Description
MPS standard
microgranules for oral use
(sublingual route)
MICRONIZED PALMITOYLETHANOLAMIDE (PEA-m)
ULTRA-MICRONIZED PALMITOYLETHANOLAMIDE (PEA-um)
GLUTEN FREE
1) PRODUCT NAME
MPS standard
2) QUALITATIVE-QUANTITATIVE COMPOSITION
2.1) Active ingredient:
normast MPS microgranules: Micronized Palmitoylethanolamide (PEA-m: particle size 2.0÷10.0 µm) 300 mg + Ultra-micronized Palmitoylethanolamide (PEA-um: particle size 0.8÷6.0 µm) 600 mg per sachet.
2.2) Excipients: each sachet of normast MPS microgranules contains 337.5 mg of a mixture of excipients (for the complete list see paragraph 7.1).
3) PRODUCT FORM
normast MPS microgranules: white granules.
4) CLINICAL INFORMATION
4.1) Indications: Palmitoylethanolamide is a nutritional factor that acts as a biological factor in the body, promoting the control of physiological tissue reactivity. It is therefore to be used under medical supervision, for the diet of subjects with disorders sustained by neuroinflammatory processes. 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. normast MPS is to be used under medical supervision, for the diet of subjects with disorders sustained by neuroinflammatory processes.
4.2) Dosage and method of use: as per medical advice, as a guideline: normast MPS microgranules 1-2 sachets per day to be placed directly under the tongue, allowing the microgranules to dissolve in the saliva.
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 in these situations.
4.7) Effects on ability to drive and use machines: Palmitoylethanolamide, 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 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 that plays an important role in the resolution of neuro-inflammatory and painful processes. Palmitoylethanolamide acts on several non-neuronal cellular targets involved in peripheral and central neuro-inflammatory processes, which manifest themselves in conditions of both acute and chronic pain as demonstrated in numerous pre-clinical studies and supported by a growing number of clinical studies.
5.3) Biokinetic properties: Palmitoylethanolamide in ultra-micronized form 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, ultra-micronized Palmitoylethanolamide is uniformly distributed in the tissues.
5.4) Mechanisms of action: the anti-inflammatory and analgesic effects of Palmitoylethanolamide are attributable to multiple mechanisms of action of a pleiotropic receptor nature. At the cellular level, Palmitoylethanolamide acts mainly on two non-neuronal cells, the mast cell and the microglia. The normalization of the excessive activation of these cells involved in peripheral, spinal and central inflammatory processes, characterized by chronic pain, is the basis of the main effects of Palmitoylethanolamide. At the molecular level, Palmitoylethanolamide interacts with multiple receptors including PPAR-a, CB2, GPR55, etc. Palmitoylethanolamide enhances the activity of endogenous N-acylethylamides with a mechanism, called entourage effect, which allows it to interact indirectly with the endocannabinoid and endovanilloid systems.
5.5) Clinical efficacy: the use of micronized and ultramicronized Palmitoylethanolamide in clinical practice has been shown to induce an improvement in the painful and functional symptoms that occur in many inflammatory, traumatic and neurodegenerative pathologies affecting the Peripheral Nervous System and the Central Nervous System.
6) TOXICOLOGY AND TOLERABILITY
Acute toxicity studies have shown that the LD/50 of Palmitoylethanolamide in rats and mice is greater than 5000 mg/kg. After sub-acute and chronic administration, the tolerability dosage was evaluated at 100 mg/kg/day in dogs and greater than 500 mg/kg/day in mice and rats. Clinical studies performed on a large number of patients demonstrate the excellent tolerability of Palmitoylethanolamide even for very high doses and the absence of clinically relevant variations in the haematological and blood chemistry tests performed.
6.1) Palmitoylethanolamide and embryotoxicity: no teratogenic or embryotoxic effect of palmitoylethanolamide was observed after administration during pregnancy of 50 mg/kg of body weight for 12 days.
6.2) Palmitoylethanolamide and mutagenicity: although a potential mutagenic effect of Palmitoylethanolamide can be excluded since it is already present in the organism of mammals, the mutagenicity of PEA has been verified using the Amest test: Palmitoylethanolamide, used at doses between 10000 and 1000 µg/ml, has not demonstrated mutagenic effects.
6.3) Palmitoylethanolamide and 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 simultaneously with diclofenac 15 mg/kg, a dosage known to induce gastric lesions, PEA decreases the ulcerogenic potential of NSAIDs, reducing the number of animals that develop ulcerations and mitigating any damage.
7) PRODUCT INFORMATION
7.1) Excipients: each sachet of normast MPS microgranules contains 337.5 mg of a mixture of excipients (Fructose, Sorbitol, Polysorbate 80, Palmitic esters of sucrose, Cross-linked sodium carboxymethylcellulose).
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 the container: heat-sealed sachets in Paper/Alu/PE in boxes of 20; bottles in food-grade Polyethylene Terephthalate (PET) with PE cap
7.6) Special precautions for disposal: no special instructions.
7.7) Gluten: These products do not contain gluten .
microgranules for oral use
(sublingual route)
MICRONIZED PALMITOYLETHANOLAMIDE (PEA-m)
ULTRA-MICRONIZED PALMITOYLETHANOLAMIDE (PEA-um)
GLUTEN FREE
1) PRODUCT NAME
MPS standard
2) QUALITATIVE-QUANTITATIVE COMPOSITION
2.1) Active ingredient:
normast MPS microgranules: Micronized Palmitoylethanolamide (PEA-m: particle size 2.0÷10.0 µm) 300 mg + Ultra-micronized Palmitoylethanolamide (PEA-um: particle size 0.8÷6.0 µm) 600 mg per sachet.
2.2) Excipients: each sachet of normast MPS microgranules contains 337.5 mg of a mixture of excipients (for the complete list see paragraph 7.1).
3) PRODUCT FORM
normast MPS microgranules: white granules.
4) CLINICAL INFORMATION
4.1) Indications: Palmitoylethanolamide is a nutritional factor that acts as a biological factor in the body, promoting the control of physiological tissue reactivity. It is therefore to be used under medical supervision, for the diet of subjects with disorders sustained by neuroinflammatory processes. 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. normast MPS is to be used under medical supervision, for the diet of subjects with disorders sustained by neuroinflammatory processes.
4.2) Dosage and method of use: as per medical advice, as a guideline: normast MPS microgranules 1-2 sachets per day to be placed directly under the tongue, allowing the microgranules to dissolve in the saliva.
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 in these situations.
4.7) Effects on ability to drive and use machines: Palmitoylethanolamide, 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 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 that plays an important role in the resolution of neuro-inflammatory and painful processes. Palmitoylethanolamide acts on several non-neuronal cellular targets involved in peripheral and central neuro-inflammatory processes, which manifest themselves in conditions of both acute and chronic pain as demonstrated in numerous pre-clinical studies and supported by a growing number of clinical studies.
5.3) Biokinetic properties: Palmitoylethanolamide in ultra-micronized form 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, ultra-micronized Palmitoylethanolamide is uniformly distributed in the tissues.
5.4) Mechanisms of action: the anti-inflammatory and analgesic effects of Palmitoylethanolamide are attributable to multiple mechanisms of action of a pleiotropic receptor nature. At the cellular level, Palmitoylethanolamide acts mainly on two non-neuronal cells, the mast cell and the microglia. The normalization of the excessive activation of these cells involved in peripheral, spinal and central inflammatory processes, characterized by chronic pain, is the basis of the main effects of Palmitoylethanolamide. At the molecular level, Palmitoylethanolamide interacts with multiple receptors including PPAR-a, CB2, GPR55, etc. Palmitoylethanolamide enhances the activity of endogenous N-acylethylamides with a mechanism, called entourage effect, which allows it to interact indirectly with the endocannabinoid and endovanilloid systems.
5.5) Clinical efficacy: the use of micronized and ultramicronized Palmitoylethanolamide in clinical practice has been shown to induce an improvement in the painful and functional symptoms that occur in many inflammatory, traumatic and neurodegenerative pathologies affecting the Peripheral Nervous System and the Central Nervous System.
6) TOXICOLOGY AND TOLERABILITY
Acute toxicity studies have shown that the LD/50 of Palmitoylethanolamide in rats and mice is greater than 5000 mg/kg. After sub-acute and chronic administration, the tolerability dosage was evaluated at 100 mg/kg/day in dogs and greater than 500 mg/kg/day in mice and rats. Clinical studies performed on a large number of patients demonstrate the excellent tolerability of Palmitoylethanolamide even for very high doses and the absence of clinically relevant variations in the haematological and blood chemistry tests performed.
6.1) Palmitoylethanolamide and embryotoxicity: no teratogenic or embryotoxic effect of palmitoylethanolamide was observed after administration during pregnancy of 50 mg/kg of body weight for 12 days.
6.2) Palmitoylethanolamide and mutagenicity: although a potential mutagenic effect of Palmitoylethanolamide can be excluded since it is already present in the organism of mammals, the mutagenicity of PEA has been verified using the Amest test: Palmitoylethanolamide, used at doses between 10000 and 1000 µg/ml, has not demonstrated mutagenic effects.
6.3) Palmitoylethanolamide and 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 simultaneously with diclofenac 15 mg/kg, a dosage known to induce gastric lesions, PEA decreases the ulcerogenic potential of NSAIDs, reducing the number of animals that develop ulcerations and mitigating any damage.
7) PRODUCT INFORMATION
7.1) Excipients: each sachet of normast MPS microgranules contains 337.5 mg of a mixture of excipients (Fructose, Sorbitol, Polysorbate 80, Palmitic esters of sucrose, Cross-linked sodium carboxymethylcellulose).
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 the container: heat-sealed sachets in Paper/Alu/PE in boxes of 20; bottles in food-grade Polyethylene Terephthalate (PET) with PE cap
7.6) Special precautions for disposal: no special instructions.
7.7) Gluten: These products do not contain gluten .
8) MARKETING AUTHORISATION HOLDER
EPITECH Group SpA - via Egadi, 7 - 20144 Milan - Italy
Italy 9) TEXT REVISION DATE 01/2016
normast MPS microgranules pack of 20 sachets.
Code 8014
