Do not use during pregnancy or lactation. The safety of Semintra has not been established in breeding, pregnant or lactating cats.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
The safety and efficacy of telmisartan has not been tested in cats under the age of 6 months. It is good clinical practice to monitor the blood pressure of cats receiving Semintra which are under anaesthesia.
Due to the mode of action of the veterinary medicinal product, transient hypotension may occur. Symptomatic treatment, e.g. fluid therapy, should be provided in case of any clinical signs of hypotension.
As known from substances acting on the Renin-Angiotensin-Aldosterone System (RAAS), a slight decrease in red blood cell count may occur. Red blood cell count should be monitored during therapy.
The following mild and transient gastrointestinal signs have rarely been observed in a clinical study (in order of decreasing frequency): mild and intermittent regurgitation, vomiting, diarrhoea or soft faeces.
Elevated liver enzymes have been very rarely observed and values normalised within a few days following cessation of therapy.
Effects attributable to the pharmacological activity of the product observed at the recommended treatment dose included reductions in blood pressure and decreases in red blood cell counts.
During concomitant therapy with amlodipine at the recommended dose no clinical evidence of hypotension was observed.
No drug-drug interactions are known from the available data in cats with CKD for the use of telmisartan and other medicinal products that interfere with RAAS (such as ARBs or ACEis). The combination of agents targeting the RAAS may alter renal function.
After administration of up to 5 times the recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section 4.6.
Administration of the product at overdose (3 to 5 times of the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN). In the event that hypotension does occur, symptomatic treatment, e.g. fluid therapy, should be provided.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary products.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Avoid eye contact. In case of accidental eye contact, rinse eyes with water. Wash hands after use.
Pregnant women should take special care to avoid contact with the product because substances acting on the RAAS, such as Angiotensin Receptor Blockers (ARBs) and ACE inhibitors (ACEi), have been found to affect the unborn child during pregnancy in humans.
People with hypersensitivity to telmisartan or other sartans/ARBs should avoid contact with the veterinary medicinal product.