LARGACTIL

Package leaflet: Information for the patient

LARGACTIL 25 mg film-coated tablets, 100 mg film-coated tablets

Chlorpromazine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LARGACTIL is and what it is used for

LARGACTIL contains the active substance chlorpromazine, which belongs to a group of
medicines called antipsychotics, used to treat certain mental illnesses.
This medicine is indicated for the treatment of the following mental disorders:

• schizophrenia, paranoid states, mania, which are diseases characterized by severe behavioral disturbances;
• mental disorders (toxic psychoses) due to intoxication by chemical substances (LSD, amphetamines, cocaine, etc.);
• mental disorders due to brain or systemic alterations accompanied by delirium;
• anxiety, when particularly severe and resistant to treatment with certain medicines (anxiolytics);
• depression, when accompanied by agitation and delirium, in combination with other medicines (antidepressants).

LARGACTIL is also indicated:

• for the treatment of intractable vomiting and intractable hiccough;
• for the treatment of severe pain, generally in combination with other medicines (narcotic analgesics);
• prior to surgery (pre-anaesthetic medication).

2. What you should know before taking LARGACTIL

Do not take LARGACTIL

• if you are allergic to chlorpromazine, substances similar to it (phenothiazines), or to any of the other ingredients of this medicine (listed in section 6);
• if you are in a coma caused by substances such as alcohol, medicines used for sleep disorders (barbiturates), or medicines used to relieve pain (opioids);
• if you have suspected or confirmed brain damage (subcortical brain damage);
• if you suffer from severe depression;
• if you suffer from severe blood disorders (hematological dyscrasias), or severe liver and kidney diseases (hepatic and renal diseases);
• if you have a tumor of the adrenal gland (pheochromocytoma);
• if you suffer from a disease characterized by muscle weakness and fatigue (myasthenia gravis);
• if you suffer from untreated epilepsy;
• if you are breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person who is to take this medicine is in early infancy (See section “Use in children”). The use of Largactil during pregnancy should be reserved, at the physician's discretion, to cases of absolute necessity (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking LARGACTIL.
Use caution with LARGACTIL and inform your doctor in the following cases:

• if you are administering this medicine to a child, especially if the child has an infectious disease, is undergoing surgery, or is to be vaccinated, as this may increase the risk of movement disorders such as stiffness, tremors, slow movements, or difficulty initiating movement (extrapyramidal reactions);
• if you are taking anticancer medicines (cytotoxic agents) that, at high doses, may cause vomiting. In this case, LARGACTIL may mask symptoms of cytotoxic overdose by reducing vomiting (antiemetic effect) (See section “Other medicines and LARGACTIL”);
• if you are elderly;
• if you or someone in your family suffers from heart problems (e.g., congenital QT prolongation);
• if you have lung problems (acute or chronic pulmonary diseases);
• if you suffer from a disease of the optic nerve of the eye (glaucoma);
• if you suffer from an enlarged prostate (prostatic hypertrophy);
• if you suffer from diseases causing narrowing of the stomach, intestines, or urinary tract;
• if you suffer from diseases such as Parkinson’s disease or other movement disorders, as this medicine may increase muscle rigidity;
• if you have a tumor of the breast (mammary neoplasms), because chlorpromazine hydrochloride, especially when taken for prolonged periods and at high doses, may cause an increase in blood levels of a hormone called prolactin;
• if you are undergoing surgery; in this case, lower doses of anesthetics will be required;
• if you are at risk of epilepsy, as this medicine may facilitate the onset of seizures (epileptic crises);
• if you are exposed to sunlight; in this case, you should use special protective creams;
• if you are exposed to extremely high or low temperatures, as you may be at risk of excessive increase or decrease in body temperature;
• if you are at risk of stroke;
• if you or someone in your family has suffered from disorders due to blood clot formation (venous thromboembolism), as LARGACTIL may increase the risk of their occurrence.

This medicine is not indicated if you suffer from memory, language, and thinking problems (dementia); in such cases, an increased risk of cerebrovascular events has been reported.
Do not take LARGACTIL if you are taking other medicines used for mental disorders (neuroleptics) (See section “Other medicines and LARGACTIL”).
During treatment with this medicine, if you experience a marked drop in blood pressure (hypotension), do not use adrenaline (a medicine used to raise blood pressure), as this may worsen symptoms.
This medicine may make it difficult to diagnose certain conditions, including intestinal obstruction, brain tumors, and Reye's syndrome; therefore, inform your doctor that you are taking chlorpromazine before undergoing tests for these conditions.
Take LARGACTIL for short periods and at the lowest effective dose, as prolonged use and high doses may cause involuntary movements, mainly of the facial muscles and tongue (tardive dyskinesia) (See section “Possible side effects”). If you experience these symptoms, stop treatment and inform your doctor immediately.
Prolonged use of this medicine may cause problems in the brain, liver, bone marrow, eyes, heart, and circulation.
During treatment with LARGACTIL, your doctor should perform periodic blood tests (complete blood count), especially between the 4th and 12th week of therapy, and monitor kidney and liver function. Inform your doctor immediately if you develop mouth, nose, or throat inflammation, as these may be due to blood disorders.
Stop treatment and inform your doctor immediately if, during treatment with LARGACTIL, you develop fever (hyperpyrexia), muscle rigidity, movement difficulties (akinesia), changes in blood pressure, sweating, increased heart rate (tachycardia), heart rhythm problems (arrhythmias), or decreased level of consciousness, which may progress to coma. These may be symptoms of a serious condition called Neuroleptic Malignant Syndrome.
If it becomes necessary to restart treatment, your doctor will closely monitor you.

Other medicines and LARGACTIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine in combination with other medicines used for mental disorders (e.g., neuroleptics) or medicines that may alter blood electrolyte levels (See section “Warnings and precautions”).
Take this medicine with great caution and inform your doctor if you are taking the following medicines, as dose adjustments may be necessary:

• barbiturates and hypnotics, used to treat sleep disorders;
• anxiolytics, for the treatment of anxiety;
• anesthetics, used during surgical procedures;
• antihistamines, for the treatment of allergies;
• analgesics and opioids, used for pain relief;
• anticonvulsants, used to treat seizures, such as phenytoin;
• antidepressants, such as serotonin reuptake inhibitors (5HT), used to treat depression.

Take this medicine with great caution and inform your doctor if you are taking the following medicines, as undesirable effects may occur:

• lithium, used to treat certain mental disorders;
• antihypertensives, used to treat high blood pressure;
• anticholinergics, medicines used to treat irritable bowel syndrome, asthma, or incontinence;
• phenylbutazone, used to treat inflammation;
• thiouracil derivatives, used for thyroid disorders;
• medicines that may cause bone marrow damage (myelotoxic agents);
• metrizamide, used as a contrast agent in radiological examinations of the spinal cord;
• lisuride, pergolide, and levodopa, used to treat Parkinson’s disease;
• antacids, used to reduce stomach acidity;
• hypoglycemic agents or insulin, used to treat diabetes;
• antiarrhythmics, used for heart rhythm disorders;
• tricyclic antidepressants, used to treat depression;
• deferoxamine, used in cases of iron accumulation in the blood.

LARGACTIL may cause darkening of the urine, alter the results of certain laboratory tests (amylase, urobilinogen, urinary porphyrins, porphobilinogens, and 5-hydroxy-indoleacetic acid tests), and give a false positive result in pregnancy tests.

LARGACTIL and alcohol
LARGACTIL may enhance the depressant effects of alcohol when taken together.
Avoid drinking alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The risk of harmful effects on the fetus following administration of chlorpromazine cannot be excluded.
Take this medicine only when strictly necessary and under direct medical supervision, as it may cause serious problems for your baby.
During pregnancy, this medicine is used as an antiemetic (to reduce vomiting) only when other medicines cannot be used.

Breastfeeding
Do not take this medicine if you are breastfeeding, as chlorpromazine hydrochloride passes into breast milk (See section “Do not take LARGACTIL”).

Driving and using machines
Avoid driving or operating machinery if you experience sedation or drowsiness.

LARGACTIL contains lactose and castor oil
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhea.

3. How to take LARGACTIL

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose based on the patient's age, the type of illness being treated, and the response to the medicine.
At the beginning of treatment, your doctor will prescribe lower doses, which will then be progressively increased.
The medicine should be administered every 6–8 hours.

Mental disorders (psychiatric disorders)
For patients with mild to moderate symptoms, the recommended dose is 25–75 mg daily, divided throughout the day. The dosage may then be increased until the desired therapeutic effect is achieved. Subsequently, it may be gradually reduced to establish the maintenance dose.
In hospitalized patients, significantly higher doses may be required, according to the specialist’s judgment.

Intractable hiccough
The recommended dose is 25–50 mg, 2–3 times daily.

Preoperative treatment (pre-anesthetic medication)
The recommended dose is 25–50 mg, administered a few hours before surgery.

Use in the elderly
In elderly patients, dosage must be carefully determined by the doctor, who may consider reducing the doses indicated above.

Use in children
For the treatment of mental disorders (psychiatric disorders) in children, the recommended dosage is 1 mg/kg/day, repeated 2–3 times daily if necessary.

If you take more LARGACTIL than you should
An overdose of this medicine may increase the occurrence of adverse effects.
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take LARGACTIL
Do not take a double dose to make up for the missed dose.

If you stop taking LARGACTIL
Do not stop using this medicine abruptly, as this may cause nausea, vomiting, dizziness, tremors, and difficulty remaining still (motor restlessness). Pay particular attention especially if you suffer from depression (psychic depression), as symptoms may worsen after discontinuation of LARGACTIL treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects that may occur are listed below:
Common (may affect up to 1 in 10 people)

• Motor disorders, movement rigidity, tremors, slow movements, or difficulty initiating movement (extrapyramidal symptoms). In particular, extrapyramidal reactions consist of: muscle dystonias characterized by contractions of neck and trunk muscles, leading to torticollis and excessive body extension causing the body to arch (opisthotonos), upward deviation of the eyes (oculogyric crisis), difficulty opening the mouth (trismus), tongue protrusion, and contractions of hands and feet (carpo-pedal spasms). These symptoms are more frequent in children, appear early, and disappear if treatment is discontinued; akathisia, common in children, characterized by motor restlessness and sometimes inability to fall asleep (insomnia), more frequent during the first days of treatment. These symptoms may resolve spontaneously; otherwise, the doctor will monitor them by reducing the dose or providing appropriate therapy;

• pseudo-parkinsonian syndromes, characterized by lack of movement (akinesia), rigidity, resting tremor, more frequent in elderly patients, especially those with brain damage. If necessary, the doctor may decide to reduce the dose or discontinue treatment;

• persistent tardive dyskinesias characterized by rhythmic and involuntary movements, mainly of the tongue, lips, and face, rarely of hands and feet, especially in elderly patients or women and in patients using the medicine for a long time and at high doses. In this case, the doctor may decide to discontinue treatment;

• low blood pressure (hypotension), especially in patients with adrenal gland tumour (pheochromocytoma) and heart problems (mitral insufficiency), increased heart rate (tachycardia), dizziness, temporary loss of consciousness due to low blood pressure (syncope).

Rare (may affect up to 1 in 1,000 people)

• heart rhythm disorders (atrial arrhythmias, AV block, ventricular arrhythmias, torsade de pointes, ventricular tachycardia, ventricular fibrillation), QT interval prolongation, cardiac arrest;
• severe blood disorders, such as decreased number of white blood cells (leucopenia, agranulocytosis), decreased number of platelets (thrombocytopenia), condition characterized by red skin spots and bleeding (purpura), decreased red blood cells (anaemia, haemolytic anaemia), and reduced bone marrow activity (aplastic anaemia).

Very rare (may affect up to 1 in 10,000 people)

• sensation of suffocation (laryngospasm) associated with bluish skin discoloration (cyanosis) and suffocation (asphyxia);
• prolonged involuntary muscle contractions leading to abnormal postures or movements, sometimes painful (tardive dystonia not associated with tardive dyskinesia), a condition that may become irreversible;
• sudden death.

Not known (frequency cannot be estimated from available data)

• neonatal withdrawal syndrome that may occur in newborns of mothers who took this medicine during pregnancy;
• sedation and drowsiness;
• inability to fall asleep (insomnia), restlessness, anxiety, euphoria, agitation in behaviour and movement, depressed mood, or worsening of mental disorders (psychotic symptoms);
• dry mouth, pupil dilation (mydriasis), visual disturbances (visual disorders), constipation (stipsis), intestinal obstruction caused by intestinal paralysis (paralytic ileus), inability of the bladder to empty (urinary retention);
• seizures;
• changes in body temperature that may be due to an allergic reaction to the medicine; in this case, treatment must be discontinued;
• conditions due to accidental inhalation of liquids or ingested substances (affections ab ingestis);
• electrocardiogram alterations;
• allergic-type reactions (hypersensitivity reactions) that may affect the whole body (systemic) or the skin (contact) and skin sensitivity to light (photosensitivity). These reactions manifest as skin irritations and inflammations (erythema, urticaria, eczema), skin peeling (exfoliative dermatitis);
• brownish skin discoloration, especially in sun-exposed areas and with prolonged treatment;
• other allergic-type reactions (hypersensitivity reactions), such as swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (laryngeal edema or angioneurotic edema), sensation of suffocation (laryngospasm), breathing difficulties (bronchospasm), allergic reactions even severe (anaphylactic), allergic reactions causing skin rashes, joint disorders, and blood problems (syndromes resembling systemic lupus erythematosus);
• increased levels of the hormone prolactin (hyperprolactinaemia), reduced levels of hormones regulating sexual functions (estrogens, progesterone, and pituitary gonadotropins);
• breast enlargement, sudden milk production, absence of menstruation (amenorrhoea) in women;
• breast development (gynaecomastia), testicular atrophy, inability to achieve or maintain erection (impotence) in men;
• weight gain, swelling due to fluid accumulation (peripheral oedema), increased blood sugar levels (hyperglycaemia), and presence of sugar in urine (glucosuria);
• liver inflammation with yellowish skin and eye discoloration (cholestatic jaundice), liver problems, and changes in certain blood test values (hyperbilirubinaemia, hypertransaminasaemia, increased alkaline phosphatase, eosinophilia). If liver function is impaired, the doctor will immediately discontinue treatment;
• appearance of particles in the eye that may cause vision problems, condition leading to reduced visual capacity (pigmentary retinopathy). These effects are related to dosage and duration of treatment, therefore the doctor will prescribe periodic checks;
• elevated body temperature (fever) associated with sweating, muscle rigidity, pronounced fatigue or fainting (Neuroleptic Malignant Syndrome) (See section 2 “Warnings and precautions”);
• liver and kidney damage;
• lung inflammation without evident clinical symptoms (silent pneumonia);
• formation of blood clots in veins (venous thromboembolism), including cases of pulmonary embolism and deep vein thrombosis.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You can also report adverse effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store LARGACTIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What LARGACTIL contains
LARGACTIL 25 mg film-coated tablets

• The active substance is chlorpromazine. Each tablet contains 28 mg of chlorpromazine hydrochloride, equivalent to 25 mg of chlorpromazine.
• The other components are: maize starch, lactose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, zein, titanium dioxide, E 172, castor oil.

LARGACTIL 100 mg film-coated tablets

• The active substance is chlorpromazine. Each tablet contains 112 mg of chlorpromazine hydrochloride, equivalent to 100 mg of chlorpromazine.
• The other components are: maize starch, lactose, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, zein, titanium dioxide, E 172, castor oil.

