Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
nortriptyline hydrochloride, Quantity: 11.4 mg (Equivalent: nortriptyline, Qty 10 mg)
Amdipharm Mercury Australia Pty Ltd
Nortriptyline hydrochloride
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch
Oral
50
(S4) Prescription Only Medicine
Treatment of major depression
Visual Identification: White to off white, round, biconvex, uncoated tablets, debossed 'NM' on one side and '10' on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-04-02
NORTRITABS _Nortriptyline hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NortriTABS. 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 NortriTABS 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 NORTRITABS IS USED FOR NortriTABS is used to treat depression. There are many different types of medicines used to treat depression. NortriTABS belongs to a group of medicines called tricyclic antidepressants (TCAs). TCAs are thought to work by their action on brain chemicals called amines, which are involved in controlling mood. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. There is not enough information to recommend the use of this medicine for children or adolescents under the age of 18 years. BEFORE YOU TAKE NORTRITABS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE NORTRITABS IF YOU HAVE AN ALLERGY TO: • any medicine containing nortriptyline • any of the ingredients listed at the end of this leaflet. • any other similar medicines such as other tricyclic antidepressants. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF: • you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI), or have been taking a MAOI within the last 14 days. Check with your doctor or pharmacist if you are unsure as to whether or not you are taking a MAOI. • you ar Soma hati kamili
NORTITABS 1 AUSTRALIAN PRODUCT INFORMATION NORTRITABS NORTRIPTYLINE HYDROCHLORIDE TABLET 1 NAME OF THE MEDICINE Nortriptyline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NortriTABS 10 mg and 25 mg tablets contain 10 mg and 25 mg nortriptyline (present as the hydrochloride) as the active ingredient, respectively. Excipients with known effect: Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM NortriTABS 10 mg White to off white, round, biconvex, uncoated tablets, debossed ‘NM’ on one side and ‘10’ on other side. NortriTABS 25 mg White to off white, round, biconvex, uncoated tablets, debossed ‘NM’ on one side and ‘25’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NortriTABS is indicated for the treatment of major depression. 4.2 DOSE AND METHOD OF ADMINISTRATION NortriTABS is not recommended for children. NortriTABS is administered orally in the form of tablets. Lower than usual dosages are recommended for elderly patients and adolescents. The dosage for outpatients should also be lower than that for hospitalised patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the NORTITABS 2 clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission. If a patient develops minor adverse reactions, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. Usual adult dose 25 mg 3 or 4 times daily; dosage should begin at a low level and be increased as required. Doses above 100 mg per day are not recommended. Use in children and adolescents (<18 years) The safety and efficacy of nortriptyline for the treatment of depression or other psychiatric disorders in children and adolescents aged less than 18 years has not been satis Soma hati kamili