Document: Leaflet CRAWFORD HEALTHCARE_PL 04854-0044 change

• Leaflet CRAWFORD HEALTHCARE_PL 04854-0044
• leaflet MAH BRAND_PL 04854-0044
• leaflet MAH GENERIC_PL 04854-0044

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Cuplex Athlete's Foot 1% w/w Cream

Terbinafine hydrochloride 1% w/w Cream    Acrawford

•    HEALTHCARE

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

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 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.

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.

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.

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 should not be used during pregnancy unless a physician advises, who decides the potential benefits outweigh any potential risks.

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.

Driving and using machines

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

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, Gyomroi ut 19-21, Hungary.

Manufactured by: Gedeon Richter Plc., 1103 Budapest, Gyomroi ut 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