Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions about Daktarin Oral Gel. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about using Daktarin Oral Gel, ask your doctor or pharmacist. Your doctor and pharmacist have more information.

Keep this leaflet with your Daktarin Oral Gel. You may need to read it again.

What DAKTARIN Oral Gel is used for

Daktarin Oral Gel is used for treating infections of the mouth and throat (e.g. thrush).

Miconazole, the active ingredient in Daktarin Oral Gel, is a medicine used for treating infections caused by fungi, including yeast.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use DAKTARIN Oral Gel

When you must not use it

Do not use Daktarin Oral Gel if you know you are allergic to it or any of the ingredients (see the last section of this leaflet for a full list of ingredients).

Symptoms of an allergic reaction may include:

• rash, itching or hives on the skin
• shortness of breath, wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body

Do not use Daktarin Oral Gel if you have liver disease. There is a slight risk of your symptoms getting worse if you use Daktarin Oral Gel when you have liver problems.

Do not give Daktarin Oral Gel to an infant below the age of 6 month. The safety of this medicine in infants under 6 months of age has not been established.

Do not use Daktarin Oral Gel if you are taking any of the following medicines because it may affect the way these medicines work:

• cisapride (used for digestive problems)
• simvastatin or lovastatin (used to lower your cholesterol)
• certain medicines used to relieve anxiety or to help you sleep (midazolam or triazolam)
• pimozide (used to treat mental disorders)
• quinidine (used to treat irregular heart beats).

Do not take Daktarin Oral Gel if:

• the packaging is torn or shows signs of tampering.
• the expiry date (month and year) printed on the pack has passed. If you take it after the expiry date it may not work.

Before you start to use it

Tell your doctor or pharmacist if you are pregnant or breast-feeding. Your doctor or pharmacist will advise whether you should use Daktarin Oral Gel.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Daktarin Oral Gel or may affect how well Daktarin Oral Gel works. You may need different amounts of your medicines, or you may need to take different medicines. Examples of these medicines are:

• medicines which slow blood clotting (warfarin or other anticoagulants) because bleeding or bruising may occur
• medicines used to treat AIDS, such as saquinavir
• medicines used to treat cancer, such as docetaxel.
• certain calcium channel blockers (used to treat high blood pressure or heart problems) such as verapamil and bepridil.
• Cyclosporine, tacrolimus and sirolimus which are medicines usually given after an organ transplant to prevent organ transplant rejection
• certain medicines taken by mouth for diabetes such as tolbutamide, tolazamide, glipizide and glimepiride.
• medicines for epilepsy (phenytoin or carbamazepine)
• alfentanil (used in surgery for pain relief and to help anaesthesia)
• sildenafil (used to treat male impotence)
• medicines for anxiety or to help you sleep (tranquillisers) such as triazolam.
• medicines used to treat tuberculosis
• methylprednisolone (given by injection to reduce inflammation).
• ergot alkaloids (used to treat migraine)
• disopyramide (used to treat unusual heart beat)
• halofantrine (used to treat malaria).

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Daktarin Oral Gel.

How to use DAKTARIN Oral Gel

How to use it

Opening Instructions:

1. Unscrew the cap.
2. Reverse the cap and push it firmly into the neck of the tube to fully puncture the safety seal.

Note: Use the spoon provided for accurate measurements.

Follow these steps to ensure you use Daktarin Oral Gel properly.

After you have finished eating, drop the measured amount of gel on to the tongue and keep it in the mouth for as long as possible before swallowing. The gel is sticky to make sure it stays in the mouth as long as possible.

If you are giving the gel to infants and young children the measured dose should be given in small amounts placed in the front of the mouth. Do not give the whole amount at once. Do not put the gel in the back of the mouth. This is to make sure that the throat does not become blocked by the gel.

How much to use

Usual dose:

Unless otherwise directed by your doctor or pharmacist, use the following quantities of Daktarin Oral Gel:

Adults and children 2 years of age and older: Half (1/2) a spoonful four times a day.

Infants (6-24 months): One quarter (1/4) of a spoonful four times a day.

How long to use it

Continue treatment for at least a week after symptoms have disappeared. This is to ensure that the treatment is complete.

If you forget to use it

If you forget to use Daktarin Oral Gel, do so as soon as you remember, and then go back to using it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the one you missed.

If you have problems remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

If you have swallowed too much Daktarin Oral Gel, contact your doctor or pharmacist or the Poisons Information Centre who will advise you what to do.

You can contact the Poisons Information Centre by dialling:

• Australia: 13 11 26
• New Zealand: 0800 POISON or 0800 764 766

You may experience nausea, vomiting and diarrhoea. If you do, you may need to take a preparation to replace the water and minerals, which are lost during vomiting and diarrhoea.

