SURMONTIL Film-coated tablet (2019)
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Περιεχόμενα
1. Name of the medicinal product
Surmontil 25mg film-coated Tablets.
2. Qualitative and quantitative composition
Each tablet contains Trimipramine Maleate equivalent to 25 mg of Trimipramine. <u>Excipients:</u> each tablet contains 4.32 mg lactose monohydrate. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet. White to pale yellow, circular, biconvex, film-coated tablet, one face impressed SURMONTIL just inside the perimeter around a centrally impressed 25, reverse face plain.
4.1. Therapeutic indications
Surmontil has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses a pronounced sedative action. It is therefore indicated in the treatment of depressive ...
4.2. Posology and method of administration
The route of administration is oral. Recommended Dosage Depression Adults The usual daily dose is 50-100 mg daily as a single dose, 2 hours before retiring. In more severe depression, dosage should be ...
4.3. Contraindications
Hypersensitivity to trimipramine or to any of the excipients. Hypersensitivity to other tricyclic antidepressants. Known risk of narrow angle glaucoma. Risk of urinary retention related to urethroprostatic ...
4.4. Special warnings and precautions for use
The drug should only be used with great caution in the elderly or the debilitated. The drug should only be used with great caution in patients with a history of epilepsy or recent convulsions, urinary ...
4.5. Interaction with other medicinal products and other forms of interaction
Non-selective monoamine oxidase (MAOIs) should not be used in combination with any imipramines due to the major risk (though not well documented) of hypotensive and hypertensive effects. Monoamine oxidase ...
4.6. Pregnancy and lactation
The maintenance of good maternal mental balance throughout pregnancy is desirable. If a medicinal treatment is required to ensure this balance, it should be started or continued an an effective dose throughout ...
4.7. Effects on ability to drive and use machines
This drug may cause drowsiness, blurry vision or effect concentration. Patients receiving this medication should not drive or operate machinery unless it has been shown not to interfere with physical or ...
4.8. Undesirable effects
Side effects include mainly drowsiness or sedation (antihistamine effect) more pronounced at the start of treatment, anti-cholinergic effects, hypotension; particularly orthostatic hypotension, central ...
4.9. Overdose
Convulsions. QT interval prolongation, torsades de pointes. Overdose may result in fatal outcome. Symptoms of overdosage may include excitement, restlessnes with marked antimuscarinic effect including ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antidepressants/Non-selective monoamine reuptake inhibitors <b>ATC code:</b> N06AA06 Trimipramine has a potent antidepressant action similar to that of tricyclic antidepressant. ...
5.2. Pharmacokinetic properties
Trimipramine is readily absorbed after oral administration. It is strongly protein bound. It is metabolised in the liver to its metabolite dimethyltrimipramine. Trimipramine is excreted in the urine mainly ...
5.3. Preclinical safety data
Not relevant.
6.1. List of excipients
Starch potato Calcium hydrogen phosphate Talc Magnesium stearate Lactose monohydrate Hypromellose Titanium dioxide E171 Macrogol 400
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Keep the container tightly closed in order to protect from light.
6.5. Nature and contents of container
Surmontil 25 mg tablets are marketed in Grey 50 ml High density polyethylene (h.d.p.e.) bottles. Each bottle contains 50 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland
8. Marketing authorization number(s)
PA0540/128/005
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1978 Date of last renewal 05 October 2010
10. Date of revision of the text
April 2019
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