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SPC, UK: SOLIAN 100mg Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Solian 100 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 100 mg of the active substance, amisulpride. Also contains 69.6 mg of lactose monohydrate. For a full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White to off-white, round, flat-faced tablet engraved AMI 100 on one face and with a breakable bar on the other face.

Therapeutic indications

Solian is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted ...

Posology and method of administration

For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively ...

Contraindications

Hypersensitivity to the active ingredient or to other ingredients of the medicinal product. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas or breast cancer (see sections 4.4 ...

Special warnings and precautions for use

As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal complication, characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK, ...

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations Levodopa Reciprocal antagonism of effects between levodopa and neuroleptics. Amisulpride may oppose the effect of dopamine agonists e.g. bromocriptine, ropinirole. Combinations ...

Fertility, pregnancy and lactation

Pregnancy There are only limited data available from the use of amisulpride in pregnant women. The safety of amisulpride during human pregnancy has not been established. Amisulpride crosses the placenta. ...

Effects on ability to drive and use machines

Even used as recommended, Solian may cause somnolence and blurred vision so that the ability to drive vehicles or operate machinery can be impaired (see section 4.8).

Undesirable effects

Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1,000; <1/100); rare (≥1/10,000; <1/1,000); very rare ...

Overdose

Experience with Solian in overdosage is limited. Exaggeration of the known pharmacological effects of the drug have been reported. These include drowsiness and sedation, coma, hypotension and extrapyramidal ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotics ATC code: N05AL05 Amisulpride binds selectively with a high affinity to human dopaminergic D<sub>2</sub>/D<sub>3</sub> receptor subtypes whereas it is devoid of ...

Pharmacokinetic properties

In man, amisulpride shows two absorption peaks: one which is attained rapidly, one hour post-dose and a second between 3 and 4 hours after administration. Corresponding plasma concentrations are 39 ± 3 ...

Preclinical safety data

An overall review of the completed safety studies indicates that Solian is devoid of any general, organ-specific, teratogenic, mutagenic or carcinogenic risk. Changes observed in rats and dogs at doses ...

List of excipients

Sodium starch glycolate Lactose monohydrate Microcrystalline cellulose Hypromellose Magnesium stearate

Incompatibilities

None known.

Shelf life

Shelf life: 3 years.

Special precautions for storage

No special precautions.

Nature and contents of container

PVC/aluminium foil blister packs containing 30, 60 or 90 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special precautions.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization number(s)

PL 04425/0651

Date of first authorization / renewal of the authorization

Date of first authorisation: 6 July 1999 Date of latest renewal: 4 April 2007

Date of revision of the text

26 July 2019

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