FENACTIL 40 mg /G Drops

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Fenactil
3. 40 mg/g, oral drops, solution
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Fenactil and what is it used for
   1. Indications:
5. Important information before taking Fenactil
   1. When not to take Fenactil
   2. Warnings and precautions
   3. Fenactil and other medicines
   4. Fenactil and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. The medicine contains alcohol (ethanol), sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate
6. How to take Fenactil
   1. Recommended dosage
   2. Use in children under 1 year of age
   3. Overdose of Fenactil
   4. Missed dose of Fenactil
   5. Discontinuation of Fenactil treatment
7. Possible side effects
   1. Symptoms requiring immediate contact with a doctor:
   2. Reporting side effects
8. How to store Fenactil
9. Contents of the pack and other information
   1. What Fenactil contains
   2. What Fenactil looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Fenactil

40 mg/g, oral drops, solution

Chlorpromazine hydrochloride

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

1. What is Fenactil and what is it used for

Fenactil belongs to a group of medicines called neuroleptics. It contains the active substance chlorpromazine hydrochloride. The medicine has antipsychotic and antiemetic effects, and to a lesser extent, hypotensive (blood pressure lowering) and sedative effects. It is available in the form of oral drops for exclusive oral use.

Indications:

• Psychiatric disorders, such as: schizophrenia and other types of psychosis (especially paranoid), manic states, hypomanic states;
• As an adjunct in the short-term treatment of anxiety states, psychomotor agitation, violent or dangerous impulsive behavior;
• Childhood schizophrenia and autism;
• Nausea and vomiting, when other medicines are ineffective or unavailable;
• Intractable hiccups.

2. Important information before taking Fenactil

When not to take Fenactil

Warnings and precautions

Fenactil should be used with caution if:

• you are elderly (over 65 years old), especially if you are exposed to high or low temperatures, which can increase or decrease body temperature. In elderly patients, the medicine may cause orthostatic hypotension (dizziness or fainting when standing up from a sitting or lying position);
• you have epilepsy or are prone to seizures, as this medicine may increase the risk of a seizure.

If you develop a fever of unknown origin during treatment, you should contact your doctor immediately, as this may be a sign of a malignant neuroleptic syndrome (see section 4: Possible side effects).
Sudden discontinuation of treatment may cause symptoms of acute withdrawal syndrome (see section: Discontinuation of Fenactil treatment).
In patients with schizophrenia, the response to neuroleptic treatment may be delayed.
If the medicine is discontinued, the symptoms of the disease may reappear only after some time (after several weeks or months).
If you are at risk of arrhythmias (heart rhythm disorders), especially if you have: heart disease, electrolyte disturbances in the blood (decreased potassium, calcium, or magnesium levels in the blood), are malnourished, abuse alcohol, or are taking other medicines that prolong the QT interval, Fenactil should only be administered when the benefit outweighs the risk. In such a patient, the doctor should perform biochemical blood tests and ECG, especially at the beginning of treatment.
Fenactil should not be used as the only medicine if depression is the main symptom. This medicine may be used with antidepressants in cases where psychoses occur simultaneously.
During treatment, you should avoid exposure to sunlight and sunbathing (including in a solarium), as Fenactil may cause sensitivity to sunlight and UV radiation.
Fenactil applied to the skin may cause discoloration, so you should protect your skin from accidental contact with the solution.
The medicine may cause urine to turn pink to orange in color.

Fenactil and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Be especially careful when taking Fenactil with the following medicines:

• adrenaline(a medicine used, among other things, in resuscitation), should not be administered to a patient after an overdose of Fenactil;
• barbiturates(medicines used to treat insomnia and epilepsy) and sedatives, as they enhance the effect of Fenactil, which may lead to respiratory depression (slowing and shallowing of breathing, apnea, and death due to suffocation);
• anticholinergics(used to treat asthma or spastic conditions of the digestive tract), as they may weaken the antipsychotic effect of Fenactil and enhance its anticholinergic effect, leading to constipation, heat strokes, etc.;
• alkalizers(neutralizing excess stomach acid), as they may weaken the effect of Fenactil;
• lithium-containing medicines(used to treat depression), as they may weaken the effect of Fenactil;
• medicines used to treat Parkinson's disease(e.g., levodopa), as they may weaken the effect of Fenactil;
• medicines that lower blood pressure(e.g., alpha-adrenergic blockers, guanethidine, propranolol, clonidine), as Fenactil may enhance or weaken their effect, act antagonistically (opposite to the effect of another medicine); regular blood pressure monitoring is recommended;
• medicines used to treat diabetes, as high doses of Fenactil may reduce their effect; the doctor should adjust the dose of these medicines accordingly;
• amphetamines;
• phenobarbital(a medicine used to treat epilepsy), as Fenactil affects its blood levels;
• deferoxamine(a medicine used to treat iron overdose), as it may lead to brain function disorders (transient metabolic encephalopathy, characterized by loss of consciousness for 48-72 hours);
• medicines that prolong the QT interval(e.g., certain antiarrhythmic medicines, antidepressants, and other antipsychotic medicines), as there is an increased risk of arrhythmias (heart rhythm disorders);
• myelosuppressive medicines(acting toxic to the bone marrow, such as carbamazepine - a medicine used to treat epilepsy, and some antibiotics and anticancer medicines), as there is a risk of developing agranulocytosis (a decrease in the number of granulocytes - one of the types of white blood cells, making you more susceptible to infections).

If you are not sure if you are taking any of the above medicines, ask your doctor or pharmacist.

Fenactil and alcohol

Do not drink any alcoholic beverages while taking Fenactil. The medicine is harmful to people with alcoholism. Alcohol enhances the effect of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Fenactil may be used in pregnant women only when, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus. The medicine may cause side effects in the fetus: apathy (passivity) or paradoxical hyperactivity, seizures, and a lower Apgar score in the newborn.
Fenactil may pass into breast milk, so you should not breastfeed during treatment.
The medicine contains ethanol (see section: The medicine contains alcohol (ethanol), sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate).

Driving and using machines

During treatment, you must not drive or operate machines.

The medicine contains alcohol (ethanol), sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate

• This medicine contains 100 mg of ethanol (alcohol) per 1 g of medicine. The amount of alcohol in 1 g of this medicine is equivalent to 3 mL of beer or 1 mL of wine. The amount of alcohol in 1.875 g of this medicine is equivalent to 5 mL of beer or 2 mL of wine. The amount of alcohol in 25 g of this medicine is equivalent to 63 mL of beer or 25 mL of wine.

The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is likely to be negligible. It may cause some effect in younger children, such as drowsiness.
The alcohol in this medicine may affect the action of other medicines. If you are taking other medicines, ask your doctor or pharmacist for advice.
If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are addicted to alcohol, ask your doctor or pharmacist for advice before taking this medicine.

• The medicine contains sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
• The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).

3. How to take Fenactil

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dosage

The dosage is determined by the doctor individually for each patient.
1 g of Fenactil contains 40 mg of chlorpromazine hydrochloride (31 drops).
1 drop of Fenactil contains 1.29 mg of chlorpromazine hydrochloride.

• treatment of schizophrenia, other psychoses, manic states, anxiety states, psychomotor agitation, and impulsive behavior, treatment of childhood schizophrenia and autism

Adults:
initial dose is 25 mg 3 times a day or 75 mg in the evening, increasing the daily dose by 25 mg until an effective maintenance dose is achieved, which is between 75 mg and 300 mg, and in some patients up to 1 g.
Children aged 1 to 6 years:
0.5 mg per kg of body weight every 4 to 6 hours, up to a recommended daily dose of 40 mg.
Children aged 6 to 12 years:
up to the adult dose, up to a maximum recommended daily dose of 75 mg.
Elderly or debilitated patients:
initial dose is half the usual adult dose, and the dose should be increased gradually.

• treatment of nausea and vomiting

Adults:
10 mg to 25 mg every 4 to 6 hours.
Children aged 1 to 6 years:
0.5 mg per kg of body weight every 4 to 6 hours, with a maximum daily dose not exceeding 40 mg.
Children aged 6 to 12 years:
0.5 mg per kg of body weight every 4 to 6 hours, with a maximum daily dose not exceeding 75 mg.
Elderly or debilitated patients:
initial dose is half the usual adult dose. Treatment should be carried out under close medical supervision.

• treatment of hiccupsAdults: 25 mg to 50 mg 3 or 4 times a day.

Children aged 1 to 12 years: no data available.
Elderly or debilitated patients: no data available.

Use in children under 1 year of age

Do not use in children under 1 year of age, except in life-threatening situations.

Overdose of Fenactil

In case of overdose, contact your doctor immediately.
Symptoms of overdose:

• drowsiness; loss of consciousness; hypotension (low blood pressure); tachycardia (rapid heart rate); changes in ECG; ventricular arrhythmia (heart rhythm disorder) and hypothermia (significantly lowered body temperature). Severe extrapyramidal dyskinesias (involuntary movements of the face and/or tongue) may occur.

Missed dose of Fenactil

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Discontinuation of Fenactil treatment

Sudden discontinuation of treatment may cause symptoms of acute withdrawal syndrome, such as nausea, vomiting, and insomnia. It may also lead to a recurrence of the disease that was the reason for treatment, so it is recommended to gradually discontinue the medicine. Extrapyramidal reactions, such as muscle tone disorders, involuntary movements of the limbs, and tremors, have been observed.
If it is necessary to discontinue the medicine, it should be done under close medical supervision.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fenactil can cause side effects, although not everybody gets them.

