Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
DULOXETINE AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD, ISRAEL
N06AX21
GASTRO RESISTANT CAPSULES
DULOXETINE AS HYDROCHLORIDE 30 MG
PER OS
Required
LILLY S.A., SPAIN
DULOXETINE
Cymbalta is indicated for the treatment of major depressive episodes.- Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy.- Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD).- Cymbalta is indicated for the management of fibromyalgia.- Cymbalta is indicated for the management of chronic muscoskeletal pain when other therapies have failed or are contra-indicated. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis.
2015-03-31
I CYMBCP A 18 Page 1 of 12 Patient Package Leaflet in Accordance WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only Cymbalta 30 mg Gastro-resistant capsules Cymbalta 60 mg Gastro-resistant capsules Active ingredient: duloxetine (as hydrochloride) 30 mg Active ingredient: duloxetine (as hydrochloride) 60 mg Inactive ingredients and allergens in the preparation: See Chapter 2 section “Important information about some of the ingredients of this medicine” and Chapter 6 “Additional information”. Read the entire leaflet carefully before using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, contact your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if their illness seems to be the same as yours. Antidepressants and antianxiety medicines increase the risk of suicidal behavior and thoughts among children, adolescents and young adults up to 24 years of age. When beginning treatment with this medicine, patients of all ages and their relatives, must monitor behavioral changes such as worsening of depression, suicidal thoughts, aggressiveness etc. If changes such as these occur, contact the doctor immediately. 1. WHAT IS THIS MEDICINE INTENDED FOR? Cymbalta is used to treat adults suffering from: major depressive episodes neuropathic pain associated with peripheral diabetic neuropathy generalized anxiety disorder (GAD) fibromyalgia chronic musculoskeletal pain when other therapies have failed or are contra-indicated. This has been established in studies in patients with chronic low back pain (CLBP) and chronic pain due to osteoarthritis. Therapeutic group: Cymbalta belongs to the SNRI family of drugs and causes an increase in the serotonin and noradrenaline levels. 2. BEFORE USING THIS MEDICINE Do not use this medicine if: you are sensitive (allergic) to the activ Đọc toàn bộ tài liệu
X CYMBCP A 18 Page 1 of 34 30 mg capsules gastro resistant capsules ® CYMBALTA gastro resistant capsules capsules mg 60 ® CYMBALTA Active substance: duloxetine (as hydrochloride) FULL PRESCRIBING INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 there was a reduction in risk with antidepressant use in patients aged 65 and older _[see Warnings and Precautions (5.1)]_. In patients of all ages who are started on antidepressant therapy monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber _[see Warnings and _ _Precautions (5.1)]_._ _Cymbalta is not approved for use in pediatric patients. 1 INDICATIONS AND USAGE - Cymbalta is indicated for the treatment of major depressive episodes. - Cymbalta is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy. _ _ - Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). _ _ - Cymbalta is indicated for the management of fibromyalgia. _ _ - Cymbalta is indicated for the management of chronic muscoskeletal pain when other therapies have failed or are contra-indicated. _ _ This has been established is studies in patients with chronic low back pain (CLBP) and chronic pain due to Osteoarthritis. 2 DOSAGE AND ADMINISTRATION 2.1 Important Administration Instructions Administer CYMBALTA orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. Cymbalta should not be administered through a gastric tube either because the pellets may obstruct the tube. If a dose of CYMBALTA i Đọc toàn bộ tài liệu