DIFFERIN <0.1%> Gel

Зміст інструкції

1. DIFFERIN 0,1% GEL
   1. What Differin is and what it is used for
   2. What you need to know before using Differin
   3. How to use Differin
   4. Possible side effects
   5. How to store Differin
   6. Contents of the pack and other information

DIFFERIN 0,1% GEL

DIFFERIN 0,1 % CREAM
adapalene
Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Differin is and what it is used for
• 2. What you need to know before you use Differin
• 3. How to use Differin
• 4. Possible side effects
• 5. How to store Differin
• 6. Contents of the pack and other information

1. What Differin is and what it is used for

Adapalene, the active substance contained in Differin, belongs to the category of retinoids, chemical compounds
related to Vitamin A. It is indicated for the local treatment (application to the skin)
of common acne with comedones (pinpoint skin elevations), papules (small raised skin lesions
without pus) and pustules (small skin lesions that contain pus).
It is suitable for the treatment of acne on the face, chest and back.

2. What you need to know before using Differin

Do not use Differin:

• if you are allergic to adapalene or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant
• If you are planning a pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before using Differin.
Avoid contact with eyes, mouth, corners of the nose or mucous membranes.
If the medicine comes into contact with your eyes, rinse them immediately with plenty of
lukewarm water. Avoid applying the medicine to broken skin (cuts or abrasions), sunburned or
eczematous skin (skin inflammation) and in case of severe, widespread acne covering large areas of the body.
Avoid excessive exposure to sunlight or UV radiation (tanning beds). When
exposure cannot be avoided, you must use sunscreen and protective clothing on the treated areas.
Stop using the medicine immediately if you experience a sensitization reaction or
severe irritation.

Children and adolescents
The safety and efficacy of adapalene have not been evaluated in children under 12 years of age.

Other medicines and Differin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• No interactions with other medicines used locally together with Differin are known; however, do not use the medicine together with other retinoids or medicines with the same mechanism of action.
• The absorption of adapalene through the skin is low and therefore interaction with other medicines for non-local use is unlikely. There is no evidence that local use of adapalene affects the effectiveness of medicines for oral use such as contraceptives (used for pregnancy prevention) or antibiotics (used for the treatment of infections).
• Differin may cause local irritation. If used concurrently with Differin and exfoliating agents (which remove dead skin cells), abrasive cleansers, strong drying agents, astringents or irritating products (containing aromatic agents or alcohol), the irritating effect may be greater. However, acne treatments, such as erythromycin solutions (up to 4%), clindamycin phosphate (1% as a base) or benzoyl peroxide aqueous gels up to 10% can be used in the morning if Differin is applied in the evening.

Pregnancy and breastfeeding
DO NOT USE Differin if you are pregnant or planning a pregnancy. Your doctor can give you
more information.
If an unplanned pregnancy occurs, stop treatment immediately.
Differin can be used during breastfeeding. To avoid exposing the infant through contact, avoid
applying Differin to the breast.

Driving and using machines
Differin does not impair the ability to drive and use machines.

Differin Gel contains:

• Methyl parahydroxybenzoate (E218) which may cause allergic reactions (including delayed ones)
• Propylene glycol which may cause skin irritation.

Differin Cream contains:

• Methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (including delayed ones)

3. How to use Differin

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or
pharmacist. If you have any doubts, ask your doctor or pharmacist.
You must apply Differin to the areas affected by acne once a day after washing and drying the skin
thoroughly. Apply only a thin layer of gel or cream avoiding contact with the eyes, lips, mucous
membranes and the corners of the nose.
The recommended daily dose is approximately 3 fingertip units (2 g of total product weight), which
corresponds to the amount needed to treat all potentially affected areas (the entire face, shoulders,
the upper part of the chest and the upper back).
One fingertip unit is the amount squeezed from the tube onto the surface of the first phalanx of the index finger.

Do not use astringent or comedogenic cosmetics (punctiform skin elevations).
The doctor will re-evaluate the therapy after 12 weeks.

If you use more Differin than you should
If you apply an excessive amount of Differin, you will not achieve better or faster results and may experience
severe redness, scaling or skin discomfort.
You must not take Differin orally.

In case of accidental ingestion of a considerable amount of Differin, immediately
notify your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Differin can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice any of the following symptoms because you may urgently
need medical treatment: swelling of the face, lips or throat, which makes it difficult to swallow or
breathe, hives, itching, skin rashes and dizziness. These could be symptoms of angioedema
or a severe allergic reaction (frequency not known, cannot be defined on the basis of
available data).
The following side effects are listed in order of frequency:

Common( may affect up to 1 in 10 people)

• skin dryness
• skin irritation
• burning sensation
• erythema (skin irritation)

Uncommon (may affect up to 1 in 100 people)

• contact dermatitis (inflammatory skin reaction)
• skin discomfort
• sunburn
• itching
• exfoliation
• acne

Side effects with unknown frequency* (cannot be defined on the basis of available
data)

• allergic dermatitis (allergic contact dermatitis)
• skin pain
• swelling
• eyelid irritation
• eyelid erythema
• eyelid itching
• eyelid swelling
• darkening of fair skin
• lightening of dark skin
• burn at the application site

* Post-marketing pharmacovigilance data
Burns at the application site (mainly superficial burns but also second degree or severe burns) have been observed.
Skin irritation is reversible by reducing or stopping the frequency of treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Differin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
The expiry date refers to the medicine in intact packaging, correctly stored.
Differin 0,1% Cream: this medicine does not require any particular storage conditions.
Differin 0,1% Gel: do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Differin 0.1% Gel contains

• The active ingredient is adapalene. 100 g of gel contains 0.1 g of adapalene
• The other components are carbomer, propylene glycol, poloxamer 182, disodium edetate, methyl parahydroxybenzoate, phenoxyethanol, sodium hydroxide for pH adjustment to 5, purified water.

What Differin 0.1% Cream contains

• The active ingredient is adapalene. 100 g of cream contains 0.1 g of adapalene
• The other components are carbomer 934P, Peg-20 methyl glucose sesquistearate, glycerol, natural squalane, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, methyl glucose sesquistearate, phenoxyethanol, cyclomethicone, sodium hydroxide for pH adjustment to 6.5 + 0.2, purified water.

Description of the appearance of Differin and contents of the pack
Gel for cutaneous use, tube of 30 g
Cream for cutaneous use, tube of 30 g

Marketing Authorisation Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 - Milan

Manufacturer
Laboratoires Galderma, Z. I. Montdésir, 74540 Alby-sur-Chéran (France)