TERBINAFINE 1% CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

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Package leaflet: Information for the user

Terbinafine 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.
• 
•  you have any further questions, ask your doctor
If
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.
In this leaflet:
W
1.  hat Terbinafine 1% cream is and what it is used for
W
2.  hat you need to know before you use Terbinafine
1% cream
H
3.  ow to use Terbinafine 1% cream
P
4.  ossible side effects
H
5.  ow to store Terbinafine 1% cream
C
6.  ontents of the pack and other information.
1. What Terbinafine 1% Cream is and what it is
used for
Terbinafine 1% Cream contains the active ingredient
terbinafine hydrochloride which is an antifungal. It kills
fungi, which cause skin infections. Terbinafine 1% cream
is used for the local treatment of fungal infections of the
skin only.
2. What you need to know before you use
Terbinafine 1% Cream
Do not use Terbinafine 1% cream if you are allergic
to terbinafine hydrochloride or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
This cream is for external use only.
Avoid contact with the eyes. If the cream gets in your
eyes accidentally, rinse thoroughly with running water
and tell your doctor immediately.
In the event of allergic reaction, the cream should be
removed and the treatment interrupted.
Other medicines and Terbinafine 1% Cream
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant you should not use Terbinafine 1%
cream unless it is clearly necessary and advised to by
your doctor.
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
this medicine.
Driving and using machines
Terbinafine 1% cream should not affect your ability to
drive or operate machines.
Terbinafine 1% cream contains cetyl alcohol and
cetostearyl alcohol
These ingredients may cause local skin reactions (e.g.
contact dermatitis). Do not use this cream if you know
you are allergic to these ingredients.
3. How to use Terbinafine 1% cream
Always use this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are
not sure.
Adults (including older people)
Terbinafine 1% Cream cream may be applied 1-2 times daily.
The recommended duration and frequency of treatment
will depend upon the type and area of infection:
Tinea pedis (Athlete’s foot): 1 week.
Tinea cruris (dhobie itch/jock itch) and Tinea corporis:
1-2 weeks.
Cutaneous Candida: 2 weeks.
Pityriasis versicolor: 2 weeks.
Infections usually appear to improve within a few days
of starting to use the cream. 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
2 weeks, talk to your doctor.
Directions for use
Cleanse and dry the affected areas thoroughly and
• 
wash your hands. Treatment can be helped by keeping
the affected areas clean by regular washing and
careful drying with your own clean towels and clothes,
and not rubbing or scratching the skin.
• 
Unscrew the cap then gently squeeze out a small
amount of the cream onto your finger.
• 
Apply just enough cream to form a thin layer on the
affected skin and surrounding areas.
• 
Rub in gently. When used between the toes, buttocks
or on the groin, the treated area may be covered with
a light, fresh gauze strip, especially at night.
• 
Replace the cap on the tube and wash your hands.
Even though you will not be using Terbinafine 1%
Cream during the second week for Athlete’s foot, full
skin healing after the infection has cleared will continue
for up to 4 weeks. If you have not noticed any signs of
improvement within 2 weeks of first starting treatment,
please seek advice from your doctor or pharmacist.
Use in children
Terbinafine 1% Cream is not recommended for children
under 12 years.

Date: 18 Feb 2014

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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
immediately. Take any remaining medicine and this
leaflet with you if possible. Symptoms of accidental
ingestion include headache, nausea (feeling sick),
dizziness and stomach pain. If the cream gets in your
eyes, rinse thoroughly with running 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
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
STOP using the cream and seek medical help
immediately if you have any of the following very
rare allergic reactions:
Not known (cannot be estimated from the available data):
•  ifficulty breathing or swallowing, swelling of the mouth,
d
face, lips, tongue or throat (severe allergic reaction).
• 
severe itching of the skin, with a red rash or raised
lumps, hives or blisters.
Other side effects
Common (may affect up to 1 in 10 people):
skin peeling, itching.
• 
Uncommon (may affect up to 1 in 100 people):
skin lesions, scab, skin colour changes, redness,
• 
burning, pain and irritation at the site of application.
These effects are harmless and usually you can continue
with the treatment.
Rare (may affect up to 1 in 1,000 people):
•  irritation, dry skin, contact dermatitis, eczema,
eye
worsening of symptoms.
Reporting of side effects
If you get 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 Terbinafine 1% Cream
Keep this medicine out of the sight and reach 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.
Discard the tube 28 days after first opening the tube.
Do not throw away any medicine 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 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.
T
• he other ingredients are sodium hydroxide, benzyl
alcohol, sorbitan monostearate, cetyl palmitate, cetyl
alcohol, cetostearyl alcohol (see section 2 'Terbinafine 1%
Cream contains cetyl alcohol and cetostearyl alcohol'),
polysorbate, isopropyl myristate and purified water.
What Terbinafine 1% cream looks like and the
contents of the pack
Terbinafine 1% Cream is a white or almost white cream
with a slight almond odour contained in aluminium
tubes of, 7.5 g, 15 g or 30 g. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Gedeon Richter Plc., Gyömrői út 19-21, Budapest
H-1103, HUNGARY
This leaflet was last revised in 10/2013
This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium Terbinafine Mylan 1 % crème
France Terbinafine 1% Mylan, crème
Germany Terbisil 10 mg/g Creme
Norway Dermatomyl 1 % krem
The Netherlands Terbinafine Mylan 10 mg/g, creme
United Kingdom Terbinafine 1% cream

368906
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Date: 18 Feb 2014

Page Count 2/2

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Time: 15:29

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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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