Description of the appearance of LARGACTIL and pack contents
LARGACTIL 25 mg film-coated tablets
Box containing 25 film-coated tablets of 25 mg.
LARGACTIL 100 mg film-coated tablets
Box containing 20 film-coated tablets of 100 mg.
Marketing Authorization Holder
TEOFARMA S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. - Viale Certosa, 8/A - 27100 Pavia
Package leaflet: information for the user

LARGACTIL 50 mg/2 ml injectable solution

Chlorpromazine
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What LARGACTIL is and what it is used for
2. What you need to know before using LARGACTIL
3. How to use LARGACTIL
4. Possible side effects
5. How to store LARGACTIL
6. Package contents and other information

1. What LARGACTIL is and what it is used for

LARGACTIL contains the active substance chlorpromazine, which belongs to a group of
medicines called antipsychotics, used to treat certain mental illnesses.
This medicine is indicated for the treatment of the following mental disorders:

• schizophrenia, paranoid states, mania, which are diseases characterized by severe disturbances in behaviour;
• mental disorders (toxic psychoses) due to intoxication by chemical substances (LSD, amphetamines, cocaine, etc.);
• mental disorders due to brain or systemic alterations accompanied by delirium;
• anxiety, when particularly severe and resistant to treatment with certain medicines (anxiolytics);
• depression, when accompanied by agitation and delirium, in combination with other medicines (antidepressants).

LARGACTIL is also indicated:

• for the treatment of intractable vomiting and persistent hiccups;
• for the treatment of severe pain, generally in combination with other medicines (narcotic analgesics);
• prior to surgery (pre-anaesthetic medication).

2. What you need to know before using LARGACTIL

Do not use LARGACTIL

• if you are allergic to chlorpromazine, to similar substances (phenothiazines), or to any of the other ingredients of this medicine (listed in section 6);
• if you are in a coma caused by substances such as alcohol, medicines used for sleep disorders (barbiturates), or medicines used to relieve pain (opioids);
• if you have suspected or confirmed brain damage (subcortical cerebral damage);
• if you suffer from severe depression;
• if you have serious blood disorders (hematological dyscrasias), or severe liver and kidney diseases (hepatic and renal diseases);
• if you have a tumor of the adrenal gland (pheochromocytoma);
• if you suffer from a disease characterized by muscle weakness and fatigue (myasthenia gravis);
• if you have untreated epilepsy;
• if you are breastfeeding (See section “Pregnancy and breastfeeding”);
• if the person who is to take this medicine is in early infancy (See section “Use in children”).

The use of LARGACTIL during pregnancy should be reserved, at the physician’s discretion, for cases of absolute necessity (See section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using LARGACTIL
This medicine should only be administered to you if the solution is clear, colorless or nearly colorless, and free from visible particles, for single use only, and must not be reused.
Use caution with LARGACTIL and inform your doctor in the following cases:

• if you are administering this medicine to a child, especially if the child has an infectious disease, is about to undergo surgery, or is to receive a vaccination, as in these cases the risk of movement disorders such as muscle rigidity, tremors, slow movements, or difficulty initiating movement (extrapyramidal reactions) may increase;
• if you are taking anticancer medicines (cytotoxic agents) that, at high doses, may cause vomiting. In this case, LARGACTIL may mask symptoms of cytotoxic overdose by reducing vomiting (antiemetic effect) (See section “Other medicines and LARGACTIL”);
• if you are elderly;
• if you or someone in your family has heart problems (e.g., congenital QT prolongation);
• if you have lung problems (acute or chronic pulmonary diseases);
• if you suffer from a disease of the optic nerve of the eye (glaucoma);
• if you suffer from an enlarged prostate (prostatic hypertrophy);
• if you suffer from diseases causing narrowing of the stomach, intestines, or urinary tract;
• if you suffer from diseases such as Parkinson’s disease or other movement disorders, as this medicine may increase muscle rigidity;
• if you have a breast tumor (mammary neoplasia), because chlorpromazine hydrochloride, especially when taken for prolonged periods and at high doses, may cause an increase in blood levels of a hormone called prolactin;
• if you are about to undergo surgery; in this case, lower doses of anesthetics will be required;
• if you are at risk of epilepsy, as this medicine may facilitate the occurrence of seizures (epileptic fits);
• if you are exposed to sunlight; in this case, you should use special sun protection creams;
• if you are exposed to extremely high or low temperatures, as you may be at risk of excessive increase or decrease in body temperature;
• if you are at risk of stroke;
• if you or someone in your family has suffered from disorders due to blood clot formation (venous thromboembolism), as LARGACTIL may increase the risk of such events.

This medicine is not indicated for memory, language, and thinking problems (dementia); in such cases, an increased risk of cerebrovascular events has been reported.
Do not use LARGACTIL if you are taking other medicines used for mental disorders (neuroleptics) (See section “Other medicines and LARGACTIL”).
During treatment with this medicine, if you experience a marked reduction in blood pressure (hypotension), do not use adrenaline (a medicine used to raise blood pressure), as symptoms may worsen.
This medicine may make it difficult to diagnose certain conditions such as intestinal obstruction, brain tumors, and Reye’s syndrome; therefore, inform your doctor that you are taking chlorpromazine before undergoing tests for these conditions.
Use LARGACTIL for short periods and at the lowest effective dose, as prolonged use and high doses may cause involuntary movements, mainly of the facial muscles and tongue (tardive dyskinesia) (See section “Possible side effects”). If you experience these symptoms, stop treatment and inform your doctor.
Prolonged use of this medicine may cause problems affecting the brain, liver, bone marrow, eyes, heart, and circulation.
During treatment with LARGACTIL, your doctor should perform periodic blood tests (complete blood count), especially between the fourth and twelfth week of therapy, and monitor kidney and liver function. Inform your doctor immediately if you develop inflammation of the mouth, nose, or throat, as these may be caused by blood disorders.
Stop treatment and inform your doctor immediately if, during treatment with LARGACTIL, you develop fever (hyperpyrexia), muscle rigidity, movement difficulties (akinesia), changes in blood pressure, sweating, increased heart rate (tachycardia), heart rhythm problems (arrhythmias), or decreased level of consciousness, which may progress to coma. These may be symptoms of a serious condition called Neuroleptic Malignant Syndrome.
If it becomes necessary to restart treatment, your doctor will closely monitor you.
Other medicines and LARGACTIL
Inform your doctor, pharmacist, or nurse if you are currently using, have recently used, or might use any other medicines.
Do not use this medicine in combination with other medicines used for mental disorders (neuroleptics) or with medicines that may alter blood electrolyte levels (See section “Warnings and precautions”).
Use this medicine with great caution and inform your doctor if you are taking the following medicines, as dose adjustments may be necessary:

• barbiturates and hypnotics, used to treat sleep disorders;
• anxiolytics, for the treatment of anxiety;
• anesthetics, used during surgical procedures;
• antihistamines, for the treatment of allergies;
• analgesics and opioids, used for pain relief;
• anticonvulsants, used for the treatment of seizures, such as phenytoin;
• antidepressants, such as serotonin reuptake inhibitors (5HT), used for the treatment of depression;

Use this medicine with great caution and inform your doctor if you are taking the following medicines, as adverse effects may occur:

• lithium, used for the treatment of certain mental disorders;
• antihypertensives, used for the treatment of high blood pressure;
• anticholinergics, medicines used for the treatment of irritable bowel syndrome, asthma, or incontinence;
• phenylbutazone, used for the treatment of inflammation;
• thiouracil derivatives, used for thyroid disorders;
• medicines that may cause bone marrow damage (myelotoxic agents);
• metrizamide, used as a contrast agent in radiological spinal examinations;
• lisuride, pergolide, and levodopa, used for the treatment of Parkinson’s disease;
• antacids, used to reduce stomach acidity;
• hypoglycemics or insulin, used for the treatment of diabetes;
• antiarrhythmics, used for heart rhythm disorders;
• tricyclic antidepressants, used for the treatment of depression;
• deferoxamine, used in cases of iron accumulation in the blood.

LARGACTIL may cause darkening of the urine, alter the results of certain laboratory tests (amylase, urobilinogen, urinary porphyrins, porphobilinogens, and 5-hydroxyindoleacetic acid tests), and give a false positive result in pregