Skip to Content

CLOTRIMAZOLE CREAM 1%

Active substance(s): CLOTRIMAZOLE

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

Clotrimazole 1% Cream
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
• Always use this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your symptoms
worsen or do not improve.
• 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 Clotrimazole is and what it is used for
2. What you need to know before you use
Clotrimazole
3. How to use Clotrimazole
4. Possible side effects
5. How to store Clotrimazole
6. Contents of the pack and other information

1. What Clotrimazole is and what it is
used for

The active substance is clotrimazole.
Clotrimazole belongs to a group of medicines
called imidazoles and is an antifungal agent
which fights the cause of fungal skin infections.
Clotrimazole is used to treat fungal skin
infections such as ringworm, athlete’s foot,
fungal nappy rash and fungal sweat rash. It
is also used to relieve irritation of the vulva
(external thrush) or the end of the penis, which
may be associated with thrush.
When Clotrimazole is applied to the infected
area of skin it works by destroying the fungus or
yeast which has caused the infection.
If you are unsure whether you (or your baby if
treating nappy rash) have one of these fungal
skin infections, seek the advice of your doctor
or pharmacist.

2. What you need to know before you
use Clotrimazole
Do not use Clotrimazole:

• if you (or your baby if treating nappy rash)
are allergic to clotrimazole or any of the
other ingredients of this medicine (listed in
section 6).

Description Clotrimazole 1% 20g,50g

Talk to your doctor
or pharmacist before
using Clotrimazole if you have used a cream
containing clotrimazole or a similar medicine
before and suffered an allergic or unpleasant
skin reaction. This may have been a skin rash or
itching in the area the cream was applied.

Other medicines and Clotrimazole

Tell your doctor or pharmacist if you are taking
or have recently taken any other medicines,
including medicines obtained without a
prescription.
Clotrimazole is not known to interact with any
other medicines.
As with other creams, Clotrimazole may reduce
the effectiveness of rubber contraceptives, such
as condoms or diaphragms. Consequently, if
you are using this cream on the vulva or penis,
you should use alternative precautions for at
least five days after using this product.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you
may be pregnant or are planning to have a
baby, tell your doctor, midwife or pharmacist
before using Clotrimazole. If you have informed
your doctor or midwife already, follow his/her
instructions carefully.

Driving and using machines

Clotrimazole will not affect your ability to drive
or operate machinery.

Clotrimazole contains cetostearyl alcohol

This medicine contains cetostearyl alcohol
which may cause local skin reactions (e.g. rash,
itching or redness).

3. How to use clotrimazole

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.
If you purchased this product without a
prescription, follow these directions closely.
• Before use, pierce the tube seal by inverting
the cap over the end of the tube and press.
• If the feet are infected, they should be washed
and dried thoroughly, especially between the
toes, before applying the cream.
• Clotrimazole should be applied thinly and
evenly to the affected areas, two or three
times daily and rubbed in gently.
• A strip of cream (½ cm long) is enough to treat
an area of about the size of the hand.
• The duration of the treatment depends upon
the type of infection. Use the cream for at least
two weeks for candida (thrush) infections or at
least one month for other infections.
• If you have athlete’s foot, it may help to use an
antifungal dusting powder as well. Ask your
doctor or pharmacist to recommend one.

Date: 12 APR 2016

Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 866873

SAP No. N/A

Colours

Superceded Affiliate Item Code 574150
TrackWise PR No. 866873
MA No. 04569/0194
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 278562
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Non-Print
Colours

1

Time: 16:08
Page Count

1/2

Black

Text Free
Area

Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 210 mm

Body Text Size 8.5 pt
Min Text Size used 8.5 pt

Sign-offs

v1/May 2015

The symptoms of skin infection such as itching
or soreness, should improve within a few days
of treatment although signs such as redness
and scaling may take longer to disappear. If
symptoms persist, consult your doctor.

Clotrimazole is for external use only.

Do not put the cream in your mouth or
swallow it.
If the cream is swallowed accidentally, tell your
doctor straight away or contact the Accident
and Emergency Department of your nearest
hospital.
If you accidentally get cream in your eyes or
mouth, wash immediately with water and
contact your doctor.

If you forget to use Clotrimazole

Apply the cream as soon as possible, then
continue the rest of your treatment as usual.

If you stop using Clotrimazole

Do not suddenly stop using Clotrimazole as
this may cause the symptoms of the infection
to return.

You can help the treatment to work if you
follow these simple self-help tips:

• Although the infected area will itch, try not to
scratch. Scratching will damage the surface
of the skin and cause the infection to spread
further.
• Keep the affected skin areas clean.
• Pay particular attention to drying the skin, but
avoid excessive rubbing.
• Do not share towels, bath mats, etc. with other
people as you could spread the infection
to them.
• Always wash your hands after treating the
infection to prevent it from spreading.

If you have athlete’s foot:

• Remember to dry the skin between the toes
thoroughly.
• Wash your socks, stockings and tights
thoroughly in hot water to remove any shed
skin or fungal spores.
• Change your footwear daily if possible.
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.
As with all medicines, some people may be
allergic to the cream. If you or your baby are
allergic, a reaction will occur soon after you
start using it. If you or your baby experience an
allergic reaction, stop using Clotrimazole and
tell your doctor straight away or contact the
Accident and Emergency Department of your
nearest hospital. Signs of an allergic reaction
may include:

• Rash
• Swallowing or breathing problems
• Swelling of the lips, face, throat or tongue
• Weakness, feeling dizzy or faint
• Nausea
After you apply the cream you might
experience:
• Itching, rash, blisters, burning, discomfort,
swelling, irritation, redness or peeling of skin.
This may mean that you are allergic to the
cream.

Reporting of side effects

If you or your baby gets 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 clotrimazole

Keep this medicine out of the sight and reach
of children.
Store in a cool dry place.
Do not use this cream after the expiry date
which is stated on the carton after EXP. 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 Clotrimazole contains

The active substance is clotrimazole. Each
gram of cream contains 10 mg of clotrimazole
(i.e. 1% w/w).
The other ingredients are benzyl alcohol,
polysorbate 60, cetyl esters wax, cetostearyl
alcohol (see section 2 “Clotrimazole contains
cetostearyl alcohol”), octyldodecanol, sorbitan
monostearate and purified water.

What Clotrimazole looks like and contents
of the pack

Clotrimazole 1% Cream is a smooth white cream
and is available in tubes of 20g or 50g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL
United Kingdom

Manufacturer

Generics [UK] Limited
Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
This leaflet was last revised in 04/2016.
866873

Description Clotrimazole 1% 20g,50g

Date: 12 APR 2016

Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 866873

SAP No. N/A

Colours

Superceded Affiliate Item Code 574150
TrackWise PR No. 866873
MA No. 04569/0194
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 278562
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Non-Print
Colours

1

Time: 16:08
Page Count

2/2

Black

Text Free
Area

Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 210 mm

Body Text Size 8.5 pt
Min Text Size used 8.5 pt

Sign-offs

v1/May 2015

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