TRAMADOL/PARACETAMOL Tablet Prolonged Release 75/650 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-05-2024
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Active ingredient:
TRAMADOL HYDROCHLORIDE PARACETAMOL PARACETAMOL
Available from:
Labopharm Europe Limited
Dosage:
75/650 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2011-08-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tramadol / Paracetamol 75 mg / 650 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 75 mg tramadol hydrochloride and 650 mg paracetamol.
Excipients: Each tablet contains 0.09 mg sunset yellow (E110).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
PROLONGED-RELEASE TABLET.
Bi-layered biconvex oval shaped film-coated tablets, consisting of an immediate-release layer (light peach) and a
prolonged-release layer (white to off-white).
The tablets are embossed “DDS 082” on the face of light peach layer.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DDS-06C tablets are indicated for the symptomatic treatment of moderate to severe pain in adults and adolescents over
the age of 12 years.
The use of DDS-06C should be restricted to patients whose moderate to severe pain is considered to require a
combination of tramadol and paracetamol (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Adults and adolescents (12 years and older)
The use of DDS-06C should be restricted to patients whose moderate to severe pain is considered to require a
combination of tramadol and paracetamol.
The dose should be individually adjusted according to intensity of pain and response of the patient.
An initial dose of one or two tablets of DDS-06C (equivalent to 75 mg or 150 mg of tramadol hydrochloride and 650
mg or 1300 mg of paracetamol) is recommended. Additional doses can be taken as needed, not exceeding four tablets
(equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.
The dosing interval should not be less than twelve hours.
DDS-06C should under no circumstances be administered for longer than is strictly ne
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