Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Adapalene, Benzoyl peroxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of your medicine is Adapalene/Benzoyl Peroxide Zentiva 0.1%/2.5% gel (called Adapalene/Benzoyl gel throughout this leaflet). Adapalene/Benzoyl gel is used for the treatment of acne. This gel combines two active ingredients, adapalene and benzoyl peroxide which work together but in different ways:
e Adapalene/Benzoyl gel Do not use Adapalene/Benzoyl gel
Common side effects (may affect up to 1 in 10 people):
Adapalene/Benzoyl 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, adolescents and children aged 9 years and over. This medicine is for external use only. Apply a thin film of gel evenly over acne affected areas once a day at bedtime, avoiding the eyes, lips and nostrils. The skin should be clean and dry before application. You should wash your hands thoroughly after you have used Adapalene/Benzoyl gel. Your doctor will tell you how long you will need to use this medicinal product. If you feel that the effect of Adapalene/Benzoyl is too strong or too weak, talk to your doctor or pharmacist. If you experience persistent irritation when using this medicine, contact your doctor. Your doctor may recommend you to apply a moisturizer, to use the gel less often or to stop for a short time, or to stop using the gel altogether. If you use more Adapalene/Benzoyl 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:
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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.
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Adapalene/Benzoyl 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 6 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
What Adapalene/Benzoyl gel contains
Adapalene / Benzoyl Peroxide Zentiva 0.1%/2.5% gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Adapalene / Benzoyl Peroxide Zentiva 0.1%/2.5% gel is adapalene, benzoyl peroxide.
Medicines with the same active substance, strength and form include: Adawell 0.1%/2.5% Gel, Adawell Forte 0.3%/2.5% Gel, Epiduo 0.1%/2.5% Gel. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Adapalene / Benzoyl Peroxide Zentiva 0.1%/2.5% gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
This medicinal product is indicated for cutaneous treatment of Acne vulgaris when comedones, papules and pustules are present (see section 5.1).
Adapalene/Benzoyl Peroxide Zentiva is indicated in adults, adolescents and children aged 9 years and above.
The gel should be applied to the entire acne affected areas once a day in the evening on a clean and dry skin. A thin film of gel should be applied, with the fingertips, avoiding the eyes and lips (see section 4.4).
If irritation occurs, the patient should be directed to apply non-comedogenic moisturizers, to use the medication less frequently (e.g. every other day), to suspend use temporarily, or to discontinue use altogether.
The duration of treatment should be determined by the Doctor on the basis of the clinical condition. Early signs of clinical improvement usually appear after 1 to 4 weeks of treatment.
The safety and effectiveness of adapalene/benzoyl peroxide have not been studied in children below 9 years of age.
Method of administration
Cutaneous use only.
Patients should be instructed to wash their hands after applying the medicinal product.
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
• Pregnancy (see section 4.6)
• Women planning a pregnancy (see section 4.6)
Adapalene/Benzoyl Peroxide Zentiva should not be applied to damaged skin, either broken (cuts or abrasions), eczematous or sunburned.
Adapalene/Benzoyl Peroxide Zentiva should not come into contact with the eyes, mouth, nostrils or mucous membranes. If product enters the eye, it should be washed immediately with warm water.
If a reaction suggesting sensitivity to any component of the formula occurs, the use of this medicinal product should be discontinued.
Excessive exposure to sunlight or UV radiation should be avoided.
Adapalene/Benzoyl Peroxide Zentiva should not come into contact with any coloured material including hair and dyed fabrics as this may result in bleaching and discoloration.
Excipients
This product contains 40 mg of propylene glycol (E1520) in each gram of gel which is equivalent to 4.00% w/w that may cause skin irritation.
This medicine can contain up to 2.5 mg of benzoic acid per g of gel, as degradation product of benzoyl peroxide. Benzoic acid may cause local irritation.
No interaction studies have been performed.
From previous experience with adapalene and benzoyl peroxide, there are no known interactions with other medicinal products which might be used cutaneously and concurrently with the gel. However, other retinoids or benzoyl peroxide or medicinal products with a similar mode of action should not be used concurrently. Caution should be exercised if cosmetics with desquamative, irritant or drying effects are used, as they may produce additive irritant effects with this medicinal product.
Absorption of adapalene through human skin is low (see section 5.2), and therefore interaction with systemic medicinal products is unlikely.
The percutaneous penetration of benzoyl peroxide in the skin is low and the drug substance is completely metabolised into benzoic acid which is rapidly eliminated. Therefore, the potential interaction of benzoic acid with systemic medicinal products is unlikely to occur.
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Pregnancy
Adapalene/benzoyl peroxide is contraindicated in pregnancy or in women planning a pregnancy (see section 4.3).
There are no or limited amount of data from the use of adapalene topically in pregnant women.
Animal studies by the oral route have shown reproductive toxicity at high systemic exposure (see section 5.3).
Clinical experience with locally applied adapalene and benzoyl peroxide in pregnancy is limited.
If the product is used during pregnancy, or if the patient becomes pregnant while using this medicinal product, treatment should be discontinued.
Breast-feeding
No study on animal or human milk transfer was conducted after cutaneous application of adapalene and benzoyl peroxide gel.
No effects on the suckling child are anticipated since the systemic exposure of the breast-feeding woman to this medicinal product is negligible. Adapalene/Benzoyl Peroxide Zentiva can be used during breast-feeding
To avoid contact exposure of the infant, application of this gel t to the chest should be avoided when used during breast-feeding.
Fertility
No human fertility studies were conducted with adapalene and benzoyl peroxide gel.
However, no effects of adapalene or benzoyl peroxide on fertility were found in rats in reproductive studies (See section 5.3).
Not relevant.
Adapalene/Benzoyl Peroxide Zentiva may cause the following adverse reactions at the site of application:
MedDRA System Organ Class
Frequency
Adverse drug reaction
Eye disorders
Not known (cannot be estimated from the available data)*
Eyelid oedema
Immune system disorders
Not known (cannot be estimated from the available data)*
Anaphylactic reaction
Respiratory, thoracic, and mediastinal disorders
Not known (cannot be estimated from the available data)*
Throat tightness, dyspnoea
Skin and subcutaneous tissue disorders
Common (≥1/100 to <1/10)
Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation (scaling)
Uncommon (≥1/1 000 to <1/100)
Pruritus, sunburn
Not known (cannot be estimated from the available data)*
Allergic contact dermatitis, swelling face, pain of skin (stinging pain), blisters (vesicles), skin discolouration (hyperpigmentation and hypopigmentation), urticaria, application site burn**
*Post marketing surveillance data
**Most of the cases of “application site burn” were superficial burns but cases with second degree burn or severe burn reactions have been reported.
If skin irritation appears after application of this medicinal product, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning and pain of skin (stinging pain) peaking during the first week and then subsiding spontaneously.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adapalene/Benzoyl Peroxide Zentiva is for once-daily cutaneous use only.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
Ask anything about Adapalene / Benzoyl Peroxide Zentiva 0.1%/2.5% gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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