Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESCITALOPRAM OXALATE
RANBAXY (MALAYSIA) SDN. BHD.
ESCITALOPRAM OXALATE
14Tablet Tablets; 14Tablet Tablets
Sun Pharmaceutical Industries Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 DEPRILEPT TABLETS _ _ _ _ Escitalopram Oxalate (10mg, 20mg) WHAT IS IN THIS LEAFLET 1. What DEPRILEPT is used for 2. How DEPRILEPT works 3. Before you use DEPRILEPT 4. How to use DEPRILEPT 5. While you are using DEPRILEPT 6. Side effects 7. Storage and disposal of DEPRILEPT 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision WHAT DEPRILEPT IS USED FOR DEPRILEPT is used to treat: depression (major depressive episodes ) anxiety disorders (such as panic disorder, social anxiety disorder) HOW DEPRILEPT WORKS DEPRILEPT contains escitalopram which belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors) which are antidepressants. They are thought to work by their actions on serotonin-system in the brain by increasing the serotonin level. Disturbance in the serotonin levels are thought to be responsible for depression and related diseases. Ask your doctor if you have any questions about why DEPRILEPT have been prescribed for you. BEFORE YOU USE DEPRILEPT _- When you must not use it _ Do not take DEPRILEPT if you are: Allergic (hypersensitive) to escitalopram, citalopram or any of the other ingredients of DEPRILEPT as mentioned in PRODUCT DESCRIPTION An allergic reaction may include: rash, itching swelling of face, lips or hands/feet breathing difficulties Taking medicines that belong to a group called monoamine oxidase inhibitors (MAOIs) e.g. moclobemide (used for treatment of depression), linezolid (antibiotic) and selegiline (used to treat Parkinson’s disease). Taking pimozide (antipsychotic medicine used to treat certain mental disorders). Born with or have had an episode of abnormal heart rhythm. Taking other medicines that are known to affect the heart’s rhythm (such as phenothiazine medicines, pimozide, haloperidol, sparfloxacin, moxifloxacin, erythromycin, pentamidine, halofantrine, astemizole, mizolastine or certain medicines for irregular Lire le document complet
1 _For the use of a Registered Medical Practitioner_ _or a Hospital or a Laboratory Only. _ PRESCRIBING INFORMATION DEPRILEPT TABLETS (10/20 MG) (ESCITALOPRAM OXALATE TABLETS 10MG/20MG) COMPOSITION DEPRILEPT TABLETS 10 MG EACH FILM COATED TABLET CONTAINS Escitalopram oxalate 12.78 mg equivalent to Escitalopram ........... 10 mg Inactive components: DEPRILEPT TABLETS 20 MG Each film coated tablet contains Escitalopram oxalate 25.55 mg equivalent to Escitalopram ........... 20 mg _INACTIVE COMPONENTS: _ _Microcrystalline Cellulose (PH101, Lactose Monohydrate, Copovidone (Plasdone-S-630), Maize Starch _ _(Purity 21), Purified water, Silicified MCC (Prosolv SMCC 90), Croscarmellose Sodium (AC-DI-SOL), _ _Purified Talc, Colloidal anhydrous silica, Magnesium stearate, Opadry White OY-S-58910 _ PRODUCT DESCRIPTION DEPRILEPT TABLETS 10 MG White to off white oval biconvex film coated tablets debossed with 'E' and '8' on either side of the eye breakline on one side and plain on the other side. DEPRILEPT TABLETS 20 MG White to off white oval biconvex film coated tablets debossed with 'E' and '9' on either side of the eye breakline on one side and plain on the other side. DESCRIPTION DEPRILEPT contain escitalopram oxalate, which is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1[3-(dimethyl-amino)propyl]- 1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. 2 STRUCTURAL FORMULA ESCITALOPRAM OXALATE PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors ATC-code: N 06 AB 10 _PHARMACODYNAMICS _ Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000-fold lower affinity. Escitalopram has no or low affinity f Lire le document complet