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Dogmatil 200 mg, scored tablets

Sulpiride base ..... 200.00 mg
For one scored tablet.

Scored tablets.

Therapeutic indications
Acute psychotic disorders.
Chronic psychotic disorders (schizophrenia, chronic non-schizophrenic delusions: paranoid delusions, chronic hallucinatory psychosis).

Posology and method of administration
Oral use.

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 drug,
prolactin-dependent tumors (e.g. pituitary gland prolactinomas and breast cancer),
known or suspected pheochromocytoma,
in combination with:
  non-antiparkinsonian dopamine agonists (cabergoline and quinagolide).

Special warnings and precautions for use
Special warnings

* 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 rigidity).

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 brain damage.

* 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. pneumonia).

Epidemiological studies suggest that treatment with conventional antipsychotic drugs may increase mortality, as is the case for atypical antipsychotic drugs.

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 carried out.

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 interaction
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 thalidomide.

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 interval prolongation.

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 drugs.

Contraindicated combinations
+Non-anti-parkinsonian dopamine agonists (cabergoline, quinagolide)
Mutual antagonism between dopamine agonists and neuroleptics.

Inadvisable combinations
+Antiparasitic agents likely to induce torsades de pointes (halofantrine, lumefantrine, pentamidine)

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, ropinirole, selegiline)
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).

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