TERBINAFINE HYDROCHLORIDE 1 % CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

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Package leaflet: Information for the user

Terbinafine 10mg/g cream
terbinafine hydrochloride
Read all of this leaflet carefully before you
start using this medicine because it contains
important information for you.
•  eep this leaflet. You may need to read it
K
again.
• f you have any further questions, ask your
I
doctor or pharmacist.
•  his medicine has been prescribed for you
T
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
• f you get any side effects talk to your doctor
I
or pharmacist. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet
1  hat Terbinafine Hydrochloride
W
10 mg/g cream (hereafter Terbinafine
cream) is and what it is used for
2  hat you need to know before you use
W
Terbinafine cream
3  ow to use Terbinafine cream
H
4  ossible side effects
P
5  ow to store Terbinafine cream
H
6  ontents of the pack and other
C

information

Other medicines and Terbinafine cream

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
There are no known drug interactionsof Terbinafine
cream with other medicinal product.

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.
Pregnancy
Ask your doctor or pharmacist for advice before
using Terbinafine cream.
Terbinafine cream should not be used during
pregnancy unless you are advised to do so by your
doctor. Your doctor will decide if the potential
benefits outweigh any potential risks.
Breast-feeding
Terbinafine passes into breast milk; therefore, it
should not be used during breastfeeding. Infants
must not be allowed to come into contact with
any treated skin, including the breast. Seek further
medical advice from your doctor before using
Terbinafine cream.

Driving and using machines

1  hat Terbinafine cream is and what it is
W

used for

Terbinafine cream is an anti-fungal preparation. It
kills fungi, which cause skin infections.
Terbinafine cream is used for the local treatment of
Fungal infections of the skin.
2  hat you need to know before you use
W

Terbinafine cream

Do not use Terbinafine cream:

• f you are allergic to terbinafine or any of the other
i
ingredients of this medicine (listed in section 6).

Warnings and precautions

Terbinafine cream is for external use only.
Avoid contact of the cream with your eyes. If it
gets into the eyes accidentally, the eyes should
be washed with plenty of water and the patient
should consult an ophthalmologist if necessary.
After application you should always wash your
hands.

Terbinafine cream has no influence on the ability to
drive and use machines.
Terbinafine cream contains cetyl alcohol and
stearyl alcohol, so the medicinal product can
cause local skin irritation (e.g. contact dermatitis).
3 How to use Terbinafine cream

Your doctor will decide the right amount of
Terbinafine cream for you to use and will tell
you how long to use your medicine. Follow your
doctor’s instructions exactly.
For application to the skin only.
Always use this medicine exactly as your doctor or
pharmacist has told you.
Check with your doctor or pharmacist if you are not
sure.

Terbinafine cream is usually applied once or twice
daily. The cream is generally used for 1 to 2 weeks,
but this will depend upon the type and area of
infection. Make sure that you have cleaned and
dried the affected skin and surrounding areas
thoroughly before applying Terbinafine cream in
a thin layer. The cream should be rubbed in gently
and the affected areas may be covered with a
gauze dressing, especially at night.

Children

The use of Terbinafine cream is not recommended
for children.
Continued top of next column

Continued over page

Terbinafine Cream 10mg/g 1 tube PIL - UK

colours/plates:
1. Black

item no:

AAAF6648

print proof no:
origination date:
originated by:

approved for print/date

AAAF6648
1
10.07.13

dimensions:

180x290

3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:
revised by:

date sent:

Non Printing Colours

Technical Approval

supplier:

Gideon Richter

2.

technically app. date:

10.07.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

5  ow to store Terbinafine cream
H

The treatment should be continued for one week
and – in case of pityriasis versicolor (a rash caused
by a yeast-like germ called malassezia) – for two
weeks.

Do not use after the expiry date stated on the pack.
The expiry date refers to the last day of that month.
This medicinal product does not require any special
storage conditions.

If you feel the effect of this medicine is too strong
or too weak, talk to your doctor.

Store in original container.

Use in children

The use of Terbinafine cream is not recommended
for children.

Do not use Terbinafine cream if you notice visible
signs of deterioration.

If you forget to use Terbinafine cream

Keep out of the sight and reach of children.

If you forget to use your cream, apply the cream as
soon as possible, and then continue the rest of your
treatment as usual.

If you use more Terbinafine cream than you
should
In case of accidental ingestion of Terbinafine
cream, headache, nausea, pain in the upper
middle part of the abdomen and dizziness may
be expected. If you or someone else including a
child, accidentally swallow the cream, contact your
doctor immediately.

If your doctor decides to stop your treatment,
return any leftover medicine to the pharmacist.
Only keep it if your doctor tells you to.
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.
6  ontents of the pack and other
C

information

What Terbinafine cream contains

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

The active substance is terbinafine hydrochloride
The other ingredients are sodium hydroxide,
benzyl alcohol, sorbitan stearate, cetyl palmitate,
cetyl alcohol, cetostearyl alcohol, polysorbate 60,
isopropyl myristate, water purified.

4  ossible side effects
P

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

What Terbinafine looks like and Contents of
the pack

In rare cases people may be allergic to Terbinafine
cream, which could cause swelling and pain,
blistering, skin rash, hives or a worsening of itch. If
you experience any of these particular symptoms,
STOP using Terbinafine cream and tell your doctor
or pharmacist immediately.

White or almost white cream, with slight almond
odour.
Packs contain 1 tube of cream (7.5 g,
15 g or 30 g)

Local symptoms listed below may occur at the site
of application. These are harmless and usually you
can continue the treatment. Adverse reactions are
presented in order of decreasing seriousness.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Application held by:
Gedeon Richter Plc., 1103 Budapest, Gyömrői út
19-21, Hungary

Common (may affect up to 1 in 10 people)
Peeling skin, itching of the skin

Manufactured by: Gedeon Richter Plc.,
1103 Budapest, Gyömrői út 19-21, Hungary

Uncommon (may affect up to 1 in 100 people)
Damage to the skin, scab, skin disorder,
pigmentation disorder, redness of the skin
(erythema), skin burning sensation, pain,
application site pain, application site irritation

Leaflet revised in March 2013.

Rare (may affect up to 1 in 1,000 people)
Eye irritation
Dry skin, redness and swelling of the skin (contact
dermatitis), eczema
Worsening of the skin condition
Not known (frequency cannot be estimated from the
available data)
rash
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.

Continued top of next column

Actavis, Barnstaple, EX32 8NS, UK

Terbinafine Cream 10mg/g 1 tube PIL - UK

colours/plates:
1. Black

item no:

AAAF6648

print proof no:
origination date:
originated by:

approved for print/date

AAAF6648
1
10.07.13

dimensions:

180x290

3.

pharmacode:

4.

min pt size:

5.
6.

DR

revision date:
revised by:

date sent:

Non Printing Colours

Technical Approval

supplier:

Gideon Richter

2.

technically app. date:

10.07.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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.

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