Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
TAPENTADOL HYDROCHLORIDE
Grünenthal Ltd
N02AX06
TAPENTADOL HYDROCHLORIDE
4 Mg/Ml
Oral Solution
Product subject to prescription which may not be renewed (A)
Other opioids
Authorised
2013-01-25
Name: GI PALEXIA 4MG/ML ORAL Artikel-Nr.: SOLUTION SC 8 pt R_JJ_180515_02 Klass.-Nr.: 50/030/23 Bez. der Vorgängerdatei: Vorgängerdatei gelöscht: 93020205 ‒ Leistungsindex: 1B/X3 Größe: 185 X 297 MM Druckfarbe: SCHWARZ Flattermarken: Faserlauf: 297 MM – Sprache: EN IRL Code: ‒ Datum: 23.11.2015 V 2 RZ geprüft: Palm SCHWARZ 1. WHAT PALEXIA IS AND WHAT IT IS USED FOR The full name of your medicine is ‘PALEXIA 4 mg/ml oral solution’. It is referred to as ‘PALEXIA’ in the rest of this leaflet. Tapentadol - the active substance in PALEXIA - is a strong painkiller which belongs to the class of opioids. PALEXIA is used in adults for the treatment of moderate to severe pain of recent onset that can only be adequately managed with an opioid painkiller. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PALEXIA DO NOT TAKE PALEXIA • if you are allergic to tapentadol or any of the other ingredients of this medicine (listed in section 6) • if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia) • if you have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach • if you have poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see ‘Other medicines and PALEXIA’) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking PALEXIA if you: • have slow or shallow breathing • suffer from increased pressure in the brain or are not fully conscious • have had a head injury or brain tumors • have had an epileptic fit or if you are at risk of having epileptic fits • suffer from liver or kidney problems (see “How to take PALEXIA”) • suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of the bile duct (biliary tract disease) • are taking medicines referred to as mixed opioid agoni Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PALEXIA 4mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml oral solution contains 4 mg tapentadol (as hydrochloride) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, colourless solution pH 3.5 to 4.5 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PALEXIA is indicated for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient. Patients should start treatment with single doses of 50 mg tapentadol as oral solution administered every 4 to 6 hours. Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements. On the first day of dosing, an additional dose may be taken as soon as one hour after the initial dose, if pain control is not achieved. The dose should then be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician. Total daily doses greater than 700 mg tapentadol on the first day of treatment and maintenance daily doses greater than 600 mg tapentadol have not been studied and are therefore not recommended. _Duration of treatment_ The oral solution is intended for acute pain siuations. If longer term treatment is anticipated or becomes necessary and effective pain relief in the absence of intolerable adverse events was achieved with PALEXIA, the possibility of switching the patient to therapy with PALEXIA prolonged-release tablets should be considered. As with all symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing basis. Calculation table for PALEXIA 4 MG/ML oral solution: _Discontinuation of treatment_ Withdr Прочитајте комплетан документ