Perazin 25 mg

Package Leaflet: Information for the Patient

PERAZIN 25 mg

25 mg, tablets

Perazinum

PERAZIN 100 mg

100 mg, tablets

Perazinum

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Perazin 25 mg and Perazin 100 mg and what are they used for
• 2. Important information before taking Perazin 25 mg and Perazin 100 mg
• 3. How to take Perazin 25 mg and Perazin 100 mg
• 4. Possible side effects
• 5. How to store Perazin 25 mg and Perazin 100 mg
• 6. Contents of the pack and other information
• 1. What is Perazin 25 mg and Perazin 100 mg and what are they used for

The active substance of Perazin 25 mg and Perazin 100 mg is perazine, which has antipsychotic and sedative effects, and eliminates hallucinations and delusions.
Indications for use arevarious forms of schizophrenia and acute psychotic disorders (including catatonic) with accompanying symptoms of psychomotor agitation, mania, and delusions.
Catonia is a syndrome of symptoms, in which motor disorders predominate, taking the form of either slowing down to inhibition of movements or sudden psychomotor agitation.

2. Important information before taking Perazin 25 mg and Perazin 100 mg

When not to take Perazin 25 mg or Perazin 100 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 a history of malignant neuroleptic syndrome,
• in case of severe bone marrow damage or blood cell damage,
• if you are in a coma,
• during pregnancy and breastfeeding,
• 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 your doctor, even if the above warnings apply to past situations.

Warnings and precautions

Before starting treatment with Perazin 25 mg or Perazin 100 mg, you should 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 may cause hypotension.
Particular caution should be exercised when treating patients with perazine who have:

• decreased white blood cell count (leukopenia) or other blood system disorders,
• heart muscle damage in the past,
• severe hypotension, sudden drop in blood pressure when changing from a lying to a standing position (orthostatic hypotension),
• seizures in the past,
• Parkinson's disease,
• glaucoma with a narrow angle of filtration,
• urination disorders, narrowing of the pylorus, prostate enlargement,
• excessive motor activity associated with involuntary movements or decreased motor activity, stiffness, and muscle tremors (extrapyramidal 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 disease and chronic liver diseases,
• narrowing of the pylorus,
• hyperthyroidism,
• adrenal chromaffin tumor,
• disorders of new blood cell formation (hematopoiesis),
• acute anemia,
• breast tumors.

During treatment with perazine, it is necessary:

• to constantly monitor blood glucose levels in patients with diabetes,
• to monitor cardiovascular function: control of blood pressure 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 recommended in patients with heart diseases and defects,
• to perform liver function tests (blood laboratory tests) at the beginning of treatment and then after 6 months.

In case of suspected malignant neuroleptic syndrome, it is recommended to immediately discontinue the medicine and seek medical help as soon as possible. Malignant neuroleptic syndrome, which occurs 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, after taking the medicine, the following occur:

• changes in blood count (decrease in leukocytes, decrease in platelets),
• nosebleeds,
• disorders of consciousness, accompanied by illusions, visual, auditory, tactile, and other hallucinations (delirium),
• depression,
• skin changes of an allergic nature or irritation,
• increased liver enzyme activity and jaundice.

In case of significant decrease in white blood cell count, as well as changes in 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 insufficient 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 25 mg or Perazin 100 mg and other medicines

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

• levodopa causes mutual cancellation of their effects,
• cimetidine causes an increase in perazine availability 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 effectiveness of antipsychotic treatment,
• ethanol, sleeping pills, and sedatives increase sedative effects and the risk of respiratory complications (respiratory paralysis),
• antiepileptic drugs (e.g., phenytoin, carbamazepine) reduce the effectiveness of perazine's antipsychotic and anticonvulsant effects,
• oral anticoagulants weaken their anticoagulant effect,
• MAO inhibitors and oral contraceptives result in a weakening of perazine's sedative effect and an increase in its side effects,
• antidiabetic drugs reduce their effectiveness,
• narcotic analgesics and other analgesic and antipyretic agents increase their analgesic and sedative effects,
• tricyclic antidepressants (TCA, e.g., imipramine, amitriptyline) cause weaker effects of the medicines (mutual inhibition of medicine uptake by tissues),
• selective serotonin reuptake inhibitors (SSRI, e.g., fluoxetine, fluvoxamine, sertraline) cause mutual inhibition of medicine uptake by tissues and a significant increase in perazine levels 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 blood count changes.

