Fenactil

Patient Information Leaflet

Fenactil
40 mg/g, oral drops, solution
Chlorpromazini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Fenactil is and what it is used for
2. What you need to know 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 Fenactil is and what it is 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 formulated as drops
for oral use only.
Indications:

• psychiatric disorders such as: schizophrenia and other types of psychosis (especially paranoid), manic states, hypomanic states;
• as an adjunct in short-term treatment of anxiety, psychomotor agitation, and sudden or dangerous impulsive behaviors;
• 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

• if the patient is allergic to chlorpromazine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has bone marrow suppression (the bone marrow does not produce blood cells);
• if the patient has kidney or liver failure;
• if the patient has Parkinson's disease;
• if the patient has epilepsy;
• if the patient has hypothyroidism;
• if the patient has heart failure;
• if the patient has a pheochromocytoma (adrenal gland tumor);
• if the patient has myasthenia gravis – a disease characterized by rapid muscle fatigue and excessive weakness of skeletal muscles;
• if the patient has benign prostatic hyperplasia;
• if the patient has hypersensitivity to phenothiazines (medicines used to treat psychiatric disorders, mainly schizophrenia);
• if the patient has agranulocytosis (a significant decrease in the number of granulocytes – a type of white blood cell, leading to increased susceptibility to infections); if use of this medicine is necessary, the doctor may order regular blood tests. In case of unexplained infection or fever, contact your doctor immediately;
• if the patient has narrow-angle glaucoma (an eye disease caused by damage to the optic nerve).

Warnings and precautions
Fenactil should be used with caution if:

• the patient is elderly (over 65 years of age), especially if exposed to high or low temperatures, which may increase or decrease body temperature. In elderly patients, the medicine may cause orthostatic hypotension (dizziness or fainting when rising from a sitting or lying position);
• the patient has epilepsy or a tendency to seizures, as this medicine may increase the risk of epileptic seizures.

If the patient develops unexplained fever during treatment, contact a doctor immediately, as this may indicate the development of neuroleptic malignant syndrome (see section 4: Possible side effects).
Abrupt discontinuation of treatment may cause symptoms of acute withdrawal syndrome (see section: Discontinuing Fenactil).
In patients with schizophrenia, the response to neuroleptic treatment may be delayed. After stopping such medicines, symptoms of the disease may reappear only after some time (after several weeks or months).
If the patient is at risk of ventricular arrhythmias (abnormal heart rhythms), especially if the patient has: heart disease, electrolyte imbalances in the blood (low levels of potassium, calcium, or magnesium), malnutrition, alcohol abuse, or is being treated with other medicines that prolong the QT interval, Fenactil should only be administered if the benefit outweighs the risk. In such patients, the doctor should perform blood biochemical tests and ECG, especially at the beginning of treatment.
Fenactil should not be used as the sole treatment if depression is the main symptom. This medicine may be used in combination with antidepressants when psychosis is also present.
During treatment, avoid exposure to sunlight and tanning (including in solariums), as Fenactil may cause photosensitivity and UV radiation sensitivity.
Fenactil applied to the skin may cause skin discoloration; therefore, protect the skin from accidental contact with the solution.
The medicine may cause urine to turn pinkish to orange in color.

Fenactil and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Exercise particular caution when using Fenactil together with the following medicines:

• adrenaline (used, among others, in resuscitation); it should not be administered to a patient after Fenactil overdose;
• barbiturates (used to treat insomnia and epilepsy) and sedatives, as they enhance the effect of Fenactil, which may lead to respiratory depression (slowed and shallow breathing, apnea, and death due to suffocation);
• anticholinergics (used to treat bronchial asthma or gastrointestinal spasms), as they may weaken the antipsychotic effect of Fenactil and intensify the usually mild anticholinergic effects of Fenactil, leading to constipation, hot flushes, etc.;
• alkalinizing agents (neutralizing excess hydrochloric acid in the stomach), as they reduce the effect of Fenactil;
• lithium-containing medicines (used to treat depression), as they reduce the effect of Fenactil;
• medicines used in Parkinson's disease (e.g. levodopa), as they reduce the effect of Fenactil;
• antihypertensive medicines (e.g. alpha-blockers, guanethidine, propranolol, clonidine), as Fenactil may enhance or reduce their effect or act antagonistically (opposite to the effect of another medicine); regular monitoring of blood pressure is recommended;
• medicines used in diabetes treatment, as high doses of Fenactil reduce their effectiveness; the doctor should adjust the dose of these medicines accordingly;
• amphetamine (a stimulant drug);
• phenobarbital (used to treat epilepsy), as Fenactil affects its blood concentration;
• deferoxamine (used to treat iron overdose), as this may lead to brain dysfunction (transient metabolic encephalopathy, manifesting as loss of consciousness for 48–72 hours);
• medicines that prolong the QT interval (e.g. certain antiarrhythmic, antidepressant, and other antipsychotic medicines), as there is an increased risk of arrhythmias (abnormal heart rhythms);
• myelosuppressive medicines (toxic to the bone marrow, such as carbamazepine – used to treat epilepsy, and certain antibiotics and anticancer drugs), as there is a risk of developing agranulocytosis (reduced number of granulocytes – a type of white blood cell, increasing susceptibility to infections).

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should consult their doctor or pharmacist.

Fenactil and alcohol
Do not consume any alcoholic beverages while taking Fenactil. The medicine is harmful for patients with alcohol-related disorders. Alcohol enhances the effect of the medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Fenactil may be used during pregnancy only if, in the doctor’s opinion, the benefit to the mother outweighs the potential risk to the fetus. The medicine may cause adverse effects on the fetus: apathy (lack of energy) or paradoxical hyperexcitability, seizures, and lower Apgar scores in the newborn.
Fenactil may pass into breast milk; therefore, breastfeeding should be avoided during treatment.
The medicine contains ethanol (see section: The medicine contains alcohol (ethanol), sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate).

Driving and operating machinery
Absolute prohibition of driving vehicles and operating machinery applies during treatment.

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

• This medicine contains 100 mg of alcohol (ethanol) 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 affect adults and adolescents, and its effect in children is probably not noticeable. It may cause some effects in younger children, for example drowsiness.
Alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, they should consult their doctor or pharmacist before using this medicine.

• The medicine contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
• The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).

3. How to take Fenactil

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Recommended dosage
The dosage is determined individually by the doctor 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 behaviours, treatment of childhood schizophrenia and autism

Adults:
initial dose is 25 mg three times daily or 75 mg in the evening, increasing the daily dose by
25 mg until an effective maintenance dose is achieved, ranging from 75 mg to
300 mg; 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 dose of 40 mg per day.
Children aged 6 to 12 years:
up to the adult dose, up to a maximum recommended dose of 75 mg per day.
Elderly or debilitated patients:
initial dose is up to the standard adult dose; 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; maximum daily dose should not exceed
40 mg.
Children aged 6 to 12 years:
0.5 mg per kg of body weight every 4 to 6 hours; maximum daily dose should not exceed
75 mg.
Elderly or debilitated patients:
initial dose is up to the standard adult dose. Treatment should be carried out under strict
medical supervision.

• treatment of hiccups

Adults:
25 mg to 50 mg three or four times daily.
Children aged 1 to 12 years: no data available.
Elderly or debilitated patients: no data available.
Use in children under 1 year of age
Should not be used in children under 1 year of age, except in life-threatening situations.
Taking more than the recommended dose of Fenactil
If more than the recommended dose of Fenactil has been taken, contact a doctor immediately.
Symptoms of overdose:

• drowsiness; loss of consciousness; hypotension (low blood pressure); tachycardia (increased heart rate); changes in ECG; ventricular arrhythmia (heart rhythm disturbances) and hypothermia (significant drop in body temperature). Severe extrapyramidal dyskinesias (involuntary muscle movements, especially of the face and/or tongue) may also occur.

Missed dose of Fenactil
If a dose of Fenactil is missed, 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 regular time.
Do not take a double dose to make up for a missed dose.
Stopping Fenactil
Abrupt discontinuation of treatment may cause acute withdrawal symptoms such as: nausea,
vomiting and insomnia. There may also be a relapse of the disease for which treatment was initiated; therefore,
gradual withdrawal of the medicine is recommended. Extrapyramidal reactions have also been observed:
muscle tone disturbances, involuntary limb movements, tremors.
If discontinuation becomes necessary, the medicine should be withdrawn under strict medical supervision.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms requiring immediate contact with a doctor:

• Allergic reactions (occurring rarely or very rarely), such as:
• Anaphylactic shock (initial symptoms may include: skin rash, facial swelling, swelling of lips or throat, difficulty breathing, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, loss of consciousness, cardiac arrest, death);
• Angioedema (sudden swelling of the face, limbs or joints without itching or pain);
• Bronchospasm (wheezing, shortness of breath);
• Urticaria (bright pink, itchy skin blisters) and various types of skin rashes;
• Systemic lupus erythematosus (a chronic disease caused by disorders of the immune system affecting multiple organs, manifested, among others, by skin changes such as a facial rash, often in the shape of a butterfly);
• Transient jaundice (very rare), manifested by yellowing of the skin and whites of the eyes. A warning sign may be sudden onset of fever 1 week to 3 weeks after starting treatment;
• Neuroleptic malignant syndrome (symptoms include: pallor, hyperthermia - a state of elevated body temperature, autonomic nervous system disturbances (sweating, blood pressure instability may be early warning signs), muscle rigidity, and disturbances of consciousness). Dehydration and organic brain disorders may predispose to the occurrence of neuroleptic malignant syndrome.

Adverse reactions occur rarely during treatment with Fenactil. The most common are disorders of the nervous system:

• Acute dystonias (sustained involuntary muscle contractions causing, for example, twisting or abnormal positioning of limbs);
• Dyskinesias (incoordinated, involuntary movements of limbs or the whole body), usually transient, more common in children and adolescents during the first four days of treatment or after dose increase;
• Tardive dyskinesias may occur during long-term treatment with high doses of Fenactil, even after discontinuation of therapy. The lowest possible doses should be used;
• Akathisia (motor restlessness with a need to frequently change body position), usually occurring after administration of a high initial dose;
• Parkinsonism, more common in adults and elderly patients, usually appearing after several weeks or months of treatment. The most common symptoms are: tremor, rigidity, akinesia (movements become delayed and clumsy);
• Insomnia;
• Agitation.

Additionally, the following may occur:

• Leukopenia (decreased number of leukocytes); rarely agranulocytosis (decreased number of granulocytes – one type of white blood cells);
• Hyperprolactinemia (increased prolactin concentration in blood), which may manifest as galactorrhea (milk discharge from breasts), gynecomastia (enlargement of breast glands in males), amenorrhea and impotence (erectile dysfunction);
• Ocular changes – in some patients, mainly women treated long-term with chlorpromazine (four to eight years), changes in the visual organ and metallic grey-violet-pink discoloration of exposed skin have been observed;
• Cardiac arrhythmia (disturbances in heart rhythm), including atrial arrhythmias, atrioventricular block, ventricular tachycardia, ventricular fibrillation, probably dose-dependent. These symptoms may occur especially in patients with heart disease, in elderly patients (over 65 years), in hypokalemia (low potassium levels in blood), or when tricyclic antidepressants are taken concomitantly. Minor changes in ECG (such as QT interval prolongation, ST segment depression, changes in U and T waves) may be observed;
• Hypotension (reduced blood pressure), usually orthostatic hypotension (dizziness or fainting when rising from sitting or lying position). It occurs especially in elderly patients or those with hypovolemia (reduced blood volume), more frequently after intramuscular administration of Fenactil;
• Dryness of the oral mucosa;
• Respiratory depression (slowed and shallow breathing, apnea, and death due to asphyxiation);
• Nasal congestion (feeling of blocked nose);
• 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 penile erection); if it occurs, contact a doctor immediately, as the patient may require treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Fenactil

Keep this medicine out of 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 stated month. Fenactil may be used within 3
months from the date of first use of the medicine, without exceeding the expiry date stated on
the packaging. The date of first use of the medicine should be entered in this box:
Store below 25 °C. Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Fenactil contains

• The active substance is chlorpromazine hydrochloride. 1 g of the solution contains 40 mg of chlorpromazine hydrochloride.
• 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 a clear, brown-coloured liquid with a characteristic thyme odour.
Pack: amber glass bottle with a polyethylene dropper cap, placed in a cardboard box.
1 bottle containing 10 g.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
Chłodna 56/60, 00-872 Warsaw
Phone: 22 620 90 81 ext. 190, fax: 22 654 92 40
e-mail: [email protected]
The Fenactil package leaflet is available in the Audio Leaflet system via a nationwide toll-free telephone number: 800 706 848.