Patient leaflet - Adapalene / Benzoyl Peroxide Perennial Pharma 0.3% / 2.5% gel
1. What Adapalene/Benzoyl Peroxide Gel is and what it is used for
Adapalene/Benzoyl Peroxide Gel belongs to a group of medicines called “anti-acne preparation for topical use”. It is used for the treatment of acne vulgaris, when comedones (blackheads, whiteheads), numerous papules and pustules (inflammatory pimples) are present.
It combines two active ingredients, adapalene and benzoyl peroxide which work together but in different ways:
Adapalene belongs to a group of products known as retinoids and acts specifically on the skin
processes that cause acne.
Benzoyl peroxide, the other active ingredient, works as an antimicrobial agent and by softening
and peeling the outer layer of the skin.
This medicinal product should only be used in adults and adolescents aged 12 years and over.
2. What you need to know before you use Adapalene/Benzoyl Peroxide Gel
Do not use Adapalene/Benzoyl Peroxide Gel
- if you are allergic to adapalene or benzoyl peroxide or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant
- if you are planning to have a baby
Warnings and precautions
Talk to your doctor or pharmacist before using this medicinal product.
You should not use this gel on areas where you have cuts, scrapes, sunburn or eczema.
Make sure the gel does not get into your eyes, mouth or nostrils, and other very sensitive areas of the body. If this occurs wash these areas immediately with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid getting the gel on your hair or coloured fabrics as it may bleach them.
Wash your hands thoroughly after you have used this medicine.
If you experience persistent skin irritation when starting treatment with this gel contact your doctor (see section 3 How to use Adapalene/Benzoyl Peroxide Gel).
Other medicines and Adapalene/Benzoyl Peroxide Gel
Do not use other acne products (containing benzoyl peroxide and/or retinoids) at the same time with this gel.
Avoid using Adapalene/Benzoyl Peroxide Gel at the same time as cosmetics that are irritant, drying or exfoliate the skin.
Other medicines may have an effect on your treatment/this gel, so tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
Pregnancy
DO NOT use Adapalene/Benzoyl Peroxide Gel if you are pregnant or if you are planning to have a baby. Your doctor can give you more information.
If you become pregnant while using this medicinal product, the treatment must be discontinued and you should inform your doctor as soon as possible for a further follow-up.
Breast-feeding
If you are breast-feeding ask your doctor for advice before using this medicine. Your doctor will advise you whether to discontinue breast-feeding or to abstain from treatment with this gel.
If your doctor advises you to continue the treatment, avoid application of the gel to the chest in order to avoid contact exposure of the infant.
Driving and using machines
Adapalene/Benzoyl Peroxide Gel has no or negligible effects on the ability to drive and use machines.
Adapalene/Benzoyl Peroxide Gel contains propylene glycol which may cause skin irritation.
This medicine contains 40 mg of propylene glycol (E1520) in each gram of gel which is equivalent to 4.00% w/w.
Adapalene/Benzoyl Peroxide Gel contains benzoic acid, a degradation product of benzoyl peroxide, which may cause local irritation.
3. How to use Adapalene/Benzoyl Peroxide Gel
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
This medicinal product is only intended for use in adults, and adolescents aged 12 years and over. This medicine is for external use only.
The doctor will decide which strength of gel you need, depending on the severity and appearance of your acne. The doctor will also decide if you need any additional treatment.
- The skin should be clean and dry before application.
Apply a thin film of gel evenly over the entire acne-affected areas of the face and/or the trunk, once a day at bedtime. Avoid contact with the eyes, lips, nostrils
and mucous membranes.
- If used on the face: Wash and dry the face and use a pea size amount to cover each part of the face (such as forehead, chin, each cheek).
- Wash your hands thoroughly immediately after you have applied the gel.
Your doctor will tell you how long you will need to use this medicinal product . If you do not see any improvement after 4-8 weeks you should discuss with your doctor the benefit of continuing the treatment.
If you experience persistent skin irritation during the first weeks when using this gel, contact your doctor. Your doctor may recommend you to apply a moisturiser, to use the gel less often, to stop for a short time, or to stop using the gel.
Do not apply cosmetics (such as other facial creams or make-up) before the daily application of the gel. These products can be used after the applied gel has dried.
Use in children
This medicinal product should not be used by children below 12 years of age.
If you use more Adapalene/Benzoyl Peroxide Gel than you should
If you use more gel than you should on your skin, you will not get rid of your acne quicker, but your skin may become irritated and red.
Please contact your doctor or the hospital:
If you have used more Adapalene/Benzoyl Peroxide Gel than you should.
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- If a child has accidentally taken this medicine.
- If you accidentally swallow this medicine.
Your doctor will advise you on action to be taken.
If you forget to use Adapalene/Benzoyl Peroxide Gel
Do not apply a double dose to make up for forgotten individual doses.
The spots (comedones, papules and pustules) will be reduced only after several applications of this medicine. Continue using this treatment as long as prescribed by your doctor.
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.
Approximately 1 in 10 people using this medicine may experience adverse skin reactions.
Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. The frequency with which these side effects occur is not known.
Common side effects (may affect up to 1 in 10 people):
- skin burning sensation
- - irritation of the skin
- - eczema
- - reddening of the skin
- - scaling
Uncommon side effects (may affect up to 1 in 100 people):
- Redness of the eyelid
- Tingling or sensation of pins and needles at the application site
- Itching of the skin, allergic skin reaction
- Rash
- Dry skin
In addition to the side effects described above, the following side effects have been reported with a lower strength of adapalene / benzoyl peroxide gel (1 mg/g + 25 mg/g):
Uncommon side effects (may affect up to 1 in 100 people):
- Sunburn
Not known (frequency cannot be estimated from the available data):
- swelling of the eyelid
- tightness in the throat
- allergic contact reactions
- swelling face
- pain of skin (stinging pain)
- blisters (vesicles)
- difficulty in breathing
- skin discolouration (change in skin colour)
- application site burn
Adverse reactions typically associated with use of Adapalene/Benzoyl Peroxide Gel include mild to moderate application site reactions, such as skin irritation with redness, dryness, scaling, stinging and or burning of the skin.
Application site burns are in general superficial, but more severe cases involving blistering, have been reported.
If you experience persistent skin irritation during the first weeks when using this medicinal product, contact your doctor. Adverse skin-reactions, such as skin irritation, are more frequent with higher strength gel than with lower strength (adapalene/benzoyl peroxide 1 mg/g + 25 mg/g gel). You may be asked to apply a moisturiser, to use the gel less often, to stop for a short time, or to stop using the gel. These reactions usually occur early in the treatment, and tend to gradually lessen over time.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: 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 Adapalene/Benzoyl Peroxide Gel
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 carton and tube. The expiry date refers to the last day of that month.
Do not store above 30°C.
After first opening of the tube, use the product within 3 months.
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 Adapalene/Benzoyl Peroxide Gel contains
The active substances are: adapalene and benzoyl peroxide. 1 g of gel contains 3 mg (0.3% w/w) adapalene and benzoyl peroxide, hydrous, equivalent to 25
mg (2.5% w/w) of anhydrous benzoyl peroxide.
The other ingredients are: propylene glycol (E1520); glycerol; sepineo P600 (Acrylamide and sodium acryloyldimethyltaurate copolymer (1:1), isohexadecane,
polysorbate 80, sorbitan oleate); poloxamer 124; disodium edetate; docusate sodium; purified water.
What Adapalene/Benzoyl Peroxide Gel looks like and contents of the pack
Homogeneous opaque gel of white to very pale-yellow colour.
Pack size of 1 tube of 30 g, 45 g or 60 g.
Gel is packed in white HDPE/LLDPE plastic tubes with a white HDPE head, having an aluminium peel-off seal and closed with a white polypropylene screw-cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Perennial Pharma Ltd
Titan Court, 2nd Floor,
3 Bishop Square,
Hatfield,
AL10 9NA,
United Kingdom
This leaflet was last revised in 12/2025.
For information in large print, Braille or on CD, telephone 01707 927427. Manufacturer 1
Beltapharm S.p.A
Via Stelvio 66 - 20095
Cusano Milanino,
Milan
Italy
Manufacturer 2
GMP Manufacturing Ltd. Marfleet House, Valletta Street Hull
HU9 5NP
United Kingdom
ARTDB034949P
