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TERBINAFINE 10 MG/G CREAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Often the skin abnormalities are located in warm,
damp areas such as the groin or under the
breasts. The symptoms consist of itching,
redness and scaling.

Terbinafine 10 mg/g cream
Terbinafine hydrochloride

6. FURTHER INFORMATION
What Terbinafine cream contains

Read all of this leaflet carefully before you start using this medicine

One gram of cream contains 10 mg
!
Keep this leaflet. You may need to read it again.
Pityriasis versicolor: 1 to 2 times a day for 2
terbinafine hydrochloride.
!
If you have further questions, please ask your doctor or your pharmacist.
weeks. Pityriasis versicolor is a rash caused by a
The other ingredients are polysorbate
!
This medicine has been prescribed for you and should not be passed on to other people. It
yeast-like germ.
80 (E433), simeticone, propyl
may harm them, even if their symptoms are the same as yours.

parahydroxybenzoate (E216), methyl
!
If any of the side effects gets serious, or if you notice any side effects not listed in this
Elderly:
parahydroxybenzoate (E218), sodium
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Terbinafine cream is and what it is used
for
2. Before you use Terbinafine cream
3. How to use Terbinafine cream
4. Possible side effects
5. How to store Terbinafine cream
6. Further information
1. WHAT TERBINAFINE CREAM IS AND
WHAT IT IS USED FOR
Terbinafine cream is a white cream which
contains 10 mg/g of terbinafine hydrochloride as
the active ingredient.
Terbinafine cream is used externally for the
treatment of fungal or yeast infections of the
skin, such as athletes foot.

Driving and using machines
No studies on the effects on the ability to drive
and use machines have been performed.
Important information about some of the
ingredients of Terbinafine cream
Terbinafine cream contains the excipient
cetostearyl alcohol, which can cause local skin
reactions (e.g. contact dermatitis). It also
includes methyl parahydroxybenzoate and
propyl parahydroxybenzoate which may cause
allergic reactions (possibly delayed).
3. HOW TO USE TERBINAFINE CREAM
Always use Terbinafine cream exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

There is no evidence that elderly patients require
a different dose or will suffer different side effects
from younger patients.

Children:
There is only limited experience with the
administration of Terbinafine cream to the skin of
children under 12 years of age and therefore use
in this age group is not recommended.
Improvement of the symptoms is usually seen
within a few days. If there are no signs of
improvement after two weeks please tell your
doctor.
If you forget to use Terbinafine cream
Apply the next dose as normal do not use a larger
amount to make up for the dose you missed. The
irregular use or stopping treatment to soon may
result in the reappearance of the symptoms.
4. POSSIBLE SIDE EFFECTS

2.BEFORE YOU USE TERBINAFINE
CREAM

metabisulphite (E223), sodium hydroxide
(E524), polyoxyl 20 cetostearyl ether, disodium
edetate dihydrate, sodium citrate dihydrate
(E331), decyl oleate, cetostearyl alcohol,
purified water.
What Terbinafine cream looks like and
contents of the pack
Terbinafine cream is presented in the form of a
cream. The contents of the aluminium tube with a
polyethylene screw cap are 10, 15, 20 and 30
grams. Not all pack sizes may be marketed.
The cream is white.
Marketing Authorisation Holder:
Morningside Healthcare Ltd, 115 Narborough
Road, Leicester. LE3 0PA, UK
Manufacturer:
Morningside Pharmaceuticals Ltd 5 Pavilion
Way, Loughborough. LE11 5GW, UK

The affected area must be completely cleaned
and dried before using Terbinafine 10 mg/g
Like all medicines Terbinafine cream can cause
cream. The cream must be applied as a thin layer
side effects, although not everybody gets them.
This medicinal product is authorised in the
over the affected skin and the surrounding area,
Do not use Terbinafine cream:
Member States of the EEA under the following
this should be gently rubbed into the skin. If the
!
if you are allergic (hypersensitive) to
Redness, skin rash, itching or a stinging
names:
inflammation is in a skin fold (under the breasts,
terbinafine or any of the other ingredients of
sensation can occur at the site where the cream
between the toes or fingers, in the groin or
Terbinafine cream (see further information)
is applied.
Sweden: Terbinafine Morningside
between the buttocks) the skin can be covered
United Kingdom: Terbinafine Cream
with a sterile gauze, especially at night. Wash
Take special care with Terbinafine cream
Rare cases of allergic reaction also have been
your hands after rubbing in, unless your hands
Terbinafine cream is for external use only.
reported such as such as itchy skin (pruritus),
This leaflet was last approved in
are the area that is being treated.
Contact with the eyes should be avoided.
rash, blistered skin inflammation (dermatitis
March 12, 2008.
The use of Terbinafine cream is not
bullous) and hives (urticaria).
Adults and adolescents (12 years and above)
recommended for use in children below age 12
years.
If any of the side effects gets serious, or if you
Duration and frequency of treatment
notice any side effects not listed in this
Athlete's foot (Tinea pedis): once a day for one
Using other medicines
leaflet, please tell your doctor or pharmacist.
week.
It is not known if Terbinafine cream interacts with
other medicines. However, it is best to tell your
5. HOW TO STORE TERBINAFINE
The symptoms that can be associated with
doctor or pharmacist if you are taking or have
CREAM
athlete's foot are itching, redness and scaling
recently taken any other medicines, including
between the toes and on the soles of the feet.
medicines obtained without a prescription.
Keep the cream out of the reach and sight of
Cracks sometimes also appear (particularly
children. This medicinal product does not require
between the toes) and oozing blisters can occur
Pregnancy and breast-feeding
any special storage conditions. Do not use this
as well. Athlete's foot usually produces an
There is no evidence of harmful effects caused
medicine after the expiry date stated on the
unpleasant odour.
by terbinafine in pregnancy. But, terbinafine
carton or the tube after EXP. The expiry date
should only be used during pregnancy after
refers to the last day of that month. Discard any
Ringworm (tinea corporis): once a day for one
careful consideration of the risks and benefits. If
remaining cream 28 days after first opening.
week
you are pregnant or you think you may be
pregnant or you are trying for a baby tell your
Medicines should not be disposed of via
Ringworm consists of slowly growing, itchy, red
doctor or pharmacists before using this medicine.
wastewater or household waste. Ask your
and scaling ring-shaped patches that can be
Terbinafine is excreted in the breast milk
pharmacist how to dispose of medicines no
dispersed over the body.
therefore women must not apply Terbinafine
longer required. These measures will help to
cream while breastfeeding or allow children to be
protect the environment
Skin fungus (cutaneous candidiasis): once a day
in contact with any treated skin areas, including
for 1 to 2 weeks.
the breast. Please tell your doctor if you are
breastfeeding.
Candida is a species of yeast that can cause an
infection of the skin in certain circumstances.

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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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