Adolene 200mg+20mg Tissue Reactivity Supplement 30 Tablets

epitech

adolene
Micronized PALMITOILETHANOLAMIDE + trans-POLYDATINE
200 mg + 20 mg

1) NAME OF THE PRODUCT
adolene (Food for Special Medical Purposes - AFMS)

2) QUALI-QUANTITATIVE COMPOSITION
2.1) Active ingredient: adolene tablets micronized palmitoylethanolamide 200 mg + trans-polydatin 20 mg per tablet.
2.2) Excipients: single 200 mg + 20 mg adolene tablets contain 96.48 mg of a mixture of excipients (for the full list see section 7.1).

3) SHAPE OF THE PRODUCT
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, favoring the control of physiological tissue reactivity even in the presence of high oxidative stress. The association 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 hyper- tissue reactivity and the onset of inflammatory processes characterized by hyperalgesia. In these subjects it is useful to physiologically counteract the endogenous production deficit of Palmitoylethanolamide, which is determined when the organism, subjected to recurrent inflammatory conditions, exhausts its natural synthesis capacity by simultaneously modulating the production of regulatory cytokines by T lymphocytes. due to the presence of trans-polydatin. adolene is to be used under medical supervision, in the control of the tissue mechanisms that induce and support Dysmenorrhea.
4.2) Dosage and method of use: on medical indication, 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 a sole source of nourishment. Keep out of the reach of children under 3 years of age.
4.5) Interactions: not highlighted.
4.6) Pregnancy: administration of the product during pregnancy is not recommended due to insufficient data regarding the use of Palmitoylethanolamide and trans-Polydatin in these situations.
4.7) Effects on the ability to drive and use machines: the combination of Palmitoylethanolamide and trans-Polydatin, at the recommended doses, does not affect the ability to drive and use machines.
4.8) Undesirable effects: up to now undesirable effects have never been reported even after long-term administration and high dosages. No cases of addiction or drug addiction have been reported.
4.9) Overdose: up to now clinical cases of overdose are not known.

5) OWNERSHIP
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 spectrum of biological activity. 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 analgesics, evident both in acute and chronic-neuropathic pain conditions, underlined by numerous experimental studies in vitro and in vivo and by a growing number of studies clinical. Trans-Polydatin (or Piceide) is a glucoside of Resveratrol, a polyphenol of a trihydroxystylbenic 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 man, 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 dosing; subsequently, plasma levels begin to decline and reach baseline within six hours. Experimental studies have shown that after oral administration, Palmitoylethanolamide is uniformly distributed in the tissues. After oral administration of trans-Polydatin in the blood, concentrations of glucuronides similar to those detected after administration of trans-Resveratrol were identified and quantified. These metabolites disappear from the plasma within 24 hours of ingestion.
5.4) Mechanisms of action: several mechanisms of action of Palmitoylethanolamide have been described in the various pathological conditions. Two main cellular targets of the molecule are known, mast cell and microglia. The normalization of the excessive activation of these immunocompetent cells involved in peripheral inflammatory processes, central neuroinflammation and 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 involved in the control of inflammatory and neuroprotective processes. In some conditions, Palmitoylethanolamide interacts with the CB2 cannabinoid receptor, a receptor present mainly on immune cells, including mast cells and microglia, whose expression increases significantly in inflammatory conditions. Palmitoiethanolamide enhances the activity of endogenous N-acylethylamides. The mechanism, called entourage effect, allows Palmitoylethanolamide to interact indirectly with the endocannabinoid and endovanilloid systems. In addition to having strong antioxidant properties, trans-polydatin 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. 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 exhibiting synergistic effects aimed at cells (mast cells and lymphocytes) strongly involved in inflammatory processes and capable of triggering reciprocal activation processes. Their association has proved 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 (intraperitoneally) in dogs is greater than 400 mg / kg, and in rats, after single administration with gavage, exceeds 5000 mg / kg, while after administration always repeated by gastric probe, 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 changes in the haematological and blood chemistry tests performed.
6.1) Embryotoxicity: no teratogenic or embryotoxic effect of Palmitoylethanolamide was observed after the administration in pregnancy of 50 mg / kg body weight for 12 days. Furthermore, infants of mothers who received PEA before delivery were more resistant to the Shigella Shigae toxin up to 10 days after delivery. Similarly, infants 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 infants through milk. There are no known embryotoxic effects of trans-polydatin.
6.2) Mutagenicity: although a potential mutagenic effect of Palmitoiethanolamide can be excluded as 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 dosages between 10000 and 1000 mcg / ml, did not significantly change the number of revertants. There are no known mutagenic effects of trans-polydatin.
6.3) Gastric tolerability: oral administration of Palmitoylethanolamide at a dose of 50 mg / kg (dose approximately 5 times higher than the active dose), and at a dose of 10 mg / kg in repeated administration for 5 days does not induce ulcer formation.
Furthermore, when administered at a dose of 50 mg / kg concomitantly with diclofenac 15 mg / kg, a dosage known to induce gastric lesions, PEA decreases the ulcerogenic potential of NSAIDs, lowering the number of animals that develop ulceration and mitigating any damage.

7) PRODUCT INFORMATION
7.1) Excipients: the 200 mg + 20 mg adolene tablets contain 96.48 mg of a mixture of excipients (microcrystalline cellulose, magnesium stearate, vegetable polysorbate, croscarmellose sodium, polyvinylpyrrolidone, silica colloidal anhydrous, polyvinyl alcohol) and are coated with a film consisting of in total from 9.5 mg of E120, E1521, E171
7.2) Incompatibility: not known.
7.3) Period of validity: 3 years.
7.4) Special precautions for storage: this product does not require any particular storage conditions.
7.5) Nature and contents of container: PVC / PVDC / aluminum foil blister in boxes of 30 tablets.
7.6) Special precautions for disposal: no particular instructions.
7.7) Gluten: This product does not contain gluten .

8) MARKETING AUTHORIZATION HOLDER
EPITECH Group SpA - via Egadi, 7 - 20144 Milan - Italy

9) MARKETING AUTHORIZATION NUMBER
adolene 200 mg + 20 mg tablets DGSAN 0011257-P
10) DATE OF FIRST MARKETING AUTHORIZATION
adolene 200 mg + 20 mg tablets 04/22/2008
11) DATE OF REVISION OF THE TEXT 04/2014