Name of medical institution

50426012018年9月作成 A0918AX-IS

[Supervising editor]

Miki TaniokaPresident, Tanioka Dermatology Clinic

Information for Users of

Epiduo® GelA treatment for acne vulgaris

Distributors

Precautions for use

■ Avoid excessive exposure to sunlight, such as in sea or mountain areas, and use of UV lamps for tanning.

■ Take care to avoid getting Epiduo® Gel on your hair or colored fabrics, as it may cause bleaching.

How to Store Epiduo® Gel

■ Keep Epiduo® Gel away from humidity and under a room temperature of 1ºC to 30ºC.

Symptoms of acne

Acne

Major causes of acne

1) Sebaceous secretion is enhanced by male hormones or other factors.

2) Pores are filled with old dead skin.

3) Acne bacteria (Propionibacterium acnes) orother acne-causing bacteria grow in pores.

To avoid acne scars,

it is important to properly

treat acne in its early stage.

Hair

Pore

If inflammation spreads to the

surrounding tissues, acne scars

might be left behind on the

skin.

The contents in pores spread

and aggravate the acne.

Acne bacteria growing in pores

invite inflammatory substances

and result in inflammation.

Acne bacteria

This picture shows the condition

in which no sebum is excreted

from pores because the pores

are closed, and appear white or

black. This condition is an ideal

environment for the growth of

acne bacteria, which like sebum

and dislike oxygen.

Sebum is produced in sebaceous

glands. Sebum is secreted through

pores and covers the surface of

skin to maintain healthy skin. Acne

bacteria also exist as indigenous

bacteria.

Sebum

Inflammatory acneNormal skin

Acne scars

Non-inflammatory acne

Yellow acne with pusRed acneComedo

Inflammatory substances

Acne bacteria

Sebaceous gland

Pore closure

Acne bacteria

Acne bacteria growing

1 2

Symptoms of acne

Acne

Major causes of acne

1) Sebaceous secretion is enhanced by male hormones or other factors.

2) Pores are filled with old dead skin.

3) Acne bacteria (Propionibacterium acnes) orother acne-causing bacteria grow in pores.

To avoid acne scars,

it is important to properly

treat acne in its early stage.

Hair

Pore

If inflammation spreads to the

surrounding tissues, acne scars

might be left behind on the

skin.

The contents in pores spread

and aggravate the acne.

Acne bacteria growing in pores

invite inflammatory substances

and result in inflammation.

Acne bacteria

This picture shows the condition

in which no sebum is excreted

from pores because the pores

are closed, and appear white or

black. This condition is an ideal

environment for the growth of

acne bacteria, which like sebum

and dislike oxygen.

Sebum is produced in sebaceous

glands. Sebum is secreted through

pores and covers the surface of

skin to maintain healthy skin. Acne

bacteria also exist as indigenous

bacteria.

Sebum

Inflammatory acneNormal skin

Acne scars

Non-inflammatory acne

Yellow acne with pusRed acneComedo

Inflammatory substances

Acne bacteria

Sebaceous gland

Pore closure

Acne bacteria

Acne bacteria growing

1 2

Effects of Epiduo® Gel

Usage of Epiduo® Gel

Epiduo® Gel contains two active ingredients: benzoyl peroxide and adapalene.

BenzoylPeroxide

This ingredient treats

the closure of pores

and inhibits the

growth of acne

bacteria and other

acne-causing bacteria.

This ingredient prevents

acne-causing pore

closure and inhibits

comedo formation.

Adapalene

*Regarding the application site, dose, and period, please follow the instructions of your physician or pharmacist.

You might have dry skin, skin irritation, skin redness, or other symptoms within 2 weeks after you begin treatment. These symptoms usually become milder in the course of treatment. However, if you are anxious about any symptoms or if the application site becomes red or swollen, stop using the gel and discuss it with your physician or pharmacist.

The number of pimples will be reduced gradually. You can see the effect of the gel if you compare your present condition with a photo of yourself taken when you started treatment.

Acne is likely to repeatedly occur for various reasons. To keep your acne relieved, continue treatment with the gel and follow the instructions of your physician.

If your symptoms are not improved within 3 months after starting treatment with Epiduo® Gel, discontinue its use.

Attreatment

start

Period for confirmationof the treatment effect

Period for maintenanceof the improved status

High

Low

Freq

uenc

y o

f sk

in ir

rita

tio

n

Great

Small

Num

ber o

f acne

Number of acne

Skin irritation

Because acne is likely to occur repeatedly,it is important to continue treatment for comedos (pore closure).

Changes over time in the number of acne and skin irritation (image)

At treatment start

Period for confirmationof the treatment effect

Period for maintenanceof the improved status

From the start of treatment to2 weeks after the start of treatment

2 weeks to 3 months afterthe start of treatment

3 months to 1 year afterthe start of treatment

Clinical Course of Treatment with Epiduo® Gel

■ Apply an adequate amount of Epiduo® Gel, once daily (in the early evening or

before going to bed). Clean and dry the skin before applying Epiduo® Gel.

Do not apply Epiduo® Gel more than once a day.

Do not use more Epiduo® Gel than prescribed.

■ To prevent dry skin, it is recommended to moisturize the skin with

non-comedogenic products before applying Epiduo® Gel.(Non-comedogenic products: Products that have been demonstrated to help avoid acne breakouts)

■ Thinly spread the gel without rubbing, taking care not to apply the gel to

your eyes, lips, nostrils, mucosa, wounds, or eczema.

If you accidentally get it in your eyes, immediately rinse your eyes with water.

■ Wash your hands after use.

Treatmentstarted

2weeks

3months

1year

3 4

Effects of Epiduo® Gel

Usage of Epiduo® Gel

Epiduo® Gel contains two active ingredients: benzoyl peroxide and adapalene.

BenzoylPeroxide

This ingredient treats

the closure of pores

and inhibits the

growth of acne

bacteria and other

acne-causing bacteria.

This ingredient prevents

acne-causing pore

closure and inhibits

comedo formation.

Adapalene

*Regarding the application site, dose, and period, please follow the instructions of your physician or pharmacist.

You might have dry skin, skin irritation, skin redness, or other symptoms within 2 weeks after you begin treatment. These symptoms usually become milder in the course of treatment. However, if you are anxious about any symptoms or if the application site becomes red or swollen, stop using the gel and discuss it with your physician or pharmacist.

The number of pimples will be reduced gradually. You can see the effect of the gel if you compare your present condition with a photo of yourself taken when you started treatment.

Acne is likely to repeatedly occur for various reasons. To keep your acne relieved, continue treatment with the gel and follow the instructions of your physician.

If your symptoms are not improved within 3 months after starting treatment with Epiduo® Gel, discontinue its use.

Attreatment

start

Period for confirmationof the treatment effect

Period for maintenanceof the improved status

High

Low

Freq

uenc

y o

f sk

in ir

rita

tio

n

Great

Small

Num

ber o

f acne

Number of acne

Skin irritation

Because acne is likely to occur repeatedly,it is important to continue treatment for comedos (pore closure).

Changes over time in the number of acne and skin irritation (image)

At treatment start

Period for confirmationof the treatment effect

Period for maintenanceof the improved status

From the start of treatment to2 weeks after the start of treatment

2 weeks to 3 months afterthe start of treatment

3 months to 1 year afterthe start of treatment

Clinical Course of Treatment with Epiduo® Gel

■ Apply an adequate amount of Epiduo® Gel, once daily (in the early evening or

before going to bed). Clean and dry the skin before applying Epiduo® Gel.

Do not apply Epiduo® Gel more than once a day.

Do not use more Epiduo® Gel than prescribed.

■ To prevent dry skin, it is recommended to moisturize the skin with

non-comedogenic products before applying Epiduo® Gel.(Non-comedogenic products: Products that have been demonstrated to help avoid acne breakouts)

■ Thinly spread the gel without rubbing, taking care not to apply the gel to

your eyes, lips, nostrils, mucosa, wounds, or eczema.

If you accidentally get it in your eyes, immediately rinse your eyes with water.

■ Wash your hands after use.

Treatmentstarted

2weeks

3months

1year

3 4

If systemic hypersensitivity reaction such as rash or fever occurs, or if treated areas or even the skin surrounding these areas become extremely reddened or swollen, discontinue the treatment with Epiduo® Gel and consult your doctor as soon as possible. Depending on the severity of your symptom, adequate action such as discontinuation or temporary suspension of the treatment with Epiduo® Gel and/or treatment of symptoms may be taken.

These symptoms are likely to occur within two weeks after you start treatment.

Even though these symptoms are usually mild and transient,

if you are anxious, discuss it with your physician or pharmacist.

The following skin symptoms might occur during treatment with the gel:

●Dry skin

●Skin discomfort (e.g. tingling)

●Skin exfoliation (i.e. small scaling of skin)

●Erythema (redness)

●Pruritus (itching)

■ If you have had an allergic reaction to any of the ingredients of this medicine.

■ If you are or may be pregnant.■ If you intend to become pregnant during treatment with this

medicine.

If you become pregnant or suspect that you are pregnant

during treatment with this product, stop using this product

immediately and consult with your doctor.

If you suspect that you are pregnant, do not use this

product. When this product was orally administered to

pregnant laboratory animals at a dose higher than that

used for treatment of acne, abnormalities in the bones and

organs of fetuses were observed.

<Reference information>

It has been reported that an oral drug of the same class had an effect on the testis when it was

administered at a high dose to male laboratory animals.

However, there is no report of such an effect on the testis with this product.

Do not use this product if you are a lactating mother.

If you have no choice but to use this product, please

stop breastfeeding.

Possible adverse reactions caused by Epiduo® Gel You must not use Epiduo® Gel

Information for pregnant women

Information for breastfeeding women

5 6

If systemic hypersensitivity reaction such as rash or fever occurs, or if treated areas or even the skin surrounding these areas become extremely reddened or swollen, discontinue the treatment with Epiduo® Gel and consult your doctor as soon as possible. Depending on the severity of your symptom, adequate action such as discontinuation or temporary suspension of the treatment with Epiduo® Gel and/or treatment of symptoms may be taken.

These symptoms are likely to occur within two weeks after you start treatment.

Even though these symptoms are usually mild and transient,

if you are anxious, discuss it with your physician or pharmacist.

The following skin symptoms might occur during treatment with the gel:

●Dry skin

●Skin discomfort (e.g. tingling)

●Skin exfoliation (i.e. small scaling of skin)

●Erythema (redness)

●Pruritus (itching)

■ If you have had an allergic reaction to any of the ingredients of this medicine.

■ If you are or may be pregnant.■ If you intend to become pregnant during treatment with this

medicine.

If you become pregnant or suspect that you are pregnant

during treatment with this product, stop using this product

immediately and consult with your doctor.

If you suspect that you are pregnant, do not use this

product. When this product was orally administered to

pregnant laboratory animals at a dose higher than that

used for treatment of acne, abnormalities in the bones and

organs of fetuses were observed.

<Reference information>

It has been reported that an oral drug of the same class had an effect on the testis when it was

administered at a high dose to male laboratory animals.

However, there is no report of such an effect on the testis with this product.

Do not use this product if you are a lactating mother.

If you have no choice but to use this product, please

stop breastfeeding.

Possible adverse reactions caused by Epiduo® Gel You must not use Epiduo® Gel

Information for pregnant women

Information for breastfeeding women

5 6

Name of medical institution

50426012018年9月作成 A0918AX-IS

[Supervising editor]

Miki TaniokaPresident, Tanioka Dermatology Clinic

Information for Users of

Epiduo® GelA treatment for acne vulgaris

Distributors

Precautions for use

■ Avoid excessive exposure to sunlight, such as in sea or mountain areas, and use of UV lamps for tanning.

■ Take care to avoid getting Epiduo® Gel on your hair or colored fabrics, as it may cause bleaching.

How to Store Epiduo® Gel

■ Keep Epiduo® Gel away from humidity and under a room temperature of 1ºC to 30ºC.