While you are using DAKTARIN Oral Gel

Things you must do

• Wash and dry the measuring spoon after use.
• If you wear dentures, as well as applying Daktarin Oral Gel to the mouth, apply a thin layer of the Gel to the dentures in the evening and leave it on overnight. Make sure you wash your dentures before putting them back in, in the morning.
• Avoid contact with eyes.

Things you must not do

Do not use this medicine to treat any other complaints unless your doctor tells you to.

Do not give it to anyone else, even if their condition seems similar to yours.

Thing to be careful of

Be careful driving or operating machinery until you know how Daktarin Oral Gel affects you. It may cause difficulty in focusing in some people.

Side Effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects.

Daktarin Oral Gel may have some unwanted side effects in a few people, even though it is usually well tolerated at the recommended dose.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor if any of the following symptoms happen and they worry you:

• nausea
• vomiting
• diarrhoea
• loss of appetite
• generally feeling unwell
• chills

Tell your doctor immediately if you notice any of the following:

• yellowing of the skin and eyes
• fever
• dark coloured urine
• severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.

Tell your doctor immediately and do not take your next dose of Daktarin Oral Gel if you experience:

• signs of allergy such as skin rash, reddening, blisters or itching, swelling of the face, lips or other parts of the body, shortness of breath or wheezing

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

Storage

• Keep your Daktarin Oral Gel in a cool dry place where the temperature stays below 30°C.
• Do not store it, or any other medicine in the bathroom or near a sink.

Heat and dampness can destroy some medicines.

• Keep it where young children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

• Medicines cannot be stored indefinitely. Do not use Daktarin Oral Gel beyond the date (month and year) printed on the pack after the letters "EXP", even if it has been stored properly.

Disposal

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

Daktarin Oral Gel is a white, jelly-like substance with an orange flavour. It comes in two tube sizes containing 15 grams or 40 grams of the gel. The tube and a 5 mL measuring spoon are included in the carton.

Ingredients

DAKTARIN Oral Gel contains 20 milligrams of miconazole in each gram. It also contains:

• Glycerol
• purified water
• potato starch
• ethanol
• polysorbate 20
• sodium saccharin
• cocoa flavour and orange flavour.

Sponsor

JANSSEN-CILAG Pty Ltd
1-5 Khartoum Road
North Ryde NSW 2113 Australia

Telephone: (02) 8875 3333 or Toll Free 1800 226 334

NZ Office: Auckland, New Zealand

Telephone: 0800 800 806

The Australian Registration Number is AUST R 13287.

This leaflet was prepared in February 2006.

Published by MIMS January 2007

1 Name of Medicine

Miconazole.

2 Qualitative and Quantitative Composition

Daktarin Oral Gel contains miconazole base 2% - white homogenous gel with orange taste. It also contains glycerol, purified - water, pregelatinised potato starch, ethanol, polysorbate 20, saccharin sodium, cocoa flavour, orange flavour.

3 Pharmaceutical Form

A white, microcrystalline powder, practically insoluble in water and slightly soluble in polyethoxylated castor oil (Cremophor EL) (1%) and ethanol (10%).

4 Clinical Particulars

4.1 Therapeutic Indications

Daktarin Oral Gel is indicated for the treatment of clinically significant oral candidiasis.

4.2 Dose and Method of Administration

Adults and children 2 years of age and older.

Infants (6-24 months).

4.3 Contraindications

Daktarin Oral Gel is contraindicated in the following situations:
In patients with a known hypersensitivity to miconazole or to any of the other ingredients of the gel or other imidazole derivatives.
In infants less than 6 months of age or in those whose swallowing reflex is not yet sufficiently developed.
In patients with liver dysfunction.
Co-administration of the following drugs that are subject to metabolism by CYP3A4 (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions):
Substrates known to prolong the QT interval, e.g. astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine.
Ergot alkaloids.
HMG-CoA reductase inhibitors such as simvastatin and lovastatin.
Triazolam and oral midazolam.
Use of miconazole oral gel in combination with the following drug that is subject to metabolism by CYP2C9 (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions):
Coumarin anticoagulants such as warfarin.

