Hloropernazinum

PATIENT INFORMATION LEAFLET: USER INFORMATION

Chloropernazinum
10 mg, tablets
(Prochlorperazine dimaleate)

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.
• Consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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. Package contents and other information

1. What is Chloropernazinum and what is it used for

Chloropernazinum is a strong antipsychotic medication.
The indication for the use of the medicine is to prevent and treat nausea and vomiting, dizziness
in Meniere's syndrome and labyrinthitis, as well as short-term supportive treatment of anxiety.

2. Important information before taking Chloropernazinum

Do not take Chloropernazinum if you are hypersensitive to prochlorperazine or any of the excipients.

When not to take Chloropernazinum

Avoid taking prochlorperazine in patients with: kidney or liver function disorders,
Parkinson's disease,
hypothyroidism,
heart failure,
chromaffin tumor of the adrenal medulla, myasthenia (muscle weakness), prostate hypertrophy. Avoid taking this medicine in patients known to be hypersensitive to phenothiazines and in patients with a history of glaucoma (with a narrow angle of filtration) or agranulocytosis (decrease in granulocyte count - white blood cells in peripheral blood).
Close monitoring of patients with a history of epilepsy or seizures is required, as phenothiazine derivatives may lower the seizure threshold.
Due to reports of the possibility of developing agranulocytosis, periodic monitoring of full blood morphology is required. The occurrence of infection symptoms or unexplained fever may indicate blood count disorders and may require urgent hematological intervention.
Treatment should be discontinued immediately in case of unexplained fever, as it may be a symptom of malignant neuroleptic syndrome (pallor, hyperthermia - overheating of the body, autonomic disorders, consciousness disorders, increased skeletal muscle tension). Symptoms of autonomic disorders, such as sweating and blood pressure fluctuations, may precede the onset of hyperthermia and may be early warning signs. Although malignant neuroleptic syndrome can occur on the basis of individual hypersensitivity, the predisposing factors are: dehydration and organic brain disease.
Symptoms of sudden withdrawal of prochlorperazine, such as nausea, vomiting, and insomnia, have been observed very rarely. After sudden cessation of high doses of neuroleptics, a relapse of symptoms may also occur. The possibility of developing extrapyramidal system disorders should be considered. Therefore, it is recommended to gradually discontinue the medicine.
Before starting treatment with Chloropernazinum, the risk versus benefit should be carefully considered. Patients with risk factors for ventricular arrhythmias (e.g., heart disease), metabolic disorders, such as hypokalemia - decreased potassium levels in the blood, hypocalcemia - decreased calcium levels in the blood, or hypomagnesemia - decreased magnesium levels in the blood, malnourished, alcohol-dependent, and those taking other medications should be closely monitored (biochemical parameters and ECG), especially in the initial phase of treatment.
Due to the risk of photosensitivity, patients should be advised to avoid exposure to sunlight.
To prevent the occurrence of skin allergies in people who frequently come into contact with medications containing phenothiazine derivatives, special attention should be paid to avoiding direct contact of the medicine with the skin.
In elderly patients, the medicine should be used with caution, especially during very hot or very cold weather (risk of hyperthermia and hypothermia). Elderly patients are particularly prone to orthostatic drops in blood pressure.
Prochlorperazine should be used with caution in elderly patients due to their increased sensitivity to central nervous system-acting medications, and therefore, it is recommended to use smaller doses of the medicine in these patients. In elderly patients, during longer-term use of the medicine, there is an increased risk of developing drug-induced parkinsonism (symptoms: tremors and muscle stiffness, slowed movement). Attention should also be paid to properly distinguishing between side effects of the medicine, e.g., orthostatic drops in blood pressure, from similar symptoms resulting from the underlying disease.
When taking Chloropernazinum, blood pressure and periodic monitoring of blood morphology and liver function tests should be performed.
During treatment, alcohol consumption should be avoided.
Patient should talk to their doctor, also if symptoms have occurred in the past.

