Description
epitech
adolescen
Micronized PALMITOYLETHANOLAMIDE + trans-POLYDATIN
200mg + 20mg
1) PRODUCT NAME
adolene (Food for Special Medical Purposes - AFMS)
2) QUALITATIVE-QUANTITATIVE COMPOSITION
2.1) Active ingredient: adolene tablets Micronized palmitoylethanolamide 200 mg + trans-Polydatin 20 mg per tablet.
2.2) Excipients: Adolene 200 mg + 20 mg single tablets contain 96.48 mg of a mixture of excipients (for a full list see section 7.1).
3) PRODUCT FORM
adolene 200 mg + 20 mg round, pink tablets.
4) CLINICAL INFORMATION
4.1) Indications: Palmitoylethanolamide and trans-Polydatin are nutritional factors that act as synergistic biological modulators in the body, promoting the control of physiological tissue reactivity even in the presence of high oxidative stress. The combination of Palmitoylethanolamide and trans-Polydatin is in fact indicated to counteract chronic, inflammatory and painful processes in the pelvic area, a district in which oxidative stress represents one of the most important stimuli capable of inducing uncontrolled mast cell degranulation, with consequent tissue hyper-reactivity and the onset of inflammatory processes characterized by hyperalgesia. In these subjects it is useful to physiologically counteract the deficit in endogenous production of Palmitoylethanolamide, which occurs when the body, subjected to recurrent inflammatory conditions, exhausts its natural capacity for synthesis while simultaneously modulating the production of regulatory cytokines by T lymphocytes due to the presence of trans-Polydatin. adolene should be used under medical supervision, in the control of tissue mechanisms that induce and sustain dysmenorrhea.
4.2) Dosage and method of use: on medical advice, as a guideline: 2-3 tablets per day for 10 days from the 20th day of the menstrual cycle.
4.3) Contraindications: none.
4.4) Warnings and precautions for use: the product is not suitable as the sole source of nutrition. Keep out of reach of children under 3 years.
4.5) Interactions: not highlighted.
4.6) Pregnancy: the administration of the product during pregnancy is not recommended, due to insufficient adequate data regarding the use of Palmitoylethanolamide and trans-Polydatin in these situations.
4.7) Effects on ability to drive and use machines: the combination of Palmitoylethanolamide and trans-Polydatin, at the recommended doses, does not interfere with the ability to drive and use machines.
4.8) Undesirable effects: no undesirable effects have been reported to date, even following long-term administration and high dosages. No cases of habituation or drug dependence have been reported.
4.9) Overdose: No clinical cases of overdose have been known to date.
5) PROPERTY
5.1) Category: Food for Special Medical Purposes.
5.2) Biodynamic properties: Palmitoylethanolamide is an endogenous N-acylethanolamide, chemically similar to the endocannabinoid anandamide and with a largely common biological activity spectrum. The main difference between the two molecules concerns the inability of Palmitoylethanolamide to interact with the CB1 receptor responsible for the psychotropic effects of the endocannabinoid, therefore its intake is not associated with these central effects. Palmitoylethanolamide has anti-inflammatory effects, which affect both peripheral inflammatory processes and central neuroinflammation, and analgesic effects, evident in both acute and chronic-neuropathic pain conditions, underlined by numerous experimental studies in vitro and in vivo and by a growing number of clinical studies. Trans-Polydatin (or Piceide) is a glucoside of Resveratrol, a polyphenol of trihydroxystilbene nature. It has a marked antioxidant activity both as a scavenger and as an inhibitor of lipid peroxidation. It has also been shown to be able to control cellular oxidative processes that play an important role in the development of pathologies of the Pelvic System.
5.3) Biokinetic properties: Palmitoylethanolamide after oral administration in humans, of single doses between 300 and 1200 mg, is present in plasma at dose-dependent concentrations. The plasma peak of Palmitoylethanolamide is observed one hour after intake; subsequently, plasma levels begin to decrease and reach the basal value within six hours. Experimental studies have shown that after oral administration, Palmitoylethanolamide is uniformly distributed in the tissues. After oral administration of trans-Polydatin at blood level, concentrations of glucuronides similar to those identified after administration of trans-Resveratrol have been identified and quantified. These metabolites disappear from the plasma within 24 hours of intake.
