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DAKTARIN SUGAR FREE 2% ORAL GEL

Active substance(s): MICONAZOLE / MICONAZOLE / MICONAZOLE

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CRR:227331
Ref: AW_125661
06 April 2017
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GB - AW_125661

miconazole

Sugar Free

2% ORAL GEL

■ This medicine is used to treat fungal and bacterial infections of the mouth and throat.
■ This medicine is for use by adults, children and infants aged 4 months and over.
■ Do not take this medicine:
■ Some people should not use this medicine. To find out if you are one of them See Section 2 c
■ 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)
■ Speak to your doctor:
■ If you suffer from any of the conditions mentioned in section 2. See Section 2 c
■ If you are taking any other medicines. See Section 2 c
■ Follow the dosage instructions carefully. Children of different ages and adults need different amounts.
These are shown in the dosage table. See Section 3 c
■ If you are giving the gel to a child or infant, ensure that the gel does not become a choking hazard by
making sure you place the gel at the front of the mouth. See Section 3 c
Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1 What the medicine is for

Daktarin Sugar Free 2% Oral Gel is a medicine which is used to treat fungal and bacterial infections of the
mouth and throat. The gel contains miconazole which works by destroying the fungus and associated
bacteria which may be present.
This medicine is for use in adults, children and infants aged 4 months and over.

2 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.
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.

Do not use this medicine…




■ 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)
■ Quinidine and dofetilide (type of drugs used to treat irregular heart beat).
■ 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 sideeffects’.
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.



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

Some of the ingredients can cause problems



3 How to use this medicine

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.





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 amount 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.
turn over c

How to apply the gel









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If you forget to take a dose, take the next dose when needed. Do not take a double dose.

If you forget to take the medicine

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

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

Dose

Apply 2,5 ml gel (½ measuring spoon) to the affected area four times
a day after meals.

Adults and children
aged 2 years and over

Adults and children aged 2 years and over

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.

Apply 1,25 ml gel (¼ measuring spoon) to the affected area four times a
day after meals.

Age









Infants and children
4 months - 2 years old

Infants and children 4 months – 2 years old
Dose
Age

Do not use in infants less than 4 months old.

Infants under 4 months old

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.















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.

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

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 effects which may occur include:









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

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.

4 Possible side-effects

17-0193
GB - AW_125661

Daktarin Sugar Free 2% Oral Gel is a white gel with an orange flavour available in tubes of 15 g.
Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG,UK.
Manufacturer: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
This leaflet was revised April 2017.
Daktarin is a registered trade mark.

What the medicine looks like

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.

What’s in this medicine?

6 Further information

Store below 30ºC.
Keep the product out of the sight and reach of children.
Do not use after the date shown as the expiry date on the packaging.
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 to protect the environment.

5 Storing this medicine

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
By reporting side effects you can help provide more information on the safety of this medicine.

Reporting of side-effects

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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