One tablet contains as active substance(s): Tramadol (as hydrochloride) 43.9 mg. Equivalent to 50 mg of tramadol hydrochloride.
White to almost white tablets with brown dots with a break line on one side, flat, with rounded edges and a characteristic smell of meat.
Tablets can be divided into 2 equal parts.
Target species: Dogs weighing more than 6.25 kg.
Indications for use, specifying the target species: For the reduction of acute and chronic mild soft tissue and musculoskeletal pain.
Contraindications: Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase inhibitors and serotonin reuptake inhibitors.
Do not use in cases of hypersensitivity to tramadol or to any of the excipients. Do not use in animals with epilepsy.
Special warnings for each target species: The analgesic effects of tramadol hydrochloride may be variable. This is thought to be due to individual differences in the metabolism of the drug to the primary active metabolite O-desmethyltramadol. In some dogs (non-responders) this may result in the product failing to provide analgesia. For chronic pain, multimodal analgesia should be considered. Dogs should be monitored regularly by a veterinarian to ensure adequate pain relief. In case of recurrence of pain or insufficient analgesia the analgesic protocol may need to be reconsidered.
Special precautions for use
Special precautions for use in animals: Use with caution in dogs with renal or hepatic impairment. In dogs with hepatic impairment the metabolism of tramadol to the active metabolites may be decreased which may reduce the efficacy of the product. One of the active metabolites of tramadol is renally excreted and therefore in dogs with renal impairment the dosing regimen used may need to be adjusted. Renal and hepatic function should be monitored when using this product. Cessation of long-term analgesic therapy should be done gradually whenever possible.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Tramadol may cause sedation, nausea and dizziness after accidental ingestion, especially by children. To avoid accidental ingestion, particularly by a child, unused tablet parts should be returned to the open blister space and inserted back into the carton and kept in a safe place out of the sight and reach of children. In case of accidental ingestion, particularly by children, seek medical advice immediately and show the package leaflet or the label to the physician. In case of accidental ingestion by adults: DO NOT DRIVE as sedation may occur. People with known hypersensitivity to tramadol or any of the excipients should avoid contact with the veterinary medicinal product. Wash hands after use.
Adverse reactions (frequency and seriousness): Mild sedation and drowsiness may commonly occur, especially when higher doses are given. Nausea and vomiting have uncommonly been observed in dogs after administration of tramadol. In rare cases hypersensitivity can occur. In cases of hypersensitivity reactions the treatment should be discontinued. In very rare cases tramadol may induce convulsions in dogs with a low seizure threshold.
Use during pregnancy, lactation or lay:
Pregnancy: In laboratory studies conducted on mice and / or rats and rabbits respectively, the use of tramadol did not reveal the existence of teratogenic, foetotoxic, maternotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
Lactation: In laboratory studies conducted on mice and / or rats and rabbits, respectively, the use of tramadol did not show any negative effects in the peri and post-natal period of offspring. Use only according to the benefit-risk assessment by the responsible veterinarian.
Fertility: In laboratory studies conducted on mice and / or rats and rabbits respectively, the use of tramadol at therapeutic doses did not induce the appearance of unfavorable reactions on reproductive parameters and fertility in the male and female. Use only according to the benefit-risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction: Concomitant administration of this product with depressant drugs of the central nervous system may potentiate the effects on C.N.S and respiratory depressant effects. This product can increase the effect of drugs that lower the seizure threshold. Drugs that inhibit (e.g. cimetidine and erythromycin) or induce (e.g. carbamazepine) CYP450 mediated metabolism may have an effect on the analgesic effect of this product. The clinical relevance of this interaction has not yet been definitively studied. The combination with mixed agonist/antagonists (e.g. buprenorphine, butorphanol) and the product is not advisable, because the analgesic effect of a pure agonist may be theoretically reduced in such circumstances.