Tramcoat 40 mg Film-coated Tablets for Dogs

Excipients:
Qualitative composition of excipients and other
constituents
Tablet CoreCellulose, microcrystallineSaccharin sodiumVanillinLactose monohydrateSodium starch glycolate (type A)Magnesium stearateSilica, colloidal hydratedTablet CoatingTitanium dioxidePolyvinyl alcoholTalcGlycerol monocaprylocaprateSodium laurilsulfatePigment:
Orange: Iron oxide yellow, Iron oxide red
Orange film-coated tablet with a modified ball shape (size 8 mm).
3. CLINICAL INFORMATION
3.1 Target species
Dogs
3.2 Indications for use for each target species
For the reduction of acute and chronic mild soft tissue and musculoskeletal pain.
3.3 Contraindications
Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase
inhibitors and serotonin reuptake inhibitors.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
Do not use in animals with epilepsy.
3.4 Special warnings
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
veterinary medicinal 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.
3.5 Special precautions for use
Special precautions for safe use in the target species:
The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of
reach of 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 veterinary medicinal 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 veterinary medicinal 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. To
avoid accidental ingestion, particularly by children, blisters should be 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 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.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs:
FrequencyAdverse eventCommon
(1 to 10 animals / 100 animals treated):
Sedation
1,2
; drowsiness –
neurological disorder
Uncommon
Nausea; vomiting
(1 to 10 animals / 1000 animals treated):
Rare
(1 to 10 animals / 10,000 animals treated):
Hypersensitivity
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Convulsion
1
Mild.
Especially when higher doses are given.
In cases of hypersensitivity reactions the treatment should be discontinued.
In dogs with a low seizure threshold.
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.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Laboratory studies in mice and/or rats and rabbits have not produced any evidence of
teratogenic, foetotoxic, maternotoxic effects and adverse effects in the peri- and
postnatal development of offspring. Use only according to the benefit-risk assessment
by the responsible veterinarian.
Fertility:
In laboratory studies in mice and/or rats and rabbits, the use of tramadol at therapeutic
doses did not adversely affect reproductive performance and fertility in males and
females. Use only according to the benefit-risk assessment by the responsible
veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
Concomitant administration of the veterinary medicinal product with central nervous
system depressants, may potentiate the CNS and respiratory depressant effects.
Tramadol 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 tramadol.
The clinical relevance of these interactions has not been studied in dogs.
The combination with mixed agonist/antagonists (e.g. buprenorphine, butorphanol) and
tramadol is not advisable, because the analgesic effect of a pure agonist may be
theoretically reduced in such circumstances.
See also section 3.3 Contraindications.
3.9 Administration routes and dosage
Oral use.
The recommended dose is 2-4 mg tramadol hydrochloride per kg body weight every 8
hours or as needed based on the intensity of pain.
The minimum dosing interval is 6 hours. The recommended maximum total daily dose is
16 mg/kg. As the individual response to tramadol is variable and partly depends on the
dosage, the age of the patient, individual differences in pain sensitivity and general
condition, the optimal dosing regimen should be individually tailored using the above
dose and re-treatment interval ranges. The dog should be examined regularly by a
veterinarian to assess if additional analgesia is subsequently required. Additional
analgesia can be administered by increasing the tramadol dose until the maximum daily
dose is reached, and/or by following a multimodal analgesic approach with the addition of
other suitable analgesics.
Please note that this dosing table is intended as a guide for dispensing the
veterinary medicinal product at the high end of the dose range: 4 mg/kg
bodyweight. It states the number and type of tablets required to administer 4 mg
tramadol hydrochloride per kg bodyweight per administration.
The recommended dose is 2-4 mg tramadol HCl per kg. In this table an example of
4 mg tramadol HCl per kg is stated.
Veterinary medicinal productBody
weight
8 mg20 mg40 mg80 mg2 kg4 kg5 kg
7 kg

+
10 kg20 kg
30 kg

+
40 kg
50 kg

+
60 kg
A suitable combination of tablet sizes should be used in order to administer the optimal
dosage for each dog. To ensure a correct dosage, body weight should be determined
as accurately as possible.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
In cases of intoxication with tramadol, symptoms similar to those observed with other
centrally acting analgesics (opioids) are likely to occur. These include in particular,
miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma,
convulsions and respiratory depression up to respiratory arrest.
General emergency measures: Maintain a patent airway, support cardiac and
respiratory function depending on the symptoms. Inducing vomiting in order to empty
the stomach is suitable unless the affected animal is showing reduced consciousness,
in which case gastric lavage may be considered.
The antidote for respiratory depression is naloxone. However, naloxone may not be
useful in all cases of tramadol overdose as it may only partially reverse some of the
other effects of tramadol. In case of seizures, administer diazepam.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary medicinal
products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4.