Descrizione Clinica
Supplements Adolene 200mg+20mg 30cpr
epitech
adolene
Micronized PALMITOILETANOLAMIDE + Trans-POLIDATINA
200 mg + 20 mg
(1) DENOMINATION OF PRODUCT
adolene (Accommodation at Fini Medici Speciali - AFMS)
(2) QUALI-QUANTITATIVE COMPOSITION
2.1) Active Ingredient: adolene palmitoiletanolamide tablets micronized 200 mg + trans-Polidatine 20 mg per tablet.
2.2) Excipients: the individual tablets of adolene 200 mg + 20 mg contain 96.48 mg of a mixture of excipients (for the full list see paragraph 7.1).
(3) PRODUCT FORMA
adolene 200 mg + 20 mg round tablets, pink.
(4) CLINICAL INFORMATION
4.1) Directions: palmitoiletanolamide and trans-Polidatin are nutritional factors that in the body act as synergistic biological modulators, favoring the control of physiological tissue reactivity even in the presence of high oxidative stress. The Palmitoiletanolamide and trans-Polidatin association is indicated in contrast to the chronic, inflammatory and painful processes of the pelvic area, a district where oxidative stress is one of the most important stimuli that induces an uncontrolled mastocitary degranulation, resulting in tissue hyper-reactivity and the occurrence of inflammatory processes characterized by hyperalgesia. In these subjects it is useful to counter physiologically the endogenous production deficit of Palmitoiletanolamide, which is determined when the organism, subject to recurrent inflammatory conditions, exhausts its natural synthesis capacity while modulating the production of regulatory cytokines by T lymphocytes for the presence of trans- Polidatina. adolene is to be used under medical control, in the control of the tissue mechanisms that induce and support Dismenorrea.
4.2) Posology and methods of use: on medical indication, in line orientation: 2-3 tablets daily for 10 days from the 20th day of the menstrual cycle.
4.3) Contraindications: none.
4.4) Notices and precautions of use: the product is not suitable as the only source of nutrition. Keep away from the reach of children under 3 years.
4.5) Interaction: not highlighted.
4.6) Pregnancy: we do not recommend the administration of the product during the pregnancy period, due to inadequate data regarding the use of Palmitoilethanolamide and trans-Polidatine in these situations.
4.7) Effects on driving vehicles and the use of machinery: the association Palmitoiletanolamide and trans-Polidatine, at the recommended doses, does not interfere with the ability to drive vehicles and the use of machinery.
4.8) Undesirable effects: undesirable effects have not been reported until now, even after long-term administration and high doses. No cases of addiction or drug addiction have been reported.
4.9) Overdose: clinical cases of overdose are not known until now.
5) PROPERTY
5.1) Category: Food at Fini Medici Speciali.
5.2) Biodynamic properties: palmitoilethanolamide is an endogenous N-acilethanolamide, chemically similar to anandamide endocannabinoid and with a broad spectrum of biological activity. The main difference between the two molecules concerns the inability of Palmitoiletanolamide to interact with the CB1 receptor responsible for the psychotropic effects of endocannabinoid, therefore its intake is not associated with these central effects. Palmitoiletanolamide has anti-inflammatory effects, affecting both peripheral inflammatory processes and central neuroinflammation, and analgesics, evident both in acute and chronic-neuropatic pain conditions, underlined by numerous experimental studies in vitro and in vivo and by an increasing number of clinical studies. Trans-Polidatin (or Piceide) is a glucoside of Resveratrol, polyphenol of trihydroxystilbenic nature. It has a marked antioxidant activity both as scavenger and as a lipid peroxidation inhibitor. It also proved able to control cell oxidative processes that play an important role in the development of Pelvico system pathologies.
5.3) Biocinetic properties: palmitoilethanolamide after oral administration in humans, of individual doses between 300 and 1200 mg, is present in plasma at dose-dependent concentrations. The plasma peak of Palmitoilethanolamide is observed at an hour from intake; later plasma levels begin to decrease and reach basal value within six hours. Experimental studies have shown that after oral administration, Palmitoilethanolamide is distributed evenly in tissues. After oral administration of trans-Polidatine at the blood level, concentrations of glucuronides similar to those identified after trans-Resveratrol were identified and quantized. These metabolites disappear from plasma within 24 hours of intake.
5.4) Action mechanisms: more action mechanisms of Palmitoilethanolamide have been described in different pathological conditions. Two main cell targets of the molecule, mastocita and microglia are known. The normalization of excessive activation of these immunocompetent cells involved in peripheral inflammatory processes, central neuroinflammation and acute and chronic-neuropatic pain processes is responsible for the main effects of Palmitoilethanolamide. At molecular level Palmitoiletanolamide interacts with multiple receptors, the main is the PPAR-α nuclear receptor, receptor implicated in the control of inflammatory and neuroprotective processes. In some conditions, Palmitoiletanolamide interacts with the CB2 cannabinoid receptor, receptor present especially on immune cells, including mastocytes and microglia, whose expression increases significantly in inflammatory conditions. Palmitoietanolamide enhances the activity of endogenic N-acilethylitis. The mechanism, called entourage effect, allows Palmitoiletanolamide to interact indirect with endocannabinoid systems and endovanilloids. Trans-Polidatin besides having strong antioxidant properties, exercises an anti-inflammatory activity related to its ability to modulate the functions of different 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.
5.5) Clinical efficacy: palmitoiletanolamide and trans-Polidatin are molecules explanatory synergistic effects aimed at cells (mastocytes and lymphocytes) strongly involved in inflammatory processes and able to trigger processes of mutual activation. Their association has proven to be a valid therapeutic intervention aimed at chronic, inflammatory and painful processes at the pelvic system.
6) TOSSICOLOGY AND TOLLERABILITY
Toxicology studies have shown that Palmitoiletanolamide DL/50 administered by injective (intraperitoneal) in the dog is more than 400 mg/kg, and in the rat, after single administration with gastric probe, exceeds 5000 mg/kg, while after repeated administration always by gastric probe, exceeds 500 mg/kg/die. Clinical studies carried out with adolene on a large number of patients demonstrate the excellent tolerability of the Palmitoiletanolamide + trans-Polidatine association also for very high doses and the absence of clinically relevant variations of the blood and blood tests performed.
6.1) Embryotoxicity: no Palmitoilethanolamide teratogenic or embryotoxic effect has been observed after pregnancy administration of 50 mg/kg body weight for 12 days. Also, mothers who received PEA before childbirth, up to 10 days after childbirth were more resistant to Shigella Shigae toxin. Similarly, newborns of mothers who received PEA before childbirth showed an increasing resistance already 5 days from birth: these data suggest that mothers may have transferred PEA to infants through milk. No embryotoxic effects of trans-Polidatin are known.
6.2) Mutagenicity: although a potential mutagenic effect of Palmitoietanolamide may be excluded as already present in the mammals organism, the mutagenicity of PEA has been verified using the Amest test, using 5 mutant species of S. typhimurium (TA 1535-TA1537-TA1538-TA98 and TA 100). With the Ames test, Palmitoiletanolamide, used for dosages between 10000 and 1000 mcg/ml did not significantly change the number of revertant. There are no known mutagenic effects of trans-Polidatin.
6.3) Gastric tolerance: oral administration of Palmitoilethanolamide at the dose of 50 mg/kg (approximately 5 times higher than the active dose), and at the dose of 10 mg/kg in repeated administrations for 5 days does not induce ulcer formation.
In addition, if administered at a dose of 50 mg/kg at the same time as diclofenac 15 mg/kg, a dosage known to induce gastric lesions, PEA decreases the ulcerative potential of NSAIDs, lowering the number of animals that develop ulcerations and mitigating the possible damage.
7) PRODUCT INFORMATION
7.1) Excipients: tablets of adolene 200 mg + 20 mg contain 96.48 mg of a mixture of excipients (Cellulosa microcrystalline, Magnesium stearate, Polysorbate vegetable, Croscarmellose sodium, Polivinylpirrolidone, Silice colloidal Anidra, Polivinilalcool) and are coated with films consisting of 9.5 mg of E120, E1521, E171
7.2) Incompatibility: not known.
7.3) Validity period: three years.
7.4) Special precautions for conservation: this product does not require any particular condition of conservation.
7.5) Nature and contents of the container: blister PVC/PVDC/aluminum film in boxes of 30 tablets.
7.6) Special precautions for disposal: no particular education.
7.7) Glutine: this product does not contain gluten.
