Instructions Belakne Duo 1 mg/g + 25 mg/g gel bottle 30 g
Composition
active ingredient: adapalene, benzoyl peroxide;
1 g of gel contains 1 mg of adapalene and 25 mg of benzoyl peroxide (as aqueous benzoyl peroxide);
excipients: disodium edetate, sodium docusate, glycerin, poloxamer 124, propylene glycol, Sipeneo P600 (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate, water), sorbitan oleate, purified water.
Dosage form
Gel.
Main physicochemical properties: opaque gel from white to very pale yellow.
Pharmacotherapeutic group
Topical acne treatments. Retinoids for topical acne treatment. Adapalene, combinations.
ATX code D10AD53
Pharmacological properties
Pharmacodynamics
Mechanism of action and pharmacodynamic effects
BELAKNE® DUO combines two active ingredients that act through different but complementary mechanisms.
Adapalene is a chemical derivative of naphthoic acid with retinoid activity. Studies of the biochemical and pharmacological profile have shown that adapalene acts on the pathology of common acne: it is a potent modulator of cell differentiation and keratinization and has anti-inflammatory properties. Mechanistically, adapalene binds to specific nuclear receptors for retinoic acid. Current evidence suggests that topical adapalene normalizes the differentiation of follicular epithelial cells, which contributes to a reduction in the formation of microcomedones. Adapalene inhibits the chemotactic (directed) and chemokinetic (random) responses of human polymorphonuclear leukocytes in in vitro assay models: it also inhibits the metabolism of arachidonic acid to inflammatory mediators.
Benzoyl peroxide: Benzoyl peroxide has been shown to have antimicrobial activity; particularly against P. acnes, which is abnormally present in the pilosebaceous unit affected by acne. In addition, benzoyl peroxide exhibits exfoliative and keratolytic activity. Benzoyl peroxide is also a sebostatic, counteracting the excessive sebum production associated with acne.
Pharmacokinetics
The pharmacokinetic (PK) properties of the fixed combination of adapalene/benzoyl peroxide are similar to the PK profile of adapalene 0.1% gel.
In a 30-day clinical pharmacokinetic study conducted in acne patients tested with either the fixed combination gel or the adapted formulation of adapalene 0.1% under maximal conditions (2 g gel per day), adapalene was not quantifiable in most plasma samples (limit of quantification 0.1 ng/mL). Low levels of adapalene (Cmax 0.1 to 0.2 ng/mL) were measured in two blood samples from subjects receiving the fixed combination of adapalene/benzoyl peroxide and in three samples from subjects receiving 0.1% adapalene gel. The highest AUC0-24h of adapalene determined in the fixed combination group was 1.99 ng×h/mL.
These results are comparable to those obtained in previous clinical pharmacokinetic studies of different formulations of adapalene 0.1%, where systemic exposure to adapalene was consistently low.
Percutaneous penetration of benzoyl peroxide is low; when applied to the skin, it is completely converted to benzoic acid, which is rapidly excreted.
Indication
Use to treat common acne (acne vulgaris) with comedones, papules, and pustules.
Contraindication
- Hypersensitivity to the active substances or to any of the excipients
- Pregnancy
- Pregnancy planning
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
From previous experience with adapalene and benzoyl peroxide, it is known that there are no interactions with other drugs that can be used subcutaneously and simultaneously with BELAKNE® DUO. However, other retinoids and benzoyl peroxide or drugs with a similar mechanism of action should not be used simultaneously. Caution should be exercised when using cosmetics with desquamative, irritating or drying effects, as they may cause habituation and irritation when using BELAKNE® DUO.
Absorption of adapalene through human skin is low (see Pharmacokinetics), so interactions with systemic drugs are unlikely.
Percutaneous penetration of benzoyl peroxide into the skin is low, and the drug substance is completely metabolized to benzoic acid, which is rapidly excreted. Therefore, the potential for interactions of benzoic acid with systemic drugs is unlikely.
Application features
BELAKNE® DUO, gel, should not be applied to damaged skin (cuts or abrasions), eczematous skin or sunburn.
BELAKNE® DUO should not come into contact with the eyes, mouth, nostrils or mucous membranes. If the product gets into the eyes, rinse them immediately with warm water.
If a reaction indicating sensitivity to any component occurs, use of BELAKNE® DUO should be discontinued.
BELAKNE® DUO should not come into contact with any colored material, including hair and dyed fabrics, as this may cause bleaching and discoloration.
This medicine contains propylene glycol, which may cause skin irritation.
Use during pregnancy or breastfeeding
Oral administration has been associated with congenital anomalies. With topical retinoids at recommended doses, systemic exposure is expected to be low due to minimal dermal absorption. However, there may be individual factors (e.g., skin barrier impairment, overuse) that contribute to increased systemic exposure.
Pregnancy
BELAKNE® DUO is contraindicated during pregnancy and in women planning to become pregnant. There are no or limited data from the use of topical adapalene in pregnant women.
Animal studies have shown reproductive toxicity at high systemic exposure following oral administration.
Clinical experience with topical adapalene and benzoyl peroxide during pregnancy is limited. If pregnancy occurs, the drug should be discontinued.
Breastfeeding
No studies have been conducted on the excretion in milk of animals or humans after application of adapalene/benzoyl peroxide fixed combination gel to the skin.
No effects on the breastfed child are expected, as the systemic exposure of BELAKNE® DUO to the breast-feeding woman is negligible. BELAKNE® DUO can be used during breast-feeding.
To avoid contact exposure to the infant, it is not recommended to apply BELAKNE® DUO gel to the chest during breastfeeding.
Fertility
No studies on the effects of adapalene/benzoyl peroxide fixed combination gel on human fertility have been conducted.
However, reproductive studies in rats showed no effect of adapalene or benzoyl peroxide on fertility.
The ability to influence the reaction speed when driving vehicles or other mechanisms. Does not affect.
Method of administration and doses
BELAKNE® DUO should be applied to the entire acne-affected area once a day in the evening on clean and dry skin. A thin layer of gel should be applied with the fingertips, avoiding the eye and lip areas (see section "Special instructions for use").
Tube: The amount of gel on the tip of your finger corresponds to approximately a 2.5 cm strip of gel or 0.5 g of gel.
Bottle: the amount of gel per pump press is about 0.5 g.
If irritation occurs, the patient should be advised to use non-comedogenic moisturizers, use BELAKNE® DUO less frequently (e.g., every other day), temporarily suspend use, or discontinue use of the product altogether.
The duration of treatment should be determined by the physician based on the clinical condition. Early signs of clinical improvement usually appear after 1–4 weeks of treatment.
Children: The safety and efficacy of BELAKNE® DUO have not been studied in children under 9 years of age.
Overdose
BELAKNE® DUO is intended for application to the skin once a day only.
In case of accidental ingestion, appropriate symptomatic measures should be taken.
Adverse reactions
The following categories are used to describe the frequency of adverse reactions: very common (≥ 1/10), common (≥ 1/100), rare (≥ 1/1000,
Vision impairment
Frequency unknown*: eyelid edema.
Immune system disorders
Frequency unknown*: anaphylactic reaction.
Respiratory, thoracic and mediastinal disorders
Frequency unknown*: tightness in the throat, shortness of breath.
Skin and subcutaneous tissue disorders
Common: dry skin, irritant contact dermatitis, skin irritation, burning sensation of the skin, erythema, skin peeling (desquamation).
Rare: itching, sunburn.
Frequency unknown*: allergic contact dermatitis, facial swelling, skin pain (burning pain), blisters (vesicles), skin discoloration (hyperpigmentation and hypopigmentation), urticaria, application site burn**.
* Post-marketing surveillance data.
** Most cases of “application site burns” were superficial burns, but cases of second-degree burns or serious burn reactions have been reported.
If skin irritation occurs after the use of BELAKNE® DUO, its intensity is usually mild to moderate, with local signs and symptoms of tolerance [erythema, dryness, scaling, burning and pain on the skin (burning pain)], which reach a maximum during the first week, and then the irritation subsides spontaneously.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
24 months.
Shelf life after first opening: 6 months at a temperature not exceeding 25 °C.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
30 g in a tube and a cardboard box; 30 g in a bottle with an airless pump and a cardboard box.
Vacation category
According to the recipe.
Producer
Belupo, pharmaceuticals and cosmetics, Inc.
Location of the manufacturer and address of its place of business.
Danica Street 5, 48000 Koprivnica, Croatia / Ulica Danica 5, 48000 Koprivnica, Croatia
