Boots Thrush Treatment 150 mg Capsule

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

1. What Boots Thrush Treatment 150 mg Capsule is and what it is used for
2. What you need to know before you take Boots Thrush Treatment 150 mg Capsule
3. How to take Boots Thrush Treatment 150 mg Capsule
4. Possible side effects
5. How to store Boots Thrush Treatment 150 mg Capsule
6. Contents of the pack and other information

• 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).
• are taking astemizole, terfenadine (antihistamine medicines for allergies)
• are taking cisapride (used for stomach upsets)
• are taking pimozide (used for treating mental illness)
• are taking quinidine (used for treating heart arrhythmia)
• are taking erythromycin (an antibiotic for treating infections)
• suffer from porphyria.

Talk to your doctor, pharmacist or nurse before taking Fluconazole if you:

• are unsure about the cause of your symptoms
• have had thrush more than twice in the last six months
• or your partner have ever been exposed to a sexually transmitted disease
• are taking any medicine other than the contraceptive pill
• suffer from any chronic disease or illness
• are aged under 16 or over 60 years
• have liver or kidney problems
• suffer from heart disease, including heart rhythm problems
• develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)
• 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 the fungal infection does not improve, an alternative antifungal therapy may be needed
• have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Boots Thrush Treatment 150 mg Capsule.

Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Boots Thrush Treatment 150 mg Capsule. Stop taking Boots Thrush Treatment 150 mg Capsule and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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.

Paediatric use is not recommended.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

There are some medicines that may interact with Fluconazole. Make sure your doctor knows if you are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics for infections)
• alfentanil, fentanyl (used as anaesthetic)
• amitriptyline, nortriptyline (used as anti-depressant)
• amphotericin B, voriconazole (anti-fungal)
• 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
• carbamazepine or phenytoin (used for treating fits)
• olaparib (used for treating ovarian cancer)
• nifedipine, isradipine, amlodipine, verapamil, felodipine and losartan (for hypertension - high blood pressure)
• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)
• cyclosphosphamide 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
• methadone (used for pain)
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-lnflammatory Drugs (NSAID))
• oral contraceptives
• prednisone (used to treat allergies)
• zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
• medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
• theophylline (used to control asthma)
• vitamin A (nutritional supplement)
• ivacaftor (used for treating cystic fibrosis)
• amiodarone (used for treating uneven heartbeats 'arrhythmias')
• hydrochlorothiazide (a diuretic)
• ibrutinib (used for treating blood cancer)
• tofacitinib (used for treating rheumatoid arthritis)
• lurasidone (used for treating schizophrenia and bipolar disorder)
• abrocitinib (used for treating atopic dermatitis)
• tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Boots Thrush Treatment 150 mg Capsule if you are pregnant, think you may be pregnant are trying to become pregnant or breast-feeding, unless your doctor has told you so.

Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken at low doses during the first trimester may slightly increase the risk of a baby being born with birth defects affecting the bones and/or muscles.

Boots Thrush Treatment 150 mg Capsule may occasionally cause dizziness or fits. If affected do not drive or use machinery.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Boots Thrush Treatment 150 mg Capsule contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

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 doctor, pharmacist or hospital emergency department immediately.

• 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)
• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine)
• Widespread rash, high body temperature and enlarged lymph node (DRESS syndrome or drug hypersensitivity syndrome).

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: may affect up to 1 in 10 people

• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increase 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, prickling or numbness, changes in sense of taste
• constipation, difficulty in digestion, 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, other blood cell changes
• blood chemistry changes (high blood levels of cholesterol, fats)
• shaking
• abnormal electrocardiogram (ECG), change in heart rate or rhythm
• hair loss.

Not known: frequency cannot be estimated from the available data

• hypersensitivity reaction with skin rash, 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).

If you get 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.

• The active substance is Fluconazole. Each capsule contains 150 mg of Fluconazole.
• The other ingredients are lactose monohydrate, maize starch, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate.
  The capsule shell is gelatin and the colouring agents are titanium dioxide (E171) and Patent Blue V (E131).

Each capsule has a blue body and cap. Boots Thrush Treatment 150 mg Capsule come in a pack containing one capsule.

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. However, 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.