NICERGOLINE / SERMION ®

INGREDIENTS:

Tablets: Each tablet contains 5 mg Nicergoline (I.N.N.). Excipients: Sucrose, calcium phosphate, sodium carboxymethyl cellulose, micro-crystalline cellulose, magnesium stearate, gum arabic, titanium dioxide, magnesium carbonate, flora wax, talc and Pal Super orange.
Drops: Each ml (20 drops) of prepared solution contains: 5 mg Nicergoline (I.N.N.), lactose, tartaric acid, methyparaben and water.

PROPERTIES:
Sermion (nicergoline) is a vasoactive pharmaceutical product, synthesised in Farmitalia research laboratories, with alpha-adrenolytic action to activate the brain's metabolism. Sermion (nicergoline) acts on different levels:

• On the cerebral level, it prompts a lowering of vascular resistance, an increase in arterial flow and the use of oxygen and glucose. In terms of lung circulation, it lowers vascular resistance. With regard to limb circulation, it brings about an increase in the flow, particularly evident in those patients with insufficient irrigation due to functional arteriopathies.
• Studies carried out in vitro and in vivo, both experimental and on human beings, have shown that Sermion (nicergoline) inhibits platelet aggregation. Sermion (nicergoline) has proved to be effective in hospital use, regulating and improving brain disorders caused by metabolic-vascular insufficiency and alterations derived from insufficient arterial irrigation in the limbs. When the therapeutic dosage is administered, Sermion (nicergoline) does not affect arterial tension. In the case of patients suffering from hypertension, it may induce a gradual lowering of tension.
• This pharmaceutical product does not induce vomiting.

INDICATIONS:
Acute and chronic cerebral metabolic-vascular disorders (cerebral arteriosclerosis, thrombosis and cerebral embolism, transitory cerebral ischaemia). Acute and chronic peripheral metabolic-vascular disorders (organic and functional arteriopathies of the limbs), Raynaud's disease and other syndromes caused by altered peripheral irrigation.

• Migraines of vascular origin
• Coadjutant therapy in clinical situations accompanied by platelet hyper-aggregability, arterial tension
• Corio-retinal vascular disorders: retinal thromboses, diabetic retinopathy, macular degeneration and retinal angiosclerosis
• Oto-vestibular problems of a vascular nature: dizziness, auditory hallucinations, hypoacusis.

DOSAGE:
By mouth: 5-10 mg (1-2 tablets or 20-40 drops) 3 times daily at regular intervals over prolonged periods of time. To facilitate absorption, take this medicine between meals.
The dosage and length of treatment are to be decided by your doctor. At times, the therapeutic effects of Sermion (nicergoline), both subjective and objective, are not immediately noticeable, but will be noted after a certain period of treatment.

DIRECTIONS FOR USING DROPS:
Pour the powder into the vial containing the solvent and shake until completely dissolved.
To measure out Sermion (nicergoline) in drops, use the accompanying syringe, sucking in the amount of liquid required for each dose.

CONTRAINDICATIONS:
None known.

PRECAUTIONS:
Although toxicology studies have not shown nicergoline to have any teratogenic effect, the use of this medicine during pregnancy should be limited to those cases where it is absolutely necessary.

INCOMPATIBILITIES:
None known.

INTERACTIONS:
The vasoactivity of Sermion (nicergoline) may heighten the effect of pharmaceutical products that produce hypotension.

ADVERSE EFFECTS:
Although very infrequently, rubeosis, a hot feeling, mild gastric upsets, hypotension and dizziness have been observed.
Should you notice any adverse reaction not described, consult your doctor or chemist.

INTOXICATION AND TREATMENT:
The chances of intoxication as a result of taking this product are very remote. Only in certain cases of overdose can the symptoms described under "Adverse Effects" appear. These subside if one stops taking the product.
In cases of overdose or accidental ingestion, consult the Toxicology Information Service.

AVAILABLE IN:
Tablets: 45-tablet container.
Drops: Container with 1 vial of powder and 1 bottle of solvent.

EXPIRY DATE:
This medicine must not be used after the expiry date printed on the container.

RECONSTITUTED SOLUTION:
Drops: Once prepared, the solution is good for 30 days at room temperature.

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

The above 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.