AMITRIPTYLINE Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Amitriptyline 25mg Film-coated Tablets.
Qualitative and quantitative composition
Each tablet contains Amitriptyline HCl 25.00mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Yellow coloured, round, biconvex, film-coated tablet plain on both sides.
Therapeutic indications
Amitriptyline tablets are indicated for: Τhe treatment of major depressive disorder in adults. Τhe treatment of neuropathic pain in adults. Τhe prophylactic treatment of chronic tension type headache (CTTH) ...
Posology and method of administration
Posology Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increments. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Recent myocardial infarction. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. ...
Special warnings and precautions for use
Cardiac arrhythmias and severe hypotension are likely to occur with high dosage. They may also occur in patients with pre-existing heart disease taking normal dosage. QT interval prolongation Cases of ...
Interaction with other medicinal products and other forms of interaction
Potential for amitriptyline to affect other medicinal products Contraindicated combinations MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of serotonin syndrome (see ...
Fertility, pregnancy and lactation
Pregnancy For amitriptyline only limited clinical data are available regarding exposed pregnancies. Animal studies have shown reproductive toxicity (see section 5.3). Amitriptyline is not recommended during ...
Effects on ability to drive and use machines
Amitriptyline is a sedative drug. Patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration and should be cautioned about their ...
Undesirable effects
Amitriptyline may induce side effects similar to other tricyclic antidepressants. Some of the below mentioned side effects e.g. headache, tremor, disturbance in attention, constipation and decreased libido ...
Overdose
Symptoms Anticholinergic symptoms: Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility. Convulsions. Fever. Sudden occurrence of CNS depression. Lowered consciousness ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants Non-selective monoamine reuptake inhibitor (tricyclic antidepressant) ATC code: N06AA09 Mechanism of action Amitriptyline is a tricyclic antidepressant and an ...
Pharmacokinetic properties
Absorption Oral administration of tablets results in maximum serum levels in about 4 hours. (t<sub>max</sub> = 3.89±1.87 hours; range 1.93-7.98 hours). After peroral administration of 50 mg the mean C ...
Preclinical safety data
Amitriptyline inhibited ion channels, which are responsible for cardiac repolarization (hERG channels), in the upper micromolar range of therapeutic plasma concentrations. Therefore, amitriptyline may ...
List of excipients
Core Tablet: Lactose Monohydrate Microcrystalline Cellulose (PH 102) Maize Starch Magnesium Stearate Colloidal Anhydrous silica Film Coat: Hydroxy Propyl Methylcellulose Ethyl Cellulose Diethyl pthalate ...
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Container pack: Do not store above 25°C. Store in the original container. Keep the container tightly closed. Blister pack: Do not store above 25°C. Store in the original package.
Nature and contents of container
High density polystyrene container with polythene lid and polyurethene/polythene insert. Pack size 100 and 500 Tablets. Polypropylene container with polypropylene or polythene lids and polyurethene/polythene ...
Special precautions for disposal and other handling
No special instructions.
Marketing authorization holder
ACCORD HEALTHCARE LIMITED, SAGE HOUSE, 319 PINNER ROAD, HARROW, MIDDLESEX, HA1 4HG, UNITED KINGDOM
Marketing authorization number(s)
PL 20075/0035
Date of first authorization / renewal of the authorization
26<sup>th</sup> April 2005
Date of revision of the text
26/10/2018
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