Glialia 400mg + 40mg Medical Device 60 Tablets

Glialia 400mg + 40mg - Medical Device

What is Glialia used for?

Glialia is a food for special medical purposes. The product does not contain gluten, lactose and sugars.
Glìalia is to be used under medical supervision in subjects with disorders sustained by neuroinflammatory processes associated with transient ischemic events (TIA); post-ictal states on an ischemic basis; post-traumatic states of the CNS; states of cognitive decline (Mild Neurocognitive Disorder - Mild-NCD); early stage dementia; parkinsonisms in the initial phase; inflammatory demyelinating diseases; motor neuron diseases; mood altering states.

Composition

Palmitoylethanolamide
It is a natural endogenous lipid substance with an N-acylethanolamide structure which in the organism has the function of physiologically intervening to maintain intersystemic tissue homeostasis.
Luteolin
It is also a natural substance belonging to the flavone family, endowed with considerable and peculiar antioxidant effects.
The combination of Palmitoylethanolamide and Luteolin in a co-ultramicronized form (ultramicrocomposite PEALUT) allows the two active ingredients to exert a synergistic effect in the control of the neuroinflammation induced by different endogenous and exogenous noxae affecting the Central Nervous System; this control is carried out through the inhibitory modulation of non-neuronal cells - astrocytes, microglia, mast cells - normally responsible for ensuring the homeodynamic balance of the central nervous tissue.

Ingredients for 1 tablet of Glialia

Palmitoylethanolamide 400 mg, Luteolin in co-ultramicronized form (Ultramicrocomposite PEALUT®) 40 mg, Blend of excipients (Microcrystalline cellulose, Magnesiostearate, Vegetable polysorbate, Polyethylene glycol / Macrogol (E1521), Croscarmellose Sodium, Polyvinylpyrrolidone, Polyvinylpyrrolidone Yellow iron oxide (E172), Titanium dioxide (E171)). 225.00 mg

Glialia dosage

Glìalia tablets must be used under medical supervision in cognitive decline (Mild Neurocognitive Disorder - Mild-NCD), in the initial states of neurodegenerative diseases, mood alterations, once the attack therapy started with Glìalia microgranules sublingually is finished. We recommend taking 2 tablets a day (one in the morning and one in the evening) for prolonged cycles of 3 - 6 months, possibly repeated. Do not exceed the dosage.

Warnings and precautions for use Glialia

Use Glialia under medical supervision. Furthermore, the product cannot represent the only source of nourishment.
It is recommended to keep the product out of the reach of children under 3 years of age.
In Pregnancy it is not recommended to administer the product during the whole ascertained or presumed period, as there are not adequate and sufficient data regarding the use of the Palmitoylethanolamide and Luteolin combination in these situations. At the recommended doses Glialia does not affect the ability to drive and use machines.

Undesirable or side effects

No undesirable effects have been reported even after long-term administration and high doses of Palmitoylethanolamide, nor have there been any reports of addiction or dependence. In humans, the administration of 100 mg / day of Luteolin for 4 months has proved to be well tolerated and safe.
In case of overdose, there are no known clinical cases of overdose.

Pharmacological properties

Health Authorization Category (Ministry of Health): Food for Special Medical Purposes.

Pharmacodynamic properties

Palmitoylethanolamide is an endogenous N-acylethanolamide, with no psychotropic effects. Preclinical studies have shown that Palmitoylethanolamide acts, in a pleiotropic way, on the mechanisms of neuroinflammation, exerting an effective neuroprotective effect. The use of translational experimental models has clearly shown that Palmitoylethanolamide is able to act on central neuroinflammation through the synchronic modulation of non-neuronal cells (astrocytes, microglia, mast cells) thus determining effective neuroprotection.
Luteolin exhibits a high normalization of the local oxidative state associated with neuroinflammation in the CNS. The available data show how the association between Palmitoylethanolamide and Luteolin, administered in the form of ultramicrocomposite. Pealut obtained by co-ultramicronization, is highly synergistic on the mechanisms of neuroinflammation in the CNS.

Mechanisms of action

Recent studies have shown that the administration of Palmitoylethanolamide + Luteolin, in the form of the Pealut ultramicro-composite obtained by co-ultramicronization in the 10: 1 mass ratio, increases the cell viability of both macrophage and astrocytic lines subjected to oxidative stress. The Pealut ultramicrocomposite synergistically inhibits lipid peroxidation, mitochondrial dysfunctions associated with cell apoptosis, nitric oxide (NO) production and the expression of inducible enzymes (NO-synthase and cyclo-oxygenase-2). Similar results were observed in organotypic hippocampal cultures damaged by the Ab1-42 amyloid protein fragment. In ischemic models, the Pealut ultramicrocomposite has been shown to completely protect neurons from cell death, confirming the synergistic effect of the two molecules in the co-ultramicronized form. Pealut has demonstrated its efficacy in vivo in CNS trauma and mood alteration models.

Pharmacokinetic properties

The temporal profile of palmitoylethanolamide in human plasma after a single oral intake of quantities between 300 and 1200 mg, shows a dose-dependent increase of the molecule. The plasma peak of Palmitoylethanolamide is observed one hour after dosing; subsequently, plasma levels begin to decline and reach baseline within six hours. At one hour, Palmitoylethanolamide plasma levels double from baseline after taking 300 mg, while they increase seven-fold after taking 1200 mg. Experimental studies have shown that after oral administration Palmitoylethanolamide is uniformly distributed in the tissues; a percentage of the administered dose crosses the blood brain barrier and reaches the brain tissues. Free luteolin has been found in plasma both in experimental animals and in humans, after oral administration, demonstrating that a part of luteolin escapes degradation due to the first hepatic passage, in any case avoided by sublingual administration. In rats, after oral administration the maximum peak of luteolin in plasma is reached after 1 hour, while the peak of maximum excretion in faeces and urine occurs around 8 hours.

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 on a large number of patients demonstrate the excellent tolerability of Palmitoylethanolamide even for very high doses and the absence of clinically relevant changes in the haematological and blood chemistry tests performed. Toxicological studies in rats have shown that administration up to 1 g / kg of Luteolin does not induce toxic effects. Chronic administration of Luteolin at a dose of 23, 48 and 87 mg / kg respectively for 26 weeks, did not show any toxic effects related to body weight, haematological, haematochemical and histopathological tests performed.
Palmitoylethanolamide and embryotoxicity : no teratogenic or embryotoxic effect of Palmitoylethanolamide was shown after administration of 50 mg / kg body weight during pregnancy for 12 days. Additionally, infants from mothers who received PEA before delivery and up to 10 days after delivery were more resistant to the Shigella Shigae toxin. Similarly, infants of mothers who received PEA after 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.
Mutagenicity : although a potential mutagenic effect of Palmitoylethanolamide can be excluded as it is already physiologically present in the mammalian organism, 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 10,000 and 1,000 µg / ml, did not significantly change the number of revertants. Even the Luteolin in the Ames test, using concentrations between 12.1 and 225.0 nmol / ml, did not show mutagenic effects.
Palmitoylethanolamide and gastric tolerability : oral administration of Palmitoylethanolamide at a dose of 50mg / kg (dose approximately 5 times higher than the active dose), and at a dose of 10mg / 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.

storage

Store Glialia at room temperature in a cool and dry place, away from heat sources. The expiry date is intended for a well preserved, intact and sealed product.

Format

Glialia is a product that is sold in packs of 20 coated tablets of 400 mg + 40 mg.