Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
Accord-UK Ltd
N06AA10
Nortriptyline hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5060333020026
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com NORTRIPTYLINE 10MG & 25MG TABLETS PIL - UK Black Profile BBBB1553 C.Grant 09/06/2021 24/09/2021 T. Hull 160 x 270 7pt Centaur Pharmaceuticals Pvt. Ltd. 09/06/2021 16/06/2021 3 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT NORTRIPTYLINE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE TABLETS 3. HOW TO TAKE NORTRIPTYLINE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NORTRIPTYLINE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT NORTRIPTYLINE TABLETS ARE AND WHAT THEY ARE USED FOR Nortriptyline belongs to a class of medicines called tricyclic antidepressants. Nortriptyline tablets are used to treat major depression in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORTRIPTYLINE TABLETS You should not take Nortriptyline Tablets until you are sure it is safe for you to do so. Nortriptyline Tablets are for adults only. DO NOT TAKE NORTRIPTYLI Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nortriptyline 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nortriptyline hydrochloride equivalent to nortriptyline 10mg Excipient with known effect Each tablet contains 43.06mg of lactose monohydrate. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off-white round biconvex tablets, debossed ‘NO’ on one side and ‘10’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nortriptyline is indicated for the treatment of Major Depressive Episodes in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS: The usual adult dose is 25mg three or four times daily. Dosage should begin at a low level (50mg once daily or 25mg 2-3 times daily). If necessary, dose could be gradually increased in 25mg increments no more rapidly than every other day to be added to the morning dose. When doses above 100mg daily are administered, monitoring of plasma levels of nortriptyline should be considered and maintained in the optimum range of 50 to 150ng/ml. Doses above 150mg per day are not recommended. Lower than usual dosages are recommended for elderly patients. Lower dosages are also recommended for outpatients than 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. The maintenance dose should be the same as the optimal therapeutic dose. If a patient develops minor side-effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. ELDERLY: 30 to 50mg/day in divided doses. Dosage should begin at a low level (10 – 20 mg daily) and be increased as required to the maximum dose of 50mg. If it is considered necessary to use higher dosing Lesen Sie das vollständige Dokument