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CUPLEX ATHLETES FOOT 1% W/W CREAM

Active substance(s): 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.
This medicine is available without prescription. Nevertheless you still need to
use Cuplex Athlete’s Foot 1% w/w Cream carefully to get the best results from it.
• Keep this leaflet. You may want to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see a doctor if your symptoms worsen or do not improve following treatment.

In this leaflet:
1. What Cuplex Athlete’s Foot 1% w/w Cream is and
what it is used for
2. 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. Further information

1. WHAT CUPLEX ATHLETE’S FOOT 1% W/W
CREAM IS AND WHAT IT IS USED FOR
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 is used for
the local treatment of the fungal infection
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 and expertly.
For external use only.
Fungal infections can develop on the feet.
• Fungal infection of the foot (Athlete’s foot) appears
on the feet, mainly between the toes. It can
spread to the soles, edges or the instep of the
feet. It may affect one or both feet. The most
common symptoms can be inflammation, cracking
or scaling of the skin, unpleasant itching. In more
severe cases, small weeping blisters, peeling
skin and painful, deep cracks can appear.
• Cuplex Athlete’s Foot 1% w/w Cream is NOT for
nail infections.

2. 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 (hypersensitive) to Terbinafine
hydrochloride or any of the other ingredients of
Cuplex Athlete’s Foot 1% w/w Cream.
• You are not sure about the nature of your skin
problems, you should consult your doctor before
starting to use Cuplex Athlete’s Foot 1% w/w Cream.
• If you are younger than 16 years of age.

TAKE SPECIAL CARE with Cuplex Athlete’s Foot
1% w/w Cream
• For external use only.
• Avoid contact of the cream with your eyes. If it
gets into the eyes accidentally, the eyes should
be washed with plenty of water and the patient
should consult an ophthalmologist if necessary.
• After application you should always wash your
hands.
Taking or using other medicines
Please tell your doctor or pharmacist if you are
taking/using or have recently taken/used any other
medicines, including medicines obtained without
a prescription.
Pregnancy and breast-feeding
Pregnancy
Ask your doctor or pharmacist for advice before
using Cuplex Athlete’s Foot 1% w/w Cream.
If you do become pregnant whilst using Cuplex
Athlete’s Foot 1% w/w Cream, tell your doctor.
Breast-feeding
Ask your doctor or pharmacist for advice before
using Cuplex Athlete’s Foot 1% w/w Cream.
Driving and using machines
Cuplex Athlete’s Foot 1% w/w Cream will not affect
your ability to drive or operate machinery when
used as directed and only externally.
Important information about some of the
ingredients of Cuplex Athlete’s Foot 1% w/w Cream
Cetyl alcohol and cetostearyl alcohol, which are
among the other ingredients of the cream, may
cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE CUPLEX ATHLETE’S FOOT
1% W/W CREAM
You can open the sealed tube by using the spike at
the top of the cap.
Always clean and dry your hands before using the
cream.
Usage of the cream
The cream should be applied once or twice daily
on the previously cleansed and dried area. The
cream should be applied to the affected skin and
surrounding area in a thin layer and rubbed in lightly.

Duration of treatment according to types of
infection
Fungal infection of the foot:

1 week; once or twice daily
Treatment should be continued for one week
even if the affected area starts healing earlier.
This way you can avoid the return of infection and
treatment will be successful.
The effect of use of the cream will stop the infection
quickly due to the killing of the pathogenic fungus.
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.
If there are no signs of improvement after therapy,
consult your doctor.
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 USE MORE Cuplex Athlete’s Foot 1% w/w
Cream than you should
Remove some of the cream if you apply more than
a thin layer.
If you or someone else, including a child,
accidentally swallow the cream, contact your
doctor immediately.

5. HOW TO STORE CUPLEX ATHLETE’S FOOT
1% W/W CREAM
Do not use after the expiry date stated on the pack.
The expiry date refers to the last day of that month.
Once the tube has been open for 28 days, do not
use the cream.
No special precautions for storage.
Store in original container.
Do not use Cuplex Athlete’s Foot 1% w/w Cream if
you notice visible signs of deterioration.
Keep out of the reach and sight of children.
Only keep it if your doctor tells you to.
If your doctor decides to stop your treatment,
return any left-over medicine to the pharmacist.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What Cuplex Athlete’s Foot 1% w/w Cream
contains
The active substance is Terbinafine hydrochloride.
One gram of cream contains 10mg of Terbinafine
hydrochloride, equivalent to 8.89 mg of Terbinafine.
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.

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 rest of
your treatment as usual.

Pack contains 1 tube of cream (15 g)

4. POSSIBLE SIDE EFFECTS

Distributed in the UK by: Crawford Healthcare Ltd,
Cheshire, WA16 0BE.
www.crawfordhealthcare.com

Like all medicines, Cuplex Athlete’s Foot 1% w/w
Cream can have side effects, although not
everybody gets them.
Redness, itching or stinging occasionally occur at
the site of application.
If these side effects occur, contact your doctor.
Hypersensitivity reactions may develop with any
medicine.
Therefore, if you experience any of the following
symptoms, such as swelling of the treated area,
pain and redness, you should stop treatment and
contact your doctor.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

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.

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 approved in: September 2014

ARTWORK DETAILS

SPECIFICATION DETAILS

Client:

Crawford Healthcare Ltd.

Origination

13 February 2014 — (as Issue 01)

Product Name:

Cuplex Athletes Foot Cream - PIL

Dimensions

148 x 210 mm

Market(s):

United Kingdom (UK)

Border

10 mm

Language(s):

English

Client Comp Codes:

TBC

QRD Doc Ref.

OT020 Document - Cuplex Athletes
Foot Cream v8.0.docx

Pharma Code:

TBC

Font details

Main title:
Custom EPS Graphic
Sub-titles:
Univers LT Std 65 Bold - 9 pt
Body copy:
Univers LT Std 55 Roman - 7.25 pt

Colours

Black - K

Client Job Number:

ACR-14-003

PD Ref.:

CRH-UK-PIL-CUPL-v10 —
(** to follow final proof)

Customer Ref.:

N/A

Issue

10

Date

10 September 2014

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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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