Package Insert: Information for the User

Dogmatil Strong 200 mg Tablets

Sulpiride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

- Keep this package insert, as you may need to refer to it again.

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

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

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

Dogmatil Fuerte belongs to the group of antipsychotic medications, also known as neuroleptics.

Dogmatil Fuerte is indicated for:

• Treatment of depressive disorders with psychotic symptoms in combination with antidepressants, when treatment with antidepressant medications 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.

Do not take Dogmatil Strong

• if you are allergic to sulpiride or any of the other ingredients 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 taking levodopa or antiparkinsonian medications (including ropinirol) (see “Use of Dogmatil Strong with other medications”)
• if you have acute porphyria (a metabolic disease)
• 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 take Dogmatil Strong:

• 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 risk factors for stroke
• If the medication is administered to elderly patients, as there is a risk of sedation, decreased blood pressure on standing, 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 Strong belongs may favor the appearance of seizures and convulsions
• If you have Parkinson's disease, as Dogmatil Strong 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 are a patient with 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 Strong
• 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

Use of Dogmatil Strong with other medications

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

Do not take Dogmatilif you are taking:

• Levodopa (Parkinson's disease medication), antiparkinsonian medications (including ropinirol) (see “Do not take Dogmatil Strong”)

Inform your doctor if you are currently taking any of the following medications:

Not recommended associations:

• Medications containing alcohol
• Antiarrhythmic agents (heart rhythm regulating medications) such as quinidine, disopyramide, amiodarone, and sotalol
• Cisapride (gastrointestinal motility disorder medication)
• Thioridazine (psychiatric disease medication)
• Intravenous erythromycin (antibiotic)
• Intravenous vincamine (cerebral blood circulation improving medication)
• Halofantrine (malaria medication)
• Pentamidine (infectious disease medication)
• Esparfloxacino (antibiotic)
• Methadone (pain medication)
• Pimozide, haloperidol, and sultopride (psychiatric disease medications)
• Bepridil (angina pectoris medication)
• Imipramine antidepressants (depression medications)
• 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 medications, clonidine and derivatives
• Lithium salts (medications for the treatment of manic-depressive disorder, also known as bipolar affective disorder)
• Sucralfate (medication for the treatment and prevention of duodenal ulcers). (See “3. How to take Dogmatil Strong”)
• Antacids. (See “3. How to take Dogmatil Strong”)
• Medications to lower blood pressure

Taking Dogmatil Strong with food, drinks, and alcohol

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

Do not ingest grapefruit juice during treatment with Dogmatil Strong

Pregnancy, breastfeeding, 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

Breastfeeding

Do not breastfeed during treatment with Dogmatil. Consult your doctor for the best way to feed your baby while taking 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 Strong contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication

Follow exactly the administration instructions of this medication as indicated by your doctor.Consult your doctor again in case of doubt.

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 oral. You must swallow the tablet with a little water.

The recommended dose is different depending on the disease you suffer from:

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

• Acute and chronic psychoses: 200-1600 mg/day of sulpiride (1 - 8 tablets/day).

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 taken 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 take more Dogmatil Fuerte than you should

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

In case of overdose, you may experience spasms of the facial, neck, and tongue muscles. 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 symptomatic and hemodialysis is partially effective for eliminating the medication. In case of overdose, implement appropriate supportive measures, recommending close monitoring of vital functions and cardiac function control until the patient recovers.

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

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 ingested.

If you forgot to take Dogmatil Fuerte

Do not take 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”).

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

Immune system disorders

Unknown frequency: anaphylactic reactions (severe allergic reaction): urticaria, difficulty breathing (dyspnea), decreased 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

Unknown frequency: decrease in sodium levels in the blood (hyponatremia), a condition called “inadequate secretion of antidiuretic hormone syndrome(
SIHAD)”.

Psychiatric disorders

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

Unknown frequency: 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 staying seated).

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

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

Unknown frequency: convulsions, neuroleptic malignant syndrome(see “Warnings and precautions”), which is a complication characterized by elevated body temperature, muscle rigidity, and can even lead to death,reduced or absent 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 their administrationfor 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.

Unknown frequency: prolonged 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 up).

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

Respiratory, thoracic, and mediastinal disorders

Unknown frequency: 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.

Unknown frequency: 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

Unknown frequency: torticollis,trismus (mandibular muscle contraction), muscle destruction that causes renal damage (rhabdomyolysis).

Pregnancy, puerperium, and perinatal conditions

Unknown frequency: 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,breast enlargement,abnormal orgasm, impotence.

Unknown frequency: breast enlargement in men.

General disorders and administration site conditions

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

Unknown frequency: fever.

Investigations

Unknown frequency: increasein the levelof creatine phosphokinase in blood (a marker 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 theSpanish 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 medicationafter 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 the packaging and medications you no longer need atthe SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dogmatil Strong

• The active principle is sulpiride. Each tablet contains 200 mg of sulpiride.
• The other components are:monohydrate lactose, gluten-free potato starch, methylcellulose, colloidal silica, talc, magnesium stearate.

Appearance of the product and content of the packaging

White tablets, scored on one face and with the inscription DOGMATIL 200 on the other.

Dogmatil Strong 200 mg tablets are presented in packaging with 36 tablets conditioned in blister packs PVC/Alu.

Other presentations:

• Dogmatil 50 mg/ml injectable solution: Packaging with 12 ampoules of 2 ml. Glass ampoules type I, colorless.

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:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: December 2019

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