Instructions for use Ademetionine Adonat Premium SAMe tablets 500 mg No. 20
Composition
active ingredient: S-adenosyl-L-methionine (ademethionine,SAMe);
1 tablet contains 990 mg of S-adenosyl-L-methionine disulfate p-toluenesulfonate, corresponding to 500 mg of ademethionine cation;
excipients: film coating: shellac, acetic acid esters, mono- and diglycerides of fatty acids, polyvinylpyrrolidone; anti-caking agent: silicon dioxide, magnesium salts of fatty acids; filler: microcrystalline cellulose, magnesium hydroxide, sodium carboxymethylcellulose.
Release form
Enteric-coated tablets.
Main physicochemical properties: film-coated tablets, oblong in shape, white in color.
Properties
S-adenosyl-L-methionine (ademethionine, SAM-e) is an amino acid present in almost all tissues and body fluids, it is a methylated form of methionine. Ademethionine mainly acts as a coenzyme and methyl group donor in transmethylation reactions, which is an essential metabolic process in humans and animals. The transfer of methyl groups (transmethylation) is also an essential metabolic process in the construction of the phospholipid bilayer in cell membranes and contributes to membrane fluidity. Ademethionine is able to penetrate the blood-brain barrier. The transmethylation process with the participation of ademethionine is key in the formation of neurotransmitters of the central nervous system, including catecholamines (dopamine, noradrenaline, adrenaline), serotonin, melatonin and histamine.
Ademethionine is also a precursor in the formation of physiological sulfur compounds (cysteine, taurine, glutathione, coenzyme A, etc.) in transsulfuration reactions. Glutathione, the most powerful antioxidant in the liver, plays an important role in hepatic detoxification. Ademethionine increases hepatic glutathione levels in patients with liver damage of both alcoholic and non-alcoholic genesis.
Folic acid (folate) and vitamin B12 are essential nutrients in the metabolism and recovery of ademetionine.
Recommendations for use
Recommended for the diet as a source of the amino acid ademetionine to compensate for the deficiency of endogenous S-adenosyl-L-methionine in the body, which can occur in the following conditions:
- depressions of various etiologies;
- intrahepatic cholestasis in adults with chronic hepatitis of various etiologies and liver cirrhosis;
- osteoarthritis;
- chronic fatigue syndrome.
Method of application
1-2 tablets per day, washed down with a small amount of liquid. The tablets should be swallowed whole, without chewing.
Adonat® tablets are coated with a special coating that dissolves only in the intestines. For better absorption of the active substance, the tablets should be taken between meals.
Adonat® tablets should be removed from the blister immediately before taking.
The daily dosage of Adonat® and the duration of administration are determined by the doctor individually.
Reservation
Do not use: in case of individual intolerance to the product components (see the "Composition" section), pregnant women (first six months of pregnancy), and breastfeeding women, patients with bipolar psychosis, children, with identified genetic defects that affect the methionine cycle and/or cause homocystinuria and/or hyperhomocysteinemia (e.g. cystathionine beta-synthase deficiency, vitamin B12 metabolism defect, patients with bipolar psychosis.
Since vitamin B12 and folic acid (folate) deficiency may lead to decreased ademetionine concentrations, patients at risk (anemia, liver disease, pregnancy, or the possibility of vitamin deficiency due to other diseases or dietary habits such as veganism) should have regular blood tests to check plasma levels of these substances. If deficiency is detected, treatment with vitamin B12 and/or folic acid (folate) is recommended before or during the use of ademetionine. If these tests are not possible, patients at risk are recommended to use vitamin B12 and/or folic acid (folate) in dosages according to the doctor's recommendations.
Ademetionine interferes with the immunoassay for homocysteine, which may falsely indicate elevated plasma homocysteine levels in patients taking ademetionine. Therefore, non-immunological methods for determining plasma homocysteine levels are recommended for such patients.
Renal impairment: There are limited clinical data on the use of ademetionine in patients with renal impairment. In such patients, ademetionine should be used after additional examinations by a physician.
Ammonia levels should be monitored in patients with pre-cirrhotic or cirrhotic stages of hyperammonemia who are taking ademetionine tablets.
Taking Adonat® before bedtime, particularly at night, is undesirable, given the accompanying tonic effect of ademetionine.
Heartburn, pain or discomfort in the epigastric region, mild dyspeptic symptoms, sleep disturbances, increased anxiety, and allergic reactions may occur while taking ademetionine.
Do not use as a substitute for a balanced diet. Do not exceed the recommended daily intake.
Consult a doctor before starting to take the product.
Dietary supplement. Not a medicinal product.
Packaging
10 tablets in a blister. 2 blisters in a cardboard box.
Storage conditions
Store in the original packaging, protected from light, out of the reach of children, at temperatures up to 25 °C.
Expiration date
Indicated on the packaging.
Producer
Adonat® is a patented trademark of GNOSIS. The active ingredient ademetionine (SAMe) is produced in Switzerland by Gnosis Bioresearch SA. Manufacturer's address: Via Lischedi, 4 6592 Sant'Antonino, Switzerland.
Tel +41.(0).91.851.91.91 (https://gnosisbylesaffre.com/ingredient/adonat/).
Tableting and packaging are carried out in Italy by FMC SRL Manufacturer's address: Via Asi Consortile Km 0+200 03013 Ferentino (Fr) Italia. Tel (+39) 0775242054 | 07751831004.
Made to order by VITASAIN SARL, Paris, France. Customer address: 52 Rue Saint-André des Arts 75006 Paris. Tel +33785904280.
Manufactured according to GMP (Good Manufacturing Practice) standards - good manufacturing practice that ensures that the product is manufactured and controlled according to quality standards, in accordance with the trade license, and meets its intended purpose.
Importer (enterprise that performs functions related to accepting claims from consumers):
LLC "VITASAN-UKRAINE", legal address: 01042, Kyiv, Ukraine, Pechersky district, NOVOPECHERSKY LANE, building 18, office 32. Tel +380673801918
