Pernazinum

PATIENT INFORMATION LEAFLET: USER INFORMATION

Pernazinum

(Perazinum)
25 mg, tablets
100 mg, tablets

Read the 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 Pernazinum and what is it used for
• 2. Important information before taking Pernazinum
• 3. How to take Pernazinum
• 4. Possible side effects
• 5. How to store Pernazinum
• 6. Contents of the pack and other information

1. What is Pernazinum and what is it used for

Pernazinum is an antipsychotic medicine used to treat acute and chronic schizophrenia; acute psychotic disorders with delusions, anxiety, hallucinations, loss of personality; catatonia (motor activity disorders), mania, and psychomotor agitation.

2. Important information before taking Pernazinum

When not to take Pernazinum

Do not take Pernazinum if you have:

• hypersensitivity to perazine or any other component of the medicine;
• severe bone marrow damage or blood cell disorders;
• malignant neuroleptic syndrome;
• comatose states;
• pregnancy and breastfeeding;
• acute poisoning with drugs acting on the nervous system, narcotics, and alcohol;
• prolactin-dependent tumors, due to increased prolactin secretion under the influence of perazine.

Warnings and precautions

Particular caution should be exercised when taking Pernazinum if you have:

• leukopenia (low white blood cell count);
• epilepsy, glaucoma, prostate hypertrophy, liver failure;
• advanced coronary heart disease, recent myocardial infarction;
• sudden drop in blood pressure, especially at the beginning of treatment;
• pyloric stenosis;
• orthostatic hypotension (sudden decrease in blood pressure when changing position or standing for a long time), especially at the beginning of treatment;
• significant decrease in blood pressure.

At the beginning of perazine treatment, a complete blood count is recommended. In case of fever, infection, or nosebleeds, a hematological examination should be performed immediately. During long-term perazine treatment, blood tests should be performed every 6 months. In case of a significant decrease in the number of leukocytes (white blood cells) below 3,000 cells/mm, as well as changes in the peripheral blood picture, the doctor may decide to discontinue perazine treatment and use another medicine. During perazine treatment, regular measurement of:

• blood glucose levels in patients with diabetes,
• blood pressure and ECG in patients with heart disease,
• and liver function tests at the beginning and after 6 months of treatment. In case of liver function disorders, the doctor will reduce the dose of the medicine accordingly. During perazine treatment, a life-threatening malignant neuroleptic syndrome may occur, characterized by fever and muscle stiffness. If suspected, the medicine should be discontinued immediately and the patient should consult a doctor. Perazine treatment has been associated with cases of photosensitivity. Patients should avoid intense sunlight and reduce sensitivity to light by using protective creams with ultraviolet radiation filters. Perazine treatment may cause allergic skin reactions. The medicine should be used with caution in patients with brain damage, cerebral vessels, and depression (due to the possibility of exacerbating depressive symptoms). In elderly patients, extrapyramidal symptoms (muscle stiffness, facial rigidity, slowed movements, restlessness, involuntary muscle contractions, and involuntary movements) are more common, and the frequency of late dyskinesias (involuntary movements of limbs or body parts) is increased. The sedative effect is stronger, and hypotension is more common. During perazine treatment, alcohol consumption is prohibited. Consult a doctor, even if the above warnings refer to past situations.

Pernazinum and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Concurrent use of perazine with other psychotropic medicines requires dose reduction. Concurrent administration of perazine with blood pressure-lowering medicines may lead to excessive blood pressure drop. Perazine treatment with antiarrhythmic medicines increases the risk of cardiac arrhythmias. Concurrent use of perazine with narcotic analgesics and nonsteroidal anti-inflammatory and antipyretic medicines increases the analgesic and sedative effects. It is not recommended to administer perazine with preparations containing reserpine. Perazine treatment with lithium increases the risk of side effects. Concurrent use of oral contraceptives with perazine increases the risk of extrapyramidal symptoms, phlebitis, and prolactin secretion. The effect of bromocriptine is reduced, and the effect of metoclopramide is increased during concurrent use with perazine. Concurrent use of antiepileptic medicines reduces the antipsychotic effect of perazine. Administration of perazine with carbamazepine increases the risk of side effects from the nervous system and blood elements. Beta-adrenergic receptor blockers in combination with perazine increase the risk of blood pressure drops. Concurrent administration of perazine with thiopental prolongs its duration of action. In habitual smokers, the effect of perazine may be weakened.

Pernazinum with food, drink, and alcohol

Perazine absorption from the gastrointestinal tract is reduced when taken with milk, coffee, tea, and fruit juices. During Pernazinum treatment, do not drink alcohol. Concurrent use of alcohol and perazine increases the effect of both substances and lowers blood pressure.

Pregnancy, breastfeeding, and fertility

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 placenta and reaches the fetal blood, so Pernazinum is contraindicated during pregnancy. Perazine and its metabolites pass into breast milk, so Pernazinum should not be used during breastfeeding.

Driving and using machines

Perazine may impair your ability to drive or operate machinery, so do not drive or operate machinery.

Pernazinum contains lactose

The medicine should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type), or glucose-galactose malabsorption syndrome.

3. How to take Pernazinum

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Adults with acute psychosis, psychomotor agitation, and manic symptoms are given 50-150 mg of perazine per day. The maintenance dose for hospitalized patients is 200-600 mg per day in divided doses. In justified cases, the dose may be increased to 600 mg per day. The maintenance dose for non-hospitalized patients is 300 mg per day in divided doses. In the treatment of chronic schizophrenia, doses of 75-600 mg of perazine per day are used in two or three divided doses. Patients who do not require hospital treatment should start with smaller doses, then the dose should be gradually increased until the desired effect is achieved. It is not recommended to change the dose abruptly, as this increases the risk of side effects. The maximum antipsychotic effect occurs after one to three weeks of treatment. After administering the appropriate dose to the patient for a longer period, the doctor will gradually reduce the dose to the smallest therapeutic dose. In renal failure, there is no need to change the dosage of the medicine. In patients with liver function disorders, it is recommended to use the minimum therapeutic doses of perazine, and in severe liver failure, the medicine should be discontinued. Elderly patients should receive half the dose used for adults. Such dosing usually ensures the desired therapeutic effect in older people. If you have any doubts about taking this medicine, ask your doctor or pharmacist.

Taking a higher dose of Pernazinum than recommended

Perazine overdose leads to the following symptoms: speech difficulties, awkwardness (disorder) of movements, vision disturbances, muscle tremors, and confusion. If you have taken a higher dose of the medicine than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Pernazinum

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

Stopping Pernazinum treatment

Your doctor will tell you how long to take Pernazinum. Do not stop treatment early, as the treatment of psychotic disorders is long-term. The dose should be reduced gradually, over several months, under the doctor's control. The doctor's decision to discontinue treatment may be based solely on clinical experience, taking into account the patient's medical history and condition.

4. Possible side effects

Like all medicines, Pernazinum can cause side effects, although not everybody gets them. The frequency of possible side effects listed below is defined as:

• very common: (affects more than 1 in 10 people);
• common: (affects 1 to 10 people in 100);
• uncommon: (affects 1 to 10 people in 1,000);
• rare: (affects 1 to 10 people in 10,000);
• very rare: (affects less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

