PSICOCEN 50 mg CAPSULES

Introduction

Package Leaflet: Information for the User

Psicocen 50 mg Capsules

Sulpiride

Contents of the pack:

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

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

3. How to take Psicocen.

4. Possible side effects.

5. How to store Psicocen.

6. Contents of the pack and other information.

1. What Psicocen is and what it is used for

Psicocen belongs to a group of medicines called antipsychotics, also known as neuroleptics.

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

• 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 is no response to habitual antivertiginous treatment.

• Treatment of acute and chronic psychoses.

2. What you need to know before you take Psicocen

Do not take Psicocen

• if you are allergic to sulpiride or any of the other ingredients of this medicine (listed in section 6)
• if you have multiple tumors (concomitant tumors) dependent on prolactin (hormone that stimulates milk secretion), such as prolactinomas of the pituitary gland and breast cancer
• if you have pheochromocytoma (tumor of the adrenal gland)
• if you are being treated with levodopa or antiparkinsonian medications (including ropinirole) (see "Using Psicocen with other medicines")
• if you have a metabolic disorder known as acute porphyria
• in patients with low heart rate (bradycardia), with rhythm disorders or with any other clinically significant heart disease

Warnings and precautions

Talk to your doctor or pharmacist before taking Psicocen.

• If you are given to patients with a clinical situation that may favor the appearance of heart rhythm disorders, since sulpiride can increase the risk of serious heart rhythm disorders.
• If there is a risk of suffering a stroke.
• If the medicine is given to elderly patients, as there is a risk of sedation, decrease in blood pressure when standing up, or the appearance of dyskinesia (abnormal, uncontrollable, repetitive movements).
• If the medicine is given to children, as sulpiride has not been extensively studied in this group of patients. Its use is not recommended in children.
• If you have kidney failure (kidney function disorder), as the dose must be reduced.
• If you have or have had epilepsy, as the group of medicines to which Psicocen belongs may favor the appearance of epileptic seizures and convulsions.
• If you have Parkinson's disease, as Psicocen is contraindicated, except in exceptional cases, in patients taking antiparkinsonian medication.
• If you experience fever of unknown origin and muscle stiffness, as it could be a malignant neuroleptic syndrome, a potentially fatal complication characterized by elevated body temperature, muscle stiffness, and nervous system dysfunction (autonomic dysfunction). In case of undiagnosed elevated body temperature, treatment with sulpiride should be discontinued (see "Possible side effects").
• If you have diabetes mellitus (high blood sugar levels) or have risk factors for developing diabetes.
• In elderly patients with psychosis related to dementia, who are being treated with antipsychotics (possibility of increased risk of death).
• In patients with risk factors for thromboembolism (obstruction of a blood vessel by a thrombus) (see "Possible side effects").
• If an infection or fever of unknown origin appears, inform your doctor, as it could be a blood disorder (see "Possible side 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 cells, granulocytes) have been reported with the use of antipsychotics, including Psicocen.
• In patients with a history of glaucoma, ileus, congenital digestive stenosis, urinary retention, or prostate hyperplasia, it should be used with caution.
• In patients with high blood pressure, especially in the elderly population, due to the risk of hypertensive crisis (high blood pressure).

Using Psicocen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, tell your doctor if you are currently taking any of the following medicines:

• Levodopa (medicine for the treatment of Parkinson's disease), antiparkinsonian medicines (including ropinirole).
• Medicines that contain alcohol.
• Antiarrhythmic agents (medicines that regulate heart rhythm) such as quinidine, disopyramide, amiodarone, and sotalol.
• Cisapride (medicine for gastrointestinal motility disorders).
• Thioridazine (medicine for psychiatric diseases).
• Intravenous erythromycin (antibiotic).
• Intravenous vincamine (medicine that improves blood circulation in the brain).
• Halofantrine (medicine for malaria).
• Pentamidine (medicine for certain infectious diseases).
• Esparfloxacino (antibiotic).
• Methadone (medicine that calms pain).
• Pimozide, haloperidol, and sultoprida (medicine for psychiatric diseases).
• Bepridil (medicine for angina pectoris).
• Imipraminic antidepressants (medicines for treating depression).
• Medicines that induce slowing of heart rate, such as diltiazem and verapamil, clonidine, guanfacine; digitalis.
• Medicines that induce a decrease in potassium levels: hypokalemic diuretics, stimulant laxatives, intravenous antiofericina B (antibiotic), glucocorticoids, tetracosactides.
• Medicines that depress the central nervous system, including narcotics, analgesics, sedating antihistamines H1, barbiturates, benzodiazepines, and other anxiolytic drugs.
• Lithium salts (medicines for the treatment of manic-depressive disorder or bipolar affective disorder).
• Sucralfate (medicine for treating and preventing duodenal ulcers).
• Antacids.
• Medicines to lower blood pressure.