Warnings and precautions

Elderly patients should receive reduced doses of prochlorperazine and should be under observation due to the tendency to develop drug-induced parkinsonism symptoms. These symptoms are often irreversible (not responsive to treatment).

Chloropernazinum and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not administer adrenaline to patients after overdosing on Chloropernazinum.
The effect of the medicine is enhanced by drinking alcohol and taking sedatives. Respiratory depression (suppression of breathing) may also occur.
Anticholinergic medications may reduce the antipsychotic effect of neuroleptics, while weak anticholinergic effects of neuroleptics may be enhanced by other anticholinergic medications, leading to constipation, heat stroke.
Medications affecting neuroleptic absorption: antacids, anti-Parkinsonian medications, and lithium salts.
If treatment of extrapyramidal symptoms caused by Chloropernazinum is required, consult a doctor.
High doses of neuroleptics reduce the effectiveness of antidiabetic medications.
Neuroleptics may enhance the effect of antihypertensive medications, especially alpha-receptor blockers.
The effect of certain medications (e.g., amphetamine, levodopa, clonidine, guanethidine, adrenaline) may be blocked by Chloropernazinum. Clinically insignificant increases or decreases in serum levels of many medications, such as propranolol or phenobarbital, have been observed.
Concomitant administration of deferoxamine and prochlorperazine caused transient loss of consciousness for 48-72 hours.
There is an increased risk of arrhythmias during concomitant use of neuroleptics with medications that prolong the QT interval in the electrocardiogram, including some antiarrhythmic, antidepressant, and other antipsychotic medications.
There is an increased risk of agranulocytosis during concomitant use of neuroleptics with medications that suppress bone marrow function, such as carbamazepine, or certain antibiotics and cytostatics.
There are rare reports of neurotoxicity in patients treated concomitantly with neuroleptics and lithium salts.

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.
There is insufficient data to confirm the safety of prochlorperazine during pregnancy. There are data indicating a harmful effect of prochlorperazine on pregnancy in animals. Chloropernazinum should not be used during pregnancy unless it is a necessary medication.
Phenothiazine derivatives may pass into breast milk, so breastfeeding should be discontinued during treatment.

Driving and using machines

Drowsiness may occur during the first days of treatment, so you should not drive or operate machines during this period.

Chloropernazinum contains lactose

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

3. How to take Chloropernazinum

Always take this medicine exactly as your doctor or pharmacist has told you.
In case of doubt, consult your doctor or pharmacist.
Oral administration.
Typically, the recommended dose of Chloropernazinum is:

• for the prevention of nausea and vomiting - 5 to 10 mg twice or three times a day;
• for the treatment of nausea and vomiting - initially 20 mg; if necessary, after 2 hours, an additional 10 mg;
• short-term supportive treatment of anxiety - initially 15 to 20 mg per day in divided doses; if necessary, the dose can be increased to a maximum of 40 mg per day, given in divided doses;
• treatment of dizziness in Meniere's syndrome - 5 mg, three times a day; if necessary, the dose can be increased to 30 mg per day; after a few weeks, the dose can be gradually reduced to 5-10 mg per day.

Use in elderly patients

Elderly patients should receive reduced doses of the medicine and should be closely monitored due to the possibility of developing drug-induced parkinsonism symptoms. These symptoms are often irreversible and not responsive to treatment.
Do not stop treatment on your own. Your doctor will tell you how long to take Chloropernazinum.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Overdose of Chloropernazinum

Symptoms of overdose are: drowsiness or impaired consciousness, hypotension, tachycardia, changes in ECG, ventricular arrhythmia, and decreased body temperature. Movement disorders may occur.
If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.
Within a short time after taking a toxic dose of the medicine (up to 6 hours), an attempt should be made to flush the stomach. 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 already time for the next regular dose.
Do not take a double dose to make up for the missed dose.

4. Possible side effects

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

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

Generally, side effects occur with a low frequency. The most common side effects are disorders of the nervous system.
Blood and lymphatic system disorders:
Uncommon: mild leukopenia (decrease in white blood cell count) occurring in patients taking high doses for a long time.
Rare: agranulocytosis (decrease in granulocyte count), which is not dose-dependent.
Endocrine disorders:
Unknown frequency: galactorrhea, breast enlargement in men, amenorrhea, impotence.
Nervous system disorders:
Unknown frequency:

• muscle tension disorders or dyskinesias (involuntary movements), usually transient, more common in children and adolescents. They usually occur within the first 4 days of treatment or after a dose increase;
• akathisia (feeling of muscle stiffness with motor restlessness) usually occurs after a high initial dose;
• parkinsonism more commonly occurs in adults and elderly patients. It usually develops after several weeks or months of treatment. One or more of the following symptoms may occur: tremors, increased muscle tone, slowed movement, or other symptoms characteristic of parkinsonism. Often, only tremors occur;
• late dyskinesias (involuntary movements of the face and tongue muscles), if they occur, are usually, but not necessarily, caused by long-term use or high doses. These symptoms may occur even after complete discontinuation of the medicine, so it is recommended to use the smallest effective doses of the medicine;

Insomnia and agitation. Eye disorders and skin and subcutaneous tissue disorders: Unknown frequency: eye changes and the development of a metallic, gray-violet discoloration of the skin exposed to direct sunlight have been observed in some people, mainly women, who have taken Chlorpromazine for a long time (from 4 to 8 years). Cardiac disorders: Unknown frequency: cardiac arrhythmias, including atrial arrhythmia, atrioventricular block, ventricular tachycardia, and ventricular fibrillation, have been reported during treatment with neuroleptics; this was probably related to the dose used. Concomitant heart disease, old age, decreased potassium levels, and concomitant use of tricyclic antidepressants are predisposing factors for changes in the ECG. Vascular disorders: Common: orthostatic drops in blood pressure, usually orthostatic. Elderly patients or dehydrated patients are particularly susceptible. Metabolic and nutritional disorders: Unknown frequency: dry mouth. Respiratory, thoracic, and mediastinal disorders: Unknown frequency: possibility of respiratory depression in susceptible individuals. Nasal congestion may also occur. Hepatobiliary disorders: Rare: jaundice, usually transient, occurs in patients taking neuroleptics. A warning sign may be the sudden onset of fever after 1-3 weeks of treatment, followed by jaundice. Skin and subcutaneous tissue disorders: Rare: contact allergy, affecting individuals who come into contact with products containing certain phenothiazine derivatives. Various skin rashes also occur in patients taking the medicine. Patients taking high doses of the medicine should be warned that they may develop photosensitivity during direct exposure to sunlight and should not stay in the sun. General disorders and administration site conditions: Unknown frequency: when using any neuroleptic, a malignant neuroleptic syndrome (hyperthermia, stupor with increased skeletal muscle tension, autonomic disorders, and consciousness disorders) may occur.

Some people may experience other side effects while taking Chloropernazinum.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported to the marketing authorization holder or 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: +48 22 492 11 00; fax: +48 22 492 11 09
e-mail: [email protected]
Reporting side effects will help to gather 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 in a temperature below 25°C.
Store 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 month.
Medicines should 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. Package contents and other information

What Chloropernazinum contains

The active substance of the medicine is prochlorperazine dimaleate.
Other ingredients are: lactose monohydrate (69.8 mg of lactose in 1 tablet), potato starch, gelatin, magnesium stearate, sodium carboxymethyl cellulose (type A).

What Chloropernazinum looks like and what the package contains

Available packages:
10 mg tablets, 20 tablets in a blister pack in a cardboard box, with a patient information leaflet.

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

Date of last revision of the leaflet: