País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
nortriptyline, Quantity: 25 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; magnesium stearate; hypromellose; glycerol; maize starch; calcium phosphate; sunset yellow FCF aluminium lake
Oral
50
(S4) Prescription Only Medicine
ALLEGRON is indicated for the treatment of major depression.
Visual Identification: an orange coated tablet upper surface regular convex lower surface regular convex scored; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1995-10-17
ALLEGRON ® 1 ALLEGRON ® _nortriptyline hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet is designed to provide you with answers to some common questions about this medicine. It does not contain all the available information and does not take the place of talking with your doctor. All medicines have risks and benefits. Your doctor has more information about this medicine than is contained in this leaflet. Also, your doctor has had the benefit of taking a full and detailed history from you and is in the best position to make an expert judgement to meet your individual needs. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ALLEGRON IS USED FOR ALLEGRON is used to treat depression. There are many different types of medicines used to treat depression. ALLEGRON 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. Your doctor may have prescribed ALLEGRON for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALLEGRON HAS BEEN PRESCRIBED FOR YOU. BEFORE TAKING ALLEGRON TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS OR IF YOU HAVE EVER EXPERIENCED ANY OF THESE CONDITIONS. _WHEN YOU MUST NOT TAKE _ _ALLEGRON _ DO NOT TAKE ALLEGRON • IF YOU HAVE HAD AN ALLERGIC REACTION TO ANY MEDICINES CONTAINING NORTRIPTYLINE OR TO ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET (SEE 'PRODUCT DESCRIPTION'). Signs of an allergic reaction may include rash, itching of the skin, shortness of breath and swelling of the tongue or face. • 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. • IF YOU ARE TAKING ANOTHER MEDICINE FOR S Llegiu el document complet
1 AUSTRALIAN PI – ALLEGRON (NORTRIPTYLINE HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Nortriptyline hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALLEGRON 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 ALLEGRON 10 mg tablets are plain, round, white tablets. ALLEGRON 25 mg tablets are orange round tablets with a scoreline on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ALLEGRON is indicated for the treatment of major depression. 4.2 D OSE AND METHOD OF ADMINISTRATION ALLEGRON is not recommended for children. ALLEGRON 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 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. 2 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 ALLEGRON for the treatment of depression or other psychiatric disorders in children and adolescents aged less than 18 years has not been satisfactorily established. ALLEGRON should not be used in this age group for the treatment of depression or other psychiatric disorders (see SECTION 4.4 SPECIAL WARNIN Llegiu el document complet