Skip to Content

DAKTARIN 2% W/W CREAM

Active substance(s): MICONAZOLE NITRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2015
GB-IE - AW_104513

2% w/w cream
Miconazole nitrate
Daktarin is a registered trademark

Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.

• 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 only. Do not pass it on to others.
It may harm them, even if their signs
of illness are the same as yours
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
1 What Daktarin cream is and what it
is used for
2 What you need to know before you
use Daktarin cream
3 How to use Daktarin cream
4 Possible side effects
5 How to store Daktarin cream
6 Contents of the pack and other
information

1 What Daktarin cream is and what it is used for
The name of your medicine is Daktarin 2%
w/w cream. It is called Daktarin cream in
this leaflet.
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 What you need to know before you use Daktarin cream
Do not use Daktarin cream:

• If you are allergic to miconazole, any
of the other ingredients of this medicine
(listed in section 6) or to other similar
antifungal medicines
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.

Warnings and Precautions

Keep this medicine away from your eyes.
If you get any cream in your eyes,
rinse with water straight away. Keep your
eyes open when you rinse.

Other medicines and Daktarin
Cream

Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines. This includes
medicines that you buy without a
prescription or herbal medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before using this medicine.
You may still be able to use Daktarin cream
if your doctor thinks you need to.

Driving and using machines

Daktarin cream is not likely to affect you
being able to drive or use any tools or
machines.

Daktarin cream contains

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

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

3 How to use Daktarin cream
Always use this medicine exactly as
described in this leaflet or as your doctor or
pharmacist has told you. 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 to use Daktarin
cream

• Do not apply the forgotten 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 forgotten dose
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4 Possible side effects
Like all medicines, this medicine 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)
• Swelling of the face, tongue or throat,
difficulty swallowing or difficulty breathing.
• Hives (also known as nettle rash or
urticaria), severe irritation, reddening or
blistering of your skin. These may be
signs of a severe allergic reaction

AW_104513.pdf - Page 1 of 3 - March 9, 2016 - 15:17:49

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 (affects less than 1 in 1,000 people)
• Local irritation of the treated area. This is
much milder than an allergic reaction

Reporting of side effects

If you get any side effects, talk to your
doctor or pharmacist. 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.

© J-C 2015

GB-IE - AW_104513

5 How to store Daktarin cream
Keep this medicine out of the sight and
reach of children.
Store the cream in its original packaging.
Do not store above 25°C.
Do not use this medicine after the expiry
date which is stated on the carton and
tube. The expiry date refers to the last day
of that month.

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other information
What Daktarin cream contains

The active substance 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.

Marketing Authorisation Holder:
Janssen-Cilag Ltd., 50-100 Holmers Farm
Way, High Wycombe, Buckinghamshire,
HP12 4EG, UK
Manufacturer: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 March 2016.

AW_104513.pdf - Page 2 of 3 - March 9, 2016 - 15:17:49

Expand view ⇕

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.

Hide