Leaflet: information for the user

Dogmatil 50 mg/ml injectable solution

Sulpiride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Dogmatil belongsto the group of medicationsantipsychotics, also known as neuroleptics.

Dogmatil 50 mg/ml injectable solution is indicated for:

- Treatment of depressive disorders with psychotic symptoms in combination with antidepressants, when treatment with antidepressants alone has not been effective and for the treatment of other severe forms of depression resistant to antidepressants.

- Treatment of vertigo in cases where there has been no response to standard antivertiginous treatment.

- Treatment of acute and chronic psychoses.

. Schizophrenia, chronic delirium, autism.

. Severe behavioral disorders.

. Neurotic states with inhibition and depression.

Do not use Dogmatil

• if you are allergic to sulpiride or any of the other components of this medication (listed in section 6)

• if you have multiple tumors (concomitant tumors) dependent on prolactin (hormone that stimulates milk secretion), for example, prolactinomas of the pituitary gland and breast cancer

• if you have pheochromocytoma (adrenal gland tumor)

• if you are being treated with levodopa or antiparkinsonian medications (including ropinirol) (see “Other medications and Dogmatil”)
• if you have a metabolic disease called acute porphyria
• in patients with low heart rate (bradycardia), with cardiac rhythm disturbances or with any other clinically important heart disease

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dogmatil:

* If administered to patients with a clinical situation that may favor the appearance of heart rhythm disorders, as sulpiride may potentiate the risk of severe cardiac rhythm disorders.

• If you have a history of stroke risk factors
• If the medication is administered to elderly patients, as there is a risk of sedation, decreased blood pressure when standing up, or the appearance of dyskinesia (involuntary and uncontrolled repetitive movements)
• If you have renal insufficiency (kidney function alteration), the dose should be reduced
• If you have a history of epilepsy, as the group of medications to which Dogmatil belongs may favor the appearance of seizures and convulsions
• If you have Parkinson's disease, as Dogmatil is contraindicated, except in exceptional cases, in patients taking antiparkinsonian medication
• Medications of this type (antipsychotics) may cause a combination of fever, muscle rigidity, and vegetative symptoms, such as sweating or faster breathing (called “neuroleptic malignant syndrome”). If this occurs, treatment should be suspended and you should speak with your doctor immediately.
• If you have diabetes mellitus (elevated blood sugar levels) or have risk factors for developing diabetes
• If you are an elderly patient with dementia-related psychosis being treated with antipsychotics (possibility of presenting a higher risk of death)
• If you have risk factors for thromboembolism (obstruction of a blood vessel by a blood clot) (see “Possible adverse effects”). Cases of venous thromboembolism, sometimes fatal, have been reported with antipsychotic medication treatment.
• If an infection or unknown fever appears, inform your doctor, as it could be a blood disorder (see “Possible adverse effects”). Cases of leukopenia (decreased white blood cell count), neutropenia (decreased neutrophil count), and agranulocytosis (decreased granulocyte count) have been reported with antipsychotic medication, including Dogmatil.
• In patients with a history of glaucoma, ileus, congenital intestinal stenosis, urinary retention, or prostate hyperplasia, use with caution.
• If you have high blood pressure, especially in the elderly population, due to the risk of hypertensive crisis (acute elevation of blood pressure)
• In patients with a history or family history of breast cancer, use with caution and monitor the patient during treatment with sulpiride.

Children and adolescents

This medication is not recommended for children, as sulpiride has not been thoroughly investigated in this patient group.

Other medications and Dogmatil

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use Dogmatilif you are being treated with:

• Levodopa (medication for Parkinson's disease treatment), antiparkinsonian medications (including ropinirol) (see “Do not use Dogmatil”).

