Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESCITALOPRAM OXALATE
PAHANG PHARMACY SDN. BHD.
ESCITALOPRAM OXALATE
30tablet Tablets
KRKA, d.d., Novo mesto
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ELICEA FILM-COATED TABLET Escitalopram (10mg) WHAT IS IN THIS LEAFLET 1. What _Elicea_ is use for 2. How _Elicea_ works 3. Before you use _Elicea_ 4. How to use _Elicea_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Elicea_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ELICEA_ IS USED FOR _Elicea_ contains escitalopram and is used to treat depression (major depressive episodes). It may take a couple of weeks before you start to feel better. You must talk to a doctor if you do not feel better or if you feel worse. HOW _ELICEA_ WORKS _Elicea_ belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin- system are considered an important factor in the development of depression and related diseases. BEFORE YOU USE _ELICEA_ - _When you must not use it_ - If you are allergic to escitalopram or any of the other ingredients of this medicine. - If you take other medicines which belong to a group called MAO inhibitors, _ _ _Pregnancy and lactation _ Do not take _Elicea _if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking _Elicea_, stop taking it immediately and contact your doctor. If you take _Elicea_ during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately. Make sure your midwife and/or doctor know you are on _Elicea_. It is expected that _Elicea_ will be excreted into breast milk. D Baca dokumen lengkapnya
1.3.1 Escitalopram SPC, Labeling and Package Leaflet MY-Malaysia PI_Text033560_2 - Updated: Page 1 of 11 ELICEA _Escitalopram_ NAME OF THE MEDICINAL PRODUCT Elicea 10 mg film-coated tablets COMPOSITION Each film-coated tablet contains 10 mg escitalopram (as 12.78 mg escitalopram oxalate). PRODUCT DESCRIPTION Tablets are white, oval, biconvex film-coated tablets, scored on one side. The tablet can be divided into equal doses. THERAPEUTIC INDICATIONS Treatment of major depressive episodes. POSOLOGY AND METHOD OF ADMINISTRATION This product is intended for oral use. Safety of daily doses above 20 mg has not been demonstrated. Elicea is administered as a single daily dose and may be taken with or without food. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response. Elderly patients (> 65 years of age) Initial dosage is 5 mg once daily. Depending on individual patient response the dose may be increased to 10 mg daily (see section Pharmacokinetic properties) Children and adolescents (<18 years) Elicea should not be used in the treatment of children and adolescents under the age of 18 years (see section Special warnings and precautions for use) 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.) (see section Pharmacokinetic properties) 1.3.1 Escitalopram SPC, Labeling and Package Leaflet MY-Malaysia PI_Text033560_2 - Updated: Page 2 of 11 Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily (see section Pharmac Baca dokumen lengkapnya