Sulpiride teva

Patient Information Leaflet

SULPIRYD TEVA, 200 mg, tablets
(Sulpiridum)
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sulpiryd Teva is and what it is used for
2. Important information before taking Sulpiryd Teva
3. How to take Sulpiryd Teva
4. Possible side effects
5. How to store Sulpiryd Teva
6. Contents of the pack and other information

1. What Sulpiryd Teva is and what it is used for

Sulpiryd is an antipsychotic medicine. It also has antidepressant properties.
Indications:
Treatment of acute and chronic psychoses in schizophrenia.

2. Important information before using Sulpiryd Teva

When not to use Sulpiryd Teva

• if the patient is allergic to sulpiride or to any of the other ingredients of this medicine (listed in section 6);
• if a patient is suspected of or has been diagnosed with a phaeochromocytoma (usually a benign tumour of the adrenal medulla, commonly causing secondary hypertension);
• in case of acute porphyria (an inherited or acquired disorder involving impaired enzyme function in the heme synthesis pathway, also known as the porphyrin pathway);
• if the patient has tumours associated with excessive prolactin secretion (e.g. pituitary adenoma, breast cancer);
• during concomitant use of levodopa;
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Sulpiryd Teva, discuss this with your doctor or pharmacist.
In some patients, sulpiride administered in high doses may cause motor restlessness.
In cases of aggression or agitation, low doses of the medicine may worsen symptoms. Caution is advised
if symptoms of hypomania (a state of elevated mood characterised by increased energy, reduced need for sleep,
and enhanced physical and mental performance) occur.
In aggressive or agitated patients with associated impulsiveness, sulpiride may be administered together with a sedative.
Extreme caution is required when using sulpiride in patients with Parkinson's disease.
In a small number of patients, extrapyramidal disorders may occur (including tremors of hands or head,
sudden muscle spasms, inability to sit still or remain in one place, unusual rhythmic involuntary movements,
most commonly affecting the face) and motor restlessness (akathisia). Dose reduction or administration of anti-Parkinson drugs may be necessary.
As with other neuroleptic drugs, there is a risk of developing the so-called neuroleptic malignant syndrome (elevated body temperature, muscle rigidity, autonomic instability, altered mental status, increased creatine phosphokinase levels), which may be life-threatening. If unexplained increase in body temperature occurs, sulpiride administration should be discontinued until the cause of fever is clarified, and medical advice should be sought immediately.
Elderly patients may be more susceptible to hypotension, excessive sedation, and extrapyramidal symptoms. Therefore, sulpiride, like other neuroleptic drugs, should be used with particular caution in these patients.
After abrupt discontinuation of antipsychotic drugs, acute withdrawal symptoms may occur, including nausea, vomiting, excessive sweating, and insomnia. Recurrence of the illness and the occurrence of involuntary movements (akathisia, dystonia, dyskinesia) may also occur. Therefore, gradual withdrawal of the medicine is recommended.
Neuroleptics may lower the seizure threshold. Seizures have been reported in patients treated with sulpiride who had no previous history of seizures. Caution should be exercised when using sulpiride in patients with unstable epilepsy, and particular attention should be paid to patients with a history of seizures. Dosage adjustments of anticonvulsant medications should not be made in patients requiring concomitant sulpiride treatment.
As with other drugs primarily excreted by the kidneys, caution is required when using sulpiride in patients with renal impairment. The dose of sulpiride should be reduced and gradually adjusted.
Sulpiride may increase the risk of severe ventricular arrhythmias.
Caution is required when using sulpiride in patients with cardiac arrhythmias and cardiovascular disorders.
Concomitant use of sulpiride with other neuroleptics should be avoided.
Particular caution is required when using the medicine if the patient or family history includes venous thrombosis. Use of this type of medicine is associated with a risk of venous thromboembolism.
Sulpiride should not be taken in the late evening hours (after 4:00 p.m.) due to the risk of sleep disturbances.
Sulpiride should be used cautiously in patients at risk of stroke.

Sulpiryd Teva and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Sulpiryd Teva should not be used with levodopa.

Concomitant use of Sulpiryd Teva with the following medicines is not recommended:

• drugs causing bradycardia, such as: beta-blockers, calcium channel blockers (e.g. diltiazem, verapamil), clonidine, guanfacine, cardiac glycosides;
• drugs causing electrolyte imbalance, particularly hypokalaemia: hypokalaemic diuretics, stimulant laxatives, intravenous amphotericin B, glucocorticoids, tetracosactide (hypokalaemia should be corrected);
• class Ia antiarrhythmic drugs, such as: quinidine, disopyramide;
• class III antiarrhythmic drugs, such as: amiodarone, sotalol;
• others: pimozide, sultopride, haloperidol, methadone, tricyclic antidepressants of the imipramine type, halofantrine, lithium, cisapride, bepridil, thioridazine, intravenous vinca alkaloids, pentamidine, erythromycin, sparfloxacin.

Sulpiryd Teva should be used with caution together with the following medicines:
Effects of central nervous system depression may be enhanced when used with medicines having such properties:

• opioids (analgesics, painkillers, antitussives, substitution therapy);
• neuroleptics;
• barbiturates and barbiturate-like drugs;
• benzodiazepines;
• anxiolytics and non-benzodiazepine hypnotics;
• sedating antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine, imipramine);
• sedating antihistamines, H1 receptor antagonists with sedative effect;
• centrally-acting antihypertensives: baclofen, thalidomide, pizotifen;
• antacids and sucralfate: may reduce sulpiride absorption; therefore, sulpiride should be taken 2 hours before these medicines;
• ropinirole;
• lithium: increased risk of extrapyramidal effects;
• clonidine and clonidine derivatives.

Sulpiryd Teva with food, drink and alcohol
Sulpiryd Teva should be taken at least one hour before a meal or two hours after a meal, as food reduces drug absorption.
During treatment with Sulpiryd Teva, all alcoholic beverages and medicines containing alcohol should be avoided.

Children
Due to insufficient clinical experience, sulpiride is not recommended for use in children under 14 years of age.

Use in patients with renal and/or hepatic impairment
The doctor should appropriately adjust the dosage according to the degree of renal function.

Use in elderly patients
Doses usually used are the same as in adults. In elderly patients with impaired renal function, the dose should be reduced.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Newborns exposed to antipsychotic medicines (including amisulpride) during the third trimester of pregnancy are at risk of developing adverse effects, including extrapyramidal disorders and/or withdrawal symptoms, which may vary depending on the severity and duration of labour. Symptoms observed include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress syndrome, or feeding difficulties. Therefore, newborns should be closely monitored.
Use of this medicine during pregnancy is not recommended.
Sulpiride passes into breast milk. Breastfeeding should not be undertaken during treatment with this medicine.

Driving and operating machinery
Patients, especially those who drive vehicles or operate machinery, should be warned about the possibility of drowsiness associated with the use of this medicine.

Sulpiryd Teva contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, this should be reported to the doctor before taking Sulpiryd Teva.

3. How to use Sulpiryd Teva

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The dosage is determined by the doctor.
If you feel that the effect of Sulpiryd Teva is too strong or too weak, consult your doctor or pharmacist.

Adults
The initial dose is 400 to 800 mg per day, administered in two divided doses (morning and early evening), depending on symptoms.
The maximum daily dose is 1200 mg. Only in cases of treatment-resistant disorders may a psychiatrist increase the daily dose up to 1600 mg, given in divided doses.

Elderly patients
Dosages are usually the same as in adults. In elderly patients with impaired kidney function, the dose should be reduced.

Patients with impaired kidney function
The dose of sulpiride should be appropriately adjusted; depending on the degree of renal function, the dose should be reduced or the interval between doses extended.
Sulpiride should not be used simultaneously with antacids or sucralfate, or within 2 hours before or after their administration.

