Food and Drug Administration has not evaluated any of the statements or claims expressed on this site. This product is not intended to diagnose, treat, cure or prevent any disease.
The global food and beverage industries use Acetaldehyde over 1 million tons a year. It can be found in most processed foods and drinks where it is used to improve the taste. It is also present in in varying quantities in most fermented products and even in some yogurts and beers.
World Health Organization, classified acetaldehyde included in and generated endogenously from alcoholic beverages as a Group I human carcinogen. The Group I include such well known carcinogens like asbestos and tobacco.
Acetium comes in Matrix granules in a hard HPMC capsule. Active ingredient is 100mg of plant-derived natural amino-acid L-cysteine made in Germany CE marked medical device to Matrix granules in which the L-cysteine is bound with a matrix former (Eudragit® RS) and an inactive excipient. This causes L-cysteine to be released at a sustained low rate locally in the stomach - exactly where acetaldehyde is formed.
Acetium capsules do not contain animal-derived substances, lactose, gluteine, sugar or allergens Package size 60 capsules Dosage 1-2 capsules with meal Acetium® is a CE marked product developed and patented by a Finnish company Biohit Oyj,
Acetium capsules include 100mg of natural amino acid as an active ingredient. L-cysteine reacts with acetaldehyde, forming harmless 2-methylthiazolidine-4-carboxylic acid (MTCA) and thus reducing the amount of acetaldehyde in the stomach and is excreted in the urine and feces.
Based on permeability studies on the Caco-2 cell line, it has been proven that L-cysteine does not absorb in the stomach to any significant extent, since the stomach mucosa does not include the LAT2 amino acid transporter responsible for the absorption of cysteine in the small intestine.
Thus, L-cysteine released from the Acetium capsules exits the stomach only by binding with acetaldehyde or advancing to the small intestine along with food.
Clinical studies have proven that when administered on an empty stomach with ethanol solution, Acetium capsules containing 200mg of L-cysteine can bind acetaldehyde for at least 45 minutes. At the end of the test, all test persons still had measurable concentrations of L-cysteine in the stomach.
Cysteine is a natural amino acid L-cysteine is a natural amino acid, 1-2g of which is digested daily along with proteins in regular food. Furthermore, it is a generally used food additive (E920) and has been approved by the European Food Safety Authority (EFSA) as a food additive suitable for both adults and children.
In actual usage, food in the stomach slows down L-cysteine's transfer to the small intestine. Therefore Acetium capsules are effective for even longer.
(The US Food and Drug Administration (FDA) has certified L-cysteine as safe and granted it a GRAS classification, Generally Regarded as Safe).
Not suitable for children, during pregnancy or breast feeding or persons suffering from kidney dysfunction.
Supplement Description and Use
1 PROPRIETARY NAME - ACETIUM 100mg
4. CLINICAL INFORMATION
4.1 Indications Removes carcinogenic acetaldehyde from stomach during eating or intake of alcohol in patients who have hypoacidic or anacidic stomach or who use anti-acid medication.
4.2 Dosage and Directions for Use 1 - 2 capsules with water before or with meal. Maximum daily dose 10 capsules (1000mg of L-cysteine)
4.3 Contra indications The preparation is not suitable for children, during pregnancy or breast feeding, or for persons suffering from renal dysfunction or cystinuria.
4.4 Interactions with Other Products No known interactions.
4.5 Pregnancy and Breast Feeding . The safety of the preparation is not verified during pregnancy and breast feeding. Women who are pregnant or breast feeding should not use Acetium.
4.6 Ability to Drive or Operate Machinery The preparation does not affect the ability to drive or operate machinery.
4.7 Side effects and Special Precautions The preparation does not cause side effects when recommended doses are used.
4.8 Known Symptoms of Over Dosage and Particulars of its Treatment A single dose of over 5 grams of L-cysteine orally may cause nausea and dizziness. If the symptoms are severe or prolonged, contact your doctor.
5.1 Description Anacidic stomach or use of anti-acid medication leads to the colonization of stomach with microbes representing normal oral flora. During meals or especially after ingestion of alcohol these microbes form carcinogenic acetaldehyde.
Acetium capsules contain amino acid L-cysteine, which readily reacts with acetaldehyde forming non-toxic 2-methyl-thiatzolidine-4-carboxylic acid (MTCA) thus reducing the amount of acetaldehyde in stomach. L-cysteine is released from Acetium capsules at a controlled rate locally in the stomach, exactly there, where acetaldehyde is formed.
The capsules are intended to be used by per- sons who have little or no acid in the stomach. These persons include those who use histamine H2 -receptor blockers (H2 -blockers) or proton pump inhibitors (PPI) or those who have corpus atrophic gastritis of the stomach mucosa usually caused by chronic Helicobacter pylori infection. Rarely the cause of atrophy is an autoimmune disease.
L-cysteine is a natural amino acid. The normal daily intake of L-cysteine from beverages con- taining proteins is 1-2g. It is broadly used as an additive in food product E920) and European Food Safety Agency (EFSA) has approved its use as an additive for both adults and children (http://www.efsa.europa.eu/EFSAIefsaJocale- 1178620753812_1178620766019.htm). The United States Food and Drug Administration (FDA) has also classified L-cysteine as a "Generally Regarded as Safe" (GRAS) substance.
5.2 Function L-cysteine is released from the capsules at a controlled rate in the stomach and dissolves thereafter rapidly. Small amounts of L-cysteine react rapidly and almost completely with acetaldehyde. The formed compound, MTCA, is excreted in urine and feces.-- -
6 INFORMATION OF THE PREPARATION
6.1 Adjuvants Eudragit® RS-PO, hypromellose (HPMC), calcium hydrogen phosphate (CaHPO,), titanium dioxide. Sugarfree. Does not contain animal derived ingredients, lactose or gluten.
6.2 Incompatibilities No known incompatibilities.
6.3 Expiration Date See on the package. Do not use the product after the expiration date on the package.
6.4 Storage Instruction Store at room temperature (18 - 25 DC). Protect from moisture. Keep out of reach of children
6.5 Identification and Presentation 60 capsules in folio/PVC blister in a carton.
6.6 Waste Disposal Discard the used package according to local and national regulations.
Biohit Oyj , Laippatie 1 , 00880 Helsinki
8 DATE OF PUBLICATION OFTHIS PACKAGE INSERT 16.11.2009/TM