Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
Le Vet Beheer B.V.
QN02AX02
Tramadol hydrochloride
80 mg/tablet
Chewable tablet
POM: Prescription Only Medicine as defined in relevant national legislation
tramadol
Authorised
2018-07-06
Health Products Regulatory Authority 10 July 2018 CRN000V6W Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tralieve 80 mg chewable tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 80 mg tablet: 1 tablet contains: ACTIVE SUBSTANCE: Tramadol hydrochloride 80 mg equivalent to 70.3 mg tramadol EXCIPIENT(S): For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. 80 mg tablet: Light brown with brown spots, round and convex flavoured 11 mm tablet with a cross-shaped break line on one side. Tablets can be divided into 2 or 4 equal parts. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the reduction of acute and chronic mild soft tissue and musculoskeletal pain. 4.3 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. Health Products Regulatory Authority 10 July 2018 CRN000V6W Page 2 of 7 4.4 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. 4.5 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 Read the complete document