Fluconazole 150mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Fluconazole I50mg Capsules carefully to get the best results from them.
• Keep this leaflet. You may want to read it again.
• Askyour pharmacist if you need more information or advice.
• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
• Ifyou get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Fluconazole I50mg Capsules are and what they are used for
2. What you need to know before you take Fluconazole I50mg Capsules
3. How to take Fluconazole I50mg Capsules
4. Possible side effects
5. How to store Fluconazole I50mg Capsules
6. Contents of the pack and other information
1. WHAT FLUCONAZOLE I50mg CAPSULES ARE AND WHATTHEYARE USED FOR
Fluconazole is an antifungal agent. Your medicine is used fortreating a fungal infection called vaginal thrush. Vaginal thrush is caused by a yeast called Candida. Many women have this yeast living in their bodies harmlessly. If something such as antibiotics, ill health or the pill upsets the natural balance that keeps Candida under control, then candidal infections occur.
The most common symptoms of vaginal thrush are:
• Redness and swelling of the tissues of the vagina and vulva
• Itching around the outside of the vagina
• Soreness
• A white, non-smelling discharge from the vagina
You may have one or more of these symptoms.
If your partner has penile thrush he may have one or more of the following symptoms:
• Soreness and redness of the penis
• Tightness ofthe foreskin
• A white non-smelling penile discharge
Tostop thrush coming back:
• Wash regularly
• Avoidtightclothing
• Wear cotton underwear and stockings rather than tights
• Avoid perfumed soaps and bath additives
• Changeyourtamponfrequently
Sexual intercourse can damage these delicate tissues and make thrush worse. Occasionally you can pass thrush to your partner through intercourse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE I50mg CAPSULES
This medicine can be used by adults between the ages of 16 and 60 years.
You should take Fluconazole I50mg Capsules only if you are sure that you have vaginal thrush. Remember that other infections can cause similar symptoms to thrush and that you could have more than one type of infection at the same time. Ifyou are in any doubt that you have thrush or thinkyou could have another infection at the same time, you should see your doctor before you take fluconazole.
Do not take Fluconazole I50mg Capsules
• Ifyou have ever had an allergic reaction (hypersensitivity) where you have developed a rash, difficulty breathing, facial swelling or general itchiness to any of the ingredients of fluconazole capsules or other medicines to treat a fungal infection (listed in section 6)
• If you have a very slow heart rate or a serious heart rhythm disturbance or heart failure. Also ifyou have ever been told that you have a long QT interval (a type of heart rhythm disturbance that is found on electrocardiograms (ECG's))
• Ifyou are taking medicines to control your heart rate or rhythm
• If you are taking terfenadine or astemizole an antihistamine (used to treat allergic illnesses such as hayfever) or cisapride (used for stomach upsets) or Pimozide (for mental health conditions) or erythromycin (an antibiotic for treating infections)
• Ifyou suffer from low levels of potassium, calcium or magnesium
in your blood which will be determined by your doctor with a
bloodtest
• Ifyou have an intolerance to some sugars, unless your doctor tells you to (this medicine contains lactose)
• If you are pregnant or breastfeeding (see "Other important information")
• If you are taking quinidine or amiodarone (used for treating heart arrhythmia).
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before taking Fluconazole ISOmg Capsules:
• If this is the first time you have had these symptoms
• Ifyou have had thrush more than twice in the last 6 months
• If you are under 16 years, or 61 years or older
• If you or your partner have been exposed to a sexually transmitted disease
• If you have liver disease, or have had unexplained jaundice (yellowing ofthe skin and eyes)
• If you have heart problems, including heart rhythm problems, or low levels of potassium, magnesium or calcium in your blood
• If you have AIDS (you may be more likely to experience skin reactions)
• Ifyou have any other long-term illness, or receive regulartreatment fromyourdoctor
• If you are taking any other medicines, except for the contraceptive "pill" (see "Ifyou use other medicines" on the backof the leaflet)
• Ifyou have lower stomach pain, or pain or a burning sensation on passing urine
• Ifyou are unsure about the cause of your symptoms
• Ifyou are a man and:
■ Your sexual partner does not have thrush
■ You have an abnormal discharge or leakage from your penis
■ You have sores, ulcers or blisters onyour penis
■ Yourpenishasstartedtosmell
• Ifyouareawomanand:
■ You have an abnormal or irregular vaginal bleeding, or a blood stained discharge
■ You have sores, ulcers or blisters onyourvulva orvagina
Other medicines and Fluconazole I50mg Capsules:
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines, in particular:
• Warfarin or coumarin drugs (to prevent blood clots)
• Oral antidiabetics (sulphonylureas) such as chlorpropamide, glibenclamide, glipizide ortolbutamide
• Diuretics, such as hydrochlorothiazide, used to treat fluid retention and high blood pressure
• Benzodiazepines(midazolam,triazolamorsimilarmedicines) used to help you sleep or for anxiety
• Carbamazepine, phenytoin (used fortreating fits)
• Medicines for mental health conditions (e.g. tricyclic antidepressants).
• Methadone (for pain relief ortreatment of opioid dependance)
• Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))
• Halofantrine (fortreatment of malaria)
• Rifampicin or rifabutin (antibiotics)
• Cidosporin, tacrolimus or sirolimus (used to affect the immune response)
• Theophylline (used to control asthma)
• Astemizole or terfenadine (antihistamines used to treat allergic reactions such as hayfever)
• Zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• Cisapride (ulcer healing drug)
• Ergot alkaloids for migraine
• HMG -CoA reductase inhibitors such as astorvastatin or fluvastatin (used to lower blood cholesterol)
• Quinidine (heart rhythm disturbance)
• Calcium channel antagonists including nifedipine, isradipine, nicardipine, amlodipine and felodipine (to control angina and/or high blood pressure)
• Losartan (to control high blood pressure)
• Trimetrexate(totreat pneumonia)
• Prednisone (asteroid)
• Amitriptyline or nortriptyline (anti-depressants)
• Celecoxib (to treat arthritis)
• Erythromycin (an antibiotic used fortreating infection)
• Cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used fortreating cancer
• Vitamin A (nutritional supplement)
• Voriconazole used to treat fungal infections.
Any other medicines includes medicines prescribed by your doctor and medicine you have bought for your self, including herbal and homeopathic remedies.
Fluconazole I50mg Capsules with food and drink
You can take your medicine with or without a meal at any time of day. Take the capsule with a glass of water.
Pregnancy and breast- feeding
Pregnancy: This medicine should not be used ifyou are pregnant, or
ifyou thinkyou may be pregnant.
Women of childbearing age: You must use a reliable form of contraception when using this medicine. The ingredients in the cream, however, may affect the latex used in barrier contraceptives such as condoms and diaphragms.
You should therefore use other methods of contraception whilst using this medicine and for at least 5 days after last using the cream. Breastfeeding: This medicine should not be used if you are breastfeeding.
Driving and using machines
Fluconazole I50mg Capsules may occasionally cause dizziness or fits. If affected do not drive or use machinery.
Fluconazole I50mg Capsules contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE FLUCONAZOLE I50mg CAPSULES
You should read the instructions on the pack. Fluconazole I50mg Capsules should only be taken by mouth.
The whole course of treatment for vaginal thrush is one capsule which you take by mouth. Take the capsule with a glass of water.
Some women notice an improvement after one day and the thrush should clear up after 2 days. If symptoms persist for more than 7 days, consult your doctor.
If after treatment with Fluconazole I50mg Capsules you have a reoccurrence of thrush, you should only take this product again if it has been more than 7 days since your last treatment.
If you experience a thrush infection more than twice over a six month period, consult your doctor.
Remember that Fluconazole can only treat thrush. It cannot treat other infections of the genitals. If you still have any sort of symptoms one or two days after you have taken Fluconazole, you should visit your doctor in case you have anothertype of infection.
If you take more Fluconazole I50mg Capsules than you should.
If you (or someone else) swallow a lot of capsules at the same time, or you think a child has swallowed any of the capsules, contact your nearest hospital casualty department oryour doctor immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. These can be seen even with a single dose of ISOmg.
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
• swellingofeyelids.faceorlips
• itching all overthe body, reddening ofthe skin or itchy red spots
• skin rash.
Fluconazole I50mg Capsules may affect your liver. The signs of liver problems include:
• tiredness
• loss of appetite
• vomiting
• yellowing of your skin orthe whites of your eyes (jaundice).
If any of these happen, stop taking Fluconazole and tell your doctor immediately.
• severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).
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 which affect I to 10 users in 100 are listed below:
• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash
Uncommon side effects which affect I to 10 users in 1,000 are listed below:
• reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• decreased appetite
• inabilitytosleep.feelingdrowsy
• fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes insense of taste
• constipation, difficult digestion, wind, dry mouth
• muscle pain
• liver damage and yellowing ofthe skin and eyes (jaundice)
• wheals, blistering (hives), itching, increased sweating
• tiredness, general feeling of being unwell, fever.
Rare side effects which affect I to 10 users in 10,000 are listed below:
• lower than normal white blood cells that help defend against infections and blood cells that help to stop bleeding
• red or purple discoloration ofthe skin which may be caused by low platelet count, other blood cell changes
• blood chemistry changes (high blood levels of cholesterol, fats)
• low blood potassium
• 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 lipsorface
• hair loss.
These other effects are less serious. If they bother you talk to a pharmacist:
• Feeling sick or being sick, heartburn, abdominal pain, diarrhoea, constipation, wind, dry mouth, taste disturbances, loss of appetite
• Difficulty sleeping, or difficulty getting to sleep
• Headache, feeling dizzy or unsteady on your feet, pins and needles, pain in the muscles, weakness or loss of strength, general feeling of tiredness or being unwell, shaking
• Red, raised, itchy skin rash, or a rash with eruptions of pus
• Increased sweating, rarely hair loss
• Changes in the way your kidneys work (that may show up in blood tests)
• Low levels of potassium, rarely increased cholesterol or blood fat levels
• Infections due to fungi (yeasts) or other organisms that are resistantto fluconazole.
Reporting of side effects
Ifyou get any side effects, talktoyour 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
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUCONAZOLE I50mg CAPSULES
Keep out ofthe sight and reach of children.
Do not use Fluconazole I50mg Capsules afterthe expiry date which is stated on the carton. The expiry date refers to the last day of that month.
The product does not require any special storage conditions within Europe.
Medicines should not be disposed of via the wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protectthe environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fluconazole I50mg Capsules contain
- The active substance is fluconazole. Each capsule contains I50mg of fluconazole.
- The other ingredients are lactose, starch, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate. The capsule shell is gelatine and the colouring agents are titanium dioxide (EI7I) and Patent Blue V (EI3I).
What Fluconazole I50mg Capsules look like and the contents of the pack
Each capsule has a blue body and cap. Fluconazole I50mg Capsules come in a pack containing one capsule.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA80RP.UK
PL20395/0042
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Date leaflet approved: October 2015.