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Hydergine Manufacturer's Insert

The following information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.

Chemical - Dihydroergotoxine mesylate

1 ml of drops in liquid (to be taken by mouth) = 1 mg dihydroergotoxine mesylate, 50 mg ethanol (96%), metansulphonic acid, glycerine, demineralised water.

Experimental studies carried out on animals have shown that dihydroergotoxine mesylate modifies cerebral neurotransmission, stimulates dopaminergic and serotoninergic receptors and blocks alpha-adrenoreceptors. It also improves diminished metabolic cerebral function; this effect can be seen in modifications of the brain's electrical activity and particularly in the energy spectrum of the electroencephalogram. This effect has also been confirmed in the course of studies on man. It has furthermore been proven that dihydroergotoxine mesylate reduces the time of cerebral circulation.

Controlled clinical assays have revealed that dihydroergotoxine improves symptoms of mental deterioration related to ageing, such as instability, dizziness, headaches, difficulty in concentrating, disorientation, memory loss, lack of initiative, depression, lack of sociability, difficulties in carrying out everyday activities and in personal care. The role played by this medicine in the treatment of cerebrovascular insufficiency has not been clearly established; it is merely symptomatic.

Administration of this medicine must be determined by a doctor according to the needs and response of each patient.

As a general rule, we recommend the administration of 4.5 mg/day in a single dose or in separate doses to be taken before meals (30 drops, 3 times daily). In certain cases, a 9-mg/day dosage may be needed.

Hypersensitivity to the product. Patients with acute or chronic psychoses of any etiology.

Before beginning treatment, a complete diagnosis should be carried out to exclude pathologies for which this type of substance does not provide effective results (delirium, dementia).

This medicine should be used with caution with severe bradycardia. Since it contains ethanol as an excipient, it may be prove to be a risk if administered to patients with hepatic illnesses, alcoholism, epilepsy, or to pregnant women and children.

Expectant and Nursing Mothers
Because of the lack of data available concerning the effect that this pharmaceutical product may have on humans, avoid using it except when absolutely necessary.

Adverse Effects
Although rare, these include nasal congestion, nausea and gastric problems, which may be prevented by taking the pharmaceutical product with food.

Such adverse effects tend to disappear with no need to take specific measures.

It may cause skin irritation of an allergic nature, headaches, reddening or blurred vision.

It may enhance the action of medicines for the treatment of hypertension or those that lower cardiac rhythm (digitalis therapy, beta blockers).

Intoxication and its Treatment
Accidental overdose may cause migraines, facial reddening and nasal congestion and, in more serious cases, nausea and vomiting, muscular weakness and significant hypotension. In extreme cases, it can cause coma.

Symptomatic medication is to be aimed above all at maintaining haemodynamic constants. Should the patient suffer from hypotension, do not administer adrenalin, but rather noradrenaline or angiotensin. In the event of overdose or accidental swallowing, consult the Toxicology Information Service.

Available in: 40-ml container of drop solution.

Keep this and all other medicines safely out of the reach of children.