Tramacet 37.5 mg/ 325 mg film-coated tablets
Grunenthal Ltd
contact details
Active ingredient
paracetamol
tramadol hydrochloride
Legal Category
POM: Prescription only medicine
1. Name of the medicinal product
TRAMACET 37.5mg/325mg Film coated tablets
Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg film-coated tablets
2. Qualitative and quantitative composition
One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol
Excipients: One film coated tablet contains 1.878 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Pale yellow film-coated tablet, marked with the manufacturer's logo on one side and 'T5' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Tramadol hydrochloride/Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain.
The use of Tramadol hydrochloride/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see also Section 5.1).
4.2 Posology and method of administration
Posology
The use of Tramadol Hydrochloride/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
The dose should be adjusted to intensity of pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be exceeded. The dosing interval should not be less than six hours.
Adults and adolescents (12 years and older)
An initial dose of two tablets of Tramadol hydrochloride/Paracetamol is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.
The dosing interval should not be less than six hours.
Tramadol hydrochloride/Paracetamol should under no circumstances be administered for longer than is strictly necessary (see also section 4.4 - Special warnings and precautions for use). If repeated use or long term treatment with Tramadol hydrochloride/Paracetamol is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment is necessary.
Paediatric population
The effective and safe use of Tramadol hydrochloride/Paracetamol has not been established in children below the age of 12 years. Treatment is therefore not recommended in this population.
Older patients
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In older people over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.
Renal insufficiency / dialysis
In patients with renal insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements.
Hepatic impairment
In patients with hepatic impairment the elimination
