Oramic

Indications

Miconazole is an antifungal medicine. The oral gel is used to treat fungal (Candida) infections of the mouth and throat, often called oral thrush. The cream is used for fungal skin infections such as ringworm, athlete's foot, jock itch, fungal infections in skin folds, and nappy rash infected with yeast.

How It Works

Miconazole stops fungi from making ergosterol, an important part of their cell wall. Without it the fungal cells leak and die, so the infection clears.

Dosage and Administration

• Oral gel, adults: usually 2.5 ml four times a day after meals. Place the gel on the sore areas and keep it in the mouth as long as possible before swallowing. Dentures should be cleaned and treated too.
• Oral gel, children and babies over 4 months: as prescribed. In babies, apply small amounts with a clean finger to the inside of the mouth, never at the back of the throat.
• Continue the oral gel for about 7 days after the symptoms have gone.
• Cream: apply a thin layer to the affected skin and a little around it once or twice a day. Keep using it for about 10 days after the skin has healed, often 2 to 6 weeks in total.

Wash hands after use. Do not use the cream in the eyes or mouth.

Interactions

The oral gel is partly absorbed into the body and can interact with other medicines. It can greatly increase the effect of Warfarin and similar blood thinners, causing bleeding. It can also raise the levels of Simvastatin, Lovastatin, Phenytoin, some diabetes tablets (such as Glibenclamide), Midazolam, Triazolam, Cisapride, Pimozide, Quinidine and ergot medicines. The cream is unlikely to interact, but tell your doctor if you take Warfarin.

Contraindications

• Allergy to miconazole, other azole antifungals or any ingredient of the product.
• Oral gel: babies under 4 months, or children who cannot swallow well, because of the risk of choking.
• Oral gel: liver disease.
• Oral gel: people taking Cisapride, Pimozide, Quinidine, Simvastatin, Lovastatin, Triazolam, Midazolam by mouth, or ergot medicines.

Side Effects

Oral gel: nausea, vomiting, diarrhoea, an unusual taste and mouth discomfort. Cream: mild burning, itching, redness or irritation at the site.

Get urgent medical help if you have a serious allergic reaction (swelling of the face, lips or throat, difficulty breathing, widespread rash), choking in a baby, or unusual bleeding or bruising while taking a blood thinner.

Pregnancy and Lactation

The cream can usually be used in pregnancy and breastfeeding on a doctor's advice. Avoid the oral gel during pregnancy unless a doctor advises it. If using the cream on the breast while breastfeeding, wipe it off before feeding.

Precautions and Warnings

If you take Warfarin, your doctor needs to check your blood clotting more often while using the oral gel. See a doctor if the infection is not better after the usual course. Keep the affected skin clean and dry, and do not share towels.

Overdose

Swallowing a large amount of gel or cream may cause vomiting and diarrhoea. Seek medical advice.

Therapeutic Class

Azole antifungal.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children. Do not freeze.