SAMe (Donamet)      

Ingredients

One 500-mg phial of lyophilized substance contains ademethionine (Sulphur-Adenosil-L-Methionine) 1.4-butandisulphonate 949 mg equal to ion 500 mg. One ampoule of solvent liquid contains water for preparing injections, L-lysine, sodium hydroxide.

One 500-mg gastro-resistant tablet contains: ademethionine (Sulphur-Adenosil-L-Methionine), 1,4-butandisulphonate 949 mg equal to ion 500 mg. Excipients: microcrystalline cellulose, magnesium stearate, polyethylene glycol 6000, polymethacrylate, polysorbates, colloidal silica, emulsified silicone, and sodium-starch glycolate talc.

Pharmaceutical Classification

For the treatment of cholestasis. DONAMET is recommended for the treatment of intrahepatic cholestasis in pre-cirrhotic and cirrhotic conditions. Treatment of intrahepatic cholestasis during pregnancy.

Contraindications

Individual hypersensitivity to the product.

Caution

The lyophilized substance must not be mixed with the solvent liquid until immediately before use. Intravenous injections should be administered very slowly. DONAMET tablets are gastro-resistant and thus protect the duodenum from the Ademethionine. The tablets should not be removed from the blister until immediately prior to taking them. Tablets are to be swallowed whole, not chewed. For better absorption of the main active ingredient and hence a more complete therapeutic effect, it is recommended that DONAMET not be taken with meals but rather between them. In the case of pre-cirrhotic or cirrhotic patients with hyper ammonia, oral treatment must be carried out under a doctor's supervision and bearing in mind the ammonia values.

Interactions

Marked interactions have not been shown. Please take note- DONAMET does not affect the patient's capacity to drive or operate machinery.

Directions for Use

Intensive treatment: 5-12 mg/kg/day to be administered by intramuscular or intravenous injection for the first two weeks of treatment (equivalent to 300-800 mg/day). Follow-up treatment: 10-25 mg/kg/day to be taken by mouth (equivalent to 800-1600 mg/day).

Overdose

No cases of overdose have been reported.

Side Effects

Side effects have not been seen either in long-term treatment or when taken in high doses. Rarely, and only in those who are particularly sensitive, has DONAMET caused disturbances in the patient's waking-sleeping rhythm. In such cases the use of a sleeping pill in the evenings may prove to be effective. Given the high pH acidity level of DONAMET to ensure its effectiveness, certain patients have reported cases of heartburn and epigastric heaviness. However such discomfort is minor and should not interfere with treatment.

If the patient notices any side effect not described in this leaflet he should consult his doctor.

Expiry Date

Observe the expiry date on the packaging of this product. It refers to the unopened product when properly stored.

Attention

Do not use this medicine once its expiry date has passed. Store DONAMET at a maximum temperature of 25° C. If the lyophilized substance should take on a colour other than white, due either to a small breakage of the phial, or exposure to heat, we recommend that the patient return the entire package to the chemist to be changed. Similarly, if the tablets should take on a colour other than white due to the presence of small holes in the aluminum covering, return the entire package to the chemist to be changed.

Easy opening safety ampoule- Instructions for opening

Position the ampoule as shown in figure 1. - Exert pressure with the thumb on the COLOURED DOT as shown in figure 2. If the lot number shown on the box includes the letter "B", the phials of lyophilized material have been manufactured by Boehringer Mannheim Italia Spa in the Monza (Milan) office. If the lot number shown on the box includes the letter "F", the Fidia Spa has manufactured the phials of lyophilized material in the Abano Terme (Padua) office.

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