Chloropernazinum

Chloropernazinum
10 mg, tablets
(Prochlorperazini dimaleas)
Please read the entire package leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Chloropernazinum and what is it used for

Chloropernazinum is a potent antipsychotic medicine.
It is indicated for the prevention and treatment of nausea and vomiting, vertigo in Meniere's syndrome and labyrinthitis, as well as short-term adjunctive treatment of anxiety.

2. Important information before using Chloropernazinum

Do not use Chloropernazinum if there is hypersensitivity to prochlorperazine or any of the excipients of the medicinal product.
When not to use Chloropernazinum
Prochlorperazine should be avoided in patients with: renal or hepatic impairment, Parkinson's disease, hypothyroidism, heart failure, pheochromocytoma, myasthenia gravis (muscle weakness), or benign prostatic hyperplasia. This medicinal product should also be avoided in patients known to be hypersensitive to phenothiazines, as well as in patients with a history of glaucoma (with narrow drainage angle) or agranulocytosis (reduction in the number of granulocytes - white blood cells in peripheral blood).
Patients with a history of epilepsy or convulsions require close monitoring, as phenothiazine derivatives may lower the seizure threshold.
Due to reports regarding the possible development of agranulocytosis, periodic complete blood counts should be performed. The occurrence of infection symptoms or unexplained fever may indicate blood dyscrasias and may require urgent hematological intervention.
Treatment must be discontinued immediately in case of unexplained fever, as it may be a symptom of neuroleptic malignant syndrome (pallor, hyperthermia - overheating of the body, autonomic dysfunction, altered consciousness, increased skeletal muscle rigidity). Symptoms of autonomic dysfunction, such as sweating and blood pressure fluctuations, may precede the onset of hyperthermia and may serve as early warning signs. Although neuroleptic malignant syndrome may occur due to individual hypersensitivity, predisposing factors include dehydration and organic brain disease.
Symptoms of abrupt prochlorperazine withdrawal, such as nausea, vomiting, and insomnia, have been observed very rarely. After sudden discontinuation of high doses of neuroleptics, a relapse of symptoms may also occur. The possibility of developing extrapyramidal system disorders should be considered. Therefore, gradual discontinuation of the drug is recommended.
Before initiating treatment with Chloropernazinum, the risk-benefit ratio should be carefully evaluated. Patients with risk factors for ventricular arrhythmias (e.g., heart disease), metabolic disorders such as hypokalemia - decreased potassium concentration in blood, hypocalcemia - decreased calcium concentration in blood, or hypomagnesemia - decreased magnesium concentration in blood, malnourished patients, alcohol-dependent patients, and those receiving concomitant therapy with other drugs should be closely monitored (biochemical parameters and ECG), especially during the initial phase of treatment.
Due to the risk of photosensitivity, patients should be advised to avoid exposure to sunlight.
To prevent skin allergies in individuals frequently exposed to medications containing phenothiazine derivatives, special attention should be paid to avoiding direct contact of the drug with the skin.
Chloropernazinum should be used with caution in elderly patients, particularly during very hot or very cold weather (risk of hyperthermia and hypothermia). Elderly patients are especially susceptible to orthostatic drops in blood pressure.
Prochlorperazine should be used cautiously in elderly patients due to their increased sensitivity to drugs acting on the central nervous system; therefore, lower doses are recommended for these patients. In elderly patients during prolonged treatment, there is an increased risk of developing drug-induced parkinsonism (symptoms: tremors and muscle stiffness, bradykinesia). Care should also be taken to properly differentiate adverse drug reactions, such as orthostatic hypotension, from similar symptoms resulting from the underlying disease.
When using Chloropernazinum, blood pressure should be monitored, and periodic blood morphology tests and liver function tests should be performed.
Alcohol consumption is strictly prohibited during treatment.
Consult a physician, even if symptoms occurred in the past.
Warnings and precautions
Elderly patients should receive reduced doses of prochlorperazine and should remain under observation due to their predisposition to develop drug-induced parkinsonism. These symptoms are often irreversible (unresponsive to treatment).
Chloropernazinum and other medicinal products
Inform your physician or pharmacist about all medicinal products currently or recently taken, as well as any medicinal products the patient plans to take.
Adrenaline should not be administered to patients who have overdosed on Chloropernazinum.
The effect of the drug is enhanced by alcohol consumption and when used concomitantly with sedatives. Respiratory depression (suppression of breathing) may also occur.
Anticholinergic drugs may reduce the antipsychotic effect of neuroleptics, while the weak anticholinergic effect of neuroleptics may be intensified by other anticholinergic drugs, leading to constipation or heat stroke.
Medicinal products affecting neuroleptic absorption: antacids, anti-Parkinson drugs, and lithium salts.
If treatment is required for extrapyramidal symptoms induced by Chloropernazinum, consult a physician.
High doses of neuroleptics reduce the effectiveness of antidiabetic drugs.
Neuroleptics may enhance the effect of antihypertensive drugs, especially alpha-receptor blockers.
The action of certain drugs (e.g., amphetamine, levodopa, clonidine, guanethidine, adrenaline) may be blocked by Chloropernazinum. Clinically insignificant increases or decreases in plasma concentrations of many drugs, such as propranolol or phenobarbital, have been observed.
Concomitant administration of deferoxamine and prochlorperazine has caused transient loss of consciousness lasting 48–72 hours.
There is an increased risk of arrhythmias when neuroleptics are used concomitantly with drugs that prolong the QT interval in the electrocardiogram, including certain antiarrhythmics, antidepressants, and other antipsychotics.
There is an increased risk of agranulocytosis when neuroleptics are used concomitantly with drugs that suppress bone marrow function, such as carbamazepine, certain antibiotics, and cytostatics.
Rare reports of neurotoxicity have been reported in patients treated concomitantly with neuroleptics and lithium salts.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a physician or pharmacist before using this medicinal product.
There are insufficient data confirming the safety of prochlorperazine use during pregnancy. Data indicate harmful effects of prochlorperazine on pregnancy in animals. Chloropernazinum should not be used during pregnancy unless absolutely necessary.
Phenothiazine derivatives may pass into breast milk; therefore, breastfeeding should be discontinued during treatment.
Driving and operating machinery
Drowsiness may occur during the first days of treatment; therefore, driving vehicles or operating machinery should be avoided during this period.
Chloropernazinum contains lactose
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking the medicinal product.

