TERBINAFINE HYDROCHLORIDE 1 % CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

TERBINAFINE HYDROCHLORIDE 1% CREAM
Read all of this leaflet carefully before you start to use Terbinafine Hydrochloride 1% Cream
• Keep this leaflet in case you want to refer to it again.
• If you want to know more about your medicine or have any questions, you should 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 any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
Terbinafine hydrochloride 1% cream will be referred to as Terbinafine Cream throughout this leaflet.
In this leaflet:
1. What Terbinafine cream is and what it is
used for
2. Before you use Terbinafine cream
3. How to use Terbinafine cream
4. Possible side effects
5. How to store Terbinafine cream
6. Further information
1.

WHAT TERBINAFINE CREAM IS AND
WHAT IT IS USED FOR

Terbinafine cream belongs to a group of
medicines called antifungals which are used to
treat fungal infections, especially of the skin. It
can be used in the treatment of infections, such
as Athlete’s foot, ringworm, itchy rash of the
groin and fungal infections of the skinfolds
(intertrigo).
2.

BEFORE YOU USE TERBINAFINE
CREAM

Do NOT use Terbinafine cream if:
• you are allergic (hypersensitive) to
terbinafine hydrochloride or any of the other
ingredients of the cream (listed in Section 6
Further Information)
• you are under 16 years of age
• you are breast-feeding.
Pregnancy and breast-feeding
If you are pregnant or trying for a baby, tell your
doctor before using the cream. If you have
already informed your doctor, follow his/her
instructions carefully. Do not use Terbinafine
cream if you are breastfeeding.
Driving and using machines
Using Terbinafine cream does not affect your
ability to drive or use machinery.

Important information about some of the
ingredients of Terbinafine cream.
The cream contains cetyl alcohol and steryl
alcohol, which may cause local skin reactions
(e.g. contact dermatitis).
3.

HOW TO USE TERBINAFINE CREAM

Take special care with Terbinafine cream as:
• your Terbinafine cream is for external use
only and should not be put in the mouth or
swallowed. If swallowed accidentally, seek
medical advice immediately and take this
leaflet with you.
• you must keep the cream away from your
eyes. If the cream gets in your eyes wipe
the cream from around the eye and then
rinse with clean water. Seek medical advice
immediately.
Before use, invert the cap over the end of the
tube and press to pierce the tube seal.
Adults including the elderly
Your doctor will tell you how much cream to use
and how long to use it for. Always follow his/her
instructions carefully.
• Wash your hands and wash and dry the
affected areas thoroughly before applying
the cream.
• Apply the cream thinly and evenly to the
affected and surrounding area once or twice
daily and rub in gently, unless directed
otherwise by your doctor.
• It may be helpful to cover the treated area
with a gauze strip, especially at night.
• The cream should normally be used for 1 to
2 weeks, but this will depend on the type
and location of the infection.
• Once opened, the cream should be used
within 2 weeks.
Continued overleaf...



If symptoms do not improve after 2 weeks
consult your doctor.
The symptoms of your skin infection, such as
itching or soreness should improve within a few
days, although signs such as redness and
scaling of the skin may take longer to disappear.
Your symptoms should continue to improve after
the end of the treatment period.
You can help the treatment to work if you follow
these 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.
• Keep the affected area clean and dry, but
avoid excessive rubbing.
• To protect yourself from further re-infection,
it may be helpful to regularly wash your own
towels and clothes and not share them with
others.
Children
The cream is not recommended for use in
children under 16 years of age.
If you use more Terbinafine cream than you
should
Do not worry just continue as previously
instructed by your doctor. If you do have any
concerns discuss them with your doctor or
pharmacist. Seek medical advice immediately if
the cream is accidentally swallowed.
If you forget to use Terbinafine cream
If you forget to use your cream, apply the cream
as soon as possible and then continue your
treatment as usual.
If you stop using Terbinafine cream
Do not stop using the cream before the
recommended time as your infection may not
have been fully treated and the infection may
re-occur. It is therefore important to complete
the course of treatment as stated by your doctor.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this cream may cause side
effects, although not everyone will get them.
Rarely, people may be allergic to the cream.
Stop using the cream and contact your
doctor IMMEDIATELY if any of the following
occur, as you may require urgent medical
attention:
• wheezing or difficulty in breathing
• pain, swelling of skin (hives), red itchy rash.

You may experience redness, stinging and
itching at the site of application after using the
cream. If the symptoms get worse or persist, or
if you notice any symptoms not mentioned
above contact your doctor.
5.

HOW TO STORE TERBINAFINE CREAM

Keep out of reach and sight of children.
There are no special storage instructions.
The cream should be used within 2 weeks of
opening.
Do not use unopened cream after the expiry
date which is printed at one end of the carton
and on the end of the tube. This date refers to
the last day of the month. Return any unused
cream or expired medicine to your pharmacist
for safe disposal.
6.

FURTHER INFORMATION

What Terbinafine cream contains:
• Terbinafine cream contains 1% w/w of the
active ingredient terbinafine hydrochloride.
• The other ingredients are sodium
hydroxide, benzyl alcohol, sorbitan stearate,
cetyl palmitate, cetyl alcohol, stearyl
alcohol, polysorbate 60, isopropyl myristrate
and purified water.
What Terbinafine cream looks like and the
contents of the pack:
Terbinafine cream is a smooth white cream.
It is available in aluminium tubes containing
7.5 g, 15 g or 30 g of cream.
Not all pack sizes may be marketed.
Manufacturer:
GP Grenzach Produktions GmbH,
Grenzach- Wyhlen,
Germany
Marketing Authorisation Holder:
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd floor,
P.C. 1060, Nicosia,
Cyprus
For more information about this medicine,
please contact the Marketing Authorisation
Holder.
This leaflet was last revised in 07/2012

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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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