemia, reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• decreased appetite
• inability to sleep, feeling drowsy
• fits, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
• indigestion, wind, dry mouth
• muscle pain
• low blood potassium, which may cause muscle cramps or weakness, nausea and changes in heart rhythm
• 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 (you may have more infections than usual such as sore throats, fever or flu-like symptoms)
• lower than normal blood cells that help to stop bleeding (you may have unexplained bruising or bleeding)
• red or purple discoloration of the skin which may be caused by low platelet count
• blood chemistry changes (high blood levels of cholesterol, fats)
• shaking
• abnormal electrocardiogram (ECG), change in heart rate or rhythm
• 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.
What Fluconazole 150mg Capsule looks like and contents of the pack
Fluconazole 150mg capsule is a yellow capsule.
Each pack contains a blister pack of 1 capsule.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland
Company responsible for release of this product to market
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, KentTN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. PL 30464/0147
Further information about thrush
Vaginal thrush (candidiasis) is a common infection that most women suffer from at some stage in their lives and is not caused by lack of personal hygiene.
Thrush is caused by a yeast (fungus) called Candida, which lives harmlessly in the vagina and other parts of the body without ever being noticed.
Flowever, the natural balance that keeps Candida under control can be upset by many factors such as hormonal changes (menstruation, contraceptive pill, pregnancy, menopause), poor health, antibiotics, perfumed soaps, bath additives and tight clothing.
If the natural pH balance is altered, the level of yeast increases and can develop into a thrush infection causing any of the following symptoms: persistent burning and/or itching around the vagina and vulva, redness, swelling and soreness of the tissues of the vagina and the vulva and a whitish, odourless discharge from the vagina.
Not everybody who has thrush has all these symptoms; you may have only one of them.
In men, Candida can also cause thrush - a condition called balanitis (inflammation of the end of the penis). It causes any of the following symptoms:
soreness and redness of the penis, tightness of the foreskin and a white, odourless discharge from the penis.
How to avoid future recurrences
• Wear cotton underwear and avoid tight clothing
• Wash daily
• After going to the toilet, wipe yourself from front to back as a thrush infection may be transferred from the bowel
• Change your sanitary protection regularly
• Try to avoid washing with perfumed soaps and using vaginal deodorants
• Do not wash or rub yourself hard with sponges or flannels
If you are still worried or have any questions about the symptoms or the treatment of thrush, contact your doctor or pharmacist for advice.
The leaflet was last revised July 2016.
5 ■ HOW TO STORE FLUCONAZOLE 150mg CAPSULE
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
Do not use Fluconazole 150mg Capsule after the expiry date, which is stated on the carton. 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.
6 ■ CONTENTS OF THE PACK AND OTHER INFORMATION
What Fluconazole 150mg Capsule contains
The active substance is fluconazole. Each capsule contains 150mg fluconazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, sodium laurilsulfate, colloidal anhydrous silica and magnesium stearate.
The capsule shell contains:
Titanium dioxide (E171), Quinoline yellow (E104), sunset yellow (E110) and gelatin.
CP.FLC.150C.P.IS.V5P3