البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ATOGEPANT AS MONOHYDRATE
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
N02CD07
TABLETS
ATOGEPANT AS MONOHYDRATE 10 MG
PER OS
Required
FOREST LABORATORIES IRELAND, LIMITED, IRELAND
ATOGEPANT
Qulipta is indicated for the preventive treatment of migraine in adults
2022-09-28
QUL_APL_ENG_NOV 23_CL PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only QULIPTA ® 10 mg Tablets QULIPTA ® 30 mg Tablets QULIPTA ® 60 mg Tablets Each tablet contains: atogepant 10 mg (equivalent to 10.3 mg of atogepant free base monohydrate). Each tablet contains: atogepant 30 mg (equivalent to 30.9 mg of atogepant free base monohydrate). Each tablet contains: atogepant 60 mg (equivalent to 61.8 mg of atogepant free base monohydrate). For the list of inactive ingredients, please see section 6 “Further Information” in this leaflet. See also “Important information about some of the medicine’s ingredients” in section 2. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for your ailment/for you. Do not pass it on to others. It may harm them even if it seems to you that their ailment/medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? QULIPTA is indicated for the preventive treatment of migraine in adults. Therapeutic group: Antimigraine preparations, calcitonin gene related peptide (CGRP) receptor antagonist. How QULIPTA works QULIPTA works by blocking the activity of the calcitonin gene-related peptide (CGRP) molecule which has been linked to migraine. This reduction in CGRP’s activity reduces migraine. 2. BEFORE USING THE MEDICINE Do not use the medicine: If you are sensitive (allergic) to the active substance atogepant or any of the other ingredients of this medicine (for the list of inactive ingredients, see section 6). Allergic reactions may include: life-threatening allergic reaction (anaphylaxis) and difficulty breathing (see below “Special warnings about using this medicine”). Special warnings about using this medicine: Before starting treatment with QULIPTA, tell your doctor if: اقرأ الوثيقة كاملة
QUL API NOV 2023 CL QULIPTA 10 mg QULIPTA 30 mg QULIPTA 60 mg QUALITATIVE AND QUANTITATIVE COMPOSITION QULIPTA 10 mg Each tablet contains 10 mg of atogepant (equivalent to 10.3 mg of atogepant free base monohydrate). QULIPTA 30 mg Each tablet contains 30 mg of atogepant (equivalent to 30.9 mg of atogepant free base monohydrate). QULIPTA 60 mg Each tablet contains 60 mg of atogepant (equivalent to 61.8 mg of atogepant free base monohydrate). 1 INDICATIONS AND USAGE QULIPTA is indicated for the preventive treatment of migraine in adults. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage QULIPTA is taken orally with or without food. Episodic Migraine The recommended dosage of QULIPTA for episodic migraine is 10 mg, 30 mg, or 60 mg taken once daily. Chronic Migraine The recommended dosage of QULIPTA for chronic migraine is 60 mg taken once daily. 2.2 Dosage Modifications Dosing modifications for concomitant use of specific drugs and for patients with renal impairment are provided in Table 1. Table 1: Dosage Modifications for Drug Interactions and for Specific Populations Dosage Modifications Recommended Once Daily Dosage for Episodic Migraine Usage and Recommended Once Daily Dosage for Chronic Migraine Concomitant Drug [see Drug Interactions (7)] Strong CYP3A4 Inhibitors (7.1) 10 mg Avoid use Strong, Moderate or Weak CYP3A4 Inducers (7.2) 30 mg or 60 mg Avoid use OATP Inhibitors (7.3) 10 mg or 30 mg 30 mg Renal Impairment [see Use in Specific Populations (8)] Severe Renal Impairment and End-Stage Renal Disease (CLcr <30 mL/min) (8.6) 10 mg Avoid use QUL API NOV 2023 CL 3 DOSAGE FORMS AND STRENGTHS QULIPTA 10 mg is supplied as white to off-white, round biconvex tablets debossed with “A” and “10” on one side. QULIPTA 30 mg is supplied as white to off-white, oval biconvex tablets debossed with “A30” on one side. QULIPTA 60 mg is supplied as white to off-white, oval biconvex tablets debossed with “A60” on one side. 4 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients l اقرأ الوثيقة كاملة