Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
methylthioninium chloride
Alfasigma S.p.A.
V04CX
methylthioninium chloride
Other diagnostic agents
Colorectal Neoplasms; Colonoscopy
Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy.
Revision: 3
Authorised
2020-08-19
22 B. PACKAGE LEAFLET _ _ 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LUMEBLUE 25 MG PROLONGED-RELEASE TABLETS methylthioninium chloride 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. 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 Lumeblue is and what it is used for 2. What you need to know before you take Lumeblue 3. How to take Lumeblue 4. Possible side effects 5. How to store Lumeblue 6. Contents of the pack and other information 1. WHAT LUMEBLUE IS AND WHAT IT IS USED FOR Lumeblue contains methylthioninium chloride (also known as methylene blue). This medicine is a blue dye. This medicineis used in adults to temporarily stain the colon (large bowel) before colonoscopy, in which a flexible instrument is inserted into the rectum to view inside the bowel. The staining allows the doctor to see the lining of the colon more clearly and improves the detection of abnormalities. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LUMEBLUE _ _ DO NOT TAKE LUMEBLUE • if you are allergic to METHYLTHIONINIUM CHLORIDE , PEANUT or SOYA , or any of the other ingredients of this medicine (listed in section 6); • if you have been told you have GLUCOSE-6-PHOSPHATE DEHYDROGENASE (G6PD) DEFICIENCY ; • if you are PREGNANT or think you MAY BE PREGNANT , or are BREASTFEEDING as your doctor may decide that you do not need to take this medicine before your procedure. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking this medicine: • If you are taking certain antidepressant medicine or a medicine for psychiatric illness. Such as: - selective serotonin reuptake inhibitor (SSRI) antidepressants s Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lumeblue 25 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 25 mg of methylthioninium chloride. Excipients with known effect Lumeblue contains 3 mg soya lecithin per prolonged-release tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. Off white to light blue, round, biconvex, enteric coated tablets, with approximate dimensions of 9 . 5 mm x 5.3 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lumeblue is indicated as a diagnostic agent enhancing visualisation of colorectal lesions in adult patients undergoing screening or surveillance colonoscopy (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults including the elderly (_ ≥ _65 years) _ The recommended total dose is 200 mg methylthioninium chloride, corresponding to eight 25 mg tablets. The total dose of the medicinal product must be taken orally during or after the intake of low-volume (e.g. 2 L) or high-volume (e.g. 4 L) polyethylene glycol (PEG) based bowel cleansing preparation and should be completed the evening prior to the colonoscopy to ensure there is enough time for the tablets to reach the colon and locally release the methylthioninium chloride prior to the colonoscopy. _Special populations _ _ _ _Elderly population _ No dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2). _Renal impairment _ No dose adjustment is required in patients with mild renal impairment. The medicinal product should be used with caution in patients with moderate to severe renal impairment as there are no data in this patient group and methylthioninium chloride is predominantly renally eliminated (see section 5.2). _ _ 3 _Hepatic impairment _ No dose adjustment is required in patients with mild or moderate hepatic impairment. There is no experience in patients with severe hepatic impairment (see section 5.2). _ _ Lestu allt skjalið