8) TYPE OF AUTHORIZATION IN COMMERCE
EPITECH Group SpA – via Egadi, 7 – 20144 Milan – Italy
9) NUMBER OF AUTHORIZATION IN COMMERCE
adolene 200 mg + 20 mg tablets DGSAN 0011257-P
10) DATA OF THE FIRST AUTHORIZATION IN COMMERCE
adolene 200 mg + 20 mg tablets 22/04/2008
11) TEXT REVISION DATA 04/2014
adolene
Micronized PALMITOILETANOLAMIDE + Trans-POLIDATINA
200 mg + 20 mg
(1) DENOMINATION OF PRODUCT
adolene (Accommodation at Fini Medici Speciali - AFMS)
(2) QUALI-QUANTITATIVE COMPOSITION
2.1) Active Ingredient: adolene palmitoiletanolamide tablets micronized 200 mg + trans-Polidatine 20 mg per tablet.
2.2) Excipients: the individual tablets of adolene 200 mg + 20 mg contain 96.48 mg of a mixture of excipients (for the full list see paragraph 7.1).
(3) PRODUCT FORMA
adolene 200 mg + 20 mg round tablets, pink.
(4) CLINICAL INFORMATION
4.1) Directions: palmitoiletanolamide and trans-Polidatin are nutritional factors that in the body act as synergistic biological modulators, favoring the control of physiological tissue reactivity even in the presence of high oxidative stress. The Palmitoiletanolamide and trans-Polidatin association is indicated in contrast to the chronic, inflammatory and painful processes of the pelvic area, a district where oxidative stress is one of the most important stimuli that induces an uncontrolled mastocitary degranulation, resulting in tissue hyper-reactivity and the occurrence of inflammatory processes characterized by hyperalgesia. In these subjects it is useful to counter physiologically the endogenous production deficit of Palmitoiletanolamide, which is determined when the organism, subject to recurrent inflammatory conditions, exhausts its natural synthesis capacity while modulating the production of regulatory cytokines by T lymphocytes for the presence of trans- Polidatina. adolene is to be used under medical control, in the control of the tissue mechanisms that induce and support Dismenorrea.
4.2) Posology and methods of use: on medical indication, in line orientation: 2-3 tablets daily for 10 days from the 20th day of the menstrual cycle.
4.3) Contraindications: none.
4.4) Notices and precautions of use: the product is not suitable as the only source of nutrition. Keep away from the reach of children under 3 years.
4.5) Interaction: not highlighted.
4.6) Pregnancy: we do not recommend the administration of the product during the pregnancy period, due to inadequate data regarding the use of Palmitoilethanolamide and trans-Polidatine in these situations.
4.7) Effects on driving vehicles and the use of machinery: the association Palmitoiletanolamide and trans-Polidatine, at the recommended doses, does not interfere with the ability to drive vehicles and the use of machinery.
4.8) Undesirable effects: undesirable effects have not been reported until now, even after long-term administration and high doses. No cases of addiction or drug addiction have been reported.
4.9) Overdose: clinical cases of overdose are not known until now.
5) PROPERTY
5.1) Category: Food at Fini Medici Speciali.
5.2) Biodynamic properties: palmitoilethanolamide is an endogenous N-acilethanolamide, chemically similar to anandamide endocannabinoid and with a broad spectrum of biological activity. The main difference between the two molecules concerns the inability of Palmitoiletanolamide to interact with the CB1 receptor responsible for the psychotropic effects of endocannabinoid, therefore its intake is not associated with these central effects. Palmitoiletanolamide has anti-inflammatory effects, affecting both peripheral inflammatory processes and central neuroinflammation, and analgesics, evident both in acute and chronic-neuropatic pain conditions, underlined by numerous experimental studies in vitro and in vivo and by an increasing number of clinical studies. Trans-Polidatin (or Piceide) is a glucoside of Resveratrol, polyphenol of trihydroxystilbenic nature. It has a marked antioxidant activity both as scavenger and as a lipid peroxidation inhibitor. It also proved able to control cell oxidative processes that play an important role in the development of Pelvico system pathologies.
5.3) Biocinetic properties: palmitoilethanolamide after oral administration in humans, of individual doses between 300 and 1200 mg, is present in plasma at dose-dependent concentrations. The plasma peak of Palmitoilethanolamide is observed at an hour from intake; later plasma levels begin to decrease and reach basal value within six hours. Experimental studies have shown that after oral administration, Palmitoilethanolamide is distributed evenly in tissues. After oral administration of trans-Polidatine at the blood level, concentrations of glucuronides similar to those identified after trans-Resveratrol were identified and quantized. These metabolites disappear from plasma within 24 hours of intake.
