Thrush Oral Gel Treatment

What is the medicine used for?

Oral thrush is usually harmless. It’s common in babies and older people with dentures. It can be easily treated with medicines bought from a pharmacy.

Key features

• This medicine is used to treat superficial fungal infections of the mouth and throat.
• Each gram of Daktarin Sugar Free 2% Oral Gel contains 20mg of miconazole.
• This medicine is for use by adults, children and infants aged 4 months and over.
• Maximum of 3 tubes per purchase in any 7 day period.
• Patient Information Leaflet

What causes oral thrush?

Low numbers of the fungus Candida are naturally found in the mouth and digestive system of most people. They don’t usually cause any problems but can lead to oral thrush if they multiply.

There are several reasons why this may happen, including:

• taking a course of antibiotics, particularly over a long period or at a high dose
• taking inhaled corticosteroid medication for asthma
• wearing dentures (false teeth), particularly if they don’t fit properly
• having poor oral hygiene
• having a dry mouth, either because of a medical condition or a medication you are taking
• smoking
• having chemotherapy or radiotherapy to treat cancer

Babies, young children and elderly people are at a particularly high risk of developing oral thrush, as are people with certain underlying conditions, including diabetes, an iron deficiency or vitamin B12 deficiency, an underactive thyroid (hypothyroidism) and HIV.

As most people already have Candida fungi living in their mouth, oral thrush is not contagious. This means it cannot be passed to others.

Symptoms to look out for;

Adults:

• Your mouth is red inside and you have white patches.
• When you wipe off the white patches, they leave red spots that can bleed.

Oral thrush in adults is not contagious.

Other symptoms in adults are:

• cracks at the corners of the mouth
• not tasting things properly
• an unpleasant taste in the mouth
• pain inside the mouth (for example, a sore tongue or sore gums)
• difficulty eating and drinking
• Oral thrush in adults is not contagious.

Babies and Children:

• A white coating on the tongue like cottage cheese – this can’t be rubbed off easily.
• Sometimes there are white spots in their mouth.

Other symptoms in babies are:

• they don’t want to feed
• nappy rash

Babies can pass oral thrush on through breastfeeding. This can cause nipple thrush in mothers.

Why not read more detailed information about Thrush.

Usage

Check the tables below to see how much medicine to use.

Each tube of the gel is sealed – use the cap to pierce the seal.

• For oral use only.
• Do not use more than the stated dose shown in the table.
• Use after meals.

How to apply the gel

• Apply directly to the affected area with a clean finger. Try to keep the gel in contact with the affected area for as long as possible. Do not swallow it straight away.
• If you are wearing dentures, remove them at bedtime and rub them with the gel. This will help prevent your dentures becoming infected as well.
• If you are giving the gel to a child or infant, make sure that the gel does not become a choking hazard by dividing each application into smaller portions – never put the whole mount into the child’s mouth all at once. Make sure you place the gel at the front of the mouth.
• If the infant is 4-6 months old and is premature or has slow development or problems swallowing, check with your doctor before using this medicine.

Do not use in infants less than 4 months old.

Infants and children 4 months – 2 years old: Apply 1,25 ml gel (¼ measuring spoon) to the affected area four times a day after meals.

• When giving to a child or infant, place the gel at the front of the mouth – never put it at the back of the throat.
• Continue treatment for up to 7 days after all the symptoms have cleared.
• If the infant is 4 – 6 months old and is premature or has slow development or problems swallowing, check with your doctor before using this medicine.
• If symptoms persist talk to your doctor

Adults and children aged 2 years and over: Apply 2,5 ml gel (½ measuring spoon) to the affected area four times a day after meals.

• Continue treatment for up to 7 days after all the symptoms have cleared.
• If symptoms persist talk to your doctor.

If anyone has used too much of this product

If anyone accidentally uses too much of Daktarin Sugar Free 2% Oral Gel, or if large quantities of the gel are accidently swallowed, contact a doctor or your nearest Accident Emergency Department (Casualty) taking this leaflet.

If anyone has used too much of this product

If anyone accidentally uses too much of Daktarin Sugar Free 2% Oral Gel, or if large quantities of the gel are accidently swallowed, contact a doctor or your nearest Accident Emergency Department (Casualty) taking this leaflet.

Ingredients

The active ingredient in 1g of Daktarin Sugar Free 2% Oral Gel is: Miconazole 20 mg.

Other ingredients are: Purified water, pregelatinised potato starch, ethanol, polysorbate 20, sodium saccharin, cocoa flavour, orange flavour and glycerol.

Precautions

Before using this medicine

This medicine is suitable for most adults and children but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

Do not use this medicine

• If you are allergic to the active substance, other similar antifungal medicines or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from liver dysfunction.
• If it is for an infant under 4 months of age because of the risk of choking.

If you are taking any of the following medicines:

• Warfarin (a drug used to thin the blood)
• Terfenadine, astemizole or mizolastine (drugs found in hayfever or antihistamine products).
• Cisapride (a drug used to treat certain digestive problems).
• Simvastatin and lovastatin (types of drugs used to treat high cholesterol).
• Tranquillisers such as midazolam (taken by mouth) and triazolam (drugs used to treat anxiety or to help you sleep).
• Pimozide and sertindole (drugs used for mood disorders)
• Bepridil, quinidine and dofetilide (type of drugs used to treat irregular heartbeat).
• Certain drugs used to treat migraine, such as ergot alkaloids

If any of these apply to you, get advice from a doctor or pharmacist without using Daktarin Sugar Free 2% Oral Gel.

If you are not sure about any of the medicines you are taking, show the tube or pack to your pharmacist.

Talk to your doctor, pharmacist or dentist if you are taking

• Oral anticoagulants (drugs used to thin the blood, such as warfarin).
• HIV Protease Inhibitors such as saquinavir (used to treat HIV).
• Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel (used to treat cancer).
• Certain calcium channel blockers such as dihydropyridines and verapamil (used to treat
• hypertension, angina and arrhythmias).
• Certain medicines that act on the heart and blood vessels such as cilostazol or disopyramide.
• Certain immunosuppressive agents such as cyclosporin, tacrolimus, sirolimus (= rapamycin) (used to treat autoimmune disorders).
• Sulphonylureas such as chlorpropamide and glibenclamide (medicines for diabetes taken by mouth).
• Other medicines such as phenytoin, carbamazepine, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam (by injection), rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.

If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.

If you are pregnant or breast-feeding

• Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, think you are pregnant, planning to become pregnant or breast-feeding. If you do breast-feed, do not apply the gel to your nipple to treat your baby.

Special warnings about this medicine

• Daktarin Sugar Free 2% Oral Gel can cause severe allergic reactions. You must be aware of the signs of an allergic reaction while you are taking Daktarin Sugar Free 2% Oral Gel. See ‘Possible side-effects’.

Infants and young children:

• Daktarin Sugar Free 2% Oral Gel is sticky. This ensures that it stays in the mouth as long as possible. It is important to make sure that the gel does not close off the child’s or infant’s throat as they could choke on it. You should place the gel at the front of the mouth – never put it at the back of the throat.
• If you are breast-feeding, never apply the gel to your nipple to treat your baby.
• If the infant is 4-6 months old and is premature or has slow development or problems swallowing, check with your doctor before using this medicine.

Some of the ingredients can cause problems

• Daktarin Sugar Free 2% Oral Gel contains small amounts of ethanol (alcohol), less than 100mg per dose.

Side effects when using

Daktarin Sugar Free 2% Oral Gel can have side-effects, like all medicines, although these don’t affect everyone and are usually mild. If Daktarin obstructs the throat, infants and children may choke.

If you experience any of the following, stop using the medicine and talk to your doctor:

• Severe allergic reactions including swelling of the face, lips, mouth, tongue or throat. Also hives, which is known as nettle rash or urticaria.
• Light headedness, generalised itch, wheezing or difficulty breathing or swallowing.
• Skin rashes which may be severe and include blistering or peeling of the skin, mouth, eyes and genitals.
• Effects on blood clotting in patients taking warfarin (a medicine to thin the blood) which can cause unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit.

Other effects which may occur include:

• Common (less than 1 in 10 people)
• Feeling sick (nausea)
• Being sick (vomiting)
• Dry mouth
• Mouth discomfort
• Regurgitation (bringing up swallowed food into the mouth)
• Abnormal product taste

Uncommon (less than 1 in 100 people)

A change in the way some things taste.

Other side-effects which may occur, but it is unknown how often:

• Inflammation of the liver (hepatitis)
• Diarrhoea
• Tongue discolouration
• Sore mouth
• Oversensitivity (allergic reactions)
• Acute generalised exanthematous pustulosis (AGEP): A serious illness with rapid blistering of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS): A group of symptoms including rash, fever and internal effects, with abnormal blood test results.

If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed here You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side affects you can help provide more information on the safety of this product.

Other Information

If you need more advice consult your doctor or pharmacist.

Keep all medicines out of the sight and reach of children.