DAKTARIN ORAL GEL

Package leaflet: Information for the user

© J-C 2017

GB - AW_125895

oral gel
Miconazole
Daktarin is a registered trademark

Read all of this leaflet carefully
before you start using this
medicine.

• 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
1 What Daktarin oral gel is and what
it is used for
2 Before you use Daktarin oral gel
3 How to use Daktarin oral gel
4 Possible side effects
5 How to store Daktarin oral gel
6 Further information

1 What Daktarin oral gel is and what it is used for
Daktarin oral gel is a medicine which is
used to treat fungal infections of the mouth,
throat, gullet, stomach or gut. 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.

2 Before you use Daktarin oral gel
Do not use Daktarin oral gel:

• 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 channelDo not use this medicine if the above applies
blockers’ such as dihydropyridines and
to you. If you are not sure, talk to your doctor
verapamil
or pharmacist before using Daktarin oral gel. • Medicines that are usually given after
an organ transplant called cyclosporin,
Take special care with Daktarin
tacrolimus or rapamycin. Another name
for rapamycin is sirolimus
oral gel
Daktarin oral gel is sticky. This ensures that • Medicines for epilepsy called phenytoin
or carbamazepine
it stays in the mouth for as long as possible.
• Alfentanil - for pain
If you are giving the gel to a child or infant,
• Medicines used for anxiety or to help you
make sure that the gel does not close off
sleep (tranquillisers), such as buspirone,
the child’s or infant’s throat as they could
alprazolam or brotizolam
choke on it. You should place the gel at the
• Midazolam - to help you relax or sleep
front of the mouth – never put it at the back
when given into a vein
of the throat. If your infant is being treated
• Rifabutin - for tuberculosis
with Daktarin oral gel, and you are breast• Methylprednisolone - for inflammation
feeding, do not apply the gel to your nipple
(given by mouth or injection)
in order to give the gel to your infant.
• Ebastine - for allergy
• Reboxetine - for depression
Blood tests
• Sulphonylureas such as chlorpropamide
If you are also taking medicines to thin the
and glibenclamide (medicines for diabetes
blood((anticoagulants, such as warfarin) or if
taken by mouth)
you are taking phenytoin (a medicine for
• Sildenafil – for erection problems
epilepsy), your doctor may want to check
• Trimetrexate – for a type of pneumonia
the level of the medicines in your body by
Tell your doctor or dentist before taking,
testing your blood.
or if you are already taking any of the above.
They may need to alter your treatment.
• 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.

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.

Pregnancy and breast-feeding

In particular, do not take this
medicine and tell your doctor
if you are taking any of the
following medicines:

You may still be able to use Daktarin oral
gel if your doctor thinks you need to.

• 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.

Please tell your doctor before using
Daktarin oral gel if you are pregnant,
think you may be pregnant or might
become pregnant.

Talk to your doctor before using this
medicine if you are breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

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

• Daktarin oral gel contains small amounts
of ethanol (alcohol), less than 100 mg
per dose.

3 How to use 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

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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 5ml 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.
Infections of the stomach and gut:
• Adults, Children and infants over
4 months: 20 mg per kg of body weight
per day. Divided into four doses a day.
Maximum dose is 10 ml of gel four times
a day.
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.

© J-C 2017

GB - AW_125895

3 How to use Daktarin oral gel (continued)
When to stop using Daktarin
oral gel

If you use more Daktarin oral gel
than you should

If you forget a dose

If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

Keep using the gel for at least a week after
all the symptoms have gone away. This will
stop the symptoms from coming back.
• 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
were told to or if someone else has taken
any, talk to a doctor or go to the nearest
hospital casualty department straight away.

4 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.

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

5 How to store 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.

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.

Daktarin oral gel is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium

The other ingredients are pregelatinised
potato starch, alcohol, polysorbate 20 (E432),
sodium saccharin, cocoa flavour, orange
flavour, glycerol and water.

OR

What Daktarin oral gel looks like
and contents of the pack
Daktarin oral gel comes in a tube
containing 80 g of a white, sugar free gel
with an orange flavour. A 5 ml plastic
spoon, marked with a 2.5 ml graduation
is provided.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe,
Buckinghamshire, HP12 4EG, UK

AW_125895.pdf - Page 2 of 3 - April 11, 2017 - 09:55:46

McGregor Cory Ltd, Middleton Close,
Banbury, OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in April 2017