Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nortriptyline hydrochloride
King Pharmaceuticals Ltd
N06AA10
Nortriptyline hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030100; GTIN: 5033003002226
PACKAGE LEAFLET: INFORMATION FOR THE USER ALLEGRON TABLETS 10MG & 25MG Nortriptyline 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 Allegron tablets are and what they are used for 2. What you need to know before you take Allegron tablets 3. How to take Allegron tablets 4. Possible side effects 5. How to store Allegron tablets 6. Contents of the pack and other information 1. WHAT ALLEGRON TABLETS ARE AND WHAT THEY ARE USED FOR Allegron tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Allegron tablets relieve the symptoms of depression. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLEGRON TABLETS _ _ DO NOT TAKE ALLEGRON TABLETS: - If you are allergic to nortriptyline hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue; - If you have had a recent heart attack or heartbeat disorder; - If you have severe liver disease; - If you suffer from mania (abnormally raised mood); - If you are breast-feeding; - If the child is under 6 years of age; - If you are taking, or have taken in the last two weeks, monoamine oxidase inhibitors (another type of antidepressant); - If you are taking adrenaline-like drugs including ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These drugs are often contained in cough and cold remedies. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmac Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allegron Tablets 10 mg Nortriptyline 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALLEGRON TABLETS 10 MG/ NORTRIPTYLINE 10 MG TABLETS: Tablets each containing Nortriptyline Hydrochloride EP equivalent to 10mg nortriptyline base. Tablets are white, unscored and have a diameter of 5.5mm. They are marked ´KING’. Excipient(s) with known effect Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Allegron Tablets 10 mg/ Nortriptyline 10 mg Tablets: Tablet. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nortriptyline is indicated for the relief of symptoms of depression. 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 and be increased as required. Alternatively, the total daily dose may be given once a day. When doses above 100mg daily are administered, plasma levels of nortriptyline should be monitored 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 and adolescents. 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 at the lowest dose that will maintain remission. 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. _ _ _The elderly:_ 30 to 50mg/day in divided doses. _ _ _Adolescent patients:_ 30 to 50mg/day in divided doses. _Plasma levels: _Optimal respon Read the complete document