Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
tramadol hydrochloride
Niche Generics Limited
N02AX02
tramadol hydrochloride
50 mg
Capsule hard
Treatment of moderate to severe pain.
2002-06-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BioDol 50mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50mg tramadol hydrochloride capsule contains: 50mg tramadol hydrochloride Excipients: Each capsule contains 70mg of lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard. Olive/yellow hard capsules imprinted “TRM” on the capsules cap and “50” on the capsules body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of the pain and the clinical response of the individual patient. Treatment periods should be short and intermittent as dependence can occur with tramadol. The benefits of continued use should be reviewed in order to ensure that they outweigh the risks of dependence (see Special Warnings and Precautions for Use and Undesirable Effects section). Adults and Children Aged 12 Years and Over _Acute pain_ An initial dose of 100mg is usually necessary. This can be followed by doses of 50 or 100 mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need. _Pain associated with chronic conditions_ Use an initial dose of 50mg and then titrate dose according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (See Section 4.4, _Special_ _Warnings and Precautions for Use_). A total daily oral dose of 400mg is not usually required or recommended. _Elderly_ The usual dosages may be used although it should be noted that in volunteers aged over 75 years Read the complete document