Blood and lymphatic system disorders
During perazine treatment, occasional changes in the peripheral blood picture occur: decreased white blood cell count, increased eosinophil count, and decreased neutrophil count.
Rare cases of decreased platelet count, anemia, and agranulocytosis have been reported.
Cardiac disorders
The most common side effects are a drop in blood pressure and cardiac arrhythmias. A drop in blood pressure occurs especially at the beginning of treatment with higher doses of perazine.
Very common: changes in the ECG recording. These changes occur with varying severity and are proportional to the doses used. They are transient in nature.
Nervous system disorders
During the first few days of perazine treatment, a reaction may occur, characterized by sudden movements of the head, neck stiffness, trismus, facial muscle spasms, and tongue muscle spasms. These movements less frequently affect larger muscle groups. Sometimes, "associated seizures" and difficulty swallowing are observed. In patients treated with high doses of perazine for a long time, an unpleasant feeling of restlessness may occur, which is often accompanied by depression.
In patients treated with perazine for a long time (many months), no uncoordinated and involuntary movements of the limbs have been observed so far. However, there is a possibility of their occurrence.
In single cases, neuroleptic treatment may cause the development of a neuroleptic syndrome, characterized by fever and muscle stiffness (increased myoglobin and creatine kinase activity in the blood). So far, there have been no reports of neuroleptic syndrome after Pernazinum treatment.
In the early period of perazine treatment (usually 5-30 days), increased muscle tone, slowed movements, muscle tremors, and usually mild muscle weakness may occur.
Psychiatric disorders
Common: sedation.
Sleep disturbances, confusion, general restlessness, increased dreaming or nightmares, disorientation, and dementia have also been observed. Perazine treatment may lead to the development of depression, the symptoms of which usually occur after acute psychoses.
Eye disorders
Perazine may cause blurred vision and changes in intraocular pressure.
During long-term therapy with high doses of perazine, changes in eye pigmentation may occur.
Respiratory, thoracic, and mediastinal disorders
Prolonged administration of perazine may lead to respiratory function disorders and nasal congestion.
Gastrointestinal disorders
The effect of perazine on the gastrointestinal tract is due to its anticholinergic effect.
During treatment with high doses of the medicine, symptoms such as constipation, dryness of the mucous membranes of the mouth, and nausea have been observed. In connection with perazine treatment, single cases of necrotizing enterocolitis and intrahepatic cholestasis have been reported.
Renal and urinary disorders
Rare: urinary incontinence or urinary retention.
Reproductive system and breast disorders
During perazine treatment, sexual disturbances may occur: erectile dysfunction and decreased libido.
Skin and subcutaneous tissue disorders
Perazine treatment occasionally causes allergic skin reactions. Sometimes, an increased skin reaction to sunlight has been observed. If possible, during perazine treatment, patients should avoid exposure to sunlight.
Perazine treatment is associated with excessive sweating.
Endocrine disorders
Other side effects that may occur during perazine treatment include galactorrhea. This symptom occurs transiently in treated women and is dose-dependent.
Menstrual disorders and gynecomastia (breast enlargement in men) may also occur.
Metabolic and nutritional disorders
Weight gain has also been reported in patients taking perazine.
Hepatobiliary disorders
In studies involving 156 patients, asymptomatic elevation of at least one liver enzyme was observed in 43% of patients treated with perazine, but none of these patients developed acute hepatitis.
Very rare: severe liver function disorders.
Rare: acute hepatitis.
Diagnostic tests
During treatment with medium and high doses of perazine, changes in glucose tolerance test results are quite common.
Immune system disorders
A single case of lupus erythematosus has been reported during perazine treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 22 49-21-301, fax: 22 49-21-309
e-mail: [email protected]
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 Pernazinum

Store in a temperature below 25°C.
Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pernazinum contains

The active substance of the medicine is perazine.
The other ingredients of the medicine are: lactose monohydrate (Pernazinum, 25 mg, tablets contain 68.4 mg of lactose in one tablet, and Pernazinum, 100 mg, tablets contain 191.6 mg of lactose), potato starch, gelatin, magnesium stearate, sodium starch glycolate.

What Pernazinum looks like and contents of the pack

Pernazinum, 25 mg, tablets: yellow, round tablet with a diameter of 8 mm
Pernazinum, 100 mg, tablets: yellow, round tablet with a diameter of 12 mm
The immediate packaging consists of a blister pack of aluminum/PVC foil.
Pernazinum, 25 mg, tablets:
blister pack of aluminum/PVC foil in a cardboard box
20 tablets (1 blister pack of 20 tablets)
Pernazinum, 25 mg, tablets:
blister pack of aluminum/PVC foil in a cardboard box
60 tablets (3 blister packs of 20 tablets)
Hospital pack Pernazinum, 25 mg, tablets:
blister pack of aluminum/PVC foil in a cardboard box
200 tablets (10 blister packs of 20 tablets)
Pernazinum, 100 mg, tablets:
blister pack of aluminum/PVC foil in a cardboard box
30 tablets (1 blister pack of 30 tablets)
Hospital pack Pernazinum, 100 mg, tablets:
blister pack of aluminum/PVC foil in a cardboard box
300 tablets (10 blister packs of 30 tablets)

Marketing authorization holder and manufacturer

LABOR Pharmaceutical-Chemical Company Ltd.
Długosza 49, 51-162 Wrocław
phone: +48 71 325 30 85
fax: +48 71 326 14 57
e-mail: [email protected]

Date of last revision of the leaflet: