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Belakne
Method of action:
Treatment option:
Dosage (Posology) and method of administration
Belakne Cream should be applied to the acne affected areas once a day before retiring and after washing. A thin film of cream should be applied, with the fingertips, avoiding the eyes and lips (see 4.4 Special warnings and special precautions for use, below). Ensure that the affected areas are dry before application.
Since it is customary to alternate therapies in the treatment of acne, it is recommended that the physician assess the continued improvement of the patient after three months of treatment with Belakne Cream.
With patients for whom it is necessary to reduce the frequency of application or to temporarily discontinue treatment, frequency of application may be restored or therapy resumed once it is judged that the patient can again tolerate the treatment.
If patients use cosmetics, these should be non-comedogenic and non-astringent.
Paediatric population: The safety and effectiveness of Belakne Cream have not been studied in children below 12 years of age.
Undesirable effects
Belakne may cause the following adverse drug reactions:
| Body System (MeDRA) | Frequency | Adverse Drug Reaction |
| Skin and subcutaneous tissue disorders | Common (>1/100 to <1/10) | Dry skin, skin irritation, skin burning sensation, erythema |
| Uncommon (>1/1000 to <1/100) | Dermatitis contact, skin discomfort, sunburn, pruritus, skin exfoliation, acne | |
| Unknown* | Dermatitis allergic (allergic contact dermatitis), pain of skin, skin swelling, | |
| Eye disorders | Unknown* | eyelid irritation, eyelid erythema, eyelid pruritus, eyelid swelling |
*Post marketing surveillance data
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. Website: www.mhra.gov.uk/yellowcard
Overdose
Belakne Cream is not to be taken orally and is for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling or discomfort may occur.
The acute oral dose of Belakne Cream required to produce toxic effects in mice is greater than 10 g/kg. Nevertheless, unless the amount accidentally ingested is small, an appropriate method of gastric emptying should be considered.
Name of the medicinal product
Qualitative and quantitative composition
Therapeutic indications
Belakne Cream is proposed for the cutaneous treatment of mild to moderate acne vulgaris where comedones, papules and pustules predominate. Belakne Cream is best suited for use on dry and fair skin. Acne of the face, chest or back is appropriate for treatment.
Contraindications
Special warnings and precautions for use
If a reaction suggesting sensitivity or severe irritation occurs, use of the medication should be discontinued. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, to discontinue use temporarily until symptoms subside or to discontinue use altogether. Belakne Cream should not come into contact with the eyes, mouth, angles of the nose or mucous membranes.
If product enters the eye, wash immediately with warm water. The product should not be applied to either broken (cuts and abrasions), sunburnt or eczematous skin, nor should it be used in patients with severe acne, or acne involving large areas of the body.
Exposure to sunlight and artificial UV irradiation, including sunlamps, should be minimised during use of adapalene. Patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions which can possibly be delayed.
Effects on ability to drive and use machines
Belakne Cream has no influence on the ability to drive and use machines.
Pharmacodynamic properties
Pharmacotherapeutic Group: D10A Anti-Acne Preparations for Topical Use
ATC code: D10AD03
Adapalene is a retinoid-like compound which in, in vivo and in vitro models of inflammation, has been demonstrated to possess anti-inflammatory properties. Adapalene is essentially stable to oxygen and light and is chemically non-reactive. Mechanically, adapalene binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin not to cytosolic receptor binding proteins.
Adapalene applied cutaneously is comedolytic in the rhino mouse model and also has effects on the abnormal processes of epidermal keratinisation and differentiation, both of which are present in the pathogenesis of acne vulgaris. The mode of action of adapalene is suggested to be a normalisation of differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Adapalene is superior to reference retinoids in standard anti-inflammatory assays, both in vivo and in vitro. Mechanistically, it inhibits chemotactic and chemokinetic responses of human polymorphonuclear leucocytes and also the metabolism by lipoxidation of arachidonic acid to pro-inflammatory mediators. This profile suggests that the cell mediated inflammatory component of acne may be modified by adapalene. Studies in human patients provide clinical evidence that cutaneous adapalene is effective in reducing the inflammatory components of acne (papules and pustules).
Pharmacokinetic properties
Absorption of adapalene through human skin is low, in clinical trials measurable plasma adapalene levels were not found following chronic cutaneous application to large areas of acneic skin with an analytical sensitivity of 0.15 ng/ml.
After administration of [14C]-adapalene in rats (IV, IP, oral and cutaneous), rabbits (IV, oral and cutaneous) and dogs (IV and oral), radioactivity was distributed in several tissues, the highest levels being found in liver, spleen, adrenals and ovaries. Metabolism in animals has been tentatively identified as being mainly by O-demethylation, hydroxylation and conjugation, and excretion is primarily by the biliary route.
Pharmacotherapeutic group
Incompatibilities
Adverse reactions possible when combined with:
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Benzodiazepines
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CNS depressants
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Antidepressants
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MAO inhibitors
Special precautions for disposal and other handling
A thin film of the cream should be applied, avoiding eyes, lips and mucous membranes.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Attention! Always consult to a doctor or pharmacist before using pills or medicines.
Medically reviewed by . Last updated on 6/26/2023
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Equivalent of Belakne found in: