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LAMISIL CREAM 30G

Active substance(s): TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE

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S1452 LEAFLET Lamisil 20150508

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

LAMISIL 1%CREAM
TERBINAFINE HYDROCHLORIDE 1%CREAM
(terbinafine hydrochloride)

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

The name of your medicine is as above and will be referred to as
Lamisil Cream throughout the following leaflet.
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.

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.

6. Further information.



Replace the cap on the tube and wash your hands.

1. WHAT LAMISIL CREAM IS AND WHAT IT IS USED FOR

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.

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

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.

Children
2. BEFORE YOU USE LAMISIL CREAM

Use in Children is NOT recommended, since there are no data to
support use in this population.

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.

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

Pregnancy and breast-feeding
Do not use the cream if you are pregnant or breastfeeding, unless
advised to by your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine.

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

Driving and using machines
Lamisil Cream is not expected to affect your ability to drive or
operate machinery.

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.

6. FURTHER INFORMATION
What Lamisil Cream contains


Lamisil Cream contains 1% w/w of active ingredient, terbinafine
hydrochloride.



Lamisil Cream also contains the following: sodium hydroxide,
benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl
alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate and
demineralised water.

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.

What Lamisil Cream looks like and contents of the pack

These common and uncommon side effects are usually harmless
and you can carry on using the cream.



Lamisil Cream is a white cream base.



Lamisil Cream is available in tubes containing 30g

Rare: (may affect up to 1 in 1000 people): eye irritation, dry skin,
contact dermatitis, eczema, worsening of symptoms.
If any of these side effects get serious, or if you notice any
side effect not listed in this leaflet, please tell your doctor.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

Reporting of side effects

This product is manufactured by

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.



Novartis Pharma Produktions GmbH, Wehr, Germany.



Novartis Pharma GmbH, Wehr, Germany.

5. HOW TO STORE LAMISIL CREAM

Leaflet revision date: 8 May 2015



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Lamisil is a registered trademark of Novartis AG, Switzerland.



Replace the cap on the tube after use.



Do not use after the expiry date printed on the carton or tube
label.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

POM

PL No.: 19488/1452

S1452 LEAFLET Lamisil 20150508

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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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