5.4) Mechanisms of action: several mechanisms of action of Palmitoylethanolamide have been described, expressed in different pathological conditions. Two main cellular targets of the molecule are known, the mast cell and microglia. The normalization of the excessive activation of these immunocompetent cells involved in peripheral inflammatory processes, central neuroinflammation and in acute and chronic-neuropathic pain processes, is responsible for the main effects of Palmitoylethanolamide. At the molecular level, Palmitoylethanolamide interacts with multiple receptors, the main one being the nuclear receptor PPAR-α, a receptor implicated in the control of inflammatory and neuroprotective processes. In some conditions, Palmitoylethanolamide interacts with the cannabinoid receptor CB2, a receptor present mainly on immune cells, including mast cells and microglia, whose expression increases significantly in inflammatory conditions. Palmitoylethanolamide enhances the activity of endogenous N-acylethylamides. The mechanism, called entourage effect, allows Palmitoylethanolamide to interact indirectly with the endocannabinoid and endovanilloid systems. Trans-Polydatin, in addition to having strong antioxidant properties, exerts an anti-inflammatory activity related to its ability to modulate the functions of various immunocompetent cells such as T lymphocytes and precisely by regulating the production, by these cells, of regulatory and pro-inflammatory cytokines. At small concentrations it is able to stimulate an immune response while at higher concentrations it inhibits it.
5.5) Clinical efficacy: Palmitoylethanolamide and trans-Polydatin are molecules that exert synergistic effects on cells (mast cells and lymphocytes) strongly involved in inflammatory processes and capable of triggering reciprocal activation processes. Their association has proven to be a valid therapeutic intervention aimed at chronic, inflammatory and painful processes at the level of the pelvic system.
6) TOXICOLOGY AND TOLERABILITY
Toxicology studies have shown that the LD/50 of Palmitoylethanolamide administered by injection (intraperitoneal) in dogs is greater than 400 mg/kg, and in rats, after a single administration by gastric tube, it exceeds 5000 mg/kg, while after repeated administration by gastric tube, it exceeds 500 mg/kg/day. Clinical studies carried out with adolene on a large number of patients demonstrate the excellent tolerability of the Palmitoylethanolamide + trans-Polydatin combination even for very high doses and the absence of clinically relevant variations in the haematological and haematochemical tests carried out.
6.1) Embryotoxicity: No teratogenic or embryotoxic effect of Palmitoylethanolamide was observed after administration during pregnancy of 50 mg/kg body weight for 12 days. Furthermore, newborns of mothers who received PEA before delivery were more resistant to Shigella Shigae toxin up to 10 days after delivery. Similarly, newborns of mothers who received PEA before delivery showed increasing resistance evident as early as 5 days after birth: these data suggest that mothers may have transferred PEA to their newborns through milk. No embryotoxic effects of trans-Polydatin are known.
6.2) Mutagenicity: although a potential mutagenic effect of Palmitoylethanolamide can be excluded since it is already present in the mammalian organism, the mutagenicity of PEA was verified using the Amest test, using 5 mutant species of S. typhimurium (TA 1535-TA1537-TA1538-TA98 and TA 100). With the Ames test, Palmitoylethanolamide, used at doses between 10000 and 1000 mcg/ml did not significantly modify the number of revertants. No mutagenic effects of trans-Polydatin are known.
6.3) Gastric tolerability: oral administration of Palmitoylethanolamide at a dose of 50 mg/kg (a dose approximately 5 times higher than the active dose), and at a dose of 10 mg/kg in repeated administrations for 5 days does not induce ulcer formation.
Furthermore, when administered at a dose of 50 mg/kg concurrently with diclofenac 15 mg/kg, a dosage known to induce gastric lesions, PEA decreases the ulcerogenic potential of NSAIDs, reducing the number of animals developing ulcerations and mitigating any damage that may occur.
7) PRODUCT INFORMATION
7.1) Excipients: Adolene 200 mg + 20 mg tablets contain 96.48 mg of a mixture of excipients (microcrystalline cellulose, magnesium stearate, vegetable polysorbate, croscarmellose sodium, polyvinylpyrrolidone, colloidal anhydrous silica, polyvinyl alcohol) and are coated with a film consisting of a total of 9.5 mg of E120, E1521, E171.
7.2) Incompatibilities: none known.
7.3) Validity period: 3 years.
7.4) Special precautions for storage: This product does not require any special storage conditions.
7.5) Nature and contents of container: PVC/PVDC/aluminium foil blister in boxes of 30 tablets.
7.6) Special precautions for disposal: no special instructions.
7.7) Gluten: This product does not contain gluten .
8) MARKETING AUTHORISATION HOLDER
EPITECH Group SpA - via Egadi, 7 - 20144 Milan - Italy
9) MARKETING AUTHORISATION NUMBER
adolene 200 mg + 20 mg tablets DGSAN 0011257-P
10) DATE OF FIRST MARKETING AUTHORISATION
adolene 200 mg + 20 mg tablets 04/22/2008
11) TEXT REVISION DATE 04/2014
adolescen
Micronized PALMITOYLETHANOLAMIDE + trans-POLYDATIN
200mg + 20mg
1) PRODUCT NAME
adolene (Food for Special Medical Purposes - AFMS)
2) QUALITATIVE-QUANTITATIVE COMPOSITION
2.1) Active ingredient: adolene tablets Micronized palmitoylethanolamide 200 mg + trans-Polydatin 20 mg per tablet.
2.2) Excipients: Adolene 200 mg + 20 mg single tablets contain 96.48 mg of a mixture of excipients (for a full list see section 7.1).
3) PRODUCT FORM
adolene 200 mg + 20 mg round, pink tablets.
4) CLINICAL INFORMATION
4.1) Indications: Palmitoylethanolamide and trans-Polydatin are nutritional factors that act as synergistic biological modulators in the body, promoting the control of physiological tissue reactivity even in the presence of high oxidative stress. The combination of Palmitoylethanolamide and trans-Polydatin is in fact indicated to counteract chronic, inflammatory and painful processes in the pelvic area, a district in which oxidative stress represents one of the most important stimuli capable of inducing uncontrolled mast cell degranulation, with consequent tissue hyper-reactivity and the onset of inflammatory processes characterized by hyperalgesia. In these subjects it is useful to physiologically counteract the deficit in endogenous production of Palmitoylethanolamide, which occurs when the body, subjected to recurrent inflammatory conditions, exhausts its natural capacity for synthesis while simultaneously modulating the production of regulatory cytokines by T lymphocytes due to the presence of trans-Polydatin. adolene should be used under medical supervision, in the control of tissue mechanisms that induce and sustain dysmenorrhea.
4.2) Dosage and method of use: on medical advice, as a guideline: 2-3 tablets per day for 10 days from the 20th day of the menstrual cycle.
4.3) Contraindications: none.
4.4) Warnings and precautions for use: the product is not suitable as the sole source of nutrition. Keep out of reach of children under 3 years.
4.5) Interactions: not highlighted.
4.6) Pregnancy: the administration of the product during pregnancy is not recommended, due to insufficient adequate data regarding the use of Palmitoylethanolamide and trans-Polydatin in these situations.
4.7) Effects on ability to drive and use machines: the combination of Palmitoylethanolamide and trans-Polydatin, at the recommended doses, does not interfere with the ability to drive and use machines.
4.8) Undesirable effects: no undesirable effects have been reported to date, even following long-term administration and high dosages. No cases of habituation or drug dependence have been reported.
4.9) Overdose: No clinical cases of overdose have been known to date.
5) PROPERTY
5.1) Category: Food for Special Medical Purposes.
5.2) Biodynamic properties: Palmitoylethanolamide is an endogenous N-acylethanolamide, chemically similar to the endocannabinoid anandamide and with a largely common biological activity spectrum. The main difference between the two molecules concerns the inability of Palmitoylethanolamide to interact with the CB1 receptor responsible for the psychotropic effects of the endocannabinoid, therefore its intake is not associated with these central effects. Palmitoylethanolamide has anti-inflammatory effects, which affect both peripheral inflammatory processes and central neuroinflammation, and analgesic effects, evident in both acute and chronic-neuropathic pain conditions, underlined by numerous experimental studies in vitro and in vivo and by a growing number of clinical studies. Trans-Polydatin (or Piceide) is a glucoside of Resveratrol, a polyphenol of trihydroxystilbene nature. It has a marked antioxidant activity both as a scavenger and as an inhibitor of lipid peroxidation. It has also been shown to be able to control cellular oxidative processes that play an important role in the development of pathologies of the Pelvic System.
5.3) Biokinetic properties: Palmitoylethanolamide after oral administration in humans, of single doses between 300 and 1200 mg, is present in plasma at dose-dependent concentrations. The plasma peak of Palmitoylethanolamide is observed one hour after intake; subsequently, plasma levels begin to decrease and reach the basal value within six hours. Experimental studies have shown that after oral administration, Palmitoylethanolamide is uniformly distributed in the tissues. After oral administration of trans-Polydatin at blood level, concentrations of glucuronides similar to those identified after administration of trans-Resveratrol have been identified and quantified. These metabolites disappear from the plasma within 24 hours of intake.
5.4) Mechanisms of action: several mechanisms of action of Palmitoylethanolamide have been described, expressed in different pathological conditions. Two main cellular targets of the molecule are known, the mast cell and microglia. The normalization of the excessive activation of these immunocompetent cells involved in peripheral inflammatory processes, central neuroinflammation and in acute and chronic-neuropathic pain processes, is responsible for the main effects of Palmitoylethanolamide. At the molecular level, Palmitoylethanolamide interacts with multiple receptors, the main one being the nuclear receptor PPAR-α, a receptor implicated in the control of inflammatory and neuroprotective processes. In some conditions, Palmitoylethanolamide interacts with the cannabinoid receptor CB2, a receptor present mainly on immune cells, including mast cells and microglia, whose expression increases significantly in inflammatory conditions. Palmitoylethanolamide enhances the activity of endogenous N-acylethylamides. The mechanism, called entourage effect, allows Palmitoylethanolamide to interact indirectly with the endocannabinoid and endovanilloid systems. Trans-Polydatin, in addition to having strong antioxidant properties, exerts an anti-inflammatory activity related to its ability to modulate the functions of various immunocompetent cells such as T lymphocytes and precisely by regulating the production, by these cells, of regulatory and pro-inflammatory cytokines. At small concentrations it is able to stimulate an immune response while at higher concentrations it inhibits it.
5.5) Clinical efficacy: Palmitoylethanolamide and trans-Polydatin are molecules that exert synergistic effects on cells (mast cells and lymphocytes) strongly involved in inflammatory processes and capable of triggering reciprocal activation processes. Their association has proven to be a valid therapeutic intervention aimed at chronic, inflammatory and painful processes at the level of the pelvic system.
6) TOXICOLOGY AND TOLERABILITY
Toxicology studies have shown that the LD/50 of Palmitoylethanolamide administered by injection (intraperitoneal) in dogs is greater than 400 mg/kg, and in rats, after a single administration by gastric tube, it exceeds 5000 mg/kg, while after repeated administration by gastric tube, it exceeds 500 mg/kg/day. Clinical studies carried out with adolene on a large number of patients demonstrate the excellent tolerability of the Palmitoylethanolamide + trans-Polydatin combination even for very high doses and the absence of clinically relevant variations in the haematological and haematochemical tests carried out.
6.1) Embryotoxicity: No teratogenic or embryotoxic effect of Palmitoylethanolamide was observed after administration during pregnancy of 50 mg/kg body weight for 12 days. Furthermore, newborns of mothers who received PEA before delivery were more resistant to Shigella Shigae toxin up to 10 days after delivery. Similarly, newborns of mothers who received PEA before delivery showed increasing resistance evident as early as 5 days after birth: these data suggest that mothers may have transferred PEA to their newborns through milk. No embryotoxic effects of trans-Polydatin are known.
6.2) Mutagenicity: although a potential mutagenic effect of Palmitoylethanolamide can be excluded since it is already present in the mammalian organism, the mutagenicity of PEA was verified using the Amest test, using 5 mutant species of S. typhimurium (TA 1535-TA1537-TA1538-TA98 and TA 100). With the Ames test, Palmitoylethanolamide, used at doses between 10000 and 1000 mcg/ml did not significantly modify the number of revertants. No mutagenic effects of trans-Polydatin are known.
6.3) Gastric tolerability: oral administration of Palmitoylethanolamide at a dose of 50 mg/kg (a dose approximately 5 times higher than the active dose), and at a dose of 10 mg/kg in repeated administrations for 5 days does not induce ulcer formation.
Furthermore, when administered at a dose of 50 mg/kg concurrently with diclofenac 15 mg/kg, a dosage known to induce gastric lesions, PEA decreases the ulcerogenic potential of NSAIDs, reducing the number of animals developing ulcerations and mitigating any damage that may occur.
7) PRODUCT INFORMATION
7.1) Excipients: Adolene 200 mg + 20 mg tablets contain 96.48 mg of a mixture of excipients (microcrystalline cellulose, magnesium stearate, vegetable polysorbate, croscarmellose sodium, polyvinylpyrrolidone, colloidal anhydrous silica, polyvinyl alcohol) and are coated with a film consisting of a total of 9.5 mg of E120, E1521, E171.
7.2) Incompatibilities: none known.
7.3) Validity period: 3 years.
7.4) Special precautions for storage: This product does not require any special storage conditions.
7.5) Nature and contents of container: PVC/PVDC/aluminium foil blister in boxes of 30 tablets.
7.6) Special precautions for disposal: no special instructions.
7.7) Gluten: This product does not contain gluten .
8) MARKETING AUTHORISATION HOLDER
EPITECH Group SpA - via Egadi, 7 - 20144 Milan - Italy
9) MARKETING AUTHORISATION NUMBER
adolene 200 mg + 20 mg tablets DGSAN 0011257-P
10) DATE OF FIRST MARKETING AUTHORISATION
adolene 200 mg + 20 mg tablets 04/22/2008
11) TEXT REVISION DATE 04/2014