5.4) Action mechanisms: more action mechanisms of Palmitoilethanolamide have been described in different pathological conditions. Two main cell targets of the molecule, mastocita and microglia are known. The normalization of excessive activation of these immunocompetent cells involved in peripheral inflammatory processes, central neuroinflammation and acute and chronic-neuropatic pain processes is responsible for the main effects of Palmitoilethanolamide. At molecular level Palmitoiletanolamide interacts with multiple receptors, the main is the PPAR-α nuclear receptor, receptor implicated in the control of inflammatory and neuroprotective processes. In some conditions, Palmitoiletanolamide interacts with the CB2 cannabinoid receptor, receptor present especially on immune cells, including mastocytes and microglia, whose expression increases significantly in inflammatory conditions. Palmitoietanolamide enhances the activity of endogenic N-acilethylitis. The mechanism, called entourage effect, allows Palmitoiletanolamide to interact indirect with endocannabinoid systems and endovanilloids. Trans-Polidatin besides having strong antioxidant properties, exercises an anti-inflammatory activity related to its ability to modulate the functions of different 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.
5.5) Clinical efficacy: palmitoiletanolamide and trans-Polidatin are molecules explanatory synergistic effects aimed at cells (mastocytes and lymphocytes) strongly involved in inflammatory processes and able to trigger processes of mutual activation. Their association has proven to be a valid therapeutic intervention aimed at chronic, inflammatory and painful processes at the pelvic system.
6) TOSSICOLOGY AND TOLLERABILITY
Toxicology studies have shown that Palmitoiletanolamide DL/50 administered by injective (intraperitoneal) in the dog is more than 400 mg/kg, and in the rat, after single administration with gastric probe, exceeds 5000 mg/kg, while after repeated administration always by gastric probe, exceeds 500 mg/kg/die. Clinical studies carried out with adolene on a large number of patients demonstrate the excellent tolerability of the Palmitoiletanolamide + trans-Polidatine association also for very high doses and the absence of clinically relevant variations of the blood and blood tests performed.
6.1) Embryotoxicity: no Palmitoilethanolamide teratogenic or embryotoxic effect has been observed after pregnancy administration of 50 mg/kg body weight for 12 days. Also, mothers who received PEA before childbirth, up to 10 days after childbirth were more resistant to Shigella Shigae toxin. Similarly, newborns of mothers who received PEA before childbirth showed an increasing resistance already 5 days from birth: these data suggest that mothers may have transferred PEA to infants through milk. No embryotoxic effects of trans-Polidatin are known.
6.2) Mutagenicity: although a potential mutagenic effect of Palmitoietanolamide may be excluded as already present in the mammals organism, the mutagenicity of PEA has been verified using the Amest test, using 5 mutant species of S. typhimurium (TA 1535-TA1537-TA1538-TA98 and TA 100). With the Ames test, Palmitoiletanolamide, used for dosages between 10000 and 1000 mcg/ml did not significantly change the number of revertant. There are no known mutagenic effects of trans-Polidatin.
6.3) Gastric tolerance: oral administration of Palmitoilethanolamide at the dose of 50 mg/kg (approximately 5 times higher than the active dose), and at the dose of 10 mg/kg in repeated administrations for 5 days does not induce ulcer formation.
In addition, if administered at a dose of 50 mg/kg at the same time as diclofenac 15 mg/kg, a dosage known to induce gastric lesions, PEA decreases the ulcerative potential of NSAIDs, lowering the number of animals that develop ulcerations and mitigating the possible damage.
7) PRODUCT INFORMATION
7.1) Excipients: tablets of adolene 200 mg + 20 mg contain 96.48 mg of a mixture of excipients (Cellulosa microcrystalline, Magnesium stearate, Polysorbate vegetable, Croscarmellose sodium, Polivinylpirrolidone, Silice colloidal Anidra, Polivinilalcool) and are coated with films consisting of 9.5 mg of E120, E1521, E171
7.2) Incompatibility: not known.
7.3) Validity period: three years.
7.4) Special precautions for conservation: this product does not require any particular condition of conservation.
7.5) Nature and contents of the container: blister PVC/PVDC/aluminum film in boxes of 30 tablets.
7.6) Special precautions for disposal: no particular education.
7.7) Glutine: this product does not contain gluten.
8) TYPE OF AUTHORIZATION IN COMMERCE
EPITECH Group SpA – via Egadi, 7 – 20144 Milan – Italy
9) NUMBER OF AUTHORIZATION IN COMMERCE
adolene 200 mg + 20 mg tablets DGSAN 0011257-P
10) DATA OF THE FIRST AUTHORIZATION IN COMMERCE
adolene 200 mg + 20 mg tablets 22/04/2008
11) TEXT REVISION DATA 04/2014
