Fluconazole 150 mg Capsules

• 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 signs of illness 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.

1. What Fluconazole 150 mg Capsules are and what they are used for
2. What you need to know before you take Fluconazole 150 mg Capsules
3. How to take Fluconazole 150 mg Capsules
4. Possible side effects
5. How to store Fluconazole 150 mg Capsules
6. Contents of the pack and other information

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 150 mg Capsules 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.

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.

• 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). The symptoms may include itching, reddening of the skin or difficulty in breathing
• taking terfenadine or astemizole (antihistamine medicines for allergies)
• taking cisapride (used for stomach upsets)
• taking pimozide (used for treating mental illness)
• taking quinidine (used for treating heart arrhythmia)
• taking erythromycin (an antibiotic for treating infections)

Talk to your doctor or pharmacist before taking Fluconazole 150 mg Capsules if you

• have liver or kidneys problems
• suffer from heart disease, including heart rhythm problems
• have abnormal levels of potassium, calcium or magnesium in your blood
• 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)
• or your partner have had exposure to a sexually transmitted disease
• are unsure about the cause of your symptoms
• have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Fluconazole 150 mg Capsules

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

Talk to your doctor or pharmacist if the fungal infection does not improve, as alternative antifungal therapy may be needed.

Women only: If you

• have any abnormal or irregular vaginal bleeding or a blood stained discharge.
• have vulval or vaginal sores, ulcers or blisters.
• 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.

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 150 mg Capsules (see section: “Do not take Fluconazole 150 mg Capsules if you are”).

There are some medicines that may interact with Fluconazole 150 mg Capsules.

Make sure your doctor knows if you are taking any of the following medicines:

• nifedipine, isradipine, amlodipine,verapamil, felodipine and losartan (for hypertension-high blood pressure)
• rifampicin, rifabutin (antibiotics for infections)
• abrocitinib (used to treat atopic dermatitis, also known as atopic eczema)
• 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)
• tolvaptan used to treat hyponatremia (low levels of sodium in your blood) or to slow kidney function decline
• zidovudine, also known as AZT, or saquinavir (used in HIV-infected patients)
• prednisone (steroid)
• oral contraceptives
• alfentanil, fentanyl (used as anaesthetic)
• 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)
• ibrutinib (used for treating blood cancer)
• lurasidone (used to treat schizophrenia)

You can take your medicine with or without a meal.

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.

If you are planning to become pregnant, it is recommended to wait a week after a single dose of fluconazole before becoming pregnant.

For longer courses of treatment with fluconazole, talk to your doctor on the need for appropriate contraception during treatment which should continue for one week after the last dose.

You should not take Fluconazole 150 mg Capsules if you are pregnant, think you may be pregnant, are trying to become pregnant unless your doctor has told you so. If you become pregnant while taking this medicine or within 1 week of the most recent dose, contact your doctor.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage.

Fluconazole taken during the first trimester may increase the risk of a baby being born with birth defects affecting the heart, bones and/or muscles.

There have been reports of babies born with birth defects affecting the skull, ears, and bones of the thigh and elbow in women treated for three months or more with high doses (400-800 mg daily) of fluconazole for coccidioidomycosis. The link between fluconazole and these cases is not clear.

You can continue breast-feeding after taking a single dose of 150 mg Fluconazole Capsules.

You should not breast-feed if you are taking a repeated dose of Fluconazole 150mg Capsules.

When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.

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 150 mg Capsules contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Contact your doctor or the nearest hospital as soon as possible.

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):

• 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
• low blood potassium
• blood chemistry changes (high blood levels of cholesterol, fats)
• 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

Frequency not known, but may occur (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 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.

• The active substance is fluconazole.
• Each hard capsule contains fluconazole 150 mg.
• The other ingredients are:

Capsule content: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate and sodium lauryl sulphate.

Capsule shell composition: Gelatin, patent blue (E131) and titanium dioxide (E171) as colouring agents.

Black printing ink contains: shellac, propylene glycol and black iron oxide (E172).

Fluconazole 150 mg Capsules are blue/ blue coloured capsules printed with ‘RANBAXY’.

Fluconazole 150 mg Capsules are available in a blister strip in a pack of 1 capsule.

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