Country: European Union
Language: English
Source: EMA (European Medicines Agency)
naloxegol oxalate
Kyowa Kirin Holdings B.V.
A06AH03
naloxegol
Peripheral opioid receptor antagonists, Drugs for constipation
Constipation; Opioid-Related Disorders
Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Revision: 15
Authorised
2014-12-07
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVENTIG 12.5 MG FILM-COATED TABLETS MOVENTIG 25 MG FILM-COATED TABLETS naloxegol 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Moventig is and what it is used for 2. What you need to know before you take Moventig 3. How to take Moventig 4. Possible side effects 5. How to store Moventig 6. Contents of the pack and other information 1. WHAT MOVENTIG IS AND WHAT IT IS USED FOR Moventig contains the active substance naloxegol. It is a medicine used in adults to treat constipation specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine) taken on a regular basis. It is used when laxatives have not provided acceptable relief of constipation. Constipation related to opioids can result in symptoms such as: • stomach pain • rectal straining (having to push very hard to move the stool out of the rectum, which can also cause pain in the anus during pushing) • hard stools (stools which are hard “like a rock”) • incomplete emptying of the rectum (after having a bowel movement, the feeling as if a stool is still in the rectum which needs to come out) In patients taking opioids with constipation, who have tried at least one laxative and had incomplete relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and improve symptoms of constipation caused by opioids. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVENTI Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Moventig 12.5 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 12.5 mg naloxegol. Moventig 25 mg film-coated tablets Each film-coated tablet contains naloxegol oxalate equivalent to 25 mg naloxegol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Moventig 12.5 mg film-coated tablet (tablet). Oval, 10.5x5.5 mm, mauve tablet. Moventig 25 mg film-coated tablet (tablet). Oval, 13x7 mm, mauve tablet. Tablets are engraved with “nGL” on one side and the strength of the tablet on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). For definition of inadequate response to laxative(s), see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Moventig is 25 mg once daily. Moventig may be used with or without laxatives. Moventig treatment must be withdrawn when systemic opioid therapy is stopped. _Special populations _ _Elderly _ No dose adjustment is recommended based on age (see section 5.2). _Renal impairment _ The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg. If side effects impacting tolerability occur, naloxegol should be discontinued. The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 5.2). 3 No dosage adjustment is required for patients with mild renal impairment. _Hepatic impairment _ No dose adjustment is required for patients with mild to moderate hepatic impairment. Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2). Use in patients with severe hepatic impairment is not recommended. _CYP3A4 inhibitors _ The starting dose for patients Read the complete document