Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
periciazine, Quantity: 10 mg
Clinect Pty Ltd
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; wheat starch; magnesium stearate; colloidal anhydrous silica
Oral
100 x 10mg tablets
Medicine Registered
(S4) Prescription Only Medicine
Severe anxiety and tension states and the maintenance treatment of the psychotic patient. It is useful in controlling such symptoms as impulsiveness and aggression.
Visual Identification: VERY PALE LIME YELLOW COLOURED, BICONVEX TABLETS WITH A MATT FINISH, SOMETIMES SHOWING LIGHT YELLOW MOTTLING OR SPECKS. DEBOSSED WITH 10 ON ONE FACE, OPPOSITE FACE SCORED.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-21
NEULACTIL ® N E U L A C T I L ® 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 NEULACTIL? Neulactil contains the active ingredient periciazine. Neulactil is used to treat patients who feel very anxious and/or tense. It is used in patients to control symptoms such as impulsiveness and aggression. It is also used in patients with severe mental conditions when a person loses contact with reality and is unable to think and judge clearly. Your doctor may have prescribed Neulactil for another reason. For more information, see Section 1. Why am I using Neulactil? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NEULACTIL? Do not use if you have ever had an allergic reaction to Neulactil 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 Neulactil? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Neulactil 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 NEULACTIL? • Swallow the tablets with a glass of water. Take Neulactil at about the same time each day. More instructions can be found in Section 4. How do I use Neulactil? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NEULACTIL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Neulactil. • Tell your doctor if you are pregnant, breastfeeding, or trying to become pregnant. THINGS YOU SHOULD NOT DO • Do not take Neulactil to treat any other complaints unless your doctor tells you to. • Do not stop taking Neulactil, or lower or raise the dosage, without checking with your doctor. DRIVING OR USING MACHINES • Be caref Прочитать полный документ
neulactil-ccdsv5-piv17-09may22 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – NEULACTIL (PERICIAZINE) 1 NAME OF THE MEDICINE Periciazine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Neulactil tablets contain periciazine (2.5 mg and 10 mg) Excipients with known effect: contains sugars (as lactose) and wheat starch. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablets 2.5 mg: yellow, scored, marked NEULACTIL 10 mg: yellow, scored, marked 10 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe anxiety and tension states and the maintenance treatment of the psychotic patient. It is useful in controlling such symptoms as impulsiveness and aggression. 4.2 DOSE AND METHOD OF ADMINISTRATION In all cases, dosage may be progressively increased until the most effective level is reached after which the dosage should be adjusted to maintain control of symptoms. MILD TO MODERATE CONDITIONS IN GENERAL PRACTICE _ADULTS _ The initial daily dosage is 15 to 30 mg divided into two portions with the larger dose given in the evening. neulactil-ccdsv5-piv17-09may22 Page 2 of 17 _GERIATRIC PATIENTS _ The starting dose is 10 mg/day, increasing according to therapeutic effect and patient tolerance, to a maximum of about 30 mg daily in divided doses. MODERATE TO SEVERE CONDITIONS _HOSPITALISED ADULT PATIENTS _ Initial dosage is 25 to 75 mg/day orally, administered in divided doses. _CHILDREN _ The initial daily dosage should not exceed 0.5 mg per year of age. Use in children below 1 year of age is contraindicated. In older children (16 years) the twenty four hour dose should be about 1 mg/year of age. Dosages up to 75 mg/day are used in hospitals without any untoward effects. 4.3 CONTRAINDICATIONS Periciazine should never be used in the following circumstances: • Circulatory collapse. • Acute intoxication with central depression and coma. • Previous history of blood dyscrasias. or agranulocytosis. • Hypersensitivity to periciazine, other phenothiazines or to any of the other ingredi Прочитать полный документ