Peptizole 370 mg/g Oral Paste for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Omeprazole

Available from:

Norbrook Laboratories Limited

ATC code:

QA02BC01

INN (International Name):

Omeprazole

Pharmaceutical form:

Oral paste

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Gastrointestinal

Authorization status:

Authorized

Authorization date:

2014-03-04

Summary of Product characteristics

Revised: December 2021
AN: 01433/2021 and 01437/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Peptizole 370 mg/g Oral Paste for Horses
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Omeprazole:
370 mg
EXCIPIENTS:
Yellow Iron Oxide (E 172):
2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral paste.
A yellow to tan oily paste
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment and prevention of gastric ulcers in horses.
4.3 CONTRAINDICATIONS
See section 4.5
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
4.4 SPECIAL WARNINGS FOR TARGET SPECIES
The veterinarian should consider the need for performing relevant
diagnostic tests
before selection of the treatment dose rate.
Revised: December 2021
AN: 01433/2021 and 01437/2021
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Not recommended for animals under 4 weeks of age or weighing less than
70 kg
bodyweight.
Stress (including high performance training and competition), feeding,
management and
husbandry practices may be associated with the development of gastric
ulceration in
horses. Individuals responsible for the wellbeing of horses should
consider reducing the
ulcerogenic challenge by modifying husbandry practices to achieve one
or more of the
following: reduced stress, reduced fasting, increased intake of
roughage and access to
grazing.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
As this product may cause irritant and hypersensitivity reactions,
avoid direct contact
with skin and eyes. Use impervious gloves and do not eat or drink when
handling and
administering the product. Wash hands or any exposed skin after use.
In case of contact
with eyes, wash immediately with clean running water and seek medical
advice. Persons
developing a reaction after contac