Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
escitalopram oxalate, Quantity: 6.37 mg (Equivalent: escitalopram, Qty 5 mg)
Strides Pharma Science Pty Ltd
escitalopram oxalate
Tablet, film coated
Excipient Ingredients: purified talc; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; titanium dioxide; magnesium stearate; macrogol 400; hypromellose
Oral
56, 98, 28, 14
(S4) Prescription Only Medicine
Treatment of major depression.,Treatment of social anxiety disorder (social phobia).,Treatment of generalised anxiety disorder.,Treatment of obsessive-compulsive disorder.
Visual Identification: White to off-white, circular, biconvex, film-coated tablet with 'C5' embossed on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2012-09-25
CILOPAM-S™ CONSUMER MEDICINE INFORMATION Escitalopram oxalate, 5 mg, 10 mg & 20 mg tablets WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about CILOPAM-S. It does not contain all the information that is known about CILOPAM-S. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CILOPAM-S IS FOR CILOPAM-S is used to treat depression. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are thought to work by their actions on brain chemicals called amines which are involved in controlling mood. Depression is longer lasting or more severe than the "low moods" everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. CILOPAM-S corrects this chemical imbalance and may help relieve the symptoms of depression. CILOPAM-S may also be used to treat patients who may avoid and/or are fearful of social situations. CILOPAM-S may also be used to treat patients who have excessive anxiety and worry. CILOPAM-S may also be used to treat irrational fears or obsessional behaviour (obsessive- compulsive disorder). Obsessive-compulsive disorder involves having both obsessions and compulsions. Obsessions are unwanted thoughts that occur over and over again. Compulsions are the ongoing need to repeat certain actions as a result of these tho Lire le document complet
Page 2 of 27 _ _ PRODUCT INFORMATION CILOPAM-S FILM-COATED TABLETS NAME OF THE MEDICINE The active ingredient in CILOPAM-S is escitalopram oxalate The structural formula is: Chemical name: S(+)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3 dihydroisobenzofuran-5-carbonitrile hydrogen oxalate. CAS number: 219861-08-2 Molecular formula: C 20 H 21 FN 2 O, C 2 H 2 O 4 Molecular weight: 414.42 DESCRIPTION Escitalopram is the active enantiomer (S-enantiomer) of citalopram. Escitalopram oxalate is a fine white to yellow, crystalline material. Escitalopram oxalate is sparingly soluble in water, slightly soluble in acetone, soluble in ethanol and freely soluble in methanol. No polymorphic forms have been detected. CILOPAM-S tablets contain the following excipients: microcrystalline cellulose, colloidal anhydrous silica, purified talc, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 400 and titanium dioxide. PHARMACOLOGY Pharmacological actions Biochemical and behavioural studies have shown that escitalopram is a potent inhibitor of serotonin (5-HT)-uptake (_in vitro _IC 50 2nM). The antidepressant action of escitalopram is presumably linked to the potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibitory effect on the reuptake of 5-HT from the synaptic cleft. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). On the basis of _in _ _vitro _studies, escitalopram had no, or minimal effect on noradrenaline (NA), dopamine (DA) and gamma aminobutyric acid (GABA) uptake. Page 3 of 27 In contrast to many tricyclic antidepressants and some of the SSRIs, escitalopram has no or very low affinity for a series of receptors including 5-HT 1A , 5-HT 2 , DA D 1 and DA D 2 receptors, α 1 -, α 2 -, β-adrenoceptors, histamine H 1 , muscarine cholinergic, benzodiazepine, and opioid receptors. A series of functional _ in vitro _ tests in isolated organs as well as functional _in vivo _tests have confirmed the lack of receptor affinity. Escitalopram has Lire le document complet