Nizoral tablets (ketoconazole)

How does it work?

Nizoral tablets contain the active ingredient ketoconazole, which is a type of medicine called an antifungal. It is used to treat infections with fungi and yeasts.

Ketoconazole kills fungi and yeasts by interfering with their cell membranes. It works by stopping the fungi from producing a substance called ergosterol, which is an essential component of fungal cell membranes. The disruption in production of ergosterol disrupts the fungal cell membrane, causing holes to appear in it.

The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As ketoconazole causes holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi and treats the infection.

When taken by mouth ketoconazole may very rarely cause serious side effects on the liver. As a result, Nizoral tablets are reserved for treating fungal infections that can't be treated with other antifungals.

What is it used for?

Nizoral tablets are used to treat fungal infections of the skin, hair or mucous membranes (eg moist linings of the mouth, nose or vagina) that can't be treated with topical ketoconazole due to the site or extent of the infection, and cannot be treated with other antifungals. These infections include the following:

chronic, recurrent vaginal thrush

candida infections of the skin, mucous membranes, mouth or throat

pityrosporum folliculitis

dermatophytosis.

Nizoral tablets are also used to treat fungal infections affecting the whole body (systemic infections) that cannot be treated with other antifungals, including the following:

paracoccidioidomycosis

histoplasmosis

coccidioidomycosis

blastomycosis.

Warning!

Nizoral tablets should be taken with a meal.

When ketoconazole is taken by mouth it may very rarely have serious side effects on the liver. For this reason, your doctor will want to check your liver function before your treatment is started and monitor your liver function regularly during the treatment. This will involve a blood test before starting the tablets, and further blood tests after two weeks, four weeks and then every month until your treatment is finished. You should tell your doctor immediately if you experience any symptoms of a liver problem during treatment. Symptoms that may suggest a liver problem include persistent nausea and vomiting, unexplained itching, abdominal pain, loss of appetite, fatigue, dark urine or the development of jaundice (a yellow colouring to the skin and the whites of the eyes).

Make sure you take this medicine regularly and complete the course as directed by your doctor. It is important to complete the course, even if your symptoms have cleared up, otherwise there is a risk of the infection returning.

On rare occasions some people may experience symptoms such as flushing, rash, swelling of the ankles, nausea or headache if they drink alcohol while taking this medicine.

Use with caution in

People with abnormal results in liver function tests.

People who have previously experienced side effects on the liver caused by treatment with any medicine.

Underactivity of the adrenal glands.

Not to be used in

Liver disease.

Allergy to other antifungals of this type (imidazoles).

Hereditary blood disorders called porphyrias.

Breastfeeding.

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Nizoral tablets contain lactose).

This medicine is not recommended for children weighing under 15kg.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this medicine for use during pregnancy has not been established. The manufacturer states that it is not recommended for use during pregnancy unless the potential benefits outweigh any potential risks to the developing baby. Seek medical advice from your doctor.

This medicine passes into breast milk. Mothers who need treatment with this medicine should not breastfeed while taking it. Seek medical advice from your doctor.

Label warnings

Take this medication with or after food.

Do not take indigestion remedies at the same time of day as this medication.

Take at regular intervals. Complete the prescribed course unless otherwise directed.

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