Index of drugs

An analgesic, adjunctive treatment of migraine attacks and related nausea and vomiting.

1 sachet contains 1620 mg of DL-lysine acetylsalicylate, equivalent to 900 mg of Acetylsalicylic acid and 10.5 mg of Metoclopramide hydrochloride.

A preparation with analgesic and antiemetic properties. Acetylsalicylic acid works mainly by inhibiting the biosynthesis and release of prostaglandins from unsaturated fatty acids due to the inhibition of arachidonic acid cyclooxygenase. Decreases platelet aggregation by blocking the release of adenosine diphosphoric acid and thromboxane A from platelets₂. Has analgesic, antipyretic and anti-inflammatory effects. Metoclopramide stimulates gastric, duodenal and intestinal motions, especially the small intestine, while not stimulating the gastric mucosa to secrete gastric juice, pancreatic enzymes and without affecting other functions of the gastrointestinal tract. It acts as an anti-emetic, it achieves its effects by affecting the nervous system - central inhibition of the action of Dopamine and peripheral sensitization of muscarinic receptors to acetylcholine. The combination of both components improves the bioavailability of acetylsalicylic acid during a migraine attack. Lysine acetylsalicylate rapidly and completely disintegrates in water; from the gastrointestinal tract is absorbed in the form of acetylsalicylic acid. In plasma, it is hydrolysed to salicylic acid. The maximum concentration of the drug in the blood occurs within 30-40 min. Salicylates are metabolized in the liver. Salicylic acid and inactive metabolites are excreted in the urine. After oral administration of Metoclopramide, the maximum concentration in blood occurs after about 40 minutes. The degree of binding to plasma proteins is about 30%. The oral bioavailability is 80%. The drug is metabolized to a very small extent. It is excreted mainly in unchanged form and in the form of sulphates in the urine. T_0,5 in the elimination phase, it is 5-6 hours.

Hypersensitivity to metoclopramide, salicylates or other components of the preparation. Third trimester of pregnancy. Breastfeeding period. Children under 15 years. Active gastric and duodenal ulcer disease. Congenital or acquired blood coagulation disorders. Bowel obstruction. Bleeding or perforation of the gastrointestinal tract. Tardive dyskinesia during the use of neuroleptics. Suspicion or diagnosis of pheochromocytoma. Phenylketonuria (the preparation contains aspartame). Simultaneous treatment with Methotrexate doses of 15 mg per week or more. Concomitant use with oral anticoagulants is contraindicated when salicylates are used in high doses (≥ 3 g per day); with preparations containing levodopa and with dopamine agonists; with alcohol (also with drugs containing alcohol). In addition, oral anticoagulants are not recommended at doses of acetylsalicylic acid <3g per day, with other NSAIDs at acetylsalicylic acid doses ≥ 3g per day in adults, as well as with Heparin, ticlopidine, medicines that increase uric acid excretion.

Caution should be exercised in patients with peptic ulcer or gastrointestinal bleeding, history of renal function, bronchial asthma, epilepsy, when using an intrauterine device. It is not recommended in patients with gout or in women with menstrual bleeding (acetylsalicylic acid may increase bleeding and prolong the duration of menses).

In the first and second trimester of pregnancy, acetylsalicylic acid can be used in case of definite necessity for a short period of time; long-term use in a dose greater than 150 mg per day is not recommended. The preparation is contraindicated in the third trimester of pregnancy. Acetylsalicylic acid should not be used during breast-feeding. Lysine acetylsalicylate may affect fertility in women - it is not recommended for women who plan to become pregnant.

During the use of the preparation may occur: tinnitus, weakness, fainting, dizziness, muscle stiffness, muscle pain, drowsiness, palpitations, diarrhea, gastric and duodenal ulcer, gastric pain, prolonged menstrual period. In addition, side effects may occur with each of the two active substances. Acetylsalicylic acid can cause: tinnitus, impaired hearing, headache, hemorrhagic syndrome, increased risk of gastric ulcer and duodenal ulcer, allergic reactions.Metoclopramide may cause: drowsiness, fatigue, dizziness, extrapyramidal symptoms, tardive dyskinesia, abnormalities of endocrine glands with hyperprolactinemia; in individual cases: depressive tendencies, headache, insomnia, intestinal transit disorders.

Orally. Adults and adolescents from 15 years of age: at the first symptoms of migraine - dissolve the contents of 1 sachet in a glass of water and drink. If necessary, the dose can be repeated after a few hours. Do not take more than 3 sachets a day.