Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Naldemedine tosilate
Shionogi B.V.
A06AH05
naldemedine
Drugs for constipation, Peripheral opioid receptor antagonists
Constipation
Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Revision: 10
Authorised
2019-02-18
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RIZMOIC 200 MICROGRAMS FILM-COATED TABLETS naldemedine 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 Rizmoic is and what it is used for 2. What you need to know before you take Rizmoic 3. How to take Rizmoic 4. Possible side effects 5. How to store Rizmoic 6. Contents of the pack and other information 1. WHAT RIZMOIC IS AND WHAT IT IS USED FOR Rizmoic contains the active substance naldemedine. It is a medicine used in adults to treat constipation caused by pain medicines, called opioids (e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone). Your opioid pain medicine may cause the following symptoms: - reduction in how often you pass stools - hard stools - stomach ache - pain in the rectum when pushing hard stools out - a feeling that the bowel is still not empty after passing stools. Rizmoic can be used in patients using an opioid medicine for cancer pain or long term non-cancer pain after they have previously been treated with a laxative. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZMOIC DO NOT TAKE RIZMOIC: - if you are allergic to naldemedine or any of the other ingredients of this medicine (listed in section 6). - if your bowel is blocked or perforated, or if there is a high risk of your bowel becoming blocked, as a blockage may cause a hole to develop in the bowel wall. DO NOT take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before ta Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Rizmoic 200 micrograms film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 micrograms naldemedine (as tosylate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Round, approximately 6.5 mm diameter, yellow tablet debossed with '222' and Shionogi logo on one side and '0.2' on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of naldemedine is 200 micrograms (one tablet) daily. Rizmoic may be used with or without laxative(s). It may be taken at any time of the day but it is recommended to be taken at the same time every day. Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required. Rizmoic must be discontinued if treatment with the opioid pain medicinal product is discontinued. _ _ _Special populations _ _Elderly _ No dose adjustment is required in patients older than 65 years of age (see section 5.2). Due to the limited therapeutic experience in patients 75 years old and older, naldemedine therapy should be initiated with caution in this age group. _ _ _Renal impairment _ No dose adjustment is required in patients with renal impairment (see section 5.2). Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine (see section 4.4). _ _ _Hepatic impairment _ No dose adjustment is required in patients with mild or moderate hepatic impairment. Use in patients with severe hepatic impairment is not recommended (see sections 4.4 and 5.2). _Paediatric population _ The safety and efficacy of naldemedine in children and adolescents aged below 18 years have not yet been established. No data are available. Aqra d-dokument sħiħ