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CUPLEX ATHLETES FOOT 1% W/W CREAM

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cuplex Athlete’s Foot 1% w/w Cream
Terbinafine hydrochloride 1% w/w Cream
Read all of this leaflet carefully before you start using this medicine, because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may want to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
What is in this leaflet:
1. What Cuplex Athlete’s Foot 1% w/w Cream is and what
it is used for
2. What you need to know before you use Cuplex Athlete’s
Foot 1% w/w Cream
3. How to use Cuplex Athlete’s Foot 1% w/w Cream
4. Possible side effects
5. How to store Cuplex Athlete’s Foot 1% w/w Cream
6. Contents of the pack and other information

1. WHAT CUPLEX ATHLETE’S FOOT 1% W/W
CREAM IS AND WHAT IT IS USED FOR

Children and adolescents
The use of Cuplex Athlete’s Foot 1%w/w Cream is not
recommended for children aged 16 and under.
Other medicines and Cuplex Athlete’s Foot 1% w/w 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 with Terbinafine.
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.

Cuplex Athlete’s Foot 1% w/w Cream is an anti-fungal
preparation. It kills fungi, which cause skin infections.

Cuplex Athlete’s Foot 1% w/w Cream should not be used
during pregnancy unless a physician advises, who
decides the potential benefits outweigh any potential risks.

Cuplex Athlete’s Foot 1% w/w Cream is used for the local
treatment of fungal infections such as Athlete’s foot.
You can treat mild, transient complaints before seeking
medical attention or supervision. To achieve optimal effect
you should use this medicine carefully.

Terbinafine passes into mother’s milk, therefore, it should
not be used during breastfeeding period. Infants must
not be allowed to come into contact with any treated skin,
including the breast.

Among others, these fungal infections may develop in
different areas of the body:
• Athlete’s foot – Fungal infection of the foot (Athlete’s foot)
appears only on the feet (usually both but not always),
usually inbetween the toes. It can also appear on the
instep, soles, or other areas of the feet. The most
common type of athlete’s foot causes cracking or
scaling of the skin, but you may also have mild swelling,
blisters, or weeping ulcers. Cuplex Athlete’s Foot 1% w/w
Cream is recommended for athlete’s foot when it
occurs between the toes. If you have a fungal nail
infection (fungus inside and under the nail) with
discolouration of the nails and changes in nail texture
(thick or flaky), you should consult your doctor because
Cuplex Athlete’s Foot 1%w/w Cream is not appropriate
for this type of infection.

Driving and using machines
Terbinafine has no influence on the ability to drive and
use machines.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE CUPLEX ATHLETE’S FOOT 1% W/W
CREAM
DO NOT USE Cuplex Athlete’s Foot 1% w/w Cream
• If you are allergic to Terbinafine or any of the other
ingredients of this medicine (listed in section 6).
The cream is NOT recommended for use on children
under 16 years of age.
Warnings and precautions
• Talk to your doctor or pharmacist before using Cuplex
Athlete’s Foot 1% w/w Cream.
• Cuplex Athlete’s Foot 1%w/w Cream is for external use
only. Do not use on the face.
• Keep out of the sight and reach of children.
• Avoid contact of the cream with eyes. If it gets into
the eyes accidentally, the eyes should be rinsed
thoroughly with running water. Consult an
ophthalmologist if necessary.
• Before and after application you should always wash
your hands.

Cuplex Athlete’s Foot 1% w/w Cream contains cetyl
alcohol and stearyl alcohol, thus, the medicinal product
can induce local skin irritation (e.g. contact dermatitis).

3. HOW TO USE CUPLEX ATHLETE’S FOOT
1% W/W CREAM
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
You can open the sealed tube by using the spike at the
top of the cap.
Adults
For Athlete’s Foot, apply the cream once a day, for one week.
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, 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 Cuplex Athlete’s Foot 1% w/w
Cream during the second week, 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.

