QUALITATIVE AND QUANTITATIVE COMPOSITION :

One 400-mg bottle of lyophilised powder contains: ademetionine (S-Adenosyl-L-Methionine), 1.4-butanedisulfonate, 760 mg equal to 400 mg. One phial of solvent solution contains: water for injectable solutions, L-lysine, sodium hydroxide. One 400-mg gastro-resistant tablet contains: ademetionine (S-Adenosyl-L-Methionine) 1.4-butanedisulfonate, 760 mg equal to 400 mg. Excipients: Microcrystalline cellulose, magnesium stearate, polyethylene glycol 6000, polymethacrylate, polysorbate, colloidal silica, emulsified silicone, sodium starch glycolate, talc.

PHARMACEUTICAL PRESENTATION:

5 400-mg bottles of lyophilised powder + 5 phials of solvent solution 20 400-mg tablets of gastro-resistant tablets

PHARMACEUTICAL CATEGORY:

Anti-depressant

THERAPEUTICAL INDICATION:

Symptoms of depression

CONTRAINDICATIONS:

Known individual hypersensitivity to the product.

PRECAUTIONS:

The lyophilised powder must be mixed with the accompanying solvent solution immediately prior to use. The intravenous injection should be carried out very slowly. SAMYR tablets are gastro-resistant, thus releasing the ademetionine in the duodenum. The tablets should not be removed from the blister pack until just prior to use. These should not be chewed but swallowed whole. For better absorption of the main principle and a more through therapeutic effect, SAMYR should be taken between meals.

INTERACTIONS

SAMYR is compatible with any other anti-depressant treatments, particularly tricyclens and monoaminoxidase inhibitors. Taking ademetionine does not cause negative interactions with alcohol.

WARNING:

Effects on the capacity to drive or use machinery. Does not interfere with the capacity to drive vehicles or to operate machinery.

DOSAGE OF, DIRECTIONS FOR AND FREQUENCY OF USE:

Ampoules: 1 bottle per day for a 15-20 day cycle, to be taken intravenously or intramuscularly. Tablets: 2-3 tablets per day according to your doctor's prescription. The treatment can be initiated parenterally (one bottle per day intravenously or intramuscularly for 15-20 days) and continued orally (2-3 tablets per day). Overdose: Cases of overdose are practically unknown.

ADVERSE EFFECTS:

Significant side effects have not been seen, not even over long periods of treatment or with a high dosage. Nor have cases been reported of habit formation or drug-dependence. Ademetionine can be taken safely during pregnancy, by the elderly and by those with chronic hepatic problems. SAMYR has been known to cause rare disturbances in the sleep rhythms of hypersensitive patients. Should this occur, a sleeping medication (hypnotic) might be useful. Given the acid pH, which for stabilising reasons is maintained in the active principle in the tablets, cases have been reported of heartburn and a sense of epigastric heaviness by patients who have taken this product orally. However, such episodes are of short duration and should not warrant stopping the treatment. If at any time the patient should note any adverse effects other than the above he should consult his doctor.

EXPIRY:

See the expiry date shown on the box. This applies to the product properly stored and packaged. Warning: Do not use this product after the expiry date printed on the box. Keep SAMYR away from sources of heat. Should the lyophilised powder take on a colour other than its original white, owing to breakage of the bottle or exposure to heat, return the product in its entirety to your chemist and have it exchanged.

PHIALS WITH SAFETY PRE-OPENING:

See Figure 1 and Figure 2 : DIRECTIONS FOR OPENING: Position the phial as shown in Figure 1. Press down on the coloured dot with the thumb, as shown in Figure 2.