Adolene 200mg+20mg 30 Tablets Adolene

epitech

adolene
micronized PALMITOYLETHANOLAMIDE + trans-POLIDATIN
200 mg + 20 mg

1) PRODUCT NAME
adolene (Food for Special Medical Purposes - FSMP)

2) QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1) Active ingredient: adolene tablets Micronized Palmitoylethanolamide 200 mg + trans-Polydatin 20 mg per tablet.
2.2) Excipients: the individual adolene 200 mg + 20 mg tablets contain 96.48 mg of an excipient mixture (for the full list, see paragraph 7.1).

3) PRODUCT FORM
adolene 200 mg + 20 mg round, pink tablets.

4) CLINICAL INFORMATION
4.1) 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 indeed indicated to counteract chronic, inflammatory, and painful processes in the pelvic area, a district where 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 such subjects, it is useful to physiologically counteract the deficit of endogenous Palmitoylethanolamide production, which occurs when the body, subjected to recurrent inflammatory conditions, exhausts its natural synthesis capacity, while 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 tissue mechanisms that induce and support Dysmenorrhea.
4.2) Dosage and Administration as directed by a physician, generally: 2-3 tablets daily 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 nutrition. Keep out of reach of children under 3 years of age.
4.5) Interactions: none observed.
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 ability to drive and use machines: the combination of Palmitoylethanolamide and trans-Polydatin, at recommended doses, does not interfere with the ability to drive or use machines.
4.8) Side effects: no side effects have been reported to date, even with long-term administration and high dosages. No cases of addiction or drug dependence have been reported.
4.9) Overdose: no clinical cases of overdose are known to date.

5) PROPERTIES
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 largely common biological activity spectrum. The main difference between the two molecules concerns Palmitoylethanolamide's inability 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, affecting both peripheral inflammatory processes and central neuroinflammation, and analgesic effects, evident in both acute and chronic-neuropathic pain conditions, highlighted by numerous in vitro and in vivo experimental studies and a growing number of clinical studies. Trans-Polydatin (or Piceid) is a resveratrol glucoside, a trihydroxystilbene polyphenol. It has marked antioxidant activity both as a scavenger and as an inhibitor of lipid peroxidation. It has also been shown to control cellular oxidative processes that play an important role in the development of pelvic system pathologies.
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 administration; subsequently, plasma levels begin to decrease and reach basal levels within six hours. Experimental studies have shown that after oral administration, Palmitoylethanolamide is uniformly distributed in tissues. After oral administration of trans-Polydatin, glucuronide concentrations similar to those identified after trans-Resveratrol administration have been identified and quantified in the blood. These metabolites disappear from plasma within 24 hours of administration.
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 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 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 the 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 correlated 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 low 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 with synergistic effects aimed at 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 in 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, exceeds 5000 mg/kg, while after repeated administration by gastric tube, it exceeds 500 mg/kg/day. Clinical studies conducted with adolene on a large number of patients demonstrate the excellent tolerability of the Palmitoylethanolamide + trans-Polydatin combination even at very high doses and the absence of clinically relevant changes in hematological and hemochemical examinations performed.
6.1) Embryotoxicity: no teratogenic or embryotoxic effect of Palmitoylethanolamide was observed after administration of 50 mg/kg body weight for 12 days during pregnancy. Furthermore, newborns of mothers who received PEA before delivery, up to 10 days after delivery, were more resistant to Shigella Shigae toxin. 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 newborns through milk. No embryotoxic effects of trans-Polydatin are known.
6.2) Mutagenicity: although a potential mutagenic effect of Palmitoylethanolamide can be excluded as it is already present in mammalian organisms, the mutagenicity of PEA was verified using the Ames 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 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 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 ulcerations and mitigating any damage.

7) PRODUCT INFORMATION
7.1) Excipients: adolene 200 mg + 20 mg tablets contain 96.48 mg of an excipient mixture (Microcrystalline cellulose, Magnesium stearate, Vegetable polysorbate, Croscarmellose sodium, Polyvinylpyrrolidone, Anhydrous colloidal silica, Polyvinyl alcohol) and are film-coated with a total of 9.5 mg of E120, E1521, E171
7.2) Incompatibilities: not known.
7.3) Shelf life: 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 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 22/04/2008
11) DATE OF REVISION OF THE TEXT 04/2014