Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Daktarin Oral Gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Miconazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
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- Keep this leaflet. You may need to read it again
- If you have any further questions, ask your doctor or pharmacist
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
- If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet
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Daktarin oral gel is a medicine which is used to treat fungal infections of the mouth, throat and gullet. The gel contains miconazole which works by destroying the fungus that is present.
This medicine is for use in adults and children aged 4 months and over.
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2 Before you use Daktarin oral gel Do not use Daktarin oral gel:
- If you are allergic to miconazole, any of the other ingredients of this medicine (listed in section 6) or to other similar antifungal medicines
- If you suffer from liver problems
- If it is for an infant under 4 months of age because of risk of choking.
Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Daktarin oral gel.
Take special care with Daktarin oral gel
Daktarin oral gel is sticky. This ensures that it stays in the mouth for as long as possible. If you are giving the gel to a child or infant, 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 your infant is being treated with Daktarin oral gel, and you are breastfeeding, do not apply the gel to your nipple in order to give the gel to your infant.
Blood tests
If you are also taking medicines to thin the blood (anticoagulants, such as warfarin) or if you are taking phenytoin (a medicine for epilepsy), your doctor may want to check the level of the medicines in your body by testing your blood.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
In particular, do not take this medicine and tell your doctor if you are taking any of the following medicines:
- Medicines for hay fever or allergy called terfenadine, astemizole or mizolastine
- Cisapride – for digestive problems
- Medicines to lower cholesterol called lovastatin or simvastatin
- Midazolam (by mouth) or triazolam – for anxiety or to help you sleep
- Pimozide or sertindole – for conditions affecting thoughts, feelings and behaviour
- Medicines for an irregular heart beat called quinidine or dofetilide
- Ergotamine – used to treat migraine. Do not start using Daktarin oral gel and tell your doctor if you are taking any of the above.
Tell your doctor or dentist before taking, or if you are already taking, any of the following medicines:
- Medicines to thin the blood (anticoagulants) such as warfarin.
- Medicines for HIV infection such as saquinivir. They are called 'antiviral protease inhibitors'
- Medicines used in the treatment of cancer such as busulfan, docetaxel and a group of medicines known as 'vinca alkaloids'
- Medicines that act on the heart and blood vessels called 'calcium channelblockers' such as dihydropyridines and verapamil
- Medicines that are usually given after an organ transplant called cyclosporin, tacrolimus or rapamycin. Another name for rapamycin is sirolimus
- Medicines for epilepsy called phenytoin or carbamazepine
- Alfentanil – for pain
- Medicines used for anxiety or to help you sleep (tranquillisers), such as buspirone, alprazolam or brotizolam
- Midazolam – to help you relax or sleep when given into a vein
- Rifabutin – for tuberculosis
- Methylprednisolone – for inflammation (given by mouth or injection)
- Ebastine – for allergy
- Reboxetine – for depression
- Sulphonylureas such as chlorpropamide and glibenclamide (medicines for diabetes taken by mouth)
- Sildenafil – for erection problems
- Trimetrexate – for a type of pneumonia Tell your doctor or dentist before taking, or if you are already taking any of the above. They may need to alter your treatment.
Pregnancy and breastfeeding Please tell your doctor before using Daktarin oral gel if you are pregnant, think you may be pregnant or might become pregnant.
You may still be able to use Daktarin oral gel if your doctor thinks you need to.
Talk to your doctor before using this medicine if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Daktarin oral gel is not likely to affect you being able to drive or use any tools or machines.
Important information about some of the ingredients of Daktarin oral gel
- This medicine contains 23 mg of alcohol (ethanol) in 2.5 ml (1/2 measuring spoon) corresponding to 7.5 mg/g. The amount of 2.5 ml (1/2 measuring spoon) is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. It may cause burning sensation on damaged skin.
- This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
- This medicine contains polysorbate which can cause allergic reactions.
- This medicine contains benzyl benzoate which may cause allergic reactions.
- This medicine contains 2.3 picograms of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions and mild local irritation. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called "gasping syndrome") in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis"). Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis").
How to take it
Daktarin oral gel Always use Daktarin oral gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
How to apply the gel
- Each tube of the gel is sealed – use the cap to pierce the seal
- For oral use only
- Keep the gel in the mouth as long as possible. Do not swallow it straight away
- If the infection is just in the mouth, apply directly to the affected area with a clean finger
- If you are wearing dentures, remove them at bedtime and rub them with the gel. This helps stop your dentures becoming infected too
- Do not use more than the stated dose
- Use after meals
- If you are giving the gel to a child or infant aged 4 months or over, make sure that the gel does not become a choking hazard by making sure you place the gel at the front of the mouth
When to stop using Daktarin oral gel
Keep using the gel for at least a week after all the symptoms have gone away. This will stop the symptoms from coming back.
If you forget a dose
- Do not apply the missed dose of gel
- Apply the next dose of gel as usual and keep using it as your doctor has told you
- Do not use a double dose of gel to make up for a missed dose
If you use more Daktarin oral gel than you should
If you use more Daktarin oral gel than you were told to or if someone else has taken any, talk to a doctor or go to the nearest hospital casualty department straight away.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
How much gel to use
Your doctor will tell you how much Daktarin oral gel to take and for how long you should take it. Your doctor will probably suggest the following treatment course: Infections of the mouth and throat:
- Adults and children over 2 years: 2.5 ml (half a 5 ml spoonful) of gel applied four times a day after food.
- Infants 4 months – 2 years: 1.25 ml (one quarter of a 5 ml spoonful) of gel applied four times a day after food. Each application should be divided into smaller portions. If the infant is 4-6 months old, and is premature or has slow development, check with your doctor before using this medicine If symptoms persist, talk to your doctor.
Possible side effects
Like all medicines, Daktarin oral gel can cause side effects, although not everybody gets them. Stop using Daktarin oral gel and tell your doctor straight away if you notice the following. You may need medical treatment.
- Sudden swelling of the face, lips, tongue or throat; difficulty swallowing; hives (also known as nettle rash or urticaria) and breathing difficulties (angioedema, anaphylactic reactions); severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction.
- Severe skin disorders with peeling and/or rashes with small pus-containing pimples (with a fever) or blistering of your skin, mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson Syndrome)
- Light headedness, generalised itch, wheezing or difficulty breathing.
- If you are taking medicines to thin the blood (anticoagulants), such as warfarin: unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit.
- An allergic skin reaction, that may include round or oval patches of redness and swelling of the skin, blistering, and itching (Fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is taken again (Frequency unknown).
Other side effects which may occur: Common (affects 1 to 10 users in 100)
- Dry mouth
- Feeling sick (nausea)
- Being sick (vomiting)
- Mouth discomfort
- Regurgitation
- Product tastes abnormal
Uncommon (affects 1 to 10 users in 1,000)
- Loss or abnormal sense of taste
The following side effects were also seen in a small number of patients
- Choking
- Diarrhoea
- Inflammation of the liver (hepatitis)
- Sore mouth
- Tongue discolouration
- Rash with pus filled pimples/blisters (acute generalised exanthematous pustulosis)
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 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.
How to store it
Daktarin oral gel Keep out of the reach and sight of children.
Store the gel in its original packaging. Do not store above 30°C.
Do not use Daktarin oral gel after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
After first opening, discard once the treatment for one episode of fungal infection is completed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6 Further information The active substance in Daktarin oral gel is miconazole. Each gram (g) of Daktarin oral gel contains 20 milligrams (mg) of miconazole.
The other ingredients are glycerol, ethanol, carbomers, polysorbate 20 (E432), saccharin sodium (E954), sodium hydroxide, cocoa flavour (contains ethanol, benzyl alcohol and benzyl benzoate), orange flavour and water.
What Daktarin oral gel looks like and contents of the pack
Daktarin oral gel comes in an aluminium tube containing 80 g of a white, sugar-free gel with an orange flavour. A 5 ml plastic spoon, marked with 1⁄4 and 1⁄2 graduations (1.25 & 2.5 ml) is provided.
The product licence is held by: McNeil Products Limited 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
The manufacturer is: JNTL Consumer Health (France) SAS, Domaine de Maigremont, 27100 Val De Reuil, France. This leaflet was last revised in September 2025
Frequently asked questions about Daktarin Oral Gel
How do I take Daktarin Oral Gel?
Daktarin Oral Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Daktarin Oral Gel?
The active substance in Daktarin Oral Gel is miconazole.
Are there equivalent medicines to Daktarin Oral Gel?
Medicines with the same active substance, strength and form include: Daktarin Sugar Free 2% Oral Gel. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Daktarin Oral Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Daktarin Oral Gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: miconazole
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Oral treatment of candidosis of the oropharynx.
Miconazole gel is for use in adults, children and infants 4 months and older.
4.2. Posology and method of administration
For oral administration.
The provided measuring device is equivalent to 122 mg for 5 ml.
Oropharyngeal candidosis
Infants: 4-24 months: 1.25 mL (1/4 measuring spoon) of gel, applied four times a day after meals. Each dose should be divided into smaller portions and the gel should be applied to the affected area(s) with a clean finger. The gel should not be applied to the back of the throat due to possible choking. The gel should not be swallowed immediately, but kept in the mouth as long as possible.
Adults and children 2 years of age and older: 2.5 mL (1/2 measuring spoon) of gel, applied four times a day after meals.
The gel should not be swallowed immediately, but kept in the mouth as long as possible.
The treatment should be continued for at least a week after the symptoms have disappeared.
For oral candidosis, dental prostheses should be removed at night and brushed with the gel.
4.3. Contraindications
Known hypersensitivity to miconazole, other imidazole derivatives or to any of the excipients listed in section 6.1.
In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed (see section 4.4)
In patients with liver dysfunction.
Coadministration of the following drugs that are subject to metabolism by CYP3A4: (See Section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction)
- Substrates known to prolong the QT-interval e.g. astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine
- Ergot alkaloids
- HMG-CoA reductase inhibitors such as simvastatin and lovastatin
- Triazolam and oral midazolam
4.4. Special warnings and precautions for use
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 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction and section 4.8 Undesirable effects).If the concomitant use of Daktarin Oral Gel with an oral anticoagulant such as warfarin is planned, caution should be exercised and the anticoagulant effect must be carefully monitored and titrated (see section 4.5).
Patients should be advised that if they experience unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit, to stop treatment with miconazole and seek medical advice.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin and with other miconazole formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
It is advisable to monitor miconazole and phenytoin levels, if these two drugs are used concomitantly.
In patients using certain oral hypoglycaemics such as sulphonylureas, 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 Medicinal Products and Other Forms of Interaction).
Choking in infants and young children
Particularly in infants and young children (aged 4 months – 2 years), caution is required, to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat. Each dose should be divided into smaller portions and applied into the mouth with a clean finger. Observe the patient for possible choking. Also due to the risk of choking, the gel must not be applied to the nipple of a breast-feeding woman for administration to an infant.
It is important to take into consideration the variability of the maturation of the swallowing function in infants, especially when giving miconazole gel to infants between the ages of 4-6 months. The lower age limit should be increased to 5-6 months of age for infants who are pre-term, or infants exhibiting slow neuromuscular development.
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). It is recommended that patients be informed about the signs of serious skin reactions, and that use of Daktarin Oral Gel be discontinued at the first appearance of skin rash.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
This medicine contains 23 mg of alcohol (ethanol) in each 2.5 ml dose corresponding to 7.5 mg/g. The amount in each 2.5 ml dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains benzyl benzoate which may cause allergic reactions.
This medicine contains 2.3 picograms of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions and mild local irritation. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor. Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
This medicine contains polysorbate which can cause allergic reactions.
4.5. Interaction with other medicinal products and other forms of interaction
When using any concomitant medication the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised 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 coadministration of the following drugs that are subject to metabolism by CYP3A4 (See Section 4.3 Contraindications);
• Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine
• Ergot alkaloids
• HMG-CoA reductase inhibitors such as simvastatin and lovastatin
• Triazolam and oral midazolam
When coadministered with oral miconazole the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse events. If necessary, their dosage should be reduced and, where appropriate, plasma levels monitored:
Drugs subject to metabolism by CYP2C9 (see Section 4.4 Special warnings and precautions for use);
• Oral anticoagulants such as warfarin,
• Oral hypoglycaemics such as sulphonylureas
• 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: cyclosporin, tacrolimus, sirolimus (= rapamycin)
• Others: carbamazepine, cilostazol, disopyramide, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.
4.6. Fertility, pregnancy and lactation
In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Daktarin Oral Gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits.
It is not known whether miconazole is excreted in human milk. Caution should be exercised when prescribing Daktarin Oral Gel to nursing mothers.
4.7. Effects on ability to drive and use machines
Daktarin should not affect alertness or driving ability.
4.8. Undesirable effects
The safety of Daktarin Oral Gel was evaluated in 111 patients with oral candidiasis or oral mycoses who participated in 5 clinical trials. Of these 111 patients, 88 were adults with oral candidiasis or oral mycoses who participated in 1 randomised, active‑controlled, double-blind clinical trial and 3 open‑label clinical trials. The other 23 patients were paediatric patients with oral candidiasis who participated in 1 randomised, active‑controlled, open‑label clinical trial in paediatric patients (aged ≤1 month to 10.7 years). These patients took at least one dose of Daktarin Oral Gel and provided safety data.
Based on the pooled safety data from these 5 clinical trials (adult and paediatric), the most commonly reported (≥1% incidence) adverse reactions were nausea (6.3%), product taste abnormal (3.6%), vomiting (3.6%), oral discomfort (2.7%), regurgitation (1.8%), and dry mouth (1.8%). Dysgeusia was reported in 0.9% of patients.
Adult Patients
Based on the pooled safety data from the 4 clinical trials in adults, common adverse reactions reported included nausea (4.5%), product taste abnormal (4.5%), oral discomfort (3.4%), dry mouth (2.3%), dysgeusia (1.1%), and vomiting (1.1%).
Paediatric Patients
In the 1 paediatric clinical trial, the frequency of nausea (13.0%) and vomiting (13.0%) was very common, and regurgitation (8.7%) was common. As identified through post-marketing experience, choking may occur in infants and young children (See Section 4.3 Contraindications and Section 4.4 Special Warnings and Special Precautions). The frequency, type, and severity of other adverse reactions in children are expected to be similar to that in adults.
Description of selected adverse reactions
Increases in INR and bleeding events such as epistaxis, contusion, haematuria, melaena, haematemesis, haematoma and haemorrhages have been reported in patients treated with oral anticoagulants such as warfarin in association with miconazole oral gel (see sections 4.4 and 4.5). Some events had fatal outcomes.
Table A includes all identified adverse reactions, including those that that have been reported from post-marketing experience.
The frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).
Table A: Adverse Drug Reactions in Patients Treated with DAKTARIN Oral Gel
System Organ Class
Adverse Drug Reactions
Frequency Category
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Not Known
Immune System Disorders
Anaphylactic reaction, Hypersensitivity
Nervous System Disorders
Dysgeusia
Respiratory, Thoracic and Mediastinal Disorders
Choking
Gastrointestinal Disorders
Dry mouth, Nausea, Oral discomfort, Vomiting, Regurgitation
Diarrhoea, Stomatitis, Tongue discolouration
Hepatobiliary Disorders
Hepatitis
Skin and Subcutaneous Tissue Disorders
Angioedema, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash, Acute generalised exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Fixed drug eruption
General Disorders and Administration Site Conditions
Product taste abnormal
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Symptoms:
In the event of accidental overdose, vomiting and diarrhoea may occur.
Treatment:
Treatment is symptomatic and supportive. A specific antidote is not available.
💬 Ask about this leaflet
Ask anything about Daktarin Oral Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.