ATROLAK Prolonged-release tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Atrolak XL 50 mg prolonged-release tablets.
Qualitative and quantitative composition
Each 50 mg prolonged release tablet contains 50 mg quetiapine (as quetiapine fumarate). Excipient(s) with known effect: 140.925 mg Lactose monohydrate per tablet For the full list of excipients, see Section ...
Pharmaceutical form
Prolonged-release tablet. Peach colored, round shaped, biconvex film coated tablets, debossed with Q50 on one side and plain on the other. Note: Diameter of the tablet 11.2 ± 0.2 mm.
Therapeutic indications
Atrolak XL 50 mg is indicated for: Τreatment of Schizophrenia. Τreatment of bipolar disorder:For the treatment of moderate to severe manic episodes in bipolar disorder. For the treatment of major depressive ...
Posology and method of administration
Posology Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition Adults For the treatment ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in Section 6.1. Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal ...
Special warnings and precautions for use
As Atrolak XL 50 mg has several indicationthe safety profile should be considered with respect to the individual patients diagnosis and the dose being administered. Long-term efficacy and safety in patients ...
Interaction with other medicinal products and other forms of interaction
Given the primary central nervous system effects of quetiapine, quetiapine should be used with caution in combination with other centrally acting medicinal products and alcohol. Caution should be exercised ...
Fertility, pregnancy and lactation
Pregnancy First trimester The moderate amount of published data from exposed pregnancies (i.e. between 300-1000 pregnancy outcomes), including individual reports and some observational studies do not suggest ...
Effects on ability to drive and use machines
Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery, until individual ...
Undesirable effects
The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%) are somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, ...
Overdose
Symptoms In general, reported signs and symptoms were those resulting from an exaggeration of the active substances known pharmacological effects, ie, drowsiness and sedation, tachycardia, hypotension ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines, thiazepines ATC code: N05AH04 Mechanism of action Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma ...
Pharmacokinetic properties
Absorption Quetiapine is well absorbed following oral administration. Quetiapine Prolonged-release Tablets achieves peak quetiapine and norquetiapine plasma concentrations at approximately 6 hours after ...
Preclinical safety data
There was no evidence of genotoxicity in a series of in vitro and in vivo genotoxicity studies. In laboratory animals at a clinically relevant exposure level the following deviations were seen, which as ...
List of excipients
<u>Core:</u> Lactose monohydrate Hypromellose Sodium chloride Povidone K-30 Silicified Microcrystalline Cellulose (Siliciumdioxide & Microcrystalline Cellulose) Talc Magnesium stearate <u>Coating:</u> ...
Incompatibilities
Not applicable.
Shelf life
30 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC-Alu blister pack or OPA/Alu/PVC–Alu blister pack. Pack size of 6, 10, 20, 28, 30, 50, 60, 90 and 100 tablets per pack. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0213
Date of first authorization / renewal of the authorization
19/06/2013
Date of revision of the text
05/07/2021
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