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TERBINAFINE HYDROCHLORIDE 1% W/W CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE

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Lamisil® 1% w/w Cream
(terbinafine hydrochloride)
Read all of this leaflet carefully before you start
taking this medicine.
- 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. 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.
The name of your medicine is Lamisil 1% w/w
Cream but it will be referred to as Lamisil Cream
throughout this leaflet.
In this leaflet:
1. What Lamisil Cream is and what it is used for
2. Before you use Lamisil Cream
3. How to use Lamisil Cream
4. Possible side effects
5. How to store Lamisil Cream
6. Further information
1. What Lamisil Cream is and what it is used
for
Lamisil Cream is used to treat patients with fungal
and certain yeast infections of the skin. It attacks
and kills the fungus or yeast which is causing your
infection.
2. Before you use Lamisil Cream
Do NOT use Lamisil Cream if you:
 are allergic (hypersensitive) to any of the
ingredients in the product (see Section 6)
The cream is NOT recommended for use on
children.

Take special care with Lamisil Cream
The cream is for external use only. Do not use on
the face. Avoid contact with eyes. In case of
accidental contact with eyes, rinse thoroughly with
running water.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including those obtained without a prescription.
Pregnancy and breast-feeding
Do not use the cream if you are pregnant or
breast-feeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Lamisil Cream is not expected to affect your ability
to drive or operate machinery.
Important information about some of the
ingredients of Lamisil Cream
 cetyl alcohol and stearyl alcohol: May cause
local skin reactions (e.g. contact dermatitis).
For other ingredients see Section 6.
3. How to use Lamisil Cream
Adults
Your doctor will decide the right amount of Lamisil
Cream for you to use and will tell you for how long
to use your medication.
Apply the cream once or twice a day, for one to
two weeks, but this will depend upon the type and
area of infection. Infections usually appear to
improve within a few days of starting to use
Lamisil Cream, but may reappear if the cream is
not applied regularly or is stopped too early.

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 Lamisil 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.
Children
Use in Children is NOT recommended, since there
are no data to support use in this population.
If you accidently swallow Lamisil Cream
Contact your doctor or nearest hospital emergency
department if you, or someone else, has swallowed
some cream. 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 you forget to use Lamisil Cream
If you miss an application, apply the cream as
soon as possible then continue your treatment as
before. If you only remember at the time of your
next application, just apply the cream and carry on
as normal. It is important to try to use the cream at
the correct times as forgotten applications could
risk the infection returning.
If you stop using Lamisil Cream
Infections may come back if you do not use the
cream regularly, or if you stop the treatment too
early.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Lamisil Cream 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:
 difficulty breathing or swallowing, swelling of the
mouth, face, lips, tongue or throat (severe
allergic reaction).
 severe itching of the skin, with a red rash or
raised lumps, hives or blisters.
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 common and uncommon side effects are
usually harmless and you can carry on using the
cream.

The other ingredients are: sodium hydroxide,
benzyl alcohol, sorbitan monostearate, cetyl
palmitate, cetyl alcohol, stearyl alcohol,
polysorbate 60, isopropyl myristate and water
If any of these side effects get serious, or if you demineralised.
notice any side effect not listed in this leaflet,
(See also end of Section 2 for further information
please tell your doctor.
on some of the ingredients).
Reporting of side effects
What Lamisil Cream looks like and contents of
If you get any side effects, talk to your doctor,
the pack
pharmacist or nurse. This includes any possible
Lamisil Cream is a white smooth cream in
side effects not listed in this leaflet. You can also
aluminium tubes with a white screw cap.
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
Lamisil Cream is available in tubes of 15g.
By reporting side effects, you can help provide
Manufactured by: Novartis Consumer Health SA,
more information on the safety of this medicine.
Nyon, Switzerland.
OR
5. How to store Lamisil Cream
Novartis Pharma Productions GmbH, Wehr,
Germany.
Do not take your medicine after the expiry date
which is stated on the carton and tube label after
Procured from within the EU and repackaged
‘Exp’. The expiry date refers to the last day of that
by the Product Licence holder: B&S Healthcare,
month.
Unit 4, Bradfield Road, Ruislip, Middlesex,
Do not store above 30°C.
HA4 0NU, UK.
POM
Replace the cap on the tube after use.
®
Keep out of the sight and reach of children.
Lamisil 1% w/w Cream; PL No: 18799/2032
Remember if your doctor tells you to stop taking
this medicine, return any unused medicine to your Leaflet date: 20.03.2017
pharmacist for safe disposal. Only keep this
Lamisil is a registered trade mark of Novartis.
medicine if your doctor tells you to.
If your cream become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Rare: (may affect up to 1 in 1000 people): eye
irritation, dry skin, contact dermatitis, eczema,
worsening of symptoms.

6. Further information
What Lamisil Cream contains
Lamisil Cream contains 1 % w/w terbinafine
hydrochloride.

Blind or partially sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

Terbinafine hydrochloride
1% w/w Cream
Read all of this leaflet carefully before you start
taking this medicine.
- 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. 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.
The name of your medicine is Terbinafine
hydrochloride 1% w/w Cream but it will be referred
to as Terbinafine hydrochloride Cream throughout
this leaflet.
In this leaflet:
1. What Terbinafine hydrochloride Cream is and
what it is used for
2. Before you use Terbinafine hydrochloride
Cream
3. How to use Terbinafine hydrochloride Cream
4. Possible side effects
5. How to store Terbinafine hydrochloride Cream
6. Further information.
1. What Terbinafine hydrochloride Cream is
and what it is used for
Terbinafine hydrochloride Cream is used to treat
patients with fungal and certain yeast infections of
the skin. It attacks and kills the fungus or yeast
which is causing your infection.
2. Before you use Terbinafine hydrochloride
Cream
Do NOT use Terbinafine hydrochloride Cream
if you:
 are allergic (hypersensitive) to any of the
ingredients in the product (see Section 6)

The cream is NOT recommended for use on
children.
Take special care with Terbinafine
hydrochloride Cream
The cream is for external use only. Do not use on
the face. Avoid contact with eyes. In case of
accidental contact with eyes, rinse thoroughly with
running water.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including those obtained without a prescription.
Pregnancy and breast-feeding
Do not use the cream if you are pregnant or
breast-feeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Terbinafine hydrochloride Cream is not expected
to affect your ability to drive or operate machinery.
Important information about some of the
ingredients of Terbinafine hydrochloride
Cream
 cetyl alcohol and stearyl alcohol: May cause
local skin reactions (e.g. contact dermatitis).
For other ingredients see Section 6.
3. How to use Terbinafine hydrochloride
Cream
Adults
Your doctor will decide the right amount of
Terbinafine hydrochloride Cream for you to use
and will tell you for how long to use your
medication.
Apply the cream once or twice a day, for one to
two weeks, but this will depend upon the type and
area of infection.

Infections usually appear to improve within a few
days of starting to use Terbinafine hydrochloride
Cream, but may reappear if the cream is not
applied regularly or is stopped too early.
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
hydrochloride 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.
Children
Use in Children is NOT recommended, since there
are no data to support use in this population.
If you accidently swallow Terbinafine
hydrochloride Cream
Contact your doctor or nearest hospital emergency
department if you, or someone else, has swallowed
some cream.

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 you forget to use Terbinafine hydrochloride
Cream
If you miss an application, apply the cream as
soon as possible then continue your treatment as
before. If you only remember at the time of your
next application, just apply the cream and carry on
as normal. It is important to try to use the cream at
the correct times as forgotten applications could
risk the infection returning.
If you stop using Terbinafine hydrochloride
Cream
Infections may come back if you do not use the
cream regularly, or if you stop the treatment too
early.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Terbinafine hydrochloride
Cream 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:
 difficulty breathing or swallowing, swelling of the
mouth, face, lips, tongue or throat (severe
allergic reaction).
 severe itching of the skin, with a red rash or
raised lumps, hives or blisters.
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 common and uncommon side effects are
usually harmless and you can carry on using the
cream.
Rare: (may affect up to 1 in 1000 people): eye
irritation, dry skin, contact dermatitis, eczema,
worsening of symptoms.

The other ingredients are: sodium hydroxide,
benzyl alcohol, sorbitan monostearate, cetyl
palmitate, cetyl alcohol, stearyl alcohol,
polysorbate 60, isopropyl myristate and water
demineralised.

(See also end of Section 2 for further information
If any of these side effects get serious, or if you on some of the ingredients).
notice any side effect not listed in this leaflet,
What Terbinafine hydrochloride Cream looks
please tell your doctor.
like and contents of the pack
Terbinafine hydrochloride Cream is a white
Reporting of side effects
smooth cream in aluminium tubes with a white
If you get any side effects, talk to your doctor,
screw cap.
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 hydrochloride
Cream
Do not take your medicine after the expiry date
which is stated on the carton and tube label after
‘Exp’. The expiry date refers to the last day of that
month.
Do not store above 30°C.
Replace the cap on the tube after use.
Keep out of the sight and reach of children.
Remember if your doctor tells you to stop taking
this medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your cream become discoloured or show any
signs of deterioration, seek the advice of your
pharmacist
6. Further information
What Terbinafine hydrochloride Cream
contains
Terbinafine hydrochloride Cream contains
1 % w/w terbinafine hydrochloride.

Terbinafine hydrochloride Cream is available in
tubes of 15g.
Manufactured by: Novartis Consumer Health SA,
Nyon, Switzerland.
OR
Novartis Pharma Productions GmbH, Wehr,
Germany.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
POM
Terbinafine hydrochloride 1% w/w Cream;
PL No: 18799/2032
Leaflet date: 20.03.2017

Blind or partially sighted?
Is this leaflet hard to see
or read?
Call 0208 515 3763 to
obtain the leaflet in a
format suitable for you.

Expand Transcript

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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