Tramvetol 50 mg Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tramadol Hydrochloride

Available from:

Virbac

ATC code:

QN02AX02

INN (International Name):

Tramadol Hydrochloride

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Neurological Agent analgesic

Authorization status:

Authorized

Authorization date:

2019-10-21

Summary of Product characteristics

Issued: October 2019
AN: 01115/2018
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tramvetol 50 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE(S):
Tramadol (as hydrochloride)
43.9 mg
Equivalent to 50 mg of tramadol hydrochloride
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
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.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs weighing more than 6.25 kg.
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Issued: October 2019
AN: 01115/2018
Page 2 of 6
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. One of the active
metabolites of
tramadol is re