Psicocen 50 mg capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Psicocen 50 mg capsules

Sulpiride

Package leaflet:

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

2.- What you need to know before taking Psicocen.

3.- How to take Psicocen.

4.- Possible side effects.

5.- Storage of Psicocen.

6.- Contents of the pack and other information.

1. What Psicocen is and what it is used for

Psicocen belongs to the group of antipsychotic medicines, 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 antidepressant medicines 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 standard antivertigo therapy.

• Treatment of acute and chronic psychoses.

2. What you need to know before taking 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 (a hormone that stimulates milk secretion), for example prolactinomas of the pituitary gland and breast cancer,
• if you have pheochromocytoma (a tumor of the adrenal gland),
• if you are being treated with levodopa or antiparkinsonian medicines (including ropinirole) (see “Use of Psicocen with other medicines”)
• if you have a metabolic disorder called acute porphyria.
• in patients with slow heart rate (bradycardia), disturbances in heart rhythm, or any other clinically significant heart disease.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Psicocen.

• If administered to patients with a clinical condition that may favor the occurrence of heart rhythm disorders, as sulpiride may increase the risk of serious heart rhythm disturbances.
• If there is a risk of stroke.
• If the medicine is given to elderly patients, as there is a risk of sedation, drop in blood pressure upon standing, or the development of dyskinesia (involuntary, repetitive abnormal movements).
• If the medicine is given to children, as sulpiride has not been thoroughly studied in this patient group. Its use in children is not recommended.
• If you have renal impairment (impaired kidney function), as the dose must be reduced.
• If you have or have had epilepsy, as the group of medicines to which Psicocen belongs may increase the risk 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 develop fever of unknown origin and muscle stiffness, as this may be neuroleptic malignant syndrome, a potentially fatal condition characterized by high body temperature, muscle rigidity, and nervous system dysfunction (autonomic dysfunction). If unexplained high body temperature occurs, treatment with sulpiride must be discontinued (see “Possible side effects”).
• If you have diabetes mellitus (high blood sugar levels) or risk factors for developing diabetes.
• In elderly patients with psychosis associated with dementia who are being treated with antipsychotics (increased risk of death).
• In patients with risk factors for thromboembolism (blockage of a blood vessel by a blood clot) (see “Possible side effects”).
• If you develop an infection or fever of unknown origin, inform your doctor, as this may indicate blood dyscrasia (blood disorder). Cases of leucopenia (reduced number of white blood cells), neutropenia (reduced number of white blood cells called neutrophils), and agranulocytosis (reduced number of a type of white blood cells, granulocytes) have been reported with antipsychotics, including Psicocen.
• Use with caution in patients with a history of glaucoma, ileus, congenital gastrointestinal stenosis, urinary retention, or prostate hyperplasia.
• In patients with high blood pressure, especially in the elderly, due to the risk of hypertensive crisis (high blood pressure).

Use of Psicocen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Levodopa (a medicine for the treatment of Parkinson's disease), antiparkinsonian medicines (including ropinirole).
• Medicines containing alcohol.
• Antiarrhythmic agents (medicines that regulate heart rhythm) such as quinidine, disopyramide, amiodarone, and sotalol.
• Cisapride (a medicine for gastrointestinal motility disorders).
• Thioridazine (a medicine for psychiatric disorders).
• Intravenous erythromycin (an antibiotic).
• Intravenous vincamine (a medicine that improves cerebral blood circulation).
• Halofantrine (a medicine for malaria).
• Pentamidine (a medicine for certain infectious diseases).
• Sparfloxacin (an antibiotic).
• Methadone (a medicine for pain relief).
• Pimozide, haloperidol, and sultopride (medicines for psychiatric disorders).
• Bepridil (a medicine for angina pectoris).
• Imipraminic antidepressants (medicines for treating depression).
• Medicines that slow heart rate, such as diltiazem and verapamil, clonidine, guanfacine, and cardiac glycosides.
• Medicines that cause a decrease in potassium levels: hypokalemic diuretics, stimulant laxatives, intravenous antifungal B (antibiotic), glucocorticoids, tetracosactide.
• Central nervous system depressants including narcotics, analgesics, sedating H1 antihistamines, barbiturates, benzodiazepines, and other anxiolytic drugs.
• Lithium salts (medicines for the treatment of manic-depressive disorder or bipolar affective disorder).
• Sucralfate (a medicine for treating and preventing duodenal ulcer).
• Antacids.
• Medicines for lowering blood pressure.

Taking Psicocen with food, drinks, and alcohol

Since alcohol enhances the sedative effect of sulpiride, consumption of alcoholic beverages or other medicines containing alcohol is not recommended while taking this medicine.

You should 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 are planning 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 difficulties, feeding problems. If your baby develops any of these symptoms, you should 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 use of machines:

Psicocen may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness, may impair your ability to drive or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

Psicocen 50 mg capsules contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take PSICOCEN

Follow exactly the instructions for administering this medicine as given by your doctor.

If in 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 stop the treatment abruptly, as symptoms of your illness may reappear.

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

The dose to be administered varies depending on the condition you have.

Adults:

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

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

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

Patients with renal insufficiency (impaired kidney function): your doctor will adjust the dose.

Elderly patients: your doctor will adjust the dose. These patients may require a lower initial dose and a more gradual dose adjustment.

If you take more PSICOCEN than you should

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

In case of overdose, muscle spasms of the face, neck, and tongue may occur. Some patients may develop parkinsonian symptoms (tremor, rigidity) with life-threatening risk and coma.

There is no specific antidote for sulpiride; treatment is purely symptomatic, and hemodialysis is partially effective in removing the drug. In case of overdose, appropriate supportive measures should be initiated, with close monitoring of vital functions and cardiac function until the patient recovers.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects associated with Psicocen are:

Blood and lymphatic system disorders

Uncommon (may affect up to 1 in 100 patients): leucopenia (reduction in the number of white blood cells) (see "Warnings and precautions").

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

Immune system disorders

Frequency not known: anaphylactic reactions (severe allergic reaction), urticaria, breathing difficulty (dyspnea), decreased blood pressure, and anaphylactic shock (a severe allergic reaction that may be life-threatening).

Endocrine disorders

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

Psychiatric 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 usually reversible if antiparkinsonian medication is administered), parkinsonism, tremor, akathisia (inability of the person to sit still or remain seated).

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

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

Frequency not known: seizures, neuroleptic malignant syndrome (see "Warnings and precautions"), a complication characterized by high body temperature, muscle rigidity, which may even lead to death, reduction or slowness of involuntary movements (hypokinesia), 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 the 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.

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

Vascular disorders

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

Frequency not known: venous thromboembolism (a condition characterized by blood clotting in the veins), pulmonary embolism, sometimes fatal, deep vein thrombosis, increased blood pressure.

Gastrointestinal disorders

Uncommon (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): maculo-papular rash (appearance of red spots and papules on the skin).

Musculoskeletal and connective tissue disorders

Frequency not known: torticollis, trismus (jaw muscle spasm).

Pregnancy, puerperium and perinatal conditions

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

Reproductive system and breast disorders

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

Uncommon (may affect up to 1 in 100 patients): 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 patients): weight gain.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Psicocen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Psicocen

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

The other components are: lactose and magnesium stearate.

Appearance of the product and contents of the pack

Hard capsules, opaque orange and opaque white in color.

Packaged in a box containing 30 capsules arranged in blister packs.

Marketing Authorization Holder and Manufacturer:

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario 14, nº 14
03006 – Alicante (Spain)

Date of the most recent review of this leaflet: April 2014

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS), http://www.aemps.gob.es/