Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Paroxetine hydrochloride hemihydrate
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
AROPAX ® 1 AROPAX ® _Paroxetine (as hydrochloride hemihydrate) _ _20mg Tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you take AROPAX tablets. This leaflet answers some common questions about AROPAX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking AROPAX against the risks this medicine could 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 IS AROPAX USED FOR? The name of your medicine is AROPAX; it is also known as paroxetine. AROPAX belongs to a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants. They are thought to work by their action on brain chemicals called amines which are involved in controlling mood. Depression is longer lasting or more severe than the 'low moods' that everyone has from time to time. 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. You may feel low in spirit, lose interest in usual activities, be unable to enjoy life, have poor appetite or over eat, have disturbed sleep, often waking up early, low energy and feel guilty over nothing. AROPAX may also be used to treat irrational fears or obsessional behaviour. These can also be due to chemical imbalance in parts of the brain. AROPAX may also be used to help prevent panic attacks. AROPAX may also be used to Read the complete document
1 AROPAX ® PRODUCT INFORMATION paroxetine (as hydrochloride hemihydrate) NAME OF THE MEDICINE AROPAX (paroxetine hydrochloride hemihydrate) is an orally administered antidepressant with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic or other available antidepressant agents. It is the hemihydrated hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4_R_-(4'-fluorophenyl)-3_S_ - [(3',4'- methylenedioxyphenoxy)methyl]-piperidine hydrochloride hemihydrate. The molecular weight of paroxetine hydrochloride hemihydrate is 374.8 (329.4 as free base). .HCl ½ H 2 O CAS Registry No.: 110429-35-1 DESCRIPTION Paroxetine hydrochloride hemihydrate is an odourless, off white powder, with a melting point range of 120 C to 138 C and solubility of 5.4 mg/mL in water. AROPAX tablets also contain titanium dioxide (white) as colourant and calcium hydrogen phosphate, hypromellose, sodium starch glycollate, magnesium stearate, polysorbate 80, macrogol 400 and titanium dioxide as excipients. AROPAX tablets 20 mg do not contain sucrose, lactose, gluten, tartrazine or any other azo dyes. PHARMACOLOGY Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake and its antidepressant action and efficacy in the treatment of OCD, Panic Disorder, Social Anxiety Disorder/Social Phobia, Generalised Anxiety Disorder and Posttraumatic Stress Disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurones. _ _ _In vitro_ studies have indicated that, in contrast t Read the complete document