AMIROL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

Amirol 10 mg film-coated tablets. Amirol 25 mg film-coated tablets.

2. Qualitative and quantitative composition

Amirol 10 mg film-coated tablets: Each film-coated tablet contains Amitriptyline Hydrochloride 10 mg. Amirol 25 mg film-coated tablets: Each film-coated tablet contains Amitriptyline Hydrochloride ...

3. Pharmaceutical form

Film-coated tablet. Amirol 10 mg film-coated tablets: Light blue, round, film-coated tablets. Amirol 25 mg film-coated tablets: Yellow, round, film-coated tablets.

4.1. Therapeutic indications

Amirol is indicated for: the treatment of major depressive disorder in adults the treatment of neuropathic pain in adults the prophylactic treatment of chronic tension type headache (CTTH) in adults the ...

4.2. 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. ...

4.3. 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. ...

4.4. 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 ...

4.5. 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 ...

4.6. 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 ...

4.7. 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 ...

4.8. 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 ...

4.9. Overdose

Symptoms Anticholinergic symptoms: Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility. Convulsions. Fever. Sudden occurrence of CNS depression. Lowered consciousness ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Psychoanaleptics, antidepressants ATC code: N06AA09 Mechanism of action Amitriptyline is a tricyclic antidepressant and an analgesic. It has marked anticholinergic ...

5.2. Pharmacokinetic properties

Absorption Oral administration of tablets results in maximum serum levels in about 4 hours. (tmax = 3.89±1.87 hours; range 1.93-7.98 hours). After peroral administration of 50 mg the mean C ...

5.3. 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 ...

6.1. List of excipients

Core: Sodium starch glycolate (type A) Cellulose, microcrystalline Lactose monohydrate Povidone Maize Starch Silica, colloidal anhydrous Magnesium Stearate Talc Coating: Hypromellose Macrogol ...

6.2. Incompatibilities

None known.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

Amirol 10 mg film-coated tablets: PVC/Aluminium blisters. Pack-size of 30 film-coated tablets. PP containers with PE closure. Pack-sizes of 100, 500 and 1000 film-coated tablets. Amirol 25 mg ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Amirol 10 mg film-coated tablets: 7749 Amirol 25 mg film-coated tablets: 7748

9. Date of first authorization / renewal of the authorization

Amirol 10 mg film-coated tablets: Date of first authorization: 02 February 1981 Date of latest renewal: 16 January 2012 Amirol 25 mg film-coated tablets: Date of first authorization: 02 February ...

10. Date of revision of the text

29/11/2021

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf