Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
paroxetine hydrochloride, Quantity: 22.2 mg
Sandoz Pty Ltd
paroxetine hydrochloride
Tablet, film coated
Excipient Ingredients: mannitol; titanium dioxide; magnesium stearate; copovidone; colloidal anhydrous silica; microcrystalline cellulose; hypromellose; sodium starch glycollate; purified talc
Oral
30 tablets
(S4) Prescription Only Medicine
Paroxetine GH is indicated for the treatment of : - Major Depression and for the prevention of relapse of depressive symptoms - Obsessive Compulsive Disorder (OCD) and prevention of relapse of OCD - Panic Disorder and for the prevention of relapse of Panic Disorder - Social Anxiety Disorder/Social Phobia - General Anxiety Disorder - Post-traumatic Stress Disorder.
Visual Identification: White, round bi-sected film-coated tablet with a one-sided breaking notch ("Snap-tab") and embossment 'PX 20' on opposite side, intact surface.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-12-18
CONSUMER MEDICINE INFORMATION PAROXETINE GH (PAROXETINE HYDROCHLORIDE) FILM COATED TABLET WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you take Paroxetine GH tablets. This leaflet answers some common questions about Paroxetine GH. It does not contain all 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 risks of you taking Paroxetine GH against the benefits it is expected to 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 PAROXETINE GH IS USED FOR The name of your medicine is Paroxetine GH. It contains the active ingredient paroxetine hydrochloride. Paroxetine hydrochloride belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs) antidepressants. They are thought to work by their action on brain chemicals called amines which are involved in controlling mood. Depression is longer lasting and/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, loss of interest in usual activities, being unable to enjoy life, have poor appetite or overeat, disturbed sleep, often waking up early, loss of sex drive, low energy and feeling guilty over nothing. Paroxetine GH may also be used to treat irrational fears or obsessional behaviour. These can also be due to chemical imbalance in parts of the brain. Paroxetine GH may also be used to help prevent panic attacks. Paroxetine GH may also be used to treat patients who may avoid and/or are fearful of social situations. Paroxetine GH may also be used to treat patients who have excessive anxiety and worry, and who feel irritable, restless, and/or tense in the muscles. Paroxetine GH may also be used to Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION – PAROXETINE GH (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED 1 NAME OF THE MEDICINE Paroxetine hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Paroxetine GH 20 mg film-coated tablets contains 22.2 mg of paroxetine hydrochloride equivalent to 20 mg of paroxetine. List of excipients with known effects: Mannitol. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Paroxetine GH 20 mg film-coated tablets are round, white tablets with a score notch on one side and embossed with ‘PX 20’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paroxetine GH is indicated for the treatment of: • Major depression and for the prevention of relapse of depressive symptoms. • Obsessive compulsive disorder (OCD) and prevention of relapse of OCD. • Panic disorder and for the prevention of relapse of panic disorder. • Social anxiety disorder/social phobia • General Anxiety Disorder • Post-traumatic Stress Disorder. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE It is recommended that paroxetine be administered once daily in the morning with food. The tablet should be swallowed rather than chewed. Depression The recommended dose is 20 mg (1 tablet) daily. Many patients will respond to a 20 mg daily dose. Patients not responding to a 20 mg dose may benefit from dose increases in 10 mg/day increments, up to a maximum of 50 mg/day according to the patient's response. Paroxetine GH v4.1 Page 2 of 28 (paroxetine hydrochloride) tablet, film coated As with all antidepressant drugs, dosage should be reviewed and adjusted if necessary within two or three weeks of initiation of therapy and thereafter as judged clinically appropriate. Dose changes should occur at intervals of at least one week. It is generally recommended that a course of antidepressant drug treatment should continue for a sufficient period, often for several months. There is no body of evidence available to answer the question of how long the patient treated w Прочитајте комплетан документ