Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM
H. Lundbeck A/S
ESCITALOPRAM
10 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
Lexapro Meltz. After stopping Lexapro Meltz you must allow 7 days before taking any of these medicines. • “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression). • “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects. • The antibiotic linezolid. • Lithium (used in the treatment of manic-depressive disorder) and tryptophan. • Imipramine and desipramine (both used to treat depression). • Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects. • Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluvoxamine (anti-depressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram. • St. John’s wort (Hypericum perforatum) - a herbal remedy used for depression. • Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti- coagulant). These may increase bleeding-tendency. • Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anti-coagulant). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Lexapro Meltz in order to verify that your dose of anti-coagulant is still adequate. • Mefloquin (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures. • Neuroleptics (medicines to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to a possible risk of a lowered threshold for seizures. • Flecainide, propafenone and metoprolol (used in cardio-vascular diseases), clomipramine and Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro Meltz 10 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg escitalopram For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet White to off white, slightly speckled, flat-faced, round (9.5 mm), beveled edge tablet debossed with ELO on one side 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 The safety of daily doses above 20 mg has not been demonstrated. Lexapro Meltz is administered as a single daily dose and should be taken without food. The tablet should be placed on the tongue, where it rapidly disintegrates and can be swallowed without water. The orodispersible tablet is fragile and should be handled carefully. The tablet does not have a tablet score line and cannot be divided into equal doses. The 5 mg dose should he administered in the form of film-coated tablets or oral drops, solution. The orodispersible tablet is the preferred dosage form for patients who have difficulties swallowing conventional tablets, or in situations in which liquids are not available. 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 ini Citiți documentul complet