Země: Švédsko
Jazyk: švédština
Zdroj: Läkemedelsverket (Medical Products Agency)
escitalopramoxalat
AS GRINDEKS
N06AB10
escitalopram oxalate
20 mg
Filmdragerad tablett
escitalopramoxalat 25,552 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 14 tabletter (plast/Al); Blister, 14 tabletter (Al); Blister, 98 tabletter (plast/Al); Blister, 56 tabletter (plast/Al); Blister, 30 tabletter (plast/Al); Blister, 28 tabletter (plast/Al); Blister, 98 tabletter (Al); Blister, 56 tabletter (Al); Blister, 30 tabletter (Al); Blister, 28 tabletter (Al); Blister, 100 tabletter (Al); Blister, 100 tabletter (plast/Al)
Godkänd
2023-06-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ESCITALOPRAM GRINDEKS 5 MG FILM-COATED TABLETS ESCITALOPRAM GRINDEKS 10 MG FILM-COATED TABLETS ESCITALOPRAM GRINDEKS 20 MG FILM-COATED TABLETS 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 [Invented name] is and what it is used for 2. What you need to know before you take [Invented name] 3. How to take [Invented name] 4. Possible side effects 5. How to store [Invented name] 6. Contents of the pack and other information 1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR [Invented name] contains the active substance escitalopram. Escitalopram 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. [Invented name] 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 [Invented name], 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME] DO NOT TAKE [INVENTED NAME]: - If you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6). - If you take other medicines which belong to a Přečtěte si celý dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Escitalopram Grindeks 5 mg film-coated tablets Escitalopram Grindeks 10 mg film-coated tablets Escitalopram Grindeks 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg: Each film-coated tablet contains escitalopram oxalate equivalent to 5 mg escitalopram. 10 mg: Each film-coated tablet contains escitalopram oxalate equivalent to 10 mg escitalopram. 20 mg: Each film-coated tablet contains escitalopram oxalate equivalent to 20 mg escitalopram. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. [Invented name] 5 mg: white to off-white, round, approximately 6 mm in diameter, biconvex film- coated tablet. [Invented name] 10 mg: white to off-white, oval, approximately 8 mm x 6 mm, biconvex film-coated tablet with inscription 1 and 0 on either side of score line on one side. The tablet can be divided into equal doses. [Invented name] 20 mg: white to off-white, oval, approximately 12 mm x 7 mm, biconvex film-coated tablet with score line on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of major depressive episodes - Treatment of panic disorder with or without agoraphobia - Treatment of social anxiety disorder (social phobia) - Treatment of generalised anxiety disorder - Treatment of obsessive-compulsive disorder 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Safety of daily doses above 20 mg has not been demonstrated. _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. _Panic disorder with or without agoraphobia_ An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further i Přečtěte si celý dokument