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TERBINAFINE HYDROCHLORIDE 1 % CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE

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Package leaflet: Information for the user

Terbinafine Hydrochloride 1% cream
terbinafine hydrochloride
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

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 interactions of 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.
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.
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.

1 What Terbinafine Hydrochloride 1% cream
Driving and using machines
Terbinafine cream has no influence on the ability to drive
(hereafter Terbinafine cream) is and what it
and use machines.
is used for
2 What you need to know before you use
Terbinafine cream contains cetyl alcohol and stearyl
alcohol, so the medicinal product can cause local skin
Terbinafine cream
irritation (e.g. contact dermatitis).
3 How to use Terbinafine cream
4 Possible side effects
3 How to use Terbinafine cream
5 How to store Terbinafine cream
6 Contents of the pack and other information
Always use this medicine exactly as your doctor or
1 What Terbinafine cream is and what it is
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 What you need to know before you use
Terbinafine cream
Do not use Terbinafine cream:

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

Warnings and precautions

Talk to your doctor or pharmacist before using
Terbinafine cream.
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 rinsed
thoroughly with running water and you should consult
an ophthalmologist if necessary.
After application you should always wash your hands.
Terbisil cream should be kept out of the reach of
children.

Children

The use of Terbinafine cream is not recommended for
children.

pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

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.
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. You should
exchange the gauze strip for a new and clean one after
each and every application of the cream.
The treatment should be continued for one week in case
of tinea pedis (fungal infection affecting the feet) and in
other cases (e.g. pityriasis versicolor: a rash caused by a
yeast-like germ called Malassezia) for two weeks.
Treatment should be continued for the recommended
period of time even if the damaged skin area seems to
be healed earlier. Thus you could avoid re-infection and
promote a successful treatment.
If there are no signs of improvement after two weeks of
treatment, consult your doctor.
If you feel the effect of this medicine is too strong or too
weak, talk to your doctor.

Terbinafine Cream 10mg/g leaflet - UK

1. black

item no:

AAAJ1475

dimensions: 180 x 290

print proof no:

1

pharmacode:

origination date: 07.07.16
approved for print/date

colours/plates:

originated by:

min pt size:

9 pt

jh
Technical Approval

revised by:

date sent:

Gedeon Richter

3.
4.
5.
6.

revision date:

supplier:

2.

approved:

07.07.16

Non Printing Colours
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2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Use in children

Keep out of the sight and reach of children.

If you forget to use Terbinafine cream

If your doctor decides to stop your treatment, return any
leftover medicine to the pharmacist. Only keep it if your
doctor tells you to.

The use of Terbinafine cream is not recommended for
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.

Discard any unused content one month after opening.
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.

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 swallowed
the cream, contact your doctor immediately.

6 Contents of the pack and other information

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.
In rare cases people may be allergic to Terbinafine
cream, which could cause swelling of the tongue, throat,
face and lips, difficulty breathing or swallowing as well
as blistering, severe 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.
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.
Common (may affect up to 1 in 10 people)
Peeling skin, itching of the skin

What Terbinafine cream contains
• 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.

What Terbinafine looks like and Contents of the
pack
White or almost white cream, with slight almond odour.
Packs contain 1 tube of cream (7.5 g, 15 g or 30 g)

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Application held by: Gedeon
Richter Plc., 1103 Budapest, Gyömrői út 19-21, Hungary
Manufactured by: Gedeon Richter Plc., 1103 Budapest,
Gyömrői út 19-21, Hungary
This leaflet was last revised in July 2015.

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
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

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.

5 How to store Terbinafine cream
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
Store in original container.
Do not use Terbinafine cream if you notice visible signs
of deterioration.

AAAJ1475

Terbinafine Cream 10mg/g leaflet - UK

1. black

item no:

AAAJ1475

dimensions: 180 x 290

print proof no:

1

pharmacode:

origination date: 07.07.16
approved for print/date

colours/plates:

originated by:

min pt size:

9 pt

jh
Technical Approval

revised by:

date sent:

Gedeon Richter

3.
4.
5.
6.

revision date:

supplier:

2.

approved:

07.07.16

Non Printing Colours
1.
2.
3.

*P
 lease note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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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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