Symptoms requiring immediate contact with a doctor:

• allergic reactions(rare or very rare), such as:
• anaphylactic shock(the first symptoms may be: skin rash, facial swelling, swelling of the lips or throat, difficulty breathing, wheezing, shortness of breath, imperceptible pulse, significantly lowered blood pressure, sweating, loss of consciousness, cardiac arrest, and death);
• angioedema(sudden swelling of the face, limbs, or joints without itching or pain);
• bronchospasm(wheezing, shortness of breath);
• urticaria(pink, itchy blisters on the skin) and various skin rashes;
• systemic lupus erythematosus(a chronic disease caused by immune system disorders, affecting many organs, characterized by skin changes, such as a butterfly-shaped rash on the face);
• transient jaundice(very rare) characterized by yellowing of the skin and whites of the eyes. A warning sign may be the sudden onset of fever 1 to 3 weeks after starting treatment;
• malignant neuroleptic syndrome(whose symptoms are: pallor, hyperthermia - a state of elevated body temperature, autonomic nervous system disorders (sweating, unstable blood pressure may be the first warning signs), muscle stiffness, and impaired consciousness). Dehydration and organic brain diseases may predispose to the development of malignant neuroleptic syndrome.

Side effects occur rarely during Fenactil treatment. The most common ones are nervous system disorders:

• acute dystonias(persistent involuntary muscle contractions causing, for example, twisting or abnormal positioning of the limbs);
• dyskinesias(uncoordinated and involuntary movements of the limbs or the whole body), usually short-term, more common in children and adolescents during the first four days of treatment or after increasing the dose;
• late dyskinesiasthat may occur during long-term use of high doses of Fenactil, even after discontinuation of treatment. The smallest possible doses of the medicine should be used;
• akathisia(motor restlessness with a need for frequent changes in body position) usually occurs after administration of a high initial dose;
• parkinsonismmore common in adults and the elderly, usually after several weeks or months of treatment. The most common symptoms are: tremors, stiffness, akinesia (body movements become delayed and inefficient);
• insomnia;
• agitation.

Additionally, the following may occur:

• leukopenia(decrease in the number of leukocytes); rarely, agranulocytosis(decrease in the number of granulocytes - one of the types of white blood cells) may occur;
• hyperprolactinemia(elevated prolactin levels in the blood), which may manifest as galactorrhea (milk leakage from the breasts), gynecomastia (breast enlargement in men), amenorrhea (absence of menstruation), and impotence (erectile dysfunction);
• eye changes- in some patients, especially women treated with chlorpromazine for a long time (from four to eight years), changes in the eyes and metal-gray-violet discoloration of exposed skin have been observed;
• heart arrhythmias(heart rhythm disorders), including atrial arrhythmias, atrioventricular block, ventricular tachycardia, atrial fibrillation, likely dose-dependent. These symptoms may occur, especially if you have heart disease, are elderly (over 65 years old), have hypokalemia (elevated potassium levels in the blood), or are taking other medicines that prolong the QT interval. Minor changes in ECG (such as: QT interval prolongation, ST segment depression, changes in U and T waves) are observed;
• hypotension(low blood pressure), usually orthostatic hypotension(dizziness or fainting when standing up from a sitting or lying position). It occurs, especially in the elderly or with hypovolemia (decreased blood volume), more common after intramuscular administration of Fenactil;
• dryness of the mucous membranes of the mouth;
• respiratory depression(slowing and shallowing of breathing, apnea, and death due to suffocation);
• decreased nasal patency(feeling of nasal congestion);
• increased skin sensitivity to sunlight and UV radiation, especially in patients taking high doses of the medicine (see section: Warnings and precautions);
• contact allergy- may occur rarely, in case of frequent skin contact with the medicine;
• priapism(painful erection), if it occurs, you should contact your doctor, as you may need 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
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fenactil

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month. Fenactil can be used for 3 months from the date of first use, without exceeding the expiry date stated on the packaging. In this window, you should enter the date of first use of the medicine:
Store in a temperature below 25°C. Store in the original packaging.
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 Fenactil contains

• The active substance of the medicine is chlorpromazine hydrochloride. 1 g of solution contains 40 mg of chlorpromazine hydrochloride.
• The other ingredients are: ethanol 96% (v/v); glycerol (E 422); liquid thyme extract; citric acid monohydrate (E 330); sucrose; methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216); purified water.

What Fenactil looks like and contents of the pack

The medicine is in the form of oral drops. The solution is clear, brown in color, and has a characteristic thyme odor.
Packaging: a brown glass bottle with a polyethylene cap and a dropper, in a cardboard box.
1 bottle of 10 g.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60, 00-872 Warsaw
tel.: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The content of the Fenactil leaflet is available in the Ulotka Audio system at the national, toll-free phone number: 800 706 848.

Date of last revision of the leaflet: