Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: 01279 775858

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

Freeze-dried tablets containing 5 mg nicergoline.

Uses

FITERGOL is indicated for improvement of ageing related disorders in dogs, particularly those of behavioural origin: e.g. diminished vigour and vigilance fatigue, sleep disorders, and psychomotor disturbances (such as episodes of ataxia).

Dosage and administration

Tablets to be given orally.

Single administration daily of between 0.25 and 0.50 mg/kg/day to be given every morning for 30 days.

Treatment may be repeated depending on outcome.

The following table specifies the number of tablets to be administered in accordance with the dog's weight:-

Weight (kg)	Number of Tablets
10 to 20	1
21 to 30	2
31 to 40	3

Because FITERGOL is presented in a freeze dried form, it is not possible to break the tablets in half, and consequently a half dose for dogs weighing 5–10 kg cannot be administered in this way. For dogs in this weight range, FITERGOL may therefore be administered in solution. Owners should be instructed to dissolve one tablet in 10 ml of water, stir or shake gently until dissolved, and then immediately administer 5 ml of the solution. The remainder of the solution must be discarded. A 10 ml syringe and suitable container should be provided for this purpose.

Contra-indications, warnings, etc

For animal treatment only.

Do not use the product within 24 hours of administration of α 2 agonists such as xylazine, medetomidine and romifidine. Do not use the product prior to treatment with vasodilators such as acepromazine and prazosin. Specific disease should receive appropriate treatment. Do not exceed the stated dose.

When FITERGOL is administered as a solution, owners should be clearly instructed not to use household utensils for preparing the solution, and that the unused portion of the solution must be discarded.

Do not break tablets.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Protect from light.

Keep out of reach of children.

Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.

Legal category

POM-V

Packaging Quantities

Cartons of 5 blister strips, each containing 10 tablets.

Further information

Nicergoline is an alpha-blocking cerebral vasodilator.

The activity of nicergoline is primarily due to blockade of α 1 and α 2 adrenoceptors.

Nicergoline also blocks serotonin and dopamine receptors.

Nicergoline demonstrates a wide safety margin.

Administration of up to 90 times the normal recommended dose in dogs for 6 months has shown no adverse effect.

Marketing authorisation number

Vm 08327/4099.