Fluconazole 200mg Capsules
CP.FLC.JNT.C.POM.V3P2 PATIENT INFORMATION LEAFLET
CP.FLC.JNT.C.POM.V3P2 PATIENT INFORMATION LEAFLET
FLUCONAZOLE 50mg AND 200mg CAPSULES
Please 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 your 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1. What your medicine is and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Further Information
1 ■ WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
2 ■ BEFORE YOU TAKE YOUR MEDICINE
3 ■ HOW TO TAKE YOUR MEDICINE
Fluconazole is one of a group of medicines called antifungal agents. Fluconazole is used to treat infections caused by fungi/yeasts. The most common cause of fungal infection is yeast called Candida.
You may be given Fluconazole to treat fungal infections such as:
• Thrush of the mouth or throat (mucosal infections)
• Skin infections (e.g. athlete’s foot, ringworm)
• Internal (systemic) fungal infections caused by Candida, e.g. infections of the blood stream, urinary tract or other body organs
• Internal (systemic) fungal infections caused by Cryptococcus,
e.g. cryptococcal meningitis and infections of other sites such as the lungs and skin
• Genital Candida infections like vaginal thrush or candidal balanitis (inflammation of the end of the penis and/or foreskin)
You may also be given Fluconazole 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)
DO NOT TAKE this medicine 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 Capsules
• are taking another drug called terfenadine (an antihistamine) or cisapride (a drug used to treat acid reflux, indigestion or decreased gastric motility)
• are pregnant or breast-feeding
• suffer from porphyria
If any of the above applies to you and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before taking Fluconazole Capsules.
Take special care if you:
• suffer from liver problems
• suffer from kidney problems
• suffer from heart problems
• have AIDS
• have imbalances in the salt levels in your blood
If you have any of these conditions and you have not already discussed this with your doctor or pharmacist, you should do so as soon as possible and before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking any of the following medicines:
• rifampicin or rifabutin (types of antibiotics, often used for the treatment of tuberculosis)
• erythromycin or azithromycin (types of antibiotics)
• hydrochlorothiazide or eplerenone (types of diuretic or “water tablet”)
• drugs which thin the blood (known as anticoagulants, e.g. warfarin)
• medicines to help you sleep (such as benzodiazepines, e.g. midazolam or triazolam)
• medicines to treat diabetes (known as sulphonylureas, e.g. chlorpropamide, glibenclamide, glipizide, tolbutamide or nateglinide)
• ciclosporin, tacrolimus or sirolimus (drugs which suppress the immune system , which are commonly used following organ transplants)
•zidovudine (AZT), nevirapine, ritanovir, tipranavir, aquinaviror saquinavir (antiviral drugs, used to treat HIV)
• cisapride (a drug used to treat acid reflux, indigestion or decreased gastric motility)
• drugs used to treat psychosis (e.g. pimozide, quetiapine, sertindole)
• anti-depressants (used to treat depression, e.g. amitriptyline, nortriptyline, citalopram, reboxetine and St. John’s Wort)
• drugs used to treat migraine (such as ergot alkaloids e.g. ergotamine or methylsergide)
• drugs used to control levels of fat in your blood (e.g. atorvastatin or simvastatin)
• calcium channel antagonists (e.g. nifedipine, amlodipine, nisoldipine)
• COX-II inhibitors (non-steroidal anti-inflammatory drugs e.g. ibuprofen, celecoxib or parecoxib)
• antimalarial drugs such as artemether and lumefantrine
• bosentan (used to treat hypertension)
• any other drugs used to treat fungal infection (e.g. amphotericin)
• prednisone (to treat serious inflammatory diseases)
• fentanyl (used to treat severe pain)
• phenytoin or carbamazepine (used to treat epilepsy)
•terfenadine orastemizole (types of antihistamines)
• ivabradine (used to treat angina)
• quinidine (an anti-arrhythmic heart drug)
• methadone (to help withdraw from heroin)
• vitamin A (a vitamin supplement)
• theophylline (a drug used to treat asthma)
• an oral contraceptive (the ‘Pill’)
• alfentanil (an anaesthetic drug used in surgery)
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
Fluconazole should not be used in pregnancy or in pregnant women of childbearing potential unless adequate contraception is used. Breast-feeding is not recommended whilst using fluconazole. Ask your doctor or pharmacist for advice before taking any medicine.
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 in your medicine
Fluconazole Capsules contain 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.
Always take Fluconazole Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The capsules should always be taken with plenty of water. They can be taken with or without food. Your dose will be dependent on the type and severity of your infection, your age, weight and kidney function. Your doctor will choose the best dose for you.
Adults
The usual dose for the treatment of vaginal thrush or candidal balanitis is one 150mg single dose.
To treat mucosal thrush of the mouth or throat, the usual dose is 50mg-1 OOmg once daily for up to 14 days. In other types of mucosal thrush, this may be continued for up to 30 days. If you have oral thrush associated with the use of dentures, you may be given a local antiseptic to use at the same time.
