מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Buprenorphine hydrochloride
Martindale Pharmaceuticals Ltd
N07BC; N07BC01
Buprenorphine hydrochloride
2 milligram(s)
Oral lyophilisate
Product subject to prescription which may not be renewed (A)
Drugs used in opioid dependence; buprenorphine
Authorised
2017-07-14
3. Remove the wafer carefully from the foil and take out from the packaging immediately. 4. Place the wafer on the tongue and close your mouth. Allow it to remain there for a few seconds until it has dissolved. Try to avoid swallowing during the first 2 minutes. Do not eat or drink for at least 5 minutes. IF YOU TAKE MORE ESPRANOR THAN YOU SHOULD Tell your doctor immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining wafers with you. IF YOU FORGET TO TAKE ESPRANOR You should tell your doctor and follow their instructions. Do not take a double dose to make up for the missed dose, unless your doctor tells you to. IF YOU STOP TAKING ESPRANOR Do not suddenly stop taking the wafers unless told to do so by your doctor, as this may cause withdrawal symptoms. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS LIKE ALL MEDICINES, THIS MEDICINE CAN CAUSE SIDE EFFECTS, ALTHOUGH NOT EVERYONE GETS THEM. For the first 24 hours of treatment, you may feel uncomfortable with some mild opiate withdrawal symptoms. TELL YOUR DOCTOR IMMEDIATELY OR SEEK URGENT MEDICAL ATTENTION if you experience uncommon side effects, such as: • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash. These may be signs of a life-threatening allergic reaction. • feeling sleepy and uncoordinated, have blurred vision, have slurred speech, cannot think well or clearly, or your breathing gets much slower than is normal for you. ALSO TELL YOUR DOCTOR IMMEDIATELY if you experience uncommon side effects such as: • severe tiredness, itching with yellowing of skin or eyes. These may be symptoms of liver damage. • seeing of hearing things that are not there (hallucination) Very common side effects (may effect more than 1 in 10 people) include: Insomnia (inability to sleep), constipation, feeling or being sick (nausea), sweating, headache, drug withdrawal syndrome. C קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Espranor 2 mg Oral Lyophilisate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each oral lyophilisate contains 2 mg of buprenorphine (as hydrochloride). Each oral lyophilisate contains 0.50 mg aspartame. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral lyophilisate. White to off-white circular oral lyophilisate with a diameter of 10.3 mm, debossed with ‘M2’ on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Treatment with Espranor oral lyophilisate is intended for use in adults and adolescents aged 15 years or over who have agreed to be treated for addiction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TREATMENT SHOULD BE UNDER THE SUPERVISION OF A CLINICIAN EXPERIENCED IN THE MANAGEMENT OF OPIATE DEPENDENCE/ADDICTION. Administration is oromucosal. The oral lyophilisate should be taken from the blister unit with dry fingers, and placed whole on the tongue until dispersed, which usually occurs within 15 seconds, and then absorbed through the oromucosa. Swallowing should be avoided for 2 minutes. The oral lyophilisate should be taken immediately after opening the blister. Patients should not consume food or drink for 5 minutes after administration. Physicians must advise patients that the oromucosal route of administration is the only effective and safe route of administration for this medicinal product. If the oral lyophilisate, or saliva containing buprenorphine are swallowed, the buprenorphine will be metabolised and excreted and have minimal effect. Adults and adolescents aged 15 years or over Precautions to be taken before induction: Prior to treatment initiation, consideration should be given to the type of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degree of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphi קרא את המסמך השלם