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

Taking Perazin 25 mg and Perazin 100 mg with alcohol

During treatment with perazine, you should not consume products containing alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should 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 it is necessary to use perazine treatment, you should stop breastfeeding.

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.

Perazin 25 mg contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should inform your doctor before taking the medicine.

3. How to take Perazin 25 mg and Perazin 100 mg

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult your doctor or pharmacist.
The medicine is taken orally.
Initially, 50 to 100 mg is taken per day, and in the further course of treatment, the dose is gradually increased to 300 to 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 one to three weeks of treatment.

Patients with renal impairment

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

Patients with liver 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.

Patients in old age

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 insufficient 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.

Taking a higher dose of Perazin 25 mg or Perazin 100 mg than recommended

Symptoms
Accidental or intentional overdose (ingestion of several or several dozen grams of perazine) usually manifests as difficulty speaking, clumsiness, visual 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 higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Perazin 25 mg or Perazin 100 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 25 mg or Perazin 100 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 doses 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 recommendations.
In case of any further doubts related to the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they will not occur in every patient.
In case of malignant neuroleptic syndrome, characterized by an increase in body temperature to 40°C and muscle stiffness, accompanied by an increase in myoglobin and creatine kinase activity in the blood, you should immediately seek medical help.
Very common(in 1 in 10 patients):
galactorrhea
Common(in 1 to 10 patients in 100):
change in intraocular pressure, swelling of the nasal mucosa, constipation, difficulty urinating, weight gain, dryness of the mucous membranes of the mouth, increased thirst, sexual function disorders (e.g., erection disorders, ejaculation).
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, and dementia.
Rare(in 1 to 10 patients in 10,000):
changes in sensation in hands and feet, seizures, hypersensitivity of the eyes to light, severe hypersensitivity reactions to light, accompanied by pigment deposition, vascular collapse, breast enlargement in men, disorders of consciousness, accompanied by illusions, visual, auditory, tactile, and other hallucinations.
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 still, often accompanied by depression, occurring usually after the manic phase of psychosis, malignant neuroleptic syndrome, occurring in individual cases, respiratory disorders, gastrointestinal disorders, nausea, necrotizing enterocolitis leading to intestinal necrosis, skin changes of a lupus-like nature, cholestasis.

Frequency not known

false pregnancy test results, arrhythmias, lowering of blood pressure, decrease in leukocyte count, decrease in platelet count, skin changes of an allergic nature or irritation, nosebleeds, increased liver enzyme activity, and jaundice, menstrual disorders, breast enlargement in women.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Perazin 25 mg and Perazin 100 mg

The medicine should be stored in a place invisible and inaccessible to children.
Store at a temperature below 25°C. Store 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 given month.
Medicines should not be disposed of via wastewater or household waste containers. You should 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 25 mg or Perazin 100 mg contains

• The active substance of the medicine is perazine. 1 tablet contains 25 mg or 100 mg of perazine.
• Other ingredients (excipients) are:

Perazin 25 mg
lactose monohydrate, potato starch, methylcellulose, colloidal silica, sodium carboxymethylcellulose, magnesium stearate.
Perazin 100 mg
heavy magnesium carbonate, povidone K-30, sodium croscarmellose, magnesium stearate.

What Perazin 25 mg and Perazin 100 mg look like and what the pack contains

Perazin 25 mg are uncoated tablets, yellow, convex on both sides, with a uniform, smooth surface.
One pack of Perazin 25 mg contains 20, 30, or 50 tablets.
Perazin 100 mg are uncoated tablets, yellow, oval, biconvex, with a smooth surface and a dividing line.
One pack of Perazin 100 mg contains 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
e-mail: [email protected]

Date of last revision of the leaflet: