Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Venlafaxine
IMED Healthcare Ltd.
N06AX; N06AX16
Venlafaxine
Prolonged-release capsule, hard
Other antidepressants; venlafaxine
2023-08-14
PACKAGE LEAFLET: INFORMATION FOR THE USER EFEXOR XL 75 MG PROLONGED-RELEASE CAPSULES, HARD venlafaxine 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 not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and norepinephrine 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 away and may become more serious and more difficult to treat. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFEXOR XL DO NOT TAKE EFEXOR XL • If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6). • If you are also taking, or have taken Lue koko asiakirja
Health Products Regulatory Authority 15 August 2023 CRN00DKTV Page 1 of 2 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 75 mg: Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine free base. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard. _Product imported from Greece:_ Opaque peach capsules printed in red with 'W' and '75' hard gelatin capsule. 4 CLINICAL PARTICULARS As per PA23355/002/002 5 PHARMACOLOGICAL PROPERTIES As per PA23355/002/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Capsule contents: _ Microcrystalline cellulose Ethylcellulose Hypromellose Talc _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 Health Products Regulatory Authority 15 August 2023 CRN00DKTV Page 2 of 2 The shelf life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 o C. 6.5 NATURE AND CONTENTS OF CONTAINER Blister packs containing 28 capsules. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Dublin 15, Ireland. 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/209/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 th August 2023 10 DATE OF REVISION OF THE TEXT Lue koko asiakirja