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Quality Assurance


(terbinafine hydrochloride)

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 please 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 any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Terbinafine 1% cream is and what it is used
2. Before you use Terbinafine 1% cream.
3. How to use Terbinafine 1% cream.
4. Possible side effects.
5. How to store Terbinafine 1% cream.
6. Further information.
Terbinafine 1% cream is an antifungal preparation.
It kills fungi, which cause skin infections. Terbinafine
1% cream is used for the local treatment of fungal
infections of the skin only.
Do not use Terbinafine 1% cream if you are
allergic (hypersensitive) to terbinafine hydrochloride or
any of the other ingredients of Terbinafine 1% cream.

Pregnancy and breast-feeding - If you are
pregnant you should not use Terbinafine 1% cream
unless it is clearly necessary.
Do not use this cream if you are breast-feeding as
terbinafine hydrochloride can pass into breast milk.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines - Terbinafine 1%
cream should not affect your ability to drive or
operate machines.
Important information about some of the
ingredients of Terbinafine 1% cream Terbinafine 1% cream contains cetyl and cetostearyl
alcohol, which may cause local skin reactions (e.g.
contact dermatitis). Do not use this cream if you
know you are allergic to these ingredients.
Dosage - Always use Terbinafine 1% cream exactly
as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
Adults (including the elderly) - Apply the cream
to the affected area and just around it, once or twice
a day.
Clean and dry the area before applying the cream in
a thin layer. Rub cream in gently.
In cases of reddened and weeping infection; if you
are treating an area between the toes, fingers,
buttocks or in the groin, the skin may be covered with
a sterile compress, especially at night.
Duration and frequency of treatment - Tinea
pedis (athlete's foot): once daily for 1 week.
Tinea cruris (dhobie itch/jock itch) and Tinea
corporis: once daily for 1 week.
Cutaneous Candida: once daily for 1 week.
Pityriasis versicolor: once daily for 2 weeks.

Take special care with Terbinafine 1% cream:
• This cream is for external use only. Avoid contact
with the eyes.
If the cream gets in your eyes, wash with clean water
and tell your doctor immediately.
Terbinafine 1% cream is not intended to treat
hyperkeratotic chronic plantar tinea pedis (moccasin
In the event of allergic reaction, the cream should be
removed and the treatment interrupted.

It is important that you use the cream regularly even if
the infection has improved. If you see no improvement
in your skin condition after a week, go to your doctor.

Taking other medicines - Terbinafine 1% cream
is not known to react with any other medicine.

Children - Terbinafine 1% cream is not
recommended for children under 12 years.

Terbinafine 1% cream cream may be applied as your
doctor has told you, usually 1-2 times daily. Treatment
may be extended to 2 weeks.

If you use more Terbinafine 1% cream than
you should - Remove some of the cream if you
apply more than a thin layer.
If you or someone else swallows the cream, go to
your doctor or nearest hospital emergency
department for advice.
If the cream gets in your eyes, wash with clean water
and tell your doctor immediately.
If you forget to use Terbinafine 1% cream - If
you forget to use the cream, apply it as soon as you
remember. If it is time for the next application, carry
on as normal. It is important to try to remember to use
the cream or you risk the infection returning.
If you stop using Terbinafine 1% cream - Do
not stop using Terbinafine 1% cream before the
recommended time, as the infection will be more
likely to return.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
Like all medicines, Terbinafine 1% cream can cause
side effects, although not everybody gets them.
Rare side effects (affecting fewer than 1 in
1,000 but more than 1 in 10,000 people):
• allergic reactions such as itching, rash, blisters,
Redness, rash and itching or a pricking sensation
may occur on the treated area. However, these
reactions rarely result in the treatment having to be
discontinued. It is important to distinguish basically
harmless symptoms from allergic reactions that may
require discontinuation of the treatment.

Keep out of the reach and sight of children.
Do not use Terbinafine 1% cream after the expiry
date stated on the label or carton after 'EXP'. The
expiry date refers to the last day of that month.
Store in the original container.
Do not freeze.
Keep the tube tightly closed.
You can use Terbinafine 1% cream 28 days after first
opening of the tube. 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 to protect
the environment.
What Terbinafine 1% cream contains - The
active substance is terbinafine hydrochloride. One
gram of cream contains 10 mg of terbinafine
hydrochloride equivalent to 8.89 mg of terbinafine.
The other ingredients are sodium hydroxide, benzyl
alcohol, sorbitan stearate, cetyl palmitate, cetyl
alcohol, cetostearyl alcohol, polysorbate, isopropyl
myristate and purified water.
What Terbinafine 1% cream looks like and
the contents of the pack - Terbinafine 1% cream
comes as a cream in aluminium tubes of, 7.5 g, 15 g
or 30 g. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Generics
[UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, UK.
McDermott Laboratories trading as Gerard
Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.

Sometimes you may suffer from mild redness, itching
or stinging of the area where the cream is applied.
These effects are harmless and usually you can
continue with the treatment.
If any side effect gets serious, or if you
notice any side effects not mentioned in the
leaflet, please tell your pharmacist or doctor.

This leaflet was last approved in: January 2010 10002602

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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.