Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ZOLMITRIPTAN 5 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N02CC03
ZOLMITRIPTAN 5 mg/stuk
Orodispergeerbare tablet
ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENZUUR 0-WATER (E 330) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF type Sweet Permaseal PHS-132960, ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 0-WATER (E 330) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; SILICIUMDIOXIDE (E 551) ; SINAASAPPELSMAAKSTOF type Sweet Permaseal PHS-132960,
Oraal gebruik
Zolmitriptan
Hulpstoffen: ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 0-WATER (E 330); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); SILICIUMDIOXIDE (E 551); SINAASAPPELSMAAKSTOF type Sweet Permaseal PHS-132960;
1900-01-01
Sandoz B.V. Page 1/8 Zolmitriptan Sandoz ® smelttablet 2,5/5 mg, orodispergeerbare tabletten RVG 106564+106565 1313-V4 1.3.1.3 Bijsluiter Juni 2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZOLMITRIPTAN SANDOZ ® SMELTTABLET, 2,5 MG, ORODISPERGEERBARE TABLETTEN ZOLMITRIPTAN SANDOZ ® SMELTTABLET, 5 MG, ORODISPERGEERBARE TABLETTEN zolmitriptan 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] contains zolmitriptan and belongs to a group of medicines called triptans. [NATIONALLY COMPLETED NAME] IS USED TO TREAT MIGRAINE HEADACHE IN ADULTS AGED 18 YEARS AND OLDER . • Migraine symptoms may be caused by the widening of blood vessels in the head. [Nationally completed name] is thought to reduce the widening of these blood vessels. This helps to take away the headache and other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and being sensitive to light and sound. • [Nationally completed name] works only when a migraine attack has started. It will not stop you from getting an attack. Sandoz B.V. Page 2/8 Zolmitriptan Sandoz ® smelttablet 2,5/5 mg, orodispergeerbare tabletten RVG 106564+106565 131 Baca dokumen lengkapnya
Sandoz B.V. Page 1/11 Zolmitriptan Sandoz smelttablet, 2,5/5 mg, orodispergeerbare tabletten RVG 106564-106565 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken Juni 2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zolmitriptan Sandoz smelttablet, 2,5 mg, orodispergeerbare tabletten Zolmitriptan Sandoz smelttablet, 5 mg, orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _[2.5 mg] _ Each orodispersible tablet contains 2.5 mg of zolmitriptan. Excipients with known effect Each orodispersible tablet contains up to 25 ng of sulphites and 2.5 mg of aspartame. _[5 mg] _ Each orodispersible tablet contains 5 mg of zolmitriptan. Excipients with known effect Each orodispersible tablet contains up to 50 ng of sulphites and 5 mg of aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. _[2.5 mg] _ White, round, flat orodispersible tablets with ‘ZMT 2.5’ debossed on one side. _[5 mg]_ White, round, flat orodispersible tablets with ‘ZMT 5’ debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] is indicated in adults aged 18 years and older for acute treatment of migraine headache with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of [ Nationally completed name] orodispersible tablets to treat a migraine attack is 2.5 mg. It is advisable that [Nationally completed name] is taken as early as possible after the onset of migraine headache but it is also effective if taken at a later stage. If symptoms of migraine should recur within 24 hours following an initial response, a second dose may be taken. If a second dose is required, it should not be taken within 2 hours of the initial dose. If a Sandoz B.V. Page 2/11 Zolmitriptan Sandoz smelttablet, 2,5/5 mg, orodispergeerbare tabletten RVG 106564-106565 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken Juni 2021 patient does not respond to the first dose, it is unlikely that a second d Baca dokumen lengkapnya