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DAKTARIN CREAM

Active substance: MICONAZOLE NITRATE

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Package leaflet: Information for the user

© J-C 2013

GB - AW_85890

cream
Miconazole nitrate
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 cream is and what
it is used for
2 Before you use Daktarin cream
3 How to use Daktarin cream
4 Possible side effects
5 How to store Daktarin cream
6 Further information

1 What Daktarin cream is and what it is used for
The name of your medicine is Daktarin
cream.
Daktarin cream contains a medicine called
miconazole. This belongs to a group of
medicines called ‘antifungals’.

Daktarin cream is used for infections of the
skin or nails caused by fungi including
yeasts, and some bacteria. Infections may
appear on the:
• Trunk
• Hands or feet
• Scalp or outer ear
• Groin
Daktarin cream works by destroying the
fungus and associated bacteria which may
be present.

2 Before you use Daktarin cream
Do not use Daktarin cream:

• If you are allergic to anything in Daktarin
cream (listed in section 6 below)
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 cream.

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 tell your doctor if you are taking:
• Medicines to thin the blood
(anticoagulants) such as warfarin.
Your doctor may check that the
anticoagulant is working properly

Pregnancy and breast-feeding
Please tell your doctor before using
Daktarin cream if you are pregnant,
think you may be pregnant or might
become pregnant.

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

• Daktarin cream contains benzoic acid
(E210). This can irritate your eyes,
eyelids, mouth and nostrils if it comes into
contact with them
• Daktarin cream also contains butylated
hydroxyanisole (E320). This can cause
local skin reactions (e.g. contact
dermatitis), or irritation to the eyes and
mucous membranes

3 How to use Daktarin cream
Always use Daktarin cream exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.

Using the cream

• Each tube of Daktarin cream is sealed.
You will need to use the cap to pierce
the seal
• Rub the cream gently into the affected
area and surrounding skin with clean
fingers
• Do not put Daktarin cream into or near
the eyes - it is for use on the skin and
nails only
• Do not swallow the cream

For skin infections

• Use the cream twice a day - once in the
morning and again at night. Keep using
the cream for at least 7 days after all
signs of infection have gone away.
This will stop the infection from coming
back.

For nail infections

• Use the cream once or twice a day.
Your doctor will tell you which one. Keep
using the cream for 10 days after all signs
of infection have gone away. This will stop
the infection from coming back.

Personal hygiene

• Unless the affected skin is on your hands,
wash your hands with soap and water
after using the cream
• Washing your hands after using the
cream will stop you spreading the
infection to other parts of your body or to
other people
• Do not allow other people to use your
flannel or towel. This will stop them from
getting your infection
• Clothing that touches infected skin should
be washed and changed often. Daktarin
cream is non-greasy and should not stain
clothes

If you swallow Daktarin cream

If you swallow any cream, talk to a doctor
or go to the nearest hospital casualty
department straight away.

If you forget a dose

• Do not apply the missed dose of cream
• Apply the next dose of cream as usual
and keep using the cream as your doctor
has told you
• Do not use a double dose of cream
to make up for a missed dose
If you have any further questions on the
use of this product, ask your doctor
or pharmacist.

4 Possible side effects
Like all medicines, Daktarin cream can
cause side effects, although not everybody
gets them.
Stop using Daktarin cream and tell your
doctor straight away if you notice the
following. You may need medical
treatment.
Very rare (affects less than 1 in
10,000 people)
• Sudden swelling of the face or throat.
Hives (also known as nettle rash or
urticaria), difficulty breathing, severe
irritation, reddening or blistering of your
skin. These may be signs of a severe
allergic reaction

AW_85890.pdf - Page 1 of 3 - May 15, 2013 - 10:51:20

Tell your doctor or pharmacist if you
notice any of the following side effects:
Very rare (affects less than 1 in 10,000
people)
• Burning sensation, itching, redness,
or rash on the skin
Rare side effects (affects less than 1 in
1,000 people)
• Local irritation of the treated area. This is
much milder than an allergic reaction
If you get any of these side effects, or other
side effects not listed in this leaflet, tell your
doctor or pharmacist straight away.

© J-C 2013

GB - AW_85890

5 How to store Daktarin cream
Keep out of the reach and sight of children.
Store the cream in its original packaging.
Do not store above 25°C.
Do not use Daktarin cream 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 cream
is miconazole nitrate. Each gram (g) of
Daktarin cream contains 20 milligrams (mg)
of miconazole nitrate (2 % w/w).
The other ingredients are water, PEG-6,
PEG-32 and glycol stearate, oleoyl
macroglycerides, liquid paraffin, benzoic
acid (E210) and butylated hydroxyanisole
(E320).

What Daktarin cream looks like and
contents of the pack

Daktarin cream comes in a tube containing
30 g of a white cream.

The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe,
Buckinghamshire, HP12 4EG, UK
Daktarin cream is made by:
Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse,
Belgium
OR
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 May 2013.

AW_85890.pdf - Page 2 of 3 - May 15, 2013 - 10:51:20

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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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