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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

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

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What Cuplex Athlete’s Foot 1% w/w Cream (hereafter Cuplex Athlete’s Foot Cream) is and
what it is used for
What you need to know before you use Cuplex Athlete’s Foot Cream
How to use Cuplex Athlete’s Foot Cream
Possible side effects
How to store Cuplex Athlete’s Foot Cream
Contents of the pack and other information

1.

What Cuplex Athlete’s Foot Cream is and what it is used for

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Cuplex Athlete’s Foot Cream is an anti-fungal preparation. It kills fungi, which cause skin infections.
Cuplex Athlete’s Foot Cream is used for the local treatment of fungal infections such as Athlete’s foot
(tinea pedis) and Dhobie itch/jock itch (tinea cruris).
You can treat mild, transient complaints before seeking medical attention or supervision. To achieve
optimal effect you should use this medicine carefully.
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 in between 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 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 Cream is
not appropriate for this type of infection.
Dhobie itch/jock itch (tinea cruris) – Dhobie itch appears in the groin and inner thigh area,
usually on both sides but often with one side more than the other, where it can spread further
between the legs to the buttocks, or up towards the stomach. Dhobie itch looks like a clearly
bordered rash, which may have blisters

2.

What you need to know before you use Cuplex Athlete’s Foot Cream

Do not use Cuplex Athlete’s Foot Cream
if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section
6).
Warnings and precautions
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Talk to your doctor or pharmacist before using Cuplex Athlete’s Foot Cream.
Cuplex Athlete’s Foot Cream is for external use only. Do not use on the face.
Keep this medicine 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.
Children and adolescents
The experience with topical terbinafine in children is still limited and its use in children and
adolescents under 16 years cannot therefore be recommended.
Other medicines and Cuplex Athlete’s Foot Cream
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known drug interactions with Cuplex Athlete’s Foot Cream.
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 Cream should not be used during pregnancy unless a physician advises, who
decides the potential benefits outweigh any potential risks.
Terbinafine, the active substance of Cuplex Athlete’s Foot Cream 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.
Driving and using machines
Cuplex Athlete’s Foot Cream has no influence on the ability to drive and use machines.
Cuplex Athlete’s Foot Cream contains cetyl alcohol and cetostearyl alcohol
This medicinal product may cause local skin reactions (e.g. contact dermatitis).

3.

How to use Cuplex Athlete’s Foot 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.
Adults and adolescents over 16 years of age
For Athlete’s foot and Dhobie itch, 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.
You can open the sealed tube by using the spike at the top of the cap.
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 Cuplex Athlete’s
Foot Cream during the second week, full skin healing after the infection has cleared will continue for
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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 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 frequently change underwear; 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.
Use in children
The use of Cuplex Athlete’s Foot Cream is not recommended for children under the age of 16 years.
If you use more Cuplex Athlete’s Foot 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 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 forget to use Cuplex Athlete’s Foot Cream
If you forget to use your cream, apply the cream as soon as possible, and then continue the 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 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 medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases people may be allergic to Cuplex Athlete’s Foot Cream, which could cause swelling of
the tongue, throat, face and lips, difficulty breathing or swallowingas well as blistering, severe skin
rash, hives or a worsening of itch. If you experience any of these particular symptoms, stop using
Cuplex Athlete’s Foot Cream and tell your doctor or pharmacist immediately.
Local symptoms listed below 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.
Common side effects (may affect up to 1 in 10 people):
Peeling skin, itching of the skin.
Uncommon side effects (may affect up to 1 in 100 people):
Damage to the skin (lesion), scab, skin disorder, skin colour changes, redness of the skin, skin burning
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sensation, pain, application site pain, application site irritation.
Rare side effects (may affect up to 1 in 1,000 people):
Eye irritation, dry skin, redness and swelling of the skin (contact dermatitis), eczema, worsening of the
skin condition.
Not known side effects (frequency cannot be estimated from the available data):
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 or
search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you
can help provide more information on the safety of this medicine.

5.

How to store Cuplex Athlete’s Foot Cream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the
last day of that month.
This medicinal product does not require any special storage conditions.
Store in original container.
Do not use this medicine if you notice visible signs of deterioration.
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 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 Cream looks like and contents of the pack
White or almost white cream, with slight almond odour.
Packs contain 1 tube of cream (7.5 g or 15 g).
Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21
Hungary
Distributed in the UK by: Crawford Healthcare Ltd, Cheshire, WA16 0BE.
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www.crawfordhealthcare.com
This leaflet was last revised in November 2017.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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