1] Name of the Veterinary Medicinal Product

Scullcap and Valerian

Sugar coated tablets

2] Qualitative and Quantitative Composition

Active substance: Each tablet contains;

Mistletoe Dry Ext (Powdered) 3:1 50mg

Valerian Dry Ext Powdered) 5:1 50mg

Scullcap herb (Powdered) 30mg

Gentian Dry Ext (Powdered ) 2:1 24mg

Excipients

Ferric oxide, yellow (E172) 0.1mg

Titanium dioxide (E171) 0.8mg

For full list of excipients, see section 6.1.

3] Pharmaceutical form

Coated tablet

Yellow tablet, 8.73mm diameter

4] Clinical particulars

Dogs and cats

4.2 Indications for use

A herbal medicine for the symptomatic relief of anxiety, nervousness, excitability and travel sickness and an adjunct in the treatment of epilepsy in dogs and cats.

None

Dogs – None necessary

Cats – None necessary

Epilepsy should only be treated in conjunction with a veterinary surgeon

Wash hands after use

4.6 Adverse reactions (frequency and seriousness)

01/05/2002 – 31/01/2007

Doses sold: 3,345,480

Adverse reactions: Three (3)

4.7 Use during pregnancy and lactation

No data is available to support the use of this product in pregnant or lactating animals. Therefore the use of this product in pregnant or lactating animals is not recommended.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

1-2 tablets per 5kgs of bodyweight daily.

Can be used on a daily basis or as and when required for specific occasions or situations.

Oral administration

4.10 Overdose

No treatment specified

4.11 Withdrawal periods

Not applicable

5] Pharmacological properties

5.1 Pharmacodynamic properties

Not known

5.2 Pharmacokinetic properties

Not known

6] Pharmaceutical particulars

Ferric oxide, yellow (E172)

Titanium dioxide (E171)

Asafoetida

Talc, purified

Magnesium stearate

Sodium starch glycollate

Sucrose, compressible

Syrup

None known

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

6.4 Special precautions for storage

Do not store above 25ºC. Store in a dry place

6.5 Nature and composition of immediate packaging

White high density polyethylene bottle

White high density polyethylene cap (tamper evident)

Available in bottles of 50, 100, 200 and 500 tablets

Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal product

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7] Marketing authorisation holder

Dorwest Herbs Ltd

Shipton Gorge

Bridport

Dorset

DT6 4LP

England

8] Marketing authorisation number

00866/4021

9] Date of first authorisation or date of renewal of the authorisation

First authorised – 01/09/1992

10] Date of revision of the text

November 2008