Do not use in horses with known hypersensitivity to pergolide mesylate or other ergot derivatives or to any of the excipients.
Do not use in horses less than 2 years of age.
Appropriate endocrinologic laboratory tests should be conducted as well as evaluation of clinical signs in order to establish a diagnosis of PPID.
Special precautions for use for each target species
Special precautions for use in animals
As the majority of cases of PPID are diagnosed in aged horses, other pathological processes are frequently present. For monitoring and frequency of testing, see section Dosage and administration.
Pregnancy: Use only according to the benefit/ risk assessment by the responsible veterinarian. The safety of this product has not been demonstrated in pregnant mares. Laboratory studies in mice and rabbits have not produced any evidence of teratogenic effects. Reduced fertility was seen in mice at a dose of 5.6 mg/kg body weight per day.
Lactation: The use is not recommended in lactating horses, in which the safety of this product has not been demonstrated. In mice, reduced body weights and survival rates in the progeny were attributed to the pharmacological inhibition of prolactin secretion resulting in lactation failure.
Use with caution if the product is co-administered with other drugs known to affect protein binding. Do not administer concurrently with dopamine antagonists, such as neuroleptics (phenothiazines - e.g. acepromazine), domperidone, or metoclopramide, as these agents may reduce the effectiveness of Pergolide. There is no clinical experience with massive overdose.
Withdrawal period
Not authorised for use in horses intended for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation. Not authorised for use in mares producing milk for human consumption.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause eye irritation, an irritating smell, or headache after splitting. Minimise exposure risks when splitting tablets. Tablets should not be crushed.
Avoid contact with the eyes and inhalation when handling the tablets.
Wash hands after use.
People with known hypersensitivity to pergolide or other ergot derivatives should avoid contact with the veterinary medicinal product and should not administer it.
Pregnant or lactating women should wear gloves when administering the product.
In case of contact with skin, wash exposed skin with water. In the event of pergolide exposure to the eye, flush the affected eye immediately with water and get medical advice. For nasal irritation, move to fresh air and seek for medical attention if breathing difficulty develops.
Pergolide, like other ergot derivatives, may cause emesis, dizziness, lethargy or low blood pressure.
Do not ingest the product.
Store this product separately away from human medicinal products and handle this product with great care to avoid accidental ingestion.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Avoid driving or operating machinery following ingestion of this product.
Children should not come into contact with the veterinary medicinal product. Accidental ingestion, especially by children, may cause adverse reactions.
Adverse reactions (frequency and seriousness)
In rare cases inappetence, transient anorexia and lethargy, mild central nervous system signs (e.g. mild depression and mild ataxia), diarrhoea and colic have been observed in horses. In very rare cases sweating has been reported. If signs of dose intolerance develop, treatment should be stopped for 2 to 3 days and reinstated at one-half of the previous dose. The total daily dose may then be titrated back up to the desired clinical effect by 0.5 mg increments every 2 to 4 weeks.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).