SULPIRYD 50 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, drinks, 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 authorisation holder and manufacturer
   4. Marketing authorisation 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 any not listed in this leaflet, please tell 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 drugs is ineffective or impossible to apply.
• Migraine and dizziness of various etiologies (including Meniere's disease).
• Supportively in the treatment of alcohol dependence.

2. Important information before taking Sulpiryd Teva

When not to take Sulpiryd Teva

• if you are allergic to sulpiride or any of the other ingredients of this medicine (listed in section 6);
• if you are suspected or confirmed to have a phaeochromocytoma (usually a benign adrenal gland tumor, which is a common cause of secondary hypertension);
• in case of acute porphyria (inherited or acquired disorder of heme synthesis, also known as porphyria pathway);
• if you have tumors associated with excessive prolactin secretion (e.g. pituitary adenoma, breast cancer);
• in case of concomitant use of levodopa;
• if you are breastfeeding.

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 drug 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-Parkinson's disease drugs.
Similarly, as with other neuroleptic drugs, 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 drugs, 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 drugs, should be used with particular caution.
After sudden withdrawal of antipsychotic drugs, 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 drug.
Neuroleptics can lower the seizure threshold. After taking sulpiride, seizures have been reported in patients who did not have them before. 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 concomitant use of sulpiride.
As with other drugs 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 drug if the patient or their family history has deep vein thrombosis. The use of such drugs 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 now or have taken recently, as well as the 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:

• drugs that cause bradycardia, such as: beta-blockers, calcium channel blockers, such as diltiazem and verapamil, clonidine, guanfacine, digitalis-like preparations;
• drugs that cause electrolyte imbalance disorders, in particular hypokalemia: diuretics that cause hypokalemia, stimulant laxatives, intravenous amphotericin B, glucocorticoids, tetracosactide (hypokalemia 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 derived from imipramine, halofantrine, lithium, cyzapride, bepridil, tiorydazine, intravenously administered vincamine, entamidine, erythromycin, sparfloxacin.

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

• opioid derivatives (painkillers, analgesics, antitussives, substitution therapy);
• neuroleptics;
• barbiturates and barbiturate-like drugs;
• benzodiazepines;
• anxiolytics and sedatives other than benzodiazepines;
• antidepressants with a sedating effect (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine);
• antihistamines with a sedating effect, H1 receptor antagonists with a sedating effect;
• antihypertensive drugs with a central action: baclofen, thalidomide, pizotifen;
• drugs that neutralize stomach acid and sucralfate: reduced absorption of sulpiride, so it should be taken 2 hours before administration of these drugs;
• ropinirole;
• lithium: increased risk of extrapyramidal effects;
• clonidine and clonidine derivatives.

Sulpiryd Teva with food, drinks, 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 drug.
During treatment with Sulpiryd Teva, all alcoholic beverages and drugs containing alcohol should be avoided.

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 drug 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, ask your doctor or pharmacist for advice before taking this medicine.
Newborns exposed to antipsychotic drugs (including amisulpride) in the third trimester of pregnancy are at risk of adverse reactions, 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 drug is not recommended during pregnancy.
Sulpiride passes into breast milk. Breastfeeding should be avoided during treatment with the drug.

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 drug.

Sulpiryd Teva contains lactose

If you have been diagnosed with 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 your doctor has told you. If you are not sure, ask 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, talk to 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, the psychiatrist may 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 drug 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 and 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 orally administered drugs, activated charcoal can be given, and the doctor may perform gastric lavage. If necessary, the patient's condition will be monitored and symptomatic treatment will be carried out in a hospital setting.
If necessary, the doctor will administer anti-Parkinson's disease drugs.
In case of overdose, you should immediately contact a doctor.

Missed dose of Sulpiryd Teva

The medicine should be taken as soon as possible, unless the time for the next dose is near - 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 adverse reactions have been used in the review:

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-Parkinson's disease drugs 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: rotational eye movements
Vascular disorders
Frequency not known: orthostatic hypotension
During the use of antipsychotic drugs, cases of venous thrombosis, including deep vein thrombosis, have been reported.
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 lower limbs (symptoms include swelling, pain, redness of the legs) can enter the lungs through the bloodstream, causing chest pain and difficulty breathing. If such symptoms occur, you should immediately consult a doctor.
In elderly patients with dementia treated with antipsychotic drugs, there is a small increase in the number of deaths compared to those not treated with such drugs.
If you experience fever without a justified cause, you should discontinue Sulpiryd Teva and consult a doctor.
Some patients taking Sulpiryd Teva may experience other side effects.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: 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 drug is sulpiride.

50 mg capsules
1 capsule contains 50 mg of 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 of 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, cylindrical with rounded ends.
100 mg hard capsules
The capsules are yellow, cylindrical with rounded ends.
Hard capsules in a PVC/Al blister pack.
2 blisters of 12 capsules 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

Date of last revision of the leaflet: March 2022