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SYCREST Sublingual tablet (2022)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Sycrest 5 mg sublingual tablets.

Qualitative and quantitative composition

Each sublingual tablet contains 5 mg asenapine (as maleate). For the full list of excipients, see section 6.1.

Pharmaceutical form

Sublingual tablet. Round, white to off-white, sublingual tablets debossed with 5 on one side.

Therapeutic indications

Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

Posology and method of administration

Posology The recommended starting dose of Sycrest as monotherapy is 5 mg twice daily. One dose should be taken in the morning and one dose should be taken in the evening. The dose can be increased to 10 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Elderly patients with dementia-related psychosis Elderly patients with dementia-related psychosis treated with antipsychotic substances are at an increased risk of death. Sycrest is not approved for the ...

Interaction with other medicinal products and other forms of interaction

Given the primary effects of asenapine on the central nervous system (CNS) (see section 4.8), caution should be used when it is taken in combination with other centrally acting medicinal products. Patients ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of Sycrest in pregnant women. Asenapine was not teratogenic in animal studies. Maternal and embryo toxic effects were found in animal studies (see section ...

Effects on ability to drive and use machines

Asenapine may cause somnolence and sedation. Therefore, patients should be cautioned about driving and using machines until they are reasonably certain that Sycrest therapy does not affect them adversely. ...

Undesirable effects

Summary of safety profile The most frequently reported adverse drug reactions (ADRs) associated with the use of asenapine in clinical trials were somnolence and anxiety. Serious hypersensitivity reactions ...

Overdose

Few cases of overdose were reported in the asenapine program. Reported estimated doses were between 15 and 400 mg. In most cases it was not clear if asenapine had been taken sublingually. Treatment-related ...

Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Psycholeptics, antipsychotics <b>ATC code:</b> N05AH05 Mechanism of action The mechanism of action of asenapine is not fully understood. However, based on its receptor ...

Pharmacokinetic properties

Absorption Following sublingual administration, asenapine is rapidly absorbed with peak plasma concentrations occurring within 0.5 to 1.5 hours. The absolute bioavailability of sublingual asenapine at ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology. Repeat-dose toxicity studies in rat and dog showed mainly dose-limiting pharmacological effects, ...

List of excipients

Gelatin Mannitol (E421)

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Store in the original package in order to protect from light and moisture. This medicinal product does not require any special temperature storage conditions.

Nature and contents of container

Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands

Marketing authorization number(s)

EU/1/10/640/001 EU/1/10/640/002 EU/1/10/640/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 01 September 2010 Date of latest renewal: 05 May 2015

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