Package leaflet: Information for the user - Fluconazole 150mg
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, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Fluconazole is and what it is used for
- What you need to know before you take Fluconazole
- How to take Fluconazole
- Possible side effects
- How to store Fluconazole
- Contents of the pack and other information
1. WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Fluconazole, the active ingredient, belongs to a group of medicines called anti-fungal agents and it is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is yeast called Candida.
Fluconazole is used to treat a fungal infection called vaginal thrush (in women) and associated candidal balanitis (in men).
What is vaginal thrush?
Vaginal thrush is caused by tiny yeast called Candida. Many women have the yeast living quite happily and problem-free within their bodies. However, the natural balance that keeps Candida under control can be upset by other factors, e.g. antibiotics, diabetes, poor general health, the Pill, or damage to vaginal tissues. Then the levels of yeast become too high and thrush develops. The most common symptoms are:
- Itching around the outside of the vagina.
- Soreness which becomes worse with rubbing and scratching. Also the salt in urine can sting the sore tissue.
- A white, non-smelling discharge from the vagina. Not every woman who has thrush will have all of these symptoms. Some general advice to help stop thrush coming back:
- Wash regularly, but do not wash and dry yourself too harshly.
- Avoid tight clothing.
- Wear cotton underwear and stockings rather than tights.
- Avoid perfumed soaps, bath additives and vaginal deodorants.
- Change your tampon frequently as a blood-soaked tampon can provide ideal conditions for yeast growth.
Sexual intercourse can damage delicate tissue and aggravate thrush. Vaginal thrush is not “VD”, but may be passed on to your partner through intercourse. If your attack of thrush was successfully treated, but keeps coming back, your partner may need to take Fluconazole himself. If you are unsure why your thrush keeps coming back, or are unsure if your partner has thrush, you or your partner should see a doctor.
What is candidal balanitis?
Candidal balanitis (penile thrush) is caused by yeast called Candida. Balanitis is the medical term used to describe inflammation of the end of the penis. The foreskin may also be inflamed.
Thrush can be passed on from your partner through sexual intercourse. (Thrush is not “VD” - see “What is vaginal thrush?”). The most common symptoms are:
- Soreness, redness and irritation of the penis.
- Tightness of the foreskin.
- A white, non-smelling discharge from the penis.
- Not every man who has candidal balanitis will have all of these symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE
Do not take FLUCONAZOLE if:
- You have ever had an allergic reaction 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.
- You are taking terfenadine or astemizole (antihistamine medicines for allergies), cisapride (used for stomach upsets), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmia), erythromycin (an antibiotic for treating infections).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fluconazole
- if you have any disease or illness affecting your liver or kidneys
- 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)
- if you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)
- if you or your partner have had exposure to a sexually transmitted disease if you are unsure about the cause of your symptoms
Women only: If
- You have any abnormal or irregular vaginal bleeding or a blood stained discharge.
- You have vulval or vaginal sores, ulcers or blisters.
- You are experiencing lower abdominal pain or burning on passing urine.
Men only: If
- Your sexual partner does not have vaginal thrush.
- You have penile sores, ulcers or blisters.
- You have an abnormal penile discharge (leakage).
- Your penis has started to smell.
- You have pain on passing urine.
Other medicines and Fluconazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription..
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 (see section: “Do not take Fluconazole if you”).
There are some medicines that may interact with Fluconazole. Make sure your doctor knows if you are taking any of the following medicines:
- nifedipine, isradipine, amlodipine, felodipine and losartan (for hypertension-high blood pressure)
- rifampicin, rifabutine (antibiotics for infections)
- medicines that thin the blood to prevent blood clots (Warfarin or similar medicines)
- benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety
- olaparib (used for treating ovarian cancer)
- chlorpropamide, glibenclamide, glipizide or tolbutamide (used to control diabetes)
- phenytoin, carbamazepine (used for treating fits)
- ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
- theophylline (used to control asthma)
- Tofacitinib (used for treating rheumatoid arthritis)
- zidovudine, also known as AZT, or saquinavir (used in HIV-infected patients)
- prednisone (steroid)
- oral contraceptives
- alfentanil, fentanyl (used as anaesthesia)
- celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))
- amitriptyline and nortriptyline (used as anti-depressant)
- amphotericin B, voriconazole (anti-fungal)
- cyclophosphamide and 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
- vitamin A (nutritional supplement)
- methadone (used for pain)
- ivacaftor (used for treating cystic fibrosis)
- amiodarone (used for treating uneven heartbeats ‘arrhythmias’)
- hydrochlorothiazide (a diuretic)
Fluconazole with food and drink
You may take the capsule with or without a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Fluconazole while you are pregnant unless your doctor has told you to. You can continue breast-feeding after taking a single dose of Fluconazole up to 150 mg. You should not breast-feed if you are taking a repeated dose of Fluconazole.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.
Fluconazole contains lactose (milk sugar) and sodium (salt)
This medicine contains a small amount of lactose (milk sugar). If your doctor has told you that you have an intolerance to some sugars, such as lactose, please contact your doctor before taking this medicine. Fluconazole capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’
3. HOW TO TAKE FLUCONAZOLE
Adults aged 16-60 years: The dose is one capsule. Swallow the capsule whole with a drink of water.
Not recommended for use in children under 16 years or adults over 60 years.
Consult your doctor if symptoms have not been relieved within 1 week of taking this medicine.
If symptoms worsen at any time talk to your doctor.
If you take more capsules than you should: Contact your doctor or the nearest hospital as soon as possible.
4. POSSIBLE SIDE-EFFECTS
Like all medicines Fluconazole may sometimes cause side-effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- If you experience any of the following serious allergic reaction (sudden wheeziness, difficulty breathing or tightness in the chest, swelling of the eyelids, face or lips, blisters or red itchy spots on the skin, itch all over the body, sores around the mouth, eyes, nose or genitals, liver disease), fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS) to Fluconazole you should STOP taking the medication and contact your doctor IMMEDIATELY.
Fluconazole 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).
Fluconazole may affect your adrenal glands and the levels of steroid hormones produced. The signs of adrenal problems include: tiredness, muscle weakness, loss of appetite, weight loss, abdominal pain.
If any of these happen, stop taking Fluconazole 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 side effects (may affect up to 1 in 10 people) are:
- headache
- stomach discomfort, diarrhoea, feeling sick, vomiting
- increases in blood tests of liver function
- rash
Uncommon side effects (may affect up to 1 in 100 people) are:
- 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 side effects (may affect up to 1 in 1,000 people) are:
- 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
- blood chemistry changes (high blood levels of cholesterol, fats)
- low blood potassium
- 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FLUCONAZOLE
- Keep out of the sight and reach of children.
- Do not store above 25oC.
- Do not use your medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of the 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 contains
The capsule contains 150mg fluconazole as the active ingredient. The capsule also contains lactose, pregelatinised maize starch, sodium laurilsulfate, colloidal anhydrous silica, magnesium stearate, purified talc and the capsule shell also contains gelatin, sodium laurilsulfate, water and the colours brilliant blue (E133) and titanium dioxide (E171).
What FLUCONAZOLE looks like and contents of pack
This medicine is supplied as a pack of single blue capsule.
Marketing Authorisation Holder and Manufacturer
FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE Hard to see or read the leaflet? Call+ 44(0) 1489 565222 for help. This leaflet was last revised in February 2020.
PACKAGE LEAFLET: INFORMATION FOR THE USER Clotrimazole Cream 1%
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- 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
What is in this leaflet:
- What Clotrimazole is and what it is used for
- What you need to know before you use Clotrimazole
- How to use Clotrimazole
- Possible side effects
- How to store Clotrimazole
- Contents of the pack and other information
1.What Clotrimazole is and what it is used for
The active substance is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal skin infections.
Clotrimazole is used to treat fungal skin infections such as ringworm, athlete’s foot, fungal nappy rash and fungal sweat rash. It is also used to relieve irritation of the vulva (external thrush) or the end of the penis, which may be associated with thrush.
When Clotrimazole is applied to the infected area of skin it works by destroying the fungus or yeast which has caused the infection. If you are unsure whether you (or your baby if treating nappy rash) have one of these fungal skin infections, seek the advice of your doctor or pharmacist.
2. What you need to know before you use Clotrimazole
Do not use Clotrimazole:
- if you (or your baby if treating nappy rash) are allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Clotrimazole if you have used a cream containing clotrimazole or a similar medicine before and suffered an allergic or unpleasant skin reaction. This may have been a skin rash or itching in the area the cream was applied.
Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Other medicines and Clotrimazole
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Clotrimazole is not known to interact with any other medicines.
As with other creams, Clotrimazole may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, if you are using this cream on the vulva or penis, you should use alternative precautions for at least five days after using this product.
Pregnancy and breastfeeding
Clotrimazole Cream 1% can be used in pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, tell your doctor, midwife or pharmacist before using Clotrimazole. If you have informed your doctor or midwife already, follow his/her instructions carefully.
Driving and using machines
Clotrimazole will not affect your ability to drive or operate machinery.
Clotrimazole contains cetostearyl alcohol
This medicine contains cetostearyl alcohol which may cause local skin reactions (e.g. rash, itching or redness).
Clotrimazole contains benzyl alcohol
This medicine contains benzyl alcohol which may cause mild local irritation
3. How to use clotrimazole
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
if you are not sure. If you purchased this product without a prescription, follow these directions closely.
- Before use, pierce the tube seal by inverting the cap over the end of the tube and press.
- If the feet are infected, they should be washed and dried thoroughly, especially between the toes, before applying the cream.
- Clotrimazole should be applied thinly and evenly to the affected areas, two or three times daily and rubbed in gently.
- A strip of cream (1⁄2 cm long) is enough to treat an area of about the size of the hand.
- The duration of the treatment depends upon the type of infection. Use the cream for at least two weeks for candida (thrush) infections or at least one month for other infections.
- If you have athlete’s foot, it may help to use an antifungal dusting powder as well. Ask your doctor or pharmacist to recommend one.
The symptoms of skin infection such as itching or soreness, should improve within a few days of treatment although signs such as redness and scaling may take longer to disappear. If symptoms persist, consult your doctor.
Clotrimazole is for external use only.
Do not put the cream in your mouth or swallow it.
If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.
If you accidentally get cream in your eyes or mouth, wash immediately with water and contact your doctor.
If you forget to use Clotrimazole
Apply the cream as soon as possible, then continue the rest of your treatment as usual.
If you stop using Clotrimazole
Do not suddenly stop using Clotrimazole as this may cause the symptoms of the infection to return.
You can help the treatment to work if you follow these simple self-help tips:
- Although the infected area will itch, try not to scratch. Scratching will damage the surface of the skin and cause the infection to spread further.
- Keep the affected skin areas clean.
- Pay particular attention to drying the skin, but avoid excessive rubbing.
- Do not share towels, bath mats, etc. with other people as you could spread the infection to them.
- Always wash your hands after treating the infection to prevent it from spreading.
- Remember to dry the skin between the toes thoroughly.
- Wash your socks, stockings and tights thoroughly in hot water to remove any shed skin or fungal spores.
- Change your footwear daily if possible.
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.
As with all medicines, some people may be allergic to the cream. If you or your baby are allergic, a reaction will occur soon after you start using it. If you or your baby experience an allergic reaction, stop using Clotrimazole and tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital. Signs of an allergic reaction may include:
- Rash
- Swallowing or breathing problems
- Swelling of the lips, face, throat or tongue
- Weakness, feeling dizzy or faint
- Nausea
After you apply the cream you might experience:
- Itching, rash, blisters, burning, discomfort, swelling, irritation, pins and needles, redness or peeling of skin. This may mean that you are allergic to the cream.
Reporting of side effects
If you or your baby gets any side effects, talk to your 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store clotrimazole
Keep this medicine out of the sight and reach of children. Store in a cool dry place.
Do not use this cream 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 Clotrimazole contains
The active substance is clotrimazole. Each gram of cream contains 10 mg of clotrimazole (i.e. 1% w/w).
The other ingredients are benzyl alcohol (see section 2 “Clotrimazole contains benzyl alcohol”), polysorbate 60, cetyl esters wax, cetostearyl alcohol (see section 2 “Clotrimazole contains cetostearyl alcohol”), octyldodecanol, sorbitan monostearate and purified water.
What Clotrimazole looks like and contents of the pack
Clotrimazole Cream 1% is a smooth white cream and is available in tubes of 20g or 50g. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan Potters Bar, Hertfordshire, EN6 1TL United Kingdom
Manufacturer
Viatris UK Healthcare Limited, Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
This leaflet was last revised in 07/2022