Contraindications
Do not use in cases of hypersensitivity to the active substance or other ergot derivatives or to any of the excipients.
Do not use in horses less than 2 years of age.
Special warnings
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
Special precautions for safe use in the target species:
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Pergolide, like other ergot derivatives, may cause emesis, dizziness, lethargy or low blood pressure.
Severe adverse events such as collapse have been observed. Ingestion may be harmful and associated with severe adverse events, especially in children or people with pre-existing heart conditions. Do not ingest this veterinary medicinal product.
In order to reduce the risk of accidental ingestion:
- Store and handle this veterinary medicinal product separately away from human medicinal products and handle it with great care.
- Tablets prepared for administration should be administered immediately and not left unattended.
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 veterinary medicinal product.
Children should not come into contact with the veterinary medicinal product.
This veterinary medicinal 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.
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 veterinary medicinal 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.
Wash hands after use.
Special precautions for the protection of the environment
Not applicable
Use during pregnancy, lactation or lay
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.
Interaction with other medicinal products and other forms of interaction
Use with caution in case the veterinary medicinal 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
There is no clinical experience with massive overdose.
Withdrawal periods
Not applicable.
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.
Adverse events
Horses (non food-producing):
Rare (1 to 10 animals / 10,000 animals treated): | Inappetence; anorexia1; lethargy1 Central nervous system disorder (e.g., central nervous system depression and ataxia)2 Diarrhoea; colic |
Very rare (< 1 animal / 10,000 animals treated, including isolated reports): | Sudation |
1 Transient
2 Mild
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.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.