Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
paroxetine hydrochloride, Quantity: 22.2 mg
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; microcrystalline cellulose; mannitol; titanium dioxide; sodium starch glycollate; colloidal anhydrous silica; hypromellose; copovidone; purified talc
Oral
30 tablets
(S4) Prescription Only Medicine
Paroxetine 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
Registered
2022-10-21
Blooms The Chemist Paroxetine 1 BLOOMS THE CHEMIST PAROXETINE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BLOOMS THE CHEMIST PAROXETINE? Blooms The Chemist Paroxetine contains the active ingredient paroxetine hydrochloride. Blooms The Chemist Paroxetine is used to treat depression, or social anxiety disorder/social phobia, general irrational fears, obsessional behaviour, post-traumatic stress disorder and prevent panic attacks. For more information, see Section 1. Why am I using Blooms The Chemist Paroxetine? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BLOOMS THE CHEMIST PAROXETINE? Do not use if you have ever had an allergic reaction to Blooms The Chemist Paroxetine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use Blooms The Chemist Paroxetine? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Blooms The Chemist Paroxetine and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BLOOMS THE CHEMIST PAROXETINE? • The usual dose for depression or social anxiety disorder/social phobia is one Blooms The Chemist Paroxetine tablet (paroxetine 20 mg) per day. • To treat obsessions and compulsions or panic attacks, the usual dose of Blooms The Chemist Paroxetine is two 20 mg tablets per day. • Your doctor may increase the dose slowly over several weeks. This may require you to break the tablet in half. More instructions can be found in Section 4. How do I use Blooms The Chemist Paroxetine? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BLOOMS THE CHEMIST PAROXETINE? THINGS YOU SHOULD DO • Remind any doctor, dent Lestu allt skjalið
221021-bloomsthechemist-paroxetine-pi Page 1 of 28 AUSTRALIAN PRODUCT INFORMATION BLOOMS THE CHEMIST PAROXETINE (PAROXETINE HYDROCHLORIDE) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Paroxetine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Blooms The Chemist Paroxetine film-coated tablet contains 22.2 mg of paroxetine hydrochloride equivalent to 20 mg paroxetine. _Excipient with known effect: _ Mannitol. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Blooms The Chemist Paroxetine tablets are white, round bi-sected film-coated tablets with a one-sided breaking notch ("Snap-tab") and embossment 'PX 20' on opposite side, intact surface. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Blooms The Chemist Paroxetine 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. D OSE 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. _ADULTS _ _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. 221021-bloomsthechemist-paroxetine-pi Page 2 of 28 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 se Lestu allt skjalið