国: オランダ
言語: オランダ語
ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ESCITALOPRAMOXALAAT 6,4 mg/stuk SAMENSTELLING overeenkomend met ; ESCITALOPRAM 5 mg/stuk
Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)
N06AB10
ESCITALOPRAMOXALAAT 6,4 mg/stuk SAMENSTELLING overeenkomend met ; ESCITALOPRAM 5 mg/stuk
Orodispergeerbare tablet
ACESULFAAM KALIUM (E 950) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; NEOHESPERIDINEDIHYDROCHALCON ; PEPERMUNTOLIE ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; ZOUTZUUR (E 507), ACESULFAAM KALIUM (E 950) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NEOHESPERIDINEDIHYDROCHALCON ; PEPERMUNTOLIE ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; ZOUTZUUR (E 507),
Oraal gebruik
Escitalopram
Hulpstoffen: ACESULFAAM KALIUM (E 950); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); MALTODEXTRINE; NEOHESPERIDINEDIHYDROCHALCON; PEPERMUNTOLIE; PEPERMUNTSMAAKSTOF; POLACRILINE KALIUM; ZOUTZUUR (E 507);
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ESCITALOPRAM POLPHARMA 5 MG ORODISPERGEERBARE TABLETTEN ESCITALOPRAM POLPHARMA 10 MG ORODISPERGEERBARE TABLETTEN ESCITALOPRAM POLPHARMA 15 MG ORODISPERGEERBARE TABLETTEN ESCITALOPRAM POLPHARMA 20 MG ORODISPERGEERBARE TABLETTEN Escitalopram READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Escitalopram Polpharma is and what it is used for 2. What you need to know before you take Escitalopram Polpharma 3. How to take Escitalopram Polpharma 4. Possible side effects 5. How to store Escitalopram Polpharma 6. Contents of the pack and other information 1. WHAT ESCITALOPRAM POLPHARMA IS AND WHAT IT IS USED FOR Escitalopram Polpharma 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. Escitalopram Polpharma contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder). It may take a couple of weeks before you start to feel better. Continue to take Escitalopram Polpharma even if it takes some time before you feel any improvement in your condition. You must talk to a doctor if you do not feel better or if you feel worse. 2. W 完全なドキュメントを読む
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Escitalopram Polpharma 5 mg orodispergeerbare tabletten Escitalopram Polpharma 10 mg orodispergeerbare tabletten Escitalopram Polpharma 15 mg orodispergeerbare tabletten Escitalopram Polpharma 20 mg orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Escitalopram Polpharma 5 mg: Each tablet contains 5 mg escitalopram, equivalent to 6.3875 mg escitalopram oxalate. Escitalopram Polpharma 10 mg: Each tablet contains 10 mg escitalopram, equivalent to 12.775 mg escitalopram oxalate. Escitalopram Polpharma 15 mg: Each tablet contains 15 mg escitalopram, equivalent to 19.1625 mg escitalopram oxalate. Escitalopram Polpharma 20 mg: Each tablet contains 20 mg escitalopram, equivalent to 25.55 mg escitalopram oxalate. Excipient(s) with known effect: lactose monohydrate and sodium. Each 5 mg tablet contains 58.935 mg lactose monohydrate. Each 10 mg tablet contains 117.87 mg lactose monohydrate. Each 15 mg tablet contains 176.805 mg lactose monohydrate. Each 20 mg tablet contains 235.74 mg lactose monohydrate. Each 5 mg, 10 mg, 15 mg, 20 mg tablet contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet Escitalopram Polpharma 5 mg: white to off-white round, flat tablets with beveled edges, a diameter of 7 mm and engraved with “5” on one side. Escitalopram Polpharma 10 mg: white to off-white round, flat tablets with beveled edges, a diameter of 9 mm and engraved with “10” on one side. Escitalopram Polpharma 15 mg: white to off-white round, flat tablets with beveled edges, a diameter of 11 mm and engraved with “15” on one side. Escitalopram Polpharma 20 mg: white to off-white round, flat tablets with beveled edges, a diameter of 12 mm and engraved with “20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of major depressive episodes. Treatment of panic disorder 完全なドキュメントを読む