NAME OF THE MEDICINAL PRODUCT
Dogmatil 200 mg, scored tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulpiride base ..... 200.00 mg
For one scored tablet.
• Acute psychotic disorders.
• Chronic psychotic disorders (schizophrenia, chronic non-schizophrenic
delusions: paranoid delusions, chronic hallucinatory psychosis).
Posology and method of administration
For use in adults only.
The minimum effective dose should always be used. If the patient's clinical
condition allows, treatment should be initiated at a low dose,
then gradual dosage titration may be used. The daily dose is 200 to 1000mg.
This drug is contraindicated in the following situations:
• hypersensitivity to sulpiride or to one of the other ingredients of the
• prolactin-dependent tumors (e.g. pituitary gland prolactinomas and breast
• known or suspected pheochromocytoma,
• in combination with:
non-antiparkinsonian dopamine agonists (cabergoline and quinagolide).
Special warnings and precautions for use
* Potentially fatal neuroleptic malignant syndrome: If unexplained fever
occurs, treatment must imperatively be discontinued since this may be one of
the symptoms of the malignant syndrome reported with neuroleptic drugs
(pallor, hyperthermia, autonomic disorders, consciousness disorders, muscle
Signs of autonomic dysfunction, such as perspiration and changes in
arterial blood pressure, may occur before hyperthermia and thus constitute
early warning signs.
Although this effect of neuroleptics may be idiosyncratic in origin,
there may be predisposing risk factors, such as dehydration and organic
* Prolonged QT interval: sulpiride can cause dose-dependent prolongation
of the QT interval. This effect, which is known to increase the risk of
serious ventricular arrhythmias, particularly torsades de pointes, is
enhanced in patients with bradycardia, hypokalemia, and congenital or
acquired QT prolongation (when sulpiride is taken with a medicinal product
prolonging the QT interval).
Consequently, before administering the drug, and if the clinical
situation permits, patients should be checked for the following risk factors
that may promote this type of arrhythmia:
• bradycardia of less than 55 beats per minute,
• congenital QT interval prolongation,
• ongoing treatment with a drug likely to induce marked bradycardia (less
than 55 beats per minute), hypokalemia, delayed intracardiac conduction or
QT interval prolongation.
Except in emergencies, it is recommended that an ECG be performed as part
of the initial evaluation of patients due to receive treatment
with a neuroleptic agent.
In randomized, placebo-controlled clinical trials in elderly patients with
dementia and treated with atypical antipsychotics, a higher risk of stroke
was observed versus placebo. The reason for this increased risk is unknown.
Increased risk with other antipsychotics or in other patient populations
cannot be ruled out. This drug should be used with caution in patients with
risk factors for stroke.
Elderly patients with dementia
The risk of mortality increases in elderly patients suffering from
dementia-related psychosis and treated with antipsychotic drugs.
Analysis of 17 placebo-controlled studies (mean duration of 10 weeks),
conducted in patients mainly taking atypical antipsychotic drugs, showed
that the risk of mortality increased 1.6- to 1.7-fold in patients treated
with these medicinal products versus placebo.
After a mean treatment period of 10 weeks, the risk of mortality was 4.5%
in the treated patient group versus 2.6% in the placebo group.
Although the causes of death varied in the clinical trials with the
atypical antipsychotic drugs, the majority of deaths appeared to to either
cardiovascular (e g. heart failure, sudden death) or infections (eg.
Epidemiological studies suggest that treatment with conventional
antipsychotic drugs may increase mortality, as is the case for atypical
The respective contribution of the antipsychotic drug and patient
characteristics to the increase in mortality found in the epidemiological
studies is unclear.
Venous thromboembolism: cases of venous thromboembolism (VTE) have been
reported with antipsychotic drugs- Since patients treated
with antipsychotic drugs often present acquired risk factors for VTE, any
potential risk factors for WE must be identified before and during treatment
with Dogmatil and preventive measures should be taken.
Administration of this medicinal product is not recommended with alcohol,
levodopa, antiparkinsonian dopamine agonies, antiparasitic agents likely to
induce torsades de pointes, methadone, other neuroleptics and medicinal
products likely to induce torsades de pointes.
This medicinal product contains lactose and is therefore not recommended
in patients with galactose intolerance, lapp lactase deficiency or glucose
and galactose malabsorption syndrome (rare hereditary diseases).
Precautions for use
in patients with diabetes or with risk factors for diabetes who are starting
treatment with sulpiride, appropriate blood glucose monitoring should be
Except in special cases, this drug should not be administered to patients
with Parkinson's disease.
In patients with renal insufficiency, reduce the dosage and increase
monitoring; in the event of serious renal insufficiency, intermittent
treatment courses are recommended.
Monitoring of treatment with sulpiride must be intensified in:
• epileptic patients, as sulpiride may lower the seizure threshold; cases of
seizure have been reported in patients treated with sulpiride,
• elderly patients with greater susceptibility to postural hypotension,
sedation and extrapyramidal effects.
Interaction with other medicinal products and other forms of
It must be taken into account that many drugs or substances can have
additive depressant effects on the central nervous system and contribute to
a decrease in alertness. These drugs include morphine derivatives
(analgesics, antitussives, and replacement therapies), neuroleptics,
barbiturates, benzodiazepines, non-benzodiazepine anxiolytics (such as
meprobamate), hypnotics, sedative antidepressants
(amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1
-antihistamines, centrally-acting antihypertensives, baclofen, and
Drugs likely to induce torsades de pointes
This serious cardiac rhythm disorder can be caused by a number
of medicinal products, anti-arrhythmics or not. Hypokalemia (see
Potassium-depleting drugs) is a promoting factor, as is bradycardia (see
Bradycardia-inducing drugs) or preexisting congenital or acquired QT
The medicines involved are in particular class Ia and III antiarrhythmics
and certain neuroleptics.
For erythromycin, spiramycin and vincamine, only intravenously
administered dosage forms are concerned by this interaction.
Coadministration of two torsadogenic drugs is generally contraindicated.
However, methadone, as well as certain sub-classes, are exceptions:
• antiparasitics (halofantrine, lumefantrine, pentamidine) are merely not
recommended in combination with other torsadogenic drugs;
• neuroleptics likely to induce torsades de pointes are also not
recommended, but not contraindicated, in combination with other torsadogenic
+Non-anti-parkinsonian dopamine agonists (cabergoline, quinagolide)
Mutual antagonism between dopamine agonists and neuroleptics.
+Antiparasitic agents likely to induce torsades de pointes (halofantrine,
Increased risk of ventricular arrhythmias, particularly torsades de pointes.
If possible, treatment with the azole antifungal agent should be
discontinued. If coadministration cannot be avoided, QT interval should be
checked before treatment and the ECG monitored.
+Antiparkinsonian dopamine agonists (amantadine, apomorphine,
bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole,
Mutual antagonism between dopamine agonists and neuroleptics. If possible,
treatment with the azole antifungal agent should be discontinued.
Dopamine agonists can cause or worsen psychotic disorders. If treatment
with neuroleptics is required in patients with Parkinson's disease treated
with dopamine agonists, these dopamine agents should be tapered off
gradually (sudden discontinuation exposes the patient to a risk of
neuroleptic malignant syndrome).