4. POSSIBLE SIDE EFFECTS
5 ■ HOW TO STORE YOUR MEDICINE
6 ■ FURTHER INFORMATION
To treat fungal skin infections (e.g. athlete’s foot, ringworm), the usual dose is 50mg once daily for up to 6 weeks.
For systemic (invasive) infections, the usual dose is 400mg on the first day, followed by 200mg-400mg daily. In cryptococcal infections, this may be continued for up to 8 weeks.
To prevent fungal infections in patients with poor immune systems, the usual dose is 50-400mg once daily, depending on the risk of infection.
To prevent cryptococcal infections coming back in AIDS patients, a usual dose of 100-200mg daily may be given indefinitely.
Elderly or patients with kidney problems
Your doctor will decide what dose to give you. This may be lower than the usual adult dose depending on your kidney function.
Children
The capsules formulation may be unsuitable for children under 5-6 years of age.
Children over 4 weeks of age
Your doctor will calculate an appropriate dose based on body weight. The usual dose for mucosal infections is 3mg/kg body weight daily. A dose of 6mg/kg may be given on the first day.
For internal infections and cryptococcal infections, the usual dose is 6-12mg/kg daily, depending on the severity of the infection. A maximum dosage of 400mg daily should not be exceeded in these cases.
To prevent fungal infections in patients with poor immune systems, a dose of 3-12mg/kg should be given daily, depending on the risk of infection. A maximum dosage of 400mg daily should not be exceeded in these cases.
Children under 4 weeks of age
In the first two weeks of life, the recommended dose for older children should be followed, but given every 72 hours. In weeks three and four, the recommended dose for older children should be followed, but given every 48 hours.
A maximum dose of 12mg/kg every 72 hours should not be exceeded during the first two weeks of life.
A maximum dose of 12mg/kg every 48 hours should not be exceeded during weeks three and four.
It is very important that you follow your doctor’s instructions as to how many Fluconazole Capsules to take, how often to take them and for how long you should continue to take your capsules.
Fluconazole Capsules are not suitable for all dosages described in this leaflet. Other products containing fluconazole are available for this.
If you take more of your medicine than you should
It is important to stick to the dose on the label of your medicine. If you or someone else swallows several of these capsules all together, 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.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose if it is almost time for your next dose.
If you stop taking your medicine
Even when you start to feel better it is important for you to keep on taking your capsules for as long as your doctor tells you. If you stop too soon, the infection may start up again. Sometimes your doctor may want you to continue taking your capsules to prevent your infection from coming back. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Fluconazole Capsules can cause side effects, although not everybody gets them.
If any of the following symptoms occur stop taking the capsules and tell your doctor immediately.
This kind of reaction is rare and may mean you are suffering from an allergic reaction (anaphylaxis) to the capsules:
• Severe rash, itching, a lumpy skin rash (’hives’) or fever
• Sudden wheeziness or tightness of the chest
• Swelling of the eyelids, face, lips or blood vessels in the skin
• Nausea (feeling sick)
• Vomiting (being sick)
Other possible side-effects which may occur, include:
• Dizziness, vertigo
• Seizures or convulsions (fits)
• Pins and needles (paraesthesia)
• Fever
•Aching muscles (myalgia)
• Flair loss (alopecia)
• Indigestion (dyspepsia)
• Changes to your sense of taste
• Increased sweating
• Dry mouth
• Sleeplessness (insomnia) or drowsiness (somnolence)
• Swelling of the face, lips, mouth or throat (angioedema)
• Severe skin disorders or itching (e.g. Stevens-Johnson Syndrome)
• Feeling tired and weak (asthenia) or generally unwell (malaise)
• Liver disease. Your liver may stop working properly, or damage or death (necrosis) of liver cells may occur. Symptoms include yellow appearance of skin and eyes, loss in appetite, swelling of the abdomen.
Your doctor may want to monitor your blood for the following:
• Increase in your cholesterol and/or lipids
• Decrease in potassium levels. Symptoms include muscles feel weak, cramp, twitch and possibly abnormal heart rhythms
• Abnormalities in blood, liver or kidney function or other biochemical tests (especially if you have a serious underlying disease such as AIDS or cancer)
If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
No special storage conditions.
Do not use Fluconazole Capsules 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.
What Fluconazole Capsules contain
The active substance is fluconazole. Each capsule contains 50mg or 200mg fluconazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, sodium laurilsulfate, colloidal anhydrous silica and magnesium stearate.
The capsule shell contains:
50mg: titanium dioxide (E171), yellow iron oxide (E172), quinilone yellow (E104), patent blue V (E131) and gelatin.
200mg: titanium dioxide (E171) and gelatin.
What Fluconazole Capsules look like and contents of the pack
50mg: green and white capsules. In a blister pack of 7 capsules.
200mg: white capsules. In a blister pack of 7 capsules.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland
Company responsible for release of this product
Kent Pharmaceuticals Ltd., Crowbridge Road, Ashford, Kent TN24 OGR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K. PL 30464/0148
The leaflet was last revised March 2013.
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.
The most common side-effects, which may occur are:
• Fleadache
• Rash
• Stomach pain or discomfort
• Diarrhoea
CP.FLC.JNT.C.POM.V3P2
• Flatulence (wind)