Perazin 50 mg

Package Leaflet: Information for the Patient

PERAZIN 50 mg

50 mg, tablets

Perazinum

PERAZIN 200 mg

200 mg, tablets

Perazinum

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, pharmacist, or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Perazin 50 mg and Perazin 200 mg and what is it used for
• 2. Important information before taking Perazin 50 mg and Perazin 200 mg
• 3. How to take Perazin 50 mg and Perazin 200 mg
• 4. Possible side effects
• 5. How to store Perazin 50 mg and Perazin 200 mg
• 6. Contents of the pack and other information

1. What is Perazin 50 mg and Perazin 200 mg and what is it used for

The active substance of Perazin 50 mg and Perazin 200 mg is perazine, which has antipsychotic and sedative effects, relieving hallucinations and delusions.

Indications for use:

• various forms of schizophrenia,
• acute psychotic disorders, including catatonic (catatonia is a syndrome characterized by dominant motor disorders, taking the form of either slowed movements up to motor inhibition or sudden intense motor excitement) with accompanying symptoms of psychomotor agitation, mania, delusions.

2. Important information before taking Perazin 50 mg and Perazin 200 mg

When not to take Perazin 50 mg and Perazin 200 mg

• if you are allergic to perazine or any of the other ingredients of this medicine (listed in section 6), or other antipsychotic medicines, especially phenothiazine derivatives,
• if you have been diagnosed with malignant neuroleptic syndrome in your medical history,
• in case of severe bone marrow damage or blood cell disorders,
• if you are in a coma,
• during pregnancy and breastfeeding,

1/7

• in case of acute poisoning with one of the following substances: sleeping pills, opioids, other neuroleptic medicines, sedatives, antidepressants, alcohol,
• if you have prolactin-dependent tumors (due to increased prolactin secretion under the influence of perazine),
• in case of liver failure,
• if you have depressive states.

You should consult a doctor, even if the above warnings concern situations that have occurred in the past.

Warnings and precautions

Before starting treatment with Perazin 50 mg and Perazin 200 mg, discuss it with your doctor, pharmacist, or nurse.
In case of liver function disorders, the dose should be reduced accordingly (see point 3).
After taking the maximum doses, severe liver damage may occur.
Caution should be exercised in patients with renal failure, as phenothiazine derivatives can cause hypotension.
Particular caution should be exercised when treating patients with perazine who have been diagnosed with:

• decreased white blood cell count (leukopenia) or other blood system disorders,
• heart muscle damage in the medical history,
• severe hypotension, sudden drop in blood pressure occurring as a result of rapid transition from a lying to a standing position (orthostatic hypotension),
• seizures in the medical history,
• Parkinson's disease,
• glaucoma with a narrow angle of filtration,
• urination disorders, narrowing of the pylorus, prostate hypertrophy,
• excessive motor activity associated with involuntary movements or decreased motor activity, stiffness, and muscle tremors (extrapyramidal system disorders),
• motor disorders, manifested by, among others, choreiform movements (dyskinesia),
• myasthenia gravis (a disease characterized by rapid fatigue and weakness of skeletal muscles),
• active peptic ulcer and chronic liver diseases,
• narrowing of the pylorus,
• hyperthyroidism,
• chromaffin tumor of the adrenal gland,
• disorders of new blood cell formation (hemopoiesis),
• acute anemia,
• breast tumors.

During treatment with perazine, it is necessary:

• constant monitoring of blood glucose levels in patients with diabetes,
• monitoring of the circulatory system: blood pressure control and observation of possible arrhythmias; for this purpose, frequent blood pressure measurements and ECG tests should be performed; this is especially important in elderly patients; ECG monitoring is necessary in patients with heart diseases and defects,
• performing liver function tests (blood laboratory tests) at the beginning of treatment and then after 6 months.

You should stop taking the medicine immediately and contact your doctor as soon as possiblein case of suspected malignant neuroleptic syndrome.
2/7
Malignant neuroleptic syndrome, occurring in individual cases, is characterized by, among other things, an increase in body temperature to 40°C and muscle stiffness.
It is recommended to reduce the dose or discontinue the medicine and immediately perform blood tests if the following occur after taking the medicine:

• changes in the blood picture (decrease in the number of leukocytes, decrease in the number of platelets),
• nosebleeds,
• disorders of consciousness, accompanied by illusions, visual, auditory, tactile, and other hallucinations (delirium),
• depression,
• skin changes of the type of urticaria or irritation,
• increased liver enzyme activity and jaundice.

In case of significant decrease in the number of leukocytes, as well as changes in the peripheral blood smear, the doctor may decide to discontinue perazine treatment and use another medicine. During long-term treatment with perazine, blood tests should be performed every 6 months.
In case of motor disorders (early dyskinesia or parkinsonian syndrome) such as choreiform movements, involuntary movements, excessive motor activity, or decreased motor activity, stiffness, and muscle tremors, the doctor may recommend reducing the dose or introducing anti-parkinsonian treatment.
During treatment with perazine, cases of hypersensitivity to light have been reported. You should avoid intense sunlight and reduce sensitivity to light by using protective creams with UV filters.
The use of perazine may cause skin allergic reactions.

Children and adolescents

There is a lack of sufficient data to assess the safety of using the medicine in children and adolescents under 16 years of age, so perazine is intended only for the treatment of adults.

Elderly patients

Elderly patients should receive reduced doses of perazine. It is recommended to use half of the adult dose. Such dosing usually provides the desired therapeutic effect in elderly patients.

Perazin 50 mg and Perazin 200 mg with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as medicines you plan to take.
Taking perazine with:

• levodopa causes mutual cancellation of their effects,
• cimetidine causes an increase in the availability of perazine in the body,
• lithium carbonate increases the risk of nervous system damage and increased blood sugar levels,
• beta-adrenergic receptor blockers (lowering blood pressure) may lead to excessive lowering of blood pressure,
• anticholinergic agents (atropine, trihexyphenidyl) increase the risk of delirium, reduce the antipsychotic effect,
• sleeping pills and sedatives increase the sedative effect and the risk of respiratory complications (respiratory paralysis),
• antiepileptic drugs (e.g., phenytoin, carbamazepine) cause a decrease in the antipsychotic effect of perazine, weakening of the anticonvulsant effect,
• oral anticoagulants weaken the anticoagulant effect,

3/7

• MAO inhibitors and contraceptives result in a weakening of the sedative effect of perazine and an increase in the occurring side effects,
• antidiabetic drugs cause a decrease in their effect,
• narcotic analgesics and other painkillers and antipyretics increase their analgesic and sedative effects,
• tricyclic antidepressants (e.g., imipramine, amitriptyline) cause a weaker effect of the medicines (there is a mutual inhibition of the uptake of medicines by tissues),
• selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine, fluvoxamine, sertraline) cause mutual inhibition of the uptake of medicines by tissues and a significant increase in the concentration of perazine in the blood,
• medicines that impair bone marrow function (myelotoxic), such as phenylbutazone, aminophenazone, chloramphenicol, result in an increased risk of bone marrow disorders and changes in the blood picture.

During perazine therapy, false pregnancy test results have been observed.

Using Perazin 50 mg and Perazin 200 mg with alcohol

During treatment with perazine, you should not consume products containing alcohol due to the risk of increased effect and respiratory complications.

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.
Perazine passes through the placental barrier, so its use in pregnant women is contraindicated.
Perazine passes into breast milk. If perazine treatment is necessary, breastfeeding should be discontinued.

Driving and using machines

The medicine may cause significant impairment of psychophysical fitness. During treatment with perazine, you should not drive vehicles or operate machines.

3. How to take Perazin 50 mg and Perazin 200 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The medicine should be taken orally.
Initially, 50 to 100 mg per day is used, and in the further course of treatment, the dose is gradually increased to 300 or 600 mg per day in divided doses.
The maximum therapeutic dose is 800 mg per day in divided doses.
The maintenance dose is 75 to 300 mg per day.
Treatment of outpatients should be started with the smallest effective doses, and then the dose can be increased until the desired response to treatment is achieved.
Sudden changes in dosage are not recommended, as this increases the risk of side effects.
The maximum antipsychotic effect is achieved after 1 to 3 weeks of treatment.
4/7

Patient with renal impairment

In renal impairment, there is no need to change the dosage of the medicine.

Patient with hepatic impairment

In patients with liver function disorders, it is recommended to reduce the doses of perazine. It is recommended to use half of the adult dose, and in severe liver failure, discontinue the medicine.

Elderly patients

Elderly patients should receive reduced doses of the medicine. It is recommended to use half of the adult dose. Such dosing usually provides the desired therapeutic effect in elderly patients.

Use in children and adolescents

There is a lack of sufficient data to assess the safety of using the medicine in children and adolescents under 16 years of age, so perazine is intended only for the treatment of adults.

Overdose of Perazin 50 mg or Perazin 200 mg

Symptoms
Accidental or intentional overdose (ingestion of several or several dozen grams of perazine) usually manifests as difficulty speaking, clumsiness, vision disturbances, muscle tremors, confusion, cardiac arrest, and respiratory failure, as well as disorders of thermoregulation (ability to maintain a constant body temperature).
Procedure in case of overdose
In case of taking a significantly larger dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missed dose of Perazin 50 mg or Perazin 200 mg

You should take the missed dose as soon as possible, unless it is already time for the next dose. You should not take a double dose to make up for the missed dose.

Stopping treatment with Perazin 50 mg or Perazin 200 mg

Treatment of psychotic disorders is long-term. After achieving satisfactory improvement, it is not recommended to reduce the dose of the medicine too quickly. The dose should be reduced gradually over several to several dozen months. Discontinuation of the medicine may only be done under the control of a doctor and strictly according to their instructions.
In case of any further doubts related to the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately consult a doctorin case of malignant neuroleptic syndrome characterized by: an increase in body temperature to 40°C, muscle stiffness with accompanying increased myoglobin levels and creatine kinase activity in the blood.

Very common (in 1 patient in 10):

• galactorrhea, i.e., milk secretion in men or women (not related to pregnancy).

5/7

Common (in 1 to 10 patients in 100):

• change in intraocular pressure,
• swelling of the nasal mucosa,
• constipation,
• urination difficulties,
• weight gain,
• dryness of the mucous membranes of the mouth, increased thirst,
• sexual function disorders (e.g., erection disorders, ejaculation disorders).

Uncommon (in 1 to 10 patients in 1000):

• motor disorders (dyskinesia, parkinsonian syndrome) manifested by choreiform movements, involuntary movements, excessive motor activity, or decreased motor activity, stiffness, and muscle tremors,
• sleep disorders, general restlessness, increased occurrence of nightmares,
• disorientation,
• dementia.

Rare (in 1 to 10 patients in 10,000):

• changes in sensation in the hands and feet,
• seizures,
• increased sensitivity of the eyes to light,
• severe hypersensitivity reactions to light, accompanied by pigment deposition,
• vascular collapse,
• breast hypertrophy in men,
• disorders of consciousness, accompanied by illusions, visual, auditory, tactile, and other hallucinations,
• thought and memory disorders.

Very rare (in less than 1 patient in 10,000):

• edema,
• decrease in granulocyte levels in the blood,
• extrapyramidal symptoms manifested by inability to remain calm in a sitting position, often accompanied by depression, usually occurring after the manic phase of psychosis,
• malignant neuroleptic syndrome, occurring in individual cases,
• respiratory disorders,
• gastrointestinal disorders, nausea, ischemic enteritis leading to intestinal necrosis,
• skin changes of the type of erythema (lupus erythematosus),
• bile duct obstruction (cholestasis).

Frequency not known:

• false pregnancy test results,
• heart rhythm disorders,
• lowering of blood pressure,
• decrease in the number of leukocytes,
• decrease in the number of platelets,
• skin changes of the type of urticaria or irritation,
• nosebleeds,
• increased liver enzyme activity and jaundice,
• menstrual disorders,
• breast enlargement in women.

Reporting side effects

6/7
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Perazin 50 mg and Perazin 200 mg

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Perazin 50 mg or Perazin 200 mg contains

• The active substance of the medicine is perazine. One tablet contains 50 mg or 200 mg of perazine.
• The other ingredients (excipients) are: heavy magnesium carbonate, Povidone K 30, sodium croscarmellose, and magnesium stearate.

What Perazin 50 mg and Perazin 200 mg look like and contents of the pack

Perazin 50 mg and Perazin 200 mg are oval, biconvex, uncoated yellow tablets, smooth with a score line.
One pack of Perazin 50 mg contains 30 or 60 tablets.
One pack of Perazin 200 mg contains 15 or 30 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: (22) 742 00 22
email: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

7/7