DEVODIL Tablet

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Devodil 50 mg tablets. Devodil 200 mg tablets.

2. Qualitative and quantitative composition

Devodil 50 mg tablets: Each tablet contains 50 mg sulpiride. Devodil 200 mg tablet: Each tablet contains 200 mg sulpiride. Excipient(s) with known effect: Devodil 50 mg tablet contains 73.10 mg ...

3. Pharmaceutical form

Tablet. Devodil 50 mg tablet: White, round, flat, scored tablets. Devodil 200 mg tablet: White, round, flat, scored tablets. The score line is only to facilitate breaking for ease of swallowing ...

4.1. Therapeutic indications

Acute and chronic schizophrenia.

4.2. Posology and method of administration

Posology Adults A starting dose of 400 mg to 800 mg daily, given as one or two tablets daily (morning and early evening) is recommended. Predominantly positive symptoms (formal thought disorder, hallucinations, ...

4.3. Contraindications

Pheochromocytoma and acute porphyria. Hypersensitivity to sulpiride or to any of the excipients listed in section 6.1. Concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast ...

4.4. Special warnings and precautions for use

Increased motor agitation has been reported at high dosage in a small number of patients: In aggressive, agitated or excited phases of the disease process, low doses of Devodil may aggravate symptoms. ...

4.5. Interaction with other medicinal products and other forms of interaction

Associations contraindicated Levodopa, antiparkinsonian drugs (including ropinirole): reciprocal antagonism of effects between levopoda or antiparkinsonian drugs (including ropinirole) and neuroleptics. ...

4.6. Fertility, pregnancy and lactation

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

4.7. Effects on ability to drive and use machines

Even used as recommended, sulpiride may cause sedation so that the ability to drive vehicles or operate machinery can be impaired (see section 4.8).

4.8. Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known ...

4.9. Overdose

Experience with sulpiride in overdosage is limited. Experience with sulpiride in overdosage is limited. In the event of an overdose, dyskinetic manifestations with spasmodic torticollis, protrusion of ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics, Antipsychotics ATC code: N05AL01 Sulpiride is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, ...

5.2. Pharmacokinetic properties

Peak sulpiride serum levels are reached 3–6 hours after an oral dose. The plasma half-life in man is approximately 8 hours. Approximately 40% sulpiride is bound to plasma proteins. 95% of the compound ...

5.3. Preclinical safety data

In long-term animal studies with neuroleptic drugs, including sulpiride, an increased incidence of various endocrine tumours (some of which have occasionally been malignant) has been seen in some but not ...

6.1. List of excipients

Cellulose, microcrystalline Sodium starch glycolate (Type A) Lactose monohydrate Starch, pregelatinised Povidone Silica, colloidal anhydrous Magnesium stearate Talc

6.2. Incompatibilities

Not applicable.

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

Devodil 50 mg tablets: PVC/Aluminium blisters. Pack sizes of 20 and 1000 tablets. PP containers with PE closure. Pack size of 1000 tablets. Devodil 200 mg tablets: PVC/Aluminium blisters. ...

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)

Devodil 50 mg tablets: 20175 Devodil 200 mg tablets: 20176

9. Date of first authorization / renewal of the authorization

Devodil 50 mg tablets: Date of first authorization: 05 January 2007 Date of latest renewal: 12 July 2013 Devodil 200 mg tablets: Date of first authorization: 05 January 2007 Date of latest ...

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