Package Insert: Information for the User

Psicocen 50 mg Capsules

Sulpiride

1.- What is Psicocen and what it is used for.

2.- What you need to know before starting to take Psicocen.

3.- How to take Psicocen.

4.- Possible side effects.

5.- Storage of Psicocen.

6.- Contents of the package and additional information.

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

Psicocen 50 mg capsules is indicated in adults in the following cases:

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

• 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 phaeochromocytoma (adrenal gland tumor),
• if you are being treated with levodopa or antiparkinsonian medications (including ropinirole) (See“Use of psicocen with other medications”)
• 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 take Psicocen.

• If administered to patients with a clinical situation that may favor the appearance of heart rhythm disorders, since sulpiride may potentiate the risk of severe cardiac rhythm disturbances.
• If there is a risk of suffering a stroke.
• If the medication is administered to elderly patients, since there is a risk of sedation, decrease in blood pressure when standing up or the appearance of dyskinesia (uncontrollable abnormal repetitive movements).
• If the medication is administered to children, since sulpiride has not been thoroughly investigated in this group of patients. Its use is not recommended in children.
• If you have kidney insufficiency (alteration of kidney function), since the dose must be reduced.
• If you have or have had epilepsy, since the group of medications to which Psicocen belongs may favor the appearance of epileptic seizures and convulsions.
• If you have Parkinson's disease, since Psicocen is contraindicated, except in exceptional cases, in patients taking antiparkinsonian medication.
• If fever of unknown origin and muscle rigidity appear, since it could be the neuroléptico malignant syndrome, a potentially fatal complication characterized by elevated body temperature, muscle rigidity and autonomic nervous system dysfunction (autonomic dysfunction). In case of undiagnosed elevated body temperature, treatment with sulpiride should be suspended (See “Possible adverse effects”).
• If you have diabetes mellitus (high blood sugar levels) or have risk factors for developing diabetes.
• In elderly patients with dementia-related psychosis, who are being treated with antipsychotics (possibility of presenting a higher risk of death).
• In patients with risk factors for thromboembolism (obstruction of a blood vessel by a blood clot) (see “Possible adverse effects”).
• If an infection or fever of unknown origin appears, inform your doctor, since it could be a blood disorder (see “Possible adverse effects”). Cases of leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of white blood cells called neutrophils) and agranulocytosis (decrease in a type of white blood cell, granulocytes) have been reported with the use of antipsychotics, including Psicocen.
• In patients with a history of glaucoma, ileus, congenital intestinal stenosis, urinary retention or prostate hyperplasia, use with caution.
• In patients with high blood pressure, especially in the elderly population, due to the risk of hypertensive crisis (high blood pressure).

Use of Psicocen with other medications

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

Specifically, inform your doctor if you are currently taking any of the following medications:

• Levodopa (Parkinson's disease medication), antiparkinsonian medications (including ropinirole).
• 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 disorders).
• Erythromycin intravenously (antibiotic).
• Vincamine intravenously (medication that improves cerebral blood circulation).
• Halofantrine (medication for malaria).
• Pentamidine (medication for certain infectious diseases).
• Fluoroquinolones (antibiotics).
• Methadone (medication for pain relief).
• Pimozide, haloperidol and sulpiride (medications for psychiatric disorders).
• Bepridil (medication for angina pectoris).
• Imipramine antidepressants (medications for 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, antofercin B intravenously (antibiotic), glucocorticoids, tetracosactides.
• Depressants of the central nervous system including narcotics, analgesics, antihistamines H1 sedatives, barbiturates, benzodiazepines and other anxiolytic drugs.
• Lithium salts (medications for the treatment of manic-depressive disorder or bipolar affective disorder).
• Sucralfate (medication for the treatment and prevention of duodenal ulcers).
• Antacids.
• Medications for lowering blood pressure.

Taking Psicocen 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 Psicocen 50 mg capsules.

Pregnancy and breastfeeding

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

The following symptoms have been reported in newborns of mothers treated with Psicocen during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle rigidity and/or muscle weakness, drowsiness, agitation, breathing problems, feeding problems. If your baby develops any of these symptoms, contact your doctor.

The use of sulpiride during pregnancy is not recommended.

Since sulpiride is excreted in breast milk, breastfeeding is not recommended during treatment with Psicocen.

Driving and operating machinery:

Psicocen 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.

Psicocen 50 mg capsules contain lactoseIf your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor again.

The duration of this treatment is limited. Your doctor will indicate the duration of treatment as well as the way 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 capsule with a little water.

The dose to be administered is different depending on the disease you suffer from.

Adults:

• Depression and dizziness: the recommended dose is 3 to 6 capsules per day (150-300mg/day). Acute and chronic psychoses: 200-1600 mg/day of sulpiride.

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 Psicocen than you should

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

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

There is no specific antidote for sulpiride, treatment is only symptomatic and 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 control 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 ingested.

If you forgot to take Psicocen

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The side effects associated with Psicocen 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 white blood cells called neutrophils) and agranulocytosis (decrease in a type of white blood cell, 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): increased normal levels of prolactin hormone.

Mental disorders

Common (may affect up to 1 in 10 patients): insomnia (difficulty sleeping).

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 (inability of the person to sit or remain seated).

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

Unknown frequency: convulsions, neuroleptic malignant syndrome (see "Warnings and precautions"), a complication characterized by elevated body temperature, muscle rigidity, and even death, bradykinesia (decreased or slowed involuntary movements), tardive dyskinesia (characterized by rhythmic and involuntary movements mainly of the tongue and/or face, as reported with all neuroleptics, after administration for more than 3 months. Antiparkinsonian medication is ineffective or may worsen symptoms).

Cardiac disorders

Rare (may affect up to 1 in 1000 patients): ventricular arrhythmia (change in heart rhythm), ventricular tachycardia (rapid succession of heartbeats originating in the ventricles), ventricular fibrillation.

Unknown frequency: QT interval prolongation (heart conduction problems), cardiac arrest, torsades 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 (decreased blood pressure when standing up).

Unknown frequency: deep vein thrombosis, pulmonary embolism, sometimes fatal, deep vein thrombosis, increased blood pressure.

Gastrointestinal disorders

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

Hepatobiliary disorders

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

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).

Pregnancy, puerperium, and perinatal conditions

Unknown frequency: extrapyramidal symptoms (involuntary movements), neonatal withdrawal syndrome (see "Pregnancy and lactation").

Reproductive and breast disorders

Common (may affect up to 1 in 10 patients): chest pain, milk secretion 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.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

Medications 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 packaging and medications you no longer need. By doing so, you will help protect the environment

Composition of Psicocen

The active principle is sulpiride. Each capsule contains 50mg of sulpiride.

The other components are: lactose and magnesium stearate.

Appearance of the product and content of the packaging

Hard capsules of orange opaque and white opaque color.

It is presented in a blister pack of 30 capsules.

Holder of marketing authorization and responsible for manufacturing:

Centrum Pharmaceutical Specialties, S.A.

C/ Sagitario 14, nº 14

03006 – Alicante (Spain)

Date of the last review of this leaflet:April 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS), http://www.aemps.gob.es/