البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
NALOXEGOL AS OXALATE
ABIR THERAPEUTICS LTD, ISRAEL
A06AH03
FILM COATED TABLETS
NALOXEGOL AS OXALATE 12.5 MG
PER OS
Required
ASTRA ZENECA AB, SWEDEN
NALOXEGOL
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
2017-07-10
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 Dispensing this medicine requires a doctor’s prescription MOVENTIG 12.5 MG MOVENTIG 25 MG FILM-COATED TABLETS EACH TABLET CONTAINS: Moventig 12.5 mg: Active ingredient: Naloxegol 12.5 mg Moventig 25 mg: Active ingredient: Naloxegol 25 mg For the list of inactive ingredients, see section 6: ‘Additional information’. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. Keep this leaflet. You may need to read it again. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. This medicine is intended for adults over 18 years old. 1. WHAT IS THIS MEDICINE INTENDED FOR? Moventig is intended to treat adults with constipation caused by treatment with opioid pain medicine where treatment with other laxatives has not produced sufficient relief. Opioid pain medicine such as: morphine, oxycodone, fentanyl, tramadol, codeine. Constipation related to treatment with opioids can result in symptoms such as: stomach pain rectal straining (pain in the anus as a result of having to push very hard to move very hard stool out of the rectum) 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 and needs to come out) THERAPEUTIC GROUP: Medicines for constipation, peripheral opioid receptor antagonist. 2. BEFORE USING THIS MEDICINE X DO NOT USE THIS MEDICINE IF: you are hypersensitive to the active ingredient naloxegol or any of the ingredients that this medicine contains (see Section 6: 'Additional information', below). your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels are at risk of becoming blocked. you have cancer in اقرأ الوثيقة كاملة
1 THIS LEAFLET FORMAT WAS DETERMINED BY THE MINISTRY OF HEALTH AND THE CONTENT THEREOF WAS CHECKED AND APPROVED IN JULY 2017 AND UPDATED ACCORDING TO THE MINISTRY OF HEALTH GUIDELINES IN JANUARY 2018 1. 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, mauve tablet. Moventig 25 mg film-coated tablet (tablet). Oval, 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. When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical effect of naloxegol is determined. _Special populations _ _Elderly Patients _ No dose adjustment is recommended based on age (see section 5.2). 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). 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 اقرأ الوثيقة كاملة