SULPIRYD 100 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is Sulpiryd Teva and what is it used for
   1. Indications for use:
3. Important information before taking Sulpiryd Teva
   1. When not to take Sulpiryd Teva
   2. Warnings and precautions
   3. Sulpiryd Teva and other medicines
   4. Sulpiryd Teva with food, drink, and alcohol
   5. Children
   6. Use in patients with renal and/or hepatic impairment
   7. Use in elderly patients
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Sulpiryd Teva contains lactose
4. How to take Sulpiryd Teva
   1. Overdose of Sulpiryd Teva
   2. Missed dose of Sulpiryd Teva
5. Possible side effects
   1. Reporting side effects
6. How to store Sulpiryd Teva
7. Contents of the pack and other information
   1. What Sulpiryd Teva contains
   2. What Sulpiryd Teva looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet: March 2022

Package Leaflet: Information for the User

SULPIRYD TEVA, 50 mg, hard capsules
SULPIRYD TEVA, 100 mg, hard capsules
(Sulpiridum)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

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

Sulpiride is an antipsychotic medicine. It also has an antidepressant effect.

Indications for use:

• Acute and chronic psychoses in schizophrenia, especially with symptoms of impaired activity.
• Chronic alcoholic psychoses, psychosomatic disorders.
• Depressive disorders, when treatment with other antidepressant medicines is ineffective or cannot be used.
• Migraine and dizziness of various etiologies (including Meniere's disease).
• Supportive therapy in the treatment of alcohol dependence.

2. Important information before taking Sulpiryd Teva

When not to take Sulpiryd Teva

• in case of concurrent use of levodopa;

Warnings and precautions

Before starting treatment with Sulpiryd Teva, discuss it with your doctor or pharmacist.
Some patients taking sulpiride in high doses have experienced motor agitation.
In the phase of aggression or agitation, small doses of the medicine may exacerbate symptoms. Caution should be exercised in case of hypomania (a state of elevated mood, characterized by increased energy, reduced need for sleep, increased physical and mental efficiency).
In aggressive or agitated patients with accompanying impulsivity, sulpiride can be administered with a sedative.
Particular caution should be exercised when using sulpiride in patients with Parkinson's disease, in whom neuroleptic treatment is necessary.
A small number of patients may experience extrapyramidal disorders (e.g., hand tremors, head, sudden muscle contractions, inability to sit or stand in one place, strange, rhythmic uncontrolled movements, most often in the face) and motor restlessness (akathisia). It may be necessary to reduce the dose or use anti-parkinsonian drugs.
Similarly, as with other neuroleptic medicines, the possibility of malignant neuroleptic syndrome (with symptoms such as body temperature increase, muscle stiffness, autonomic instability, consciousness disorders, increased CPK levels) should be considered, which can be life-threatening. In case of such symptoms, all antipsychotic medicines, including sulpiride, should be discontinued.
Elderly patients may be more prone to orthostatic hypotension, excessive sedation, and extrapyramidal symptoms. Therefore, in these patients, sulpiride, like other neuroleptic medicines, should be used with particular caution.
After sudden discontinuation of antipsychotic medicines, acute symptoms may occur, including nausea, vomiting, increased sweating, and insomnia. There may also be a recurrence of the disease and the occurrence of involuntary movements (akathisia, dystonia, dyskinesia). Therefore, it is recommended to gradually discontinue the medicine.
Neuroleptics can lower the seizure threshold. Seizures have been reported in patients taking sulpiride who had not previously experienced them. During sulpiride treatment, caution should be exercised in patients with unstable epilepsy, and patients with a history of seizures should be closely monitored. The dosage of antiepileptic drugs should not be changed in patients who require concurrent use of sulpiride.
As with other medicines mainly excreted by the kidneys, caution should be exercised when using sulpiride in patients with renal impairment. The dose of sulpiride should be reduced and adjusted gradually.
Sulpiride may increase the risk of severe ventricular arrhythmias.
Caution should be exercised when using sulpiride in patients with cardiac arrhythmias and cardiovascular disorders.
Sulpiride should be avoided with other neuroleptics.
Particular caution should be exercised when using the medicine if the patient or their family history has deep vein thrombosis. The use of such medicines is associated with the risk of venous thrombosis.
Sulpiride should not be taken in the late evening hours (after 4:00 PM), due to the possibility of sleep disturbances.
Sulpiride should be used with caution in patients at risk of stroke.

Sulpiryd Teva and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Sulpiryd Teva should not be used with levodopa.
It is not recommended to use Sulpiryd Teva with the following medicines:

• medicines that cause bradycardia, such as beta-blockers, calcium channel blockers, such as diltiazem and verapamil, clonidine, guanfacine, and digitalis-like medicines;
• medicines that cause electrolyte imbalance, particularly hypokalemia: diuretics that cause hypokalemia, stimulant laxatives, intravenous amphotericin B, glucocorticoids, tetracosactide (hypokalemia should be corrected);
• antiarrhythmic medicines of class Ia, such as quinidine, disopyramide;
• antiarrhythmic medicines of class III, such as amiodarone, sotalol;
• others: pimozide, sultopride, haloperidol, methadone, tricyclic antidepressants, imipramine derivatives, halofantrine, lithium, cyzaprid, bepridil, tiordiazine, intravenous vincamine, entamidine, erythromycin, sparfloxacin.

Sulpiryd Teva should be used with caution with the following medicines:
Symptoms of the inhibitory effect on the central nervous system may be exacerbated during the use of medicines with such properties:

• opium derivatives (painkillers, analgesics, antitussives, substitution therapy);
• neuroleptics;
• barbiturates and barbiturate-like medicines;
• benzodiazepines;
• anxiolytics and sedatives other than benzodiazepines;
• antidepressants with a sedative effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine);
• antihistamines with a sedative effect, H1 receptor antagonists with a sedative effect;
• antihypertensive medicines with a central effect: baclofen, thalidomide, pizotifen;
• gastric acid reducers and sucralfate: reduced sulpiride absorption, so it should be taken 2 hours before administration of 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 the presence of food reduces the absorption of the medicine.
During treatment with Sulpiryd Teva, you should avoid all alcoholic beverages and medicines containing alcohol.

Children

Due to the lack of sufficient 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 adjust the dose of the medicine according to the degree of renal function.

Use in elderly patients

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Newborns exposed to antipsychotic medicines (including amisulpride) in the third trimester of pregnancy are at risk of adverse effects, including extrapyramidal disorders and/or withdrawal symptoms, which may vary in severity and duration depending on the time of delivery. Observed symptoms include agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorders. In this regard, newborns should be closely monitored.
The use of the medicine is not recommended during pregnancy.
Sulpiride passes into breast milk. Breastfeeding should be avoided during treatment with the medicine.

Driving and using machines

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

Sulpiryd Teva contains lactose

If you have been diagnosed with an intolerance to some sugars, inform your doctor before taking Sulpiryd Teva.

3. How to take Sulpiryd Teva

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The dose 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.
Schizophrenia
Adults
The initial dose is 400-800 mg per day, given in two divided doses (morning and early evening), depending on the symptoms.
The maximum daily dose is 1200 mg. Only in cases of treatment-resistant disorders may the psychiatrist increase the daily dose to 1600 mg, given in divided doses.
Depressive disorders
The initial dose is 50-150 mg per day. Then the dose is increased to 150-300 mg per day.
Psychosomatic disorders, neuroses
Usually 150-300 mg per day.
Migraine and dizziness (e.g., Meniere's disease)
Usually 50-200 mg per day.
Elderly patients
Usually, the same doses are used as in adults. In elderly patients with impaired renal function, the dose of the medicine should be reduced.
Patients with renal impairment
The dose of sulpiride should be adjusted accordingly; depending on the degree of renal function, the dose should be reduced or the interval between doses extended.
Sulpiride should not be taken simultaneously or within 2 hours of taking antacids or sucralfate.

Overdose of Sulpiryd Teva

Symptoms of overdose are: excessive sedation, restlessness, confusion (disorientation), consciousness disorders, agitation, extrapyramidal symptoms (e.g., hand tremors, head, sudden muscle contractions, inability to sit or stand in one place, strange, rhythmic uncontrolled movements, most often in the face), hypotension. Coma may occur.
There is no specific antidote for sulpiride. As with poisoning with other oral medicines, activated charcoal can be given, and the doctor may perform gastric lavage. If necessary, the patient will be monitored and treated symptomatically in a hospital setting.
If necessary, the doctor will administer anti-parkinsonian medicines.
In case of overdose, you should immediately contact your doctor.

Missed dose of Sulpiryd Teva

The medicine should be taken as soon as possible, unless it is almost time for the next dose - in this case, take the medicine at the scheduled time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Sulpiryd Teva can cause side effects, although not everybody gets them.
The side effects of sulpiride are listed below, divided by system and organ, and by frequency of occurrence, if available.
The following definitions of frequency of occurrence of side effects have been used:

very common - observed more often than in 1 in 10 patients;
common - observed more often than in 1, but less often than in 10 out of 100 patients;
uncommon - observed more often than in 1, but less often than in 10 out of 1000 patients;
rare - observed more often than in 1, but less often than in 10 out of 10,000 patients;
very rare, including isolated cases - occurring in less than 1 in 10,000 patients.

Cardiac disorders
Isolated cases: Torsades de pointes

Endocrine disorders
Frequency not known: hyperprolactinemia, amenorrhea, gynecomastia, sexual dysfunction, and impotence

Hepatobiliary disorders
Very rare: increased liver enzyme activity

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

Reproductive system and breast disorders
Frequency not known: galactorrhea (outside of breastfeeding), amenorrhea, gynecomastia

Eye disorders
Rare: rotatory eye movements

Vascular disorders
Frequency not known: orthostatic hypotension
During the use of antipsychotic medicines, cases of venous thrombosis have been reported, including deep vein thrombosis

Gastrointestinal disorders
Frequency not known: excessive salivation

Musculoskeletal and connective tissue disorders
Rare: spastic neck contraction, jaw tension

Pregnancy, puerperium, and perinatal period
Neonatal withdrawal syndrome (see section Pregnancy, breastfeeding, and fertility)

Investigations
Isolated cases: prolonged QT interval

General disorders and administration site conditions
Frequency not known: malignant neuroleptic syndrome, which can be life-threatening (as with all neuroleptics), weight gain

Skin and subcutaneous tissue disorders
Very rare: maculopapular rash

Thrombosis in the veins, especially in the legs (symptoms include swelling, pain, redness of the legs) can enter the lungs through the bloodstream, causing chest pain and difficulty breathing. If you experience such symptoms, you should immediately consult a doctor.
In elderly patients with dementia treated with antipsychotic medicines, there is a small increase in the number of deaths compared to those not treated with such medicines.
In case of unexplained fever, you should discontinue Sulpiryd Teva and consult your doctor.
Some people taking Sulpiryd Teva may experience other side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sulpiryd Teva

Store in a temperature below 25°C, in a dry place.
Medicines should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: Expiry date (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sulpiryd Teva contains

• The active substance of the medicine is sulpiride.

50 mg capsules
1 capsule contains 50 mg sulpiride and excipients: cornstarch, lactose monohydrate, colloidal anhydrous silica, magnesium stearate.
Capsule composition: gelatin and titanium dioxide (E 171).
100 mg capsules
1 capsule contains 100 mg sulpiride and excipients: cornstarch, lactose monohydrate, colloidal anhydrous silica, magnesium stearate.
Capsule composition: gelatin, quinoline yellow (E 104), red iron oxide (E 172), and titanium dioxide (E 171).

What Sulpiryd Teva looks like and contents of the pack

50 mg hard capsules
The capsules are white, oval, with rounded ends.
100 mg hard capsules
The capsules are yellow, oval, with rounded ends.
Hard capsules in a PVC/Al blister.
2 blisters of 12 capsules in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: March 2022