Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tramadol hydrochloride
Sandoz Ltd
N02AX02
Tramadol hydrochloride
200mg
Modified-release tablet
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Caution - AMP level prescribing advised
BNF: 04070200
WHAT IS IN THIS LEAFLET 1. What Larapam SR Tablets are and what they are used for 2. What you need to know before you take Larapam SR Tablets 3. How to take Larapam SR Tablets 4. Possible side effects 5. How to store Larapam SR Tablets 6. Contents of the pack and other information Tramadol, the active substance in Larapam SR Tablets, is a painkiller (analgesic) of the opioid group. Its pain alleviating effect is due to its influence on specific nerve cells in the spinal cord and in the brain. Larapam SR Tablets are used in the treatment of moderate to severe pain. DO NOT TAKE LARAPAM SR TABLETS: • if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6) • in acute poisoning with alcohol, sleeping agents, centrally acting painkillers, opioids or other psychotropic medicines (medicines which influence mood, emotional status and disposition). • if you are also taking certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat depression or Parkinson’s disease) or have taken them in the last 14 days before treatment with Larapam SR Tablets (see “Other medicines and Larapam SR Tablets”) • if you have epilepsy and your fits are not adequately controlled by treatment • as a drug substitute in drug withdrawal treatment WARNINGS AND PRECAUTIONS Talk to your doctor before taking Larapam SR Tablets if you: • think you may already be dependent on other opioid painkillers • react sensitively to opiates • have a consciousness disturbance (if you feel that you are going to faint) • are in shock (cold sweat can be an indication of this) • have difficulty in breathing • suffer from increased pressure in the brain (possibly after a head injury or brain disease) • have a liver or kidney disorder • suffer from epilepsy or seizures (fits) or have had them in the past. If any of the above applies to you, please talk to your doctor before starting to take this medicine. Sleep-related breathing disorders: Larapam SR Tablets contains an Soma hati kamili
1. NAME OF THE MEDICINAL PRODUCT Larapam 200mg SR Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 200 mg tramadol hydrochloride. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release tablet. Larapam 200mg SR Tablets are off white capsule shaped tablets 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. Daily doses of 400 mg tramadol hydrochloride should not be exceeded, except in special clinical circumstances. Unless otherwise prescribed, Larapam SR Tablets should be given as follows: _Adults and adolescents above the age of 12 years_ The usual initial dose is one Larapam 100mg SR Tablet, twice daily, in the morning and evening. The dose interval must not be less than 8 hours. If the pain relief is insufficient, the dose may be increased to: one Larapam 150mg SR Tablet, twice daily or one Larapam 200mg SR Tablet, twice daily. Larapam SR Tablets should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary. _Paediatric population_ Larapam SR is not suitable for children under the age of 12 years. _Elderly _ A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly people over 75 years elimination may be prolonged. Therefore, if necessary the dose interval is to be extended according to the patient's requirements. _Renal insufficiency/dialysis and hepatic impairment_ In patients with renal and/or hepatic Soma hati kamili