Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESCITALOPRAM OXALATE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
ESCITALOPRAM OXALATE
30 Tablet Tablets; 100Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ ESPRAN TABLET Escitalopram Oxalate (5mg, 10mg, 20mg) 1 WHAT IS IN THIS LEAFLET 1. What is Espran is used for 2. How Espran works 3. Before you use Espran 4. How to use Espran 5. While you are using it 6. Side effects 7. Storage and Disposal of Espran 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ESPRAN IS USED FOR It is indicated for the treatment of more severe form of depression HOW ESPRAN WORKS Espran contains an active substance called Escitalopram. Espran belongs to a group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs). Espran act by increasing the serotonin level in the brain. Disturbances in the serotonin level are considered an important factor in the development of depression and related diseases. BEFORE YOU USE ESPRAN - _When you must not use it _ Do not take Espran if: • You are allergic (hypersensitive) to Escitalopram or Citalopram or any of the other ingredients of Espran (see section PRODUCT DESCRIPTION ). • You take other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs) used for the treatment or within 14 days of discontinuing treatment with an MAOI. _Pregnancy and breastfeeding _ _ _ Do not take Espran if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Espran if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor: • If you have epilepsy. Treatment with Espran should be stopped if seizures occur for the first time, or if there is an increase in the seizure frequency. • If you have diabetes. Treatment with Espran may alter glucose control. Insulin and/or oral antidiabetic dosage may need to be adjusted. • If you have a decreased level of sodium in the blood. • If you ha Olvassa el a teljes dokumentumot
PRODUCT NAME : ITEM / PACK : DESIGN STYLE : CODE : DIMENSIONS (MM) : THERAPEUTIC RANGE : ART WORK SIZE : DATE : Reviewed By NO. OF COLORS: 1 COUNTRY : Malaysia Front/Back Espran Insert S/S 180 x 290 - xxxxxxxxxx-5253 Black 02-07-2012 PANTONE SHADE NOS.: ACTIVITIES DEPARTMENT NAME SIGNATURE DATE Prepared By PKG.DEV PKG.DEV RA Reviewed By LOCATION : Chhatral CQA Approved By Elderly Patients (> 65 years of age) Initial treatment with half the usually recommended dose and a lower maximum dose should be considered. Children and Adolescents (<18 years) ESPRAN should not be used in the treatment of children and adolescents under the age of 18 years. Reduced Renal Function Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CL CR less than 30 ml/min.). Reduced Hepatic Function An initial dose of 5mg daily for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily. Poor Metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10mg daily. Discontinuation symptoms When stopping treatment with ESPRAN the dose should be gradually reduced over a period of at least one to two weeks in order to avoid possible discontinuation symptoms. MODE OF ADMINISTRATION: Oral CONTRAINDICATIONS: MONOAMINE OXIDASE INHIBITORS (MAOIS) Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. HYPERSENSITIVITY TO ESCITALOPRAM OR CITALOPRAM Escitalopram is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Escitalopram. WARNING AND PRECAUTIONS: Antidepressants should not be used in the treatment of children and adolescents under age at l8 years. Suicide related behaviors (s Olvassa el a teljes dokumentumot