3. How to use Chloropernazinum

This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Oral administration.
The usual dose of Chloropernazinum:

• for prevention of nausea and vomiting – 5 to 10 mg two or three times daily;
• for treatment of nausea and vomiting – initially 20 mg; if necessary, an additional 10 mg after 2 hours;
• short-term adjunctive treatment of anxiety – initially 15 to 20 mg daily in divided doses; if necessary, the dose may be increased up to a maximum of 40 mg daily, administered in divided doses;
• treatment of vertigo in Meniere's syndrome – 5 mg three times daily; if necessary, the dose may be increased to 30 mg daily; after several weeks, the dose may be gradually reduced to 5–10 mg daily.

Use in elderly patients
Elderly patients should receive reduced doses of the medicine and must be closely observed due to the risk of developing drug-induced parkinsonism. These symptoms are often irreversible and unresponsive to treatment.
Do not discontinue treatment on your own. The doctor will advise how long to continue taking Chloropernazinum.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Taking more than the recommended dose of Chloropernazinum
Symptoms of overdose include: drowsiness or impaired consciousness, hypotension, tachycardia,
changes in ECG recording, ventricular arrhythmia, and decreased body temperature. Movement disorders may also occur.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist.
If a toxic dose has been taken recently (within 6 hours), gastric lavage should be attempted. Activated charcoal should be administered. There is no specific antidote. Treatment of poisoning is symptomatic.
Missed dose of Chloropernazinum
Take the missed dose as soon as possible, unless it is almost time for the next scheduled dose.
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of the possible adverse effects listed below is defined as follows:

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

In general, adverse effects occur infrequently. The most commonly occurring adverse effects are
neurological disorders.
Disorders of blood and lymphatic system:
Uncommon: mild leukopenia (reduction in the number of white blood cells in blood) occurring in
patients receiving high doses for prolonged periods.
Rare: agranulocytosis (reduction in the number of granulocytes in blood), which is not dose-dependent.
Endocrine disorders:
Frequency unknown: galactorrhea, gynecomastia in males, amenorrhea, impotence.
Nervous system disorders:
Frequency unknown:

• muscle tone disturbances or dyskinesias (involuntary movements), usually transient, more commonly observed in children and adolescents. These usually occur within the first 4 days of treatment or after dose increase;

• akathisia (a feeling of muscular stiffness with motor restlessness), usually occurring after administration of a high initial dose;

• parkinsonism, more commonly occurring in adults and elderly patients. It usually develops after several weeks or months of treatment. One or more of the following symptoms may occur: tremor, increased muscle tone, bradykinesia, or other symptoms characteristic of parkinsonism. Tremor alone is often present;

• tardive dyskinesia (involuntary movements of facial and tongue muscles); if it occurs, it is usually, though not necessarily, caused by long-term use or high doses. These symptoms may even appear after complete discontinuation of the medicine; therefore, it is recommended to use the lowest effective doses;

• insomnia and agitation. Eye disorders, skin and subcutaneous tissue disorders: Frequency unknown: ocular changes and development of a metallic, grey-violet-pink skin discoloration in skin exposed directly to sunlight have been observed in some individuals, mainly women, who have taken Chlorpromazinum for a prolonged period (from 4 to 8 years). Cardiac disorders: Frequency unknown: cardiac arrhythmias, including atrial arrhythmia, atrioventricular block, ventricular tachycardia and ventricular fibrillation, have been reported during treatment with neuroleptics; these were probably related to the dose administered. Concomitant heart disease, advanced age, decreased potassium levels, and concomitant use of tricyclic antidepressants are predisposing factors for ECG changes. Vascular disorders: Common: hypotension, usually orthostatic. Elderly or dehydrated individuals are particularly susceptible. Metabolism and nutrition disorders: Frequency unknown: dry mouth. Respiratory, thoracic and mediastinal disorders: Frequency unknown: possibility of respiratory depression in predisposed individuals. Nasal obstruction may also occur. Hepatic and biliary disorders: Rare: jaundice, usually transient, occurring in patients taking neuroleptics. Prodromal symptoms may include sudden onset of fever after 1–3 weeks of treatment, followed by development of jaundice. Skin and subcutaneous tissue disorders: Rare: contact allergy of the skin, affecting individuals who have contact with products containing certain phenothiazine derivatives. Various types of skin rashes may also occur in patients taking the medicine. Patients receiving high doses of the medicine should be warned that they may develop photosensitivity upon direct exposure to sunlight, and therefore should avoid direct sunlight. General disorders and administration site conditions: Frequency unknown: during treatment with any neuroleptic, neuroleptic malignant syndrome may occur (hyperthermia, stupor with increased skeletal muscle tone, autonomic dysfunction, and altered mental status).

In some individuals during treatment with Chloropernazinum other adverse effects may occur.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a healthcare professional (physician, dentist, pharmacist, nurse, midwife, laboratory diagnostician, paramedic, or pharmaceutical technician).
Adverse effects can be reported either to the marketing authorization holder or directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 492 11 00; Fax: +48 22 492 11 09
Email: [email protected]
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Chloropernazinum

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton. 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. This will help protect the environment.

6. Contents of the pack and other information

What Chloropernazinum contains
The active substance is prochlorperazine maleate.
The other ingredients are: monohydrate lactose (69.8 mg lactose in 1 tablet), potato starch,
gelatin, magnesium stearate, sodium carboxymethyl starch (type A).
What Chloropernazinum looks like and contents of the pack
Available pack sizes:
10 mg tablets, 20 tablets in a blister pack in a cardboard box, with patient leaflet.
Marketing Authorisation Holder and Manufacturer
LABOR Pharmaceutical and Chemical Company Sp. z o.o.
ul. Długosza 49
51-162 Wrocław
tel.: +48 71 325 30 85
fax: +48 71 326 14 57