Perazin 50 mg

Package leaflet: Information for the patient

PERAZIN 50 mg
50 mg, tablets
Perazinum
PERAZIN 200 mg
200 mg, tablets
Perazinum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Perazin 50 mg and Perazin 200 mg are and what they are 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 Perazin 50 mg and Perazin 200 mg are and what they are used for

The active substance in Perazin 50 mg and Perazin 200 mg is perazine, which has antipsychotic and sedative properties and reduces hallucinations and delusions.
Indications:

• various forms of schizophrenia,
• acute psychotic disorders, including catatonic states (catatonia is a syndrome characterized by motor disturbances, manifesting either as slowing down to complete suppression of movement, or as violent psychomotor agitation), accompanied by symptoms of psychomotor agitation, mania, and delusions.

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

When not to use Perazin 50 mg and Perazin 200 mg

• if the patient is allergic to perazine or any of the other ingredients of this medicine (listed in section 6), or to other antipsychotic medicines, particularly phenothiazine derivatives,
• if the patient has a history of neuroleptic malignant syndrome,
• in case of severe bone marrow or blood cell damage,
• if the patient is in a comatose state,
• during pregnancy and breastfeeding,

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• in case of acute intoxication with any of the following: hypnotics, opioids, other neuroleptics, sedatives, antidepressants, alcohol,
• if the patient has prolactin-dependent tumours (due to increased prolactin secretion caused by perazine),
• in case of liver failure,
• if the patient suffers from depressive states.

Consult a doctor, even if the above warnings relate to conditions that 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 impaired liver function, doses should be appropriately reduced (see section 3).
After administration of maximum doses, severe liver damage may occur.
Exercise caution in patients with renal failure, as phenothiazine derivatives may
cause hypotension.
Particular caution is required when treating patients with perazine who have a history of:

• reduced white blood cell count (leukopenia) or other blood-forming system disorders,
• myocardial damage in the past,
• severe hypotension, sudden drop in blood pressure upon rapid change from lying to standing position (orthostatic hypotension),
• history of seizures,
• Parkinson's disease,
• narrow-angle glaucoma,
• urinary retention, pyloric stenosis, benign prostatic hyperplasia,
• excessive mobility associated with involuntary movements or reduced mobility, rigidity and muscle tremors (extrapyramidal system disorders),
• movement disorders, including choreiform movements (dyskinesias),
• myasthenia gravis (characterized by rapid fatigue and weakness of skeletal muscles),
• active peptic ulcer disease and chronic liver diseases,
• pyloric stenosis,
• hyperthyroidism,
• pheochromocytoma,
• disorders of blood cell formation (hemopoiesis),
• acute anaemia,
• breast tumours.

During perazine treatment, it is necessary to:

• continuously monitor blood glucose levels in diabetic patients,
• monitor cardiovascular function: blood pressure control and observation of possible cardiac arrhythmias; for this purpose, frequent blood pressure measurements and ECG examinations should be performed; this is particularly important in elderly patients; ECG monitoring is recommended in patients with heart diseases or defects,
• perform liver function tests (blood laboratory tests) at the beginning of treatment and then after 6 months.

Immediately discontinue the medicine and contact your doctor as soon as possible if
neuroleptic malignant syndrome is suspected.
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Neuroleptic malignant syndrome, occurring in isolated cases, is characterized
among others by elevated body temperature up to 40°C and muscular rigidity.
Dose reduction or discontinuation of the medicine and immediate blood tests are recommended if the following occur after administration of the medicine:

• changes in blood picture (decreased leukocyte count, decreased platelet count),
• nosebleeds,
• disturbances of consciousness accompanied by illusions, visual, auditory, tactile hallucinations and others (delirium),
• depression,
• skin changes resembling urticaria or irritation,
• increased liver enzyme activity and jaundice.

In case of significant leukopenia, as well as changes in peripheral blood smear, the doctor may decide to discontinue perazine treatment and initiate alternative therapy. During long-term perazine treatment, blood tests should be performed every 6 months.
If movement disorders (early dyskinesia or parkinsonism symptoms) occur, such as: choreiform movements, involuntary movements, excessive mobility or reduced mobility, rigidity and muscle tremors, the doctor may recommend dose reduction or initiation of anti-parkinsonian treatment.
Photosensitivity reactions have been reported during perazine treatment. Avoid intense sunlight and reduce light sensitivity by using protective creams containing ultraviolet (UV) radiation filters.
Perazine may cause skin allergic reactions.
Children and adolescents
There is insufficient data to assess the safety of the medicine in children and adolescents under 16 years of age; therefore, perazine is intended exclusively for adult use.
Elderly patients
Elderly patients should receive perazine doses reduced by half.
Perazin 50 mg and Perazin 200 mg with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used or planned to be used by the patient.
Administration of perazine together with:

• levodopa results in mutual neutralization of their effects,
• cimetidine increases perazine availability in the body,
• lithium carbonate increases the risk of nervous system damage and elevated blood glucose levels,
• beta-adrenergic receptor blocking drugs (lower blood pressure) may lead to excessive drop in blood pressure,
• anticholinergic drugs (atropine, trihexyphenidyl) increases the risk of delirium and reduces antipsychotic efficacy,
• hypnotics and sedatives increases sedative effects and risk of respiratory complications (respiratory centre paralysis),
• antiepileptic drugs (e.g. phenytoin, carbamazepine) reduces perazine's antipsychotic effect and weakens anticonvulsant action,
• oral anticoagulants weakens anticoagulant effect,

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• MAO inhibitors and contraceptive agents results in reduced sedative effect of perazine and increased occurrence of adverse effects,
• antidiabetic drugs reduces their efficacy,
• narcotic analgesics and other analgesics and antipyretics enhances their analgesic and sedative effects,
• tricyclic antidepressants (e.g. imipramine, amitriptyline) results in weaker drug action (mutual inhibition of tissue uptake occurs),
• antidepressants from the group of selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine, fluvoxamine, sertraline) results in mutual inhibition of tissue uptake and significant increase in perazine blood concentration,
• drugs impairing bone marrow function (myelotoxic drugs), such as: phenylbutazone, aminophenazone, chloramphenicol, increases the risk of bone marrow dysfunction and blood picture abnormalities.

False positive results in pregnancy tests have been observed during perazine therapy.
Use of Perazin 50 mg and Perazin 200 mg with alcohol
During perazine treatment, patients should not consume products containing alcohol due to the risk of enhanced effects and respiratory complications.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Perazine crosses the placental barrier; therefore, use of the medicine in pregnant women is contraindicated.
Perazine passes into breast milk. If perazine treatment is necessary, breastfeeding should be discontinued.
Driving and operating machinery
The medicine may cause significant impairment of psychophysical performance. During perazine treatment, driving vehicles or operating machinery should be avoided.

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

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
This medicine is taken orally.
Initially, a dose of 50 to 100 mg per day is administered, gradually increasing in the further course of treatment
to 300 or up to 600 mg per day in divided doses.
The maximum therapeutic dose is 800 mg per day in divided doses.
The maintenance dose ranges from 75 to 300 mg per day.
Treatment of outpatients should begin with the lowest effective doses, which may then be increased
until the desired treatment response is achieved.
Sudden changes in dosage are not recommended, as this increases the risk of adverse effects.
Maximum antipsychotic effect is achieved after 1 to 3 weeks of treatment.
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Patients with renal impairment
There is no need to adjust the dosage in patients with renal impairment.
Patients with hepatic impairment
In patients with impaired liver function, a reduced dosage of perazine is recommended. A half-adult dose is advised. In cases of severe hepatic impairment, treatment should be discontinued.
Elderly patients
Elderly patients should receive reduced doses of the medicine. A half-adult dose is recommended. Such dosing usually ensures the desired therapeutic effect in elderly individuals.
Use in children and adolescents
There is insufficient data available to assess the safety of this medicine in children and adolescents under 16 years of age; therefore, perazine is intended for use in adults only.
Taking more than the recommended dose 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, unsteadiness of movement, visual disturbances, muscle tremors, confusion, cardiac and circulatory arrest, shortness of breath, respiratory arrest, and disturbances in thermoregulation (the ability to maintain stable body temperature).
Management in case of overdose
If a significantly higher than recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist.
Missing a dose of Perazin 50 mg or Perazin 200 mg
Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping treatment with Perazin 50 mg or Perazin 200 mg
Treatment of psychotic disorders is long-term. After achieving satisfactory improvement, rapid dose reduction is not recommended. Doses should be tapered gradually over several to several dozen months. Discontinuation of the medicine may only occur under medical supervision and strictly according to the doctor's instructions.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediate medical attention must be sought if a neuroleptic malignant syndrome occurs, characterised by:
elevation of body temperature up to 40°C, muscle rigidity accompanied by increased blood levels of myoglobin and creatine kinase activity.

Very common (in 1 out of 10 patients):

• galactorrhoea, i.e. milk secretion in men or women (unrelated to pregnancy).

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Common (in 1 to 10 out of 100 patients):

• changes in intraocular pressure,
• nasal mucosal swelling,
• constipation,
• difficulty in urination,
• weight gain,
• dryness of oral mucous membranes, increased thirst,
• sexual dysfunction (e.g. erectile dysfunction, ejaculation disorders).

Uncommon (in 1 to 10 out of 1,000 patients):

• movement disorders (dyskinesias, parkinsonism symptoms) manifesting as choreiform movements, involuntary movements, excessive or reduced mobility, muscle stiffness, and tremor,
• sleep disturbances, general restlessness, increased occurrence of nightmares,
• disorientation,
• dementia.

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

• sensory disturbances in hands and feet,
• seizures,
• photosensitivity,
• severe phototoxic reactions associated with pigment deposition,
• vascular collapse,
• gynaecomastia in men,
• disturbances of consciousness accompanied by illusions, visual, auditory, tactile and other hallucinations,
• disturbances of thinking and memory.

Very rare (in less than 1 out of 10,000 patients):

• oedema,
• decrease in blood granulocyte levels,
• extrapyramidal symptoms manifesting as inability to remain still in a sitting position, often associated with depression occurring usually after the manic phase of psychosis,
• neuroleptic malignant syndrome, occurring in isolated cases,
• breathing difficulties,
• gastrointestinal disorders, nausea, necrotising enterocolitis leading to intestinal necrosis,
• skin changes of a lupus erythematosus type,
• cholestasis in the bile ducts.

Frequency not known:

• false positive pregnancy test results,
• cardiac arrhythmias,
• hypotension,
• decreased white blood cell count,
• decreased platelet count,
• skin reactions such as urticaria or irritation,
• nosebleeds,
• increased liver enzyme activity and jaundice,
• menstrual disorders,
• breast enlargement in women.

Reporting of adverse reactions
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If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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: [email protected]
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

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

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Perazin 50 mg or Perazin 200 mg contains

• The active substance 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 Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicinal Product Information
tel.: (22) 742 00 22
email: [email protected]
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