The effect of use of the cream will stop the infection
quickly due to the killing of the fungus that causes the
infection. However, complete healing may take longer
depending on the extent of inflammation. The effect
of Cuplex Athlete’s Foot 1% w/w Cream persists after
treatment, even when you have finished using the
preparation.
To avoid re-infection it is important to take the following
hygienic measures:
The affected area should be kept clean; after use of the
cream you should always wash your hands; you should
use your own towel; you should wear cotton socks and
it is advised to disinfect footwear. Avoid scratching the
affected area, although it may be itchy, because it can
cause further damage to the skin and slow down the
healing process or spread the infection.
If you feel the effect of this medicine is too strong or too
weak, talk to your doctor.
Use in children
The use of Cuplex Athlete’s Foot 1% w/w Cream is not
recommended for children under the age of 16 years.
If you USE MORE Cuplex Athlete’s Foot 1% w/w Cream
than you should
Since the cream is for external use only, and just a very
little portion of the active ingredient enters the body
through the skin, overdose is extremely unlikely.
If you accidentally swallow Cuplex Athlete’s Foot 1% w/w
Cream, headache, nausea (feeling sick) , upper abdominal
pain, and dizziness may be expected.
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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
If you FORGET TO USE Cuplex Athlete’s Foot 1% w/w Cream
If you forget to use your cream, apply the cream as soon
as possible, and then continue the 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 Cuplex Athlete’s Foot 1% w/w 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, this medicine can cause side effects,
although not everybody gets them.
Local symptoms such as itching, peeling of the skin,
application site pain, application site irritation,
pigmentation disorder, skin burning sensation, redness
of the skin, scab, etc. may occur at the site of application.
These harmless symptoms must be distinguished from
hypersensitivity reactions including rash, which are
reported in sporadic cases and require discontinuation
of therapy. In case of accidental contact with the eyes
terbinafine may be irritating to the eyes. In rare cases the
underlying fungal infection may be worsened.
Adverse reactions are listed below by system organ class
and frequency. Frequencies are defined as:
Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Not known: frequency cannot be estimated from the
available data.
Within each frequency grouping, adverse reactions are
presented in order of decreasing seriousness.

Common :

Peeling skin, itching of the skin

Uncommon:
Damage to the skin (lesion), scab,
skin disorder, skin color changes, redness of the skin
(erythema), skin burning sensation, pain, application site
pain, application site irritation
Rare :
Eye irritation, dry skin, redness and
swelling of the skin (contact dermatitis), eczema,
worsening of the skin condition
Not known:

Hypersensitivity, 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 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 CUPLEX ATHLETE’S FOOT
1% W/W CREAM
Do not use this medicine after the expiry date stated on
the pack.
The expiry date refers to the last day of that month.
No special precautions for storage.
Store in original container.
Do not use this medicine if you notice visible signs of
deterioration.
Keep out of the sight and reach of children.
Only keep it if your doctor tells you to.
If your doctor decides to stop your treatment, return any
leftover medicine to the pharmacist.
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.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Cuplex Athlete’s Foot 1% w/w 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 Cuplex Athlete’s Foot 1% w/w Cream looks like and
contents of the pack
White or almost white cream, with slight almond odour.
Packs contain 1 tube of cream (15 g).
Marketing Authorisation Holder and Manufacturer
MA Holder: Gedeon Richter Plc., 1103 Budapest, Gyömrői
út 19-21, Hungary.
Manufactured by: Gedeon Richter Plc., 1103 Budapest,
Gyömrői út 19-21, Hungary.
Distributed in the UK by: Crawford Healthcare Ltd,
Cheshire, WA16 0BE.
www.crawfordhealthcare.com

If you need this information in large
print or in an audio version, or just
want to find out more about how
Cuplex Athlete’s Foot 1% w/w Cream
could help you, simply contact us on
01565 654920 or email
info@crawfordpharma.com
This leaflet was last revised in April 2016

ARTWORK DETAILS

SPECIFICATION DETAILS

Client:

Crawford Healthcare Ltd.

Origination

13 February 2014 — (as Issue 01)

Product Name:

Cuplex Athletes Foot Cream - PIL

Dimensions

180 x 290 mm

Market(s):

United Kingdom (UK)

Border

10 mm

Language(s):

English

Client Comp Codes:

TBC

QRD Doc Ref.

mod-PILDP004529_2-clean.doc

Pharma Code:

TBC

Client Job Number:

CHL 7702

Font details

PD Ref.:

CRH-UK-PIL-CUPL-v13 —
(** to follow final proof)

Customer Ref.:

N/A

Main title:
Custom EPS Graphic
Sub-titles:
Univers LT Std 65 Bold - 10 pt
Body copy:
Univers LT Std 55 Roman - 8 pt

Issue

13

Colours

Black - K

Date

09 May 2016

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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