4.4 Special Warnings and Precautions for Use

Administration of Daktarin Oral Gel has been shown to induce mild side effects (see Section 4.8 Adverse Effects (Undesirable Effects)) but no haematological or biochemical abnormalities have been reported.
Prolonged use of miconazole may result in superinfection from non-susceptible organisms. If superinfection occurs, the sensitivity of the organism should be determined to decide the most appropriate therapy.
Miconazole is systemically absorbed and is known to inhibit CYP2C9 and CYP3A4 (see Section 5.2 Pharmacokinetic Properties) which can lead to prolonged effects of warfarin. Bleeding events, some with fatal outcomes, have been reported with concurrent use of miconazole oral gel and warfarin (see Section 4.3 Contraindications).
It is advisable to monitor miconazole and phenytoin levels, if they are used concomitantly.
In patients using certain oral hypoglycaemic such as sulfonylureas, an enhanced therapeutic effect leading to hypoglycaemia may occur during concomitant treatment with miconazole and appropriate measures should be considered (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Oral Gel (see Section 4.8 Adverse Effects (Undesirable Effects)). If a reaction suggesting sensitivity should occur, treatment should be discontinued.
Serious skin reactions (e.g. Toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported in patients receiving Daktarin Oral Gel (see Section 4.8 Adverse Effects (Undesirable Effects)). It is recommended that patients be informed about the signs of serious skin reactions, and that the use of Daktarin Oral Gel be discontinued at the first appearance of skin rash.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

When using any concomitant medication, consult the corresponding label for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.
Oral miconazole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 (see Section 4.3 Contraindications):
Substrates known to prolong the QT-interval for example, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; ergot alkaloids; HMG-CoA reductase inhibitors such as simvastatin and lovastatin; triazolam and oral midazolam.
Miconazole oral gel is contraindicated with the co-administration of the following drug that is subject to metabolism by CYP2C9 (see Section 4.3 Contraindications):
Warfarin.
When co-administered with oral miconazole, the following drugs must be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse effects. If necessary, reduce their dosage and, where appropriate, monitor plasma levels:
Drugs subject to metabolism by CYP2C9 (see Section 4.4 Special Warnings and Precautions for Use); oral hypoglycemics such as sulfonylureas (CYP2C9); phenytoin.
Other drugs subject to metabolism by CYP3A4:
HIV protease inhibitors such as saquinavir; certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel; certain calcium channel blockers such as dihydropyridines and verapamil; certain immunosuppressive agents: cyclosporine, tacrolimus, sirolimus (rapamycin); others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil, and trimetrexate.
Antagonism between miconazole and amphotericin B has been reported in vitro and in vivo. In this study miconazole and amphotericin combination were shown to be antagonistic in antifungal activity against Candida albicans.

4.6 Fertility, Pregnancy and Lactation

(Category A)
Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin Oral Gel during pregnancy should always be weighed against the expected therapeutic benefits.
There is no information whether miconazole or its metabolites are excreted in breast milk. Therefore, miconazole is not recommended for nursing mothers unless its use is considered essential or alternative feeding arrangements can be made for the baby.

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Daktarin does not affect the alertness. However, it may affect the ability to focus the eyes. Patients should be warned not to drive or operate machinery if affected.

4.8 Adverse Effects (Undesirable Effects)

In a randomized, active-controlled, open-labelled trial of 47 paediatric patients, 0-10.7 years of age with oral candidiasis due to various predisposing conditions, efficacy and safety of Daktarin Oral Gel were compared to nystatin suspension. The adverse drug reactions reported for ≥ 1% of patients in either treatment group are presented in Table 1. Patients were examined daily, and treatment was continued for 3 days after symptoms had disappeared.
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of miconazole based on the comprehensive assessment of the available adverse event information. A causal relationship with miconazole cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of Daktarin Oral Gel was evaluated in 88 adult patients with oral candidiasis or oral mycoses who participated in one randomized, active controlled, double blind clinical trial and three open label clinical trials. These patients took at least one dose of Daktarin Oral Gel and provided safety data.
Adverse reactions reported by Daktarin Oral Gel treated adult patients in the four clinical trials are shown in Table 2.
The safety of Daktarin Oral Gel was evaluated in 23 pediatric patients with oral candidiasis who participated in one randomized, active controlled, open label clinical trial in pediatric patients aged ≤ 1 month to 10.7 years. These patients took at least one dose of Daktarin Oral Gel and provided safety data.
Adverse reactions reported for Daktarin Oral Gel treated pediatric patients in the one clinical trial are presented in Table 3.

Postmarketing data.

Immune system disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Hepatobiliary disorders.

Skin and subcutaneous tissue disorders.

General disorders.

Reporting suspected adverse effects.

4.9 Overdose

In the event of accidental dosage, vomiting and diarrhoea may occur. Accidental ingestion of large quantities of Daktarin may have clinically relevant implications for patients concomitantly using medication metabolised by cytochrome P450 subsystems 3A4 and/or 2C9 (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Treatment of overdose is symptomatic and supportive. A specific antidote is not available. For the latest treatment advice, contact the Poisons Information Centre on 131126 in Australia or 0800 764 766 in New Zealand.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Daktarin Oral Gel supplied in 15 g and 40 g tubes each with a measuring spoon.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Chemical name.

Chemical formula.

MW.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacy Medicine (S3).

Summary Table of Changes