Taking Psicocen with food, drinks, and alcohol

Since alcohol enhances the sedative effect of sulpiride, it is not recommended to consume alcoholic beverages or other medicines that contain alcohol in their composition while taking this medicine.

Do not drink grapefruit juice during treatment with Psicocen 50 mg capsules.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, feeding problems. If your baby develops any of these symptoms, you should contact your doctor.

The use of sulpiride is not recommended during pregnancy.

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

Driving and using machines

Psicocen may cause symptoms such as drowsiness, dizziness, or vision changes, and decrease reaction capacity. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Psicocen 50 mg capsules contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Psicocen

Follow the administration instructions of this medicine exactly as indicated by your doctor.

In case of doubt, consult your doctor again.

The duration of this treatment is limited. Your doctor will indicate the duration of the treatment as well as the way to increase the dose. Do not stop treatment abruptly, as symptoms of your illness may reappear.

The route of administration is oral. You should swallow the capsule with a little water.

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

Adults:

• Depression and vertigo: 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 administered preferably before meals.

Sulpiride should be taken at least two hours before antacids and sucralfate.

Patient with kidney failure (kidney malfunction): your doctor will adjust the dose.

Elderly 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 of 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 in eliminating the medicine. 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 Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Psicocen

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects associated with Psicocen are:

Blood and lymphatic system disorders

Uncommon (may affect up to 1 in 100 people): leukopenia (decrease in the number of white blood cells) (see "Warnings and precautions").

Frequency not known: neutropenia (decrease in the number of white blood cells called neutrophils) and agranulocytosis (decrease in a type of white blood cells, granulocytes) (see "Warnings and precautions").

Immune system disorders

Frequency not known: 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 people): increase in normal levels of prolactin hormone.

Psychiatric disorders

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

Nervous system disorders

Common (may affect up to 1 in 10 people): sedation or drowsiness, extrapyramidal disorder (these symptoms are generally reversible if antiparkinsonian medication is administered), parkinsonism, tremor, akathisia (inability to sit or remain seated).

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

Rare (may affect up to 1 in 1000 people): oculogyric crisis (involuntary deviation of gaze).

Frequency not known: convulsions, malignant neuroleptic syndrome (see "Warnings and precautions"), a complication characterized by elevated body temperature, muscle stiffness, and nervous system dysfunction (autonomic dysfunction), leading to death, decrease or slowness of involuntary movements (hypothesis), 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 people): ventricular arrhythmia (change in heart rhythm), ventricular tachycardia (rapid succession of heartbeats whose cause resides in the ventricles), ventricular fibrillation.

Frequency not known: prolongation of the QT interval (heart conduction problems), cardiac arrest, torsades de pointes (heart rhythm disorder), sudden death (see "Warnings and precautions").

Vascular disorders

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

Frequency not known: venous thromboembolism (process characterized by blood coagulation in the veins), pulmonary embolism, sometimes fatal, deep vein thrombosis, increase in blood pressure.

Gastrointestinal disorders

Uncommon (may affect up to 1 in 100 people): increased salivation.

Hepatobiliary disorders

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

Skin and subcutaneous tissue disorders

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

Musculoskeletal and connective tissue disorders

Frequency not known: torticollis, trismus (contraction of the jaw muscles).

Pregnancy, puerperium, and perinatal disorders

Frequency not known: extrapyramidal symptoms (involuntary movements), withdrawal syndrome in newborns (see "Pregnancy and breastfeeding").

Reproductive system and breast disorders

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

Uncommon (may affect up to 1 in 100 people): absence of menstruation in a fertile woman, breast enlargement, abnormal orgasm, impotence.

Frequency not known: breast enlargement in men.

General disorders and administration site conditions

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Psicocen

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Psicocen

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

The other ingredients are: lactose and magnesium stearate.

Appearance of the product and pack contents

Hard capsules of orange opaque and white opaque color.

It is presented in a box of 30 capsules packaged in blister packs.

Marketing authorization holder and manufacturer:

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario 14, nº 14

03006 – Alicante (Spain)

Date of last revision of this leaflet:April 2014

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/