Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Tramadol hydrochloride
KRKA, d.d., Novo mesto
N02AX; N02AX02
Tramadol hydrochloride
50 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Other opioids; tramadol
Marketed
2018-03-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRAMADOL KRKA 50 MG HARD CAPSULES tramadol hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tramadol Krka is and what it is used for 2. What you need to know before you take Tramadol Krka 3. How to take Tramadol Krka 4. Possible side effects 5. How to store Tramadol Krka 6. Contents of the pack and other information 1. WHAT TRAMADOL KRKA IS AND WHAT IT IS USED FOR Tramadol – the active substance in Tramadol Krka – is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramadol Krka capsules are used for the treatment of moderate to severe pain in adults and children aged 12 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL KRKA DO NOT TAKE TRAMADOL KRKA - 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 pills, pain relievers or other medicines that affect mood and emotions; - if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with Tramadol Krka (see "Other medicines and Tramadol Krka"); - if you suffer from epilepsy and your fits are not adequately controlled by treatment; - as a substitute in drug withdrawal. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Tramadol Krka: - if you think t Læs hele dokumentet
Health Products Regulatory Authority 11 July 2022 CRN00CTQZ Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tramadol Krka 50mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg tramadol hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule) The body of the capsule is white and the cap is blue. Capsules are filled with white or almost white powder. The size of the capsule is No: 4. The length of filled capsules is 14-15 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain in adults and adolescents aged 12 years and over. 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. The total daily dose of 400 mg active substance should not be exceeded, except in special circumstances. Unless otherwise prescribed, Tramadol Krka should be administered as follows: _Adults and adolescents aged 12 years and over_ Dosage form Single dose Total daily dose Tramadol Krka 50-100 mg Every 4 to 6 hours (1 to 2 hard capsules) (see section 5.1) 400 mg (Up to 8 hard capsules) If there is no sufficient pain relief after administration of a single dose of 50 mg tramadol hydrochloride within 30 to 60 minutes, a second single dose of 50 mg can be administered. If in severe pain the demand is likely to be higher, the higher single dose of Tramadol Krka (100 mg tramadol hydrochloride) may be given as the initial dose. ACUTE PAIN: An initial dose of 100 mg is usually necessary. This can be followed by doses of 50 or 100 mg at 4 - 6 hourly intervals, and duration of treatment should be matched to clinical need. PAIN ASSOCIATED WITH CHRONIC CONDITIONS: An initial dose of 50 mg is advised and then titration according to pain severity. The need for continued treatment should be assessed at regular intervals as withdr Læs hele dokumentet