Inform your doctor if you are currently being treated with any of the following medications:

Not recommended associations:

• Medications containing alcohol
• Antiarrhythmic agents (medications that regulate heart rhythm) such as quinidine, disopyramide, amiodarone, and sotalol
• Cisapride (medication for gastrointestinal motility disorders)
• Thioridazine (medication for psychiatric diseases)
• Intravenous erythromycin (antibiotic)
• Intravenous vincamine (medication that improves cerebral blood circulation)
• Halofantrine (medication for malaria)
• Pentamidine (medication for certain infectious diseases)
• Esparfloxacino (antibiotic)
• Methadone (medication for pain relief)
• Pimozide, haloperidol, and sultopride (medications for psychiatric diseases)
• Bepridil (medication for angina pectoris)
• Imipramine antidepressants (medications for treating depression)
• Medications that slow down heart rate, such as diltiazem and verapamil, clonidine, guanfacine; digitalis
• Medications that induce a decrease in potassium levels: hypocalcemic diuretics, laxatives, anfotericin B intravenous (antibiotic), glucocorticoids, tetracosactides

Associations to be taken into account:

• Depressants of the central nervous system, including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines, and other anxiolytic drugs, clonidine, and derivatives
• Lithium salts (medications for treating manic-depressive disorder, also known as bipolar affective disorder)
• Sucralfate (medication for treating and preventing duodenal ulcers)
• Antacids
• Medications for lowering blood pressure

Use of Dogmatil with food, drinks, and alcoholand alcohol

Since alcohol potentiates the sedative effect of sulpiride, it is not recommended to consume alcoholic beverages or other medications containing alcohol while using this medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication is not recommended during pregnancy and in women of childbearing age who do not use an effective contraceptive method.

If you use Dogmatil during the last three months of pregnancy, your baby may experience agitation, increased muscle tension, involuntary body tremors, drowsiness, breathing difficulties, or feeding disorders. Consult your doctor if your baby presents any of these symptoms.

Lactation

Do not breastfeed during treatment with Dogmatil. Consult your doctor for the best way to feed your baby if you are being treated with Dogmatil.

Driving and operating machinery

Dogmatil may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor evaluates your response to this medication.

Even when used as recommended, this medication may cause sedation, which may alter your ability to drive and operate machinery.

Dogmatil 50 mg/ml injectable solution contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 1 ml of injectable solution; it is essentially “sodium-free”.

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Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be administered exactly as directed by your doctor.In case of doubt, consult your doctor again..

The duration of this treatment is limited.Your doctor will inform you of the treatment duration and how to increase the dose.Do not abruptly stop treatment, as symptoms of your disease may reappear.

The administration route is intramuscular.

The dose to be administered varies depending on the disease you suffer from:

• Depression and dizziness: the recommended dose is 150-300 mg/day.

• Acute and chronic psychoses: 200-1600 mg/day of sulpiride.

In these cases, treatment should be initiated with Dogmatil 50 mg/ml injectable solution, administered intramuscularly, for the first two weeks.

The dose should be divided into three doses throughout the day, and preferably administered before meals.

Sulpiride should be administered at least two hours before anti-acids and sucralfate.

• Patients with renal insufficiency (kidney malfunction):Your doctor will adjust the dose.
• Older patients:Your doctor will adjust the dose.These patients may need a lower initial dose and a more gradual dose adjustment.

If you use more Dogmatil than you should

If you have used more Dogmatil than you should, consult your doctor or pharmacist immediately or go to the nearest hospital.

In case of overdose, muscle spasms of the face, neck, and tongue may appear.Some patients may develop parkinsonian manifestations (tremor, rigidity) with vital risk and coma.

Fatal outcomes have been reported, mainly in combination with other medications that act on the central nervous system (psychoactive agents).

There is no specific antidote for sulpiride, and treatment is only symptomaticand hemodialysis is partially effective for eliminating the medication.In case of overdose, appropriate supportive measures should be initiated, recommending close monitoring of vital functions and cardiac function until the patient recovers.

In case of severe extrapyramidal symptoms (tremor, increased muscle tone, decreased movement, hypersalivation, etc.), anticholinergic agents should be administered.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount administered or ingested.

If you forgot to use Dogmatil

Do not use a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects associated with Dogmatil are:

Blood and lymphatic system disorders

Rare (may affect up to 1 in 100 patients): leucopenia (decrease in the number of white blood cells)(see “Warnings and precautions”).

Frequency unknown:neutropenia (decrease in the number of a type of white blood cells called neutrophils) and agranulocytosis (decrease in a type of white blood cells called granulocytes)(see “Warnings and precautions”).

Immune system disorders

Frequency unknown: anaphylactic reactions (severe allergic reaction): urticaria, difficulty breathing (dyspnea), decrease in blood pressure, and anaphylactic shock (severe allergic reaction that can be life-threatening).

Endocrine disorders

Common (may affect up to 1 in 10 patients):increase in prolactin hormone levels.

Metabolism and nutrition disorders

Frequency unknown: decrease in sodium levels in the blood (hyponatremia), a disease called “inadequate secretion syndrome of antidiuretic hormone (SIHAD)”.

Psychiatric disorders

Common (may affect up to 1 in 10 patients):insomnia (difficulty falling or staying asleep).

Frequency unknown: confusion.

Nervous system disorders

Common (may affect up to 1 in 10 patients): sedation or somnolence, extrapyramidal disorder (these symptoms are generally reversible if antiparkinsonian medication is administered), parkinsonism, tremor,akathisia(difficulty sitting or remaining seated).

Rare (may affect up to 1 in 100 patients):increased muscle tone,discinesia(abnormal and involuntary movements),dystonia (muscle contractions).

Very rare (may affect up to 1 in 1,000 patients):oculogyric crisis (involuntary deviation of the gaze).

Frequency unknown: convulsions, neuroleptic malignant syndrome(see “Warnings and precautions”),which is a complication characterized by elevated body temperature, muscle rigidity, and even death,lack or reduction of voluntary movements(hypokinesia),late discinesia (characterized by rhythmic and involuntary movements mainly of the tongue and/or face, as has been reportedwith all neuroleptics, after administration for more than 3 months. Antiparkinsonian medication is ineffective or may worsen the symptoms).

Cardiac disorders

Very rare (may affect up to 1 in 1,000 patients): ventricular arrhythmia(change in heart rhythm), ventricular tachycardia(rapid succession of heartbeats whose cause resides in the ventricles), ventricular fibrillation.

Frequency unknown: prolongation of the QT interval(problems with heart conduction), cardiac arrest, torsade de pointes (alteration of heart rhythm), sudden death(see “Warnings and precautions”).

Vascular disorders

Rare (may affect up to 1 in 100 patients): orthostatic hypotension (decrease in blood pressure when standing).

Frequency unknown: venous thromboembolism (process characterized by blood coagulation in the veins), pulmonary embolism, deep vein thrombosis, increase in blood pressure(see “Warnings and precautions”).

Respiratory, thoracic, and mediastinal disorders

Frequency unknown: aspiration pneumonia (mainly in association with other central nervous system depressants).

Gastrointestinal disorders

Common (may affect up to 1 in 10 patients): constipation.

Rare (may affect up to 1 in 100 patients): increased salivation.

Hepatobiliary disorders

Common (may affect up to 1 in 10 patients): increase in liver enzymes.

Frequency unknown: liver damage (hepatocellular, cholestatic, or mixed damage).

Skin and subcutaneous tissue disorders

Common (may affect up to 1 in 10 patients):maculopapular rash(appearance of red patches and papules on the skin).

Musculoskeletal and connective tissue disorders

Frequency unknown: torticollis,trismus (mandibular muscle contraction), muscle destruction that causes kidney damage (rhabdomyolysis).

Pregnancy, puerperium, and perinatal conditions

Frequency unknown: extrapyramidal symptoms (involuntary movements), withdrawal syndrome in newborns (see “Pregnancy and lactation”).

Reproductive and breast disorders

Common (may affect up to 1 in 10 patients):chest pain, secretion of milk from the breasts outside the pregnancy period.

Rare (may affect up to 1 in 100 patients):amenorrhea in a fertile woman,increase in breast size,abnormal orgasm, impotence.

Frequency unknown: increase in breast size in men.

General disorders and administration site conditions

Common (may affect up to 1 in 10 patients): weight gain.

Frequency unknown: fever.

Investigations

Frequency unknown: increase in creatine phosphokinase levels in blood (indicator of muscle damage).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dogmatil 50 mg/ml injectable solution

• The active ingredient is sulpiride. Each 2 ml of solution contains 100 mg of sulpiride.
• The other components are:sulphuric acid, sodium chloride, water for injection preparations.

Appearance of the product and contents of the packaging

Dogmatil 50 mg/ml injectable solution is presented in a package with 12 glass type I colourless ampoules of 2 ml.

Other presentations:

• Dogmatil Strong 200 mg tablets: Packages with 36 tablets conditioned in PVC/Alu blister packs.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69,

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Delpharm Dijon

6, Boulevard de l´Europe

21800 Quetigny

France

Last review date of this leaflet: September 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/