Overdose of Sulpiryd Teva
Symptoms of overdose include excessive sedation, restlessness, confusion (disorientation), disturbances of consciousness, agitation, extrapyramidal symptoms (e.g. tremor of hands or head, sudden muscle spasms, inability to sit still or remain in one place, unusual rhythmic involuntary movements, most commonly affecting the face), and low blood pressure. Coma may occur.
There is no specific antidote for sulpiride. As with poisoning by other orally ingested drugs, activated charcoal may be administered, and the doctor may perform gastric lavage. If necessary, patient monitoring and symptomatic treatment will be carried out under hospital conditions. If required, the doctor may administer anti-parkinsonian drugs.
In case of overdose, contact a doctor immediately.

Missed dose of Sulpiryd Teva
Take the missed dose as soon as possible, unless it is almost time for the next dose – in that case, take the medicine at the scheduled time. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions of sulpiride are listed below, classified by system organ class and frequency of occurrence, where available.
In the following review, the following definitions of frequency of adverse reactions have been used:
Very common – observed in more than 1 in 10 patients;
Common – observed in more than 1 but less than 10 in 100 patients;
Uncommon – observed in more than 1 but less than 10 in 1,000 patients;
Rare – observed in more than 1 but less than 10 in 10,000 patients;
Very rare – including isolated cases – occurring in less than 1 in 10,000 patients.

Cardiac disorders
Isolated cases: torsade de pointes

Endocrine disorders
Frequency unknown: hyperprolactinaemia, amenorrhoea, gynaecomastia, sexual anhedonia and impotence

Hepatobiliary and biliary tract disorders
Very rare: increased liver enzyme activity

Nervous system disorders
Common: calming, drowsiness
Rare: extrapyramidal symptoms and acute dyskinesia, tardive dyskinesia (rhythmic involuntary movements, mainly of the tongue and/or facial muscles), observed, as with other neuroleptics, after long-term treatment. Anticholinergic anti-Parkinson drugs are ineffective in such cases and may even exacerbate symptoms, neuroleptic malignant syndrome

Reproductive system and breast disorders
Frequency unknown: galactorrhoea (outside lactation period), amenorrhoea, gynaecomastia

Eye disorders
Rare: rotatory eye movements

Vascular disorders
Frequency unknown: orthostatic hypotension
During treatment with antipsychotic drugs, cases of venous thrombosis, including deep vein thrombosis, have been reported.

Gastrointestinal disorders
Frequency unknown: excessive salivation

Musculoskeletal and connective tissue disorders
Rare: spastic torticollis, trismus

Pregnancy, peripartum and postpartum period
Neonatal withdrawal syndrome

Diagnostics tests:
Isolated cases: QT interval prolongation

General disorders and administration site conditions
Frequency unknown: neuroleptic malignant syndrome, which may be life-threatening (as with all neuroleptics), weight gain

Skin and subcutaneous tissue disorders
Very rare: maculopapular rash

Blood clots in veins, especially in the lower limbs (symptoms include swelling, pain, redness of the legs), may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical advice.

In elderly patients with dementia treated with antipsychotic drugs, a slightly increased incidence of fatal outcomes has been observed compared to patients not treated with these drugs.

If fever develops without apparent cause, Sulpirid Teva should be discontinued and a doctor contacted immediately.

Other adverse reactions may occur in some individuals during treatment with Sulpirid Teva.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sulpiryd Teva

Store below 25°C, in a dry place.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Sulpiryd Teva contains

• The active substance is sulpiride.
• The other ingredients are: maize starch, lactose monohydrate, povidone, microcrystalline cellulose, magnesium stearate.

What Sulpiryd Teva looks like and contents of the pack
The tablets are white, round, biconvex with a smooth surface, odourless, with a slightly bitter taste.
PVC/Al blisters.
1 blister containing 12 tablets or 2 blisters containing 15 tablets each in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer:
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków