Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Venlafaxine
IMED Healthcare Ltd.
N06AX; N06AX16
Venlafaxine
75 milligram(s)
Prolonged-release capsule
Other antidepressants; venlafaxine
2009-07-31
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER EFEXOR ® XL 75MG PROLONGED-RELEASE CAPSULES, HARD venlafaxine (as venlafaxine hydrochloride) Your medicine is available using the above names, but will be referred to as ‘Efexor XL’ throughout this leaflet. 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 Efexor XL is and what it is used for 2. What you need to know before you take Efexor XL 3. How to take Efexor XL 4. Possible side effects 5. How to store Efexor XL 6. Contents of the pack and other information 1. WHAT EFEXOR XL IS AND WHAT IT IS USED FOR Efexor XL contains the active substance venlafaxine. Efexor XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain. Efexor XL is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go awa read_full_document
Health Products Regulatory Authority 09 October 2020 CRN009XL5 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Efexor XL 75 mg prolonged-release capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Efexor XL 75mg hard prolonged-release capsules contain 75mg of venlafaxine as venlafaxine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard prolonged-release capsule. _Product imported from Italy, Czech Republic & the UK._ Opaque peach capsules printed in red with ‘W’ on the cap and ‘75' on the body. 4 CLINICAL PARTICULARS As per PA0822/072/002 5 PHARMACOLOGICAL PROPERTIES As per PA0822/072/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from Italy:_ Microcrystalline cellulose Ethylcellulose Hypromellose Gelatin Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) Printing ink: Pharmaceutical glaze Red iron oxide (E172) N-butyl alcohol Isopropyl alcohol Ammonium hydroxide Simeticone Propylene glycol _Product imported from Czech Republic and the UK:_ Capsule contents: Microcrystalline cellulose Ethylcellulose Hypromellose Talc Health Products Regulatory Authority 09 October 2020 CRN009XL5 Page 2 of 3 Capsule shell: Gelatin Red and yellow iron oxides (E172) Titanium dioxide (E171) Capsule printing ink: Shellac Red iron oxide (E172) Ammonium hydroxide Simeticone Propylene glycol 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product is the date shown on the blister strips and outer carton of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE _Product imported from Italy_ Store in the original packaging. Do not store above 25 o C. _Product imported from Czech Republic:_ Do not store above 30 o C. Store in the original package in order to protect from light and moisture. _Product imported from the UK:_ Do not store above 30 o C. 6.5 NATURE AND CONTENTS OF CONTAINER Cardboard outer containing blister strips. Pack size: 28 cap read_full_document