VEIKIRIN Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
VEIKIRIN 10 (film-coated tablets). VEIKIRIN 25 (film-coated tablets). VEIKIRIN 50 (film-coated tablets).
2. Qualitative and quantitative composition
VEIKIRIN 10: Each film-coated tablet contains 10 mg amitriptyline hydrochloride. Contains sugar: lactose monohydrate 10 mg. VEIKIRIN 25: Each film-coated tablet contains 25 mg amitriptyline hydrochloride. ...
3. Pharmaceutical form
Film-coated tablet. <u>VEIKIRIN 10:</u> Round blue colored biconvex tablets debossed 1 on one side and plain on other side. <u>VEIKIRIN 25:</u> Round yellow colored biconvex tablets plain on both sides. ...
4.1. Therapeutic indications
VEIKIRIN is indicated for the treatment of depression in adults (18 years and older).
4.2. Posology and method of administration
Posology Adults Initially 75 mg to 150 mg daily in divided doses. Maintenance dose is 50 mg to 100 mg daily in divided doses. Method of administration Amitriptyline is for oral use. The tablets should ...
4.3. Contraindications
VEIKIRIN is contraindicated in: Patients with hypersensitivity to amitriptyline or to any of the excipients (see section 6.1). Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days ...
4.4. Special warnings and precautions for use
<b>VEIKIRIN should at all times be kept out of reach of children as even small doses may be fatal to them.</b> Anticholinergic effects Peripheral anticholinergic adverse events such as dry mouth, constipation ...
4.5. Interaction with other medicinal products and other forms of interaction
Simultaneous administration of monoamine oxidase inhibitors (MAOls) and VEIKIRIN may cause serotonin syndrome (a combination of symptoms such as hyperthermia, convulsions, myoclonus, confusion, agitation). ...
4.6. Fertility, pregnancy and lactation
Pregnancy Safety and efficacy of VEIKIRIN during pregnancy has not been established (see section 4.3). Only limited data are available regarding exposed pregnancies. Animal studies have shown reproductive ...
4.7. Effects on ability to drive and use machines
At the time of initiation of therapy, patients should be advised not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery for at least several days. In these situations, impaired ...
4.8. Undesirable effects
a. Summary of the safety profile VEIKIRIN may induce adverse events similar to other tricyclic antidepressants. Some of the below mentioned adverse events e.g. headache, tremor, disturbance in attention, ...
4.9. Overdose
Overdosage and poisoning may be characterised by central nervous system depression or excitation, severe anticholinergic effects and cardiotoxicity. The signs and symptoms of an overdosage include: drowsiness, ...
5.1. Pharmacodynamic properties
<b>Category and Class:</b> A 1.2 Psychoanaleptics (antidepressants). Pharmacotherapeutic group: Antidepressants Non-selective monoamine reuptake inhibitor (tricyclic antidepressant) <b>ATC code:</b> N06AA09 ...
5.2. Pharmacokinetic properties
Absorption Amitriptyline is absorbed after oral administration, reaching its maximum plasma concentration approximately 6 hours after administration. Distribution Amitriptyline and nortriptyline are widely ...
6.1. List of excipients
<u>Tablet core:</u> Colloidal silicon dioxide Corn maize starch Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Talc <u>Tablet coating VEIKIRIN 10:</u> Hypromellose ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. Store at or below 25°C.
6.4. Special precautions for storage
No special precautions for storage exist for VEIKIRIN.
6.5. Nature and contents of container
VEIKIRIN 10 are packed in PVC/PVdC/Aluminium blisters containing 30 film-coated tablets. The blister strips are packed in a printed carton. VEIKIRIN 25 are packed in PVC/PVdC/Aluminium blisters containing ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Strides Pharma SA (Pty) Ltd, 106 16th Road, Building 2, Midrand
8. Marketing authorization number(s)
VEIKIRIN 10: 54/1.2/0681 VEIKIRIN 25: 54/1.2/0682 VEIKIRIN 50: 54/1.2/0683
9. Date of first authorization / renewal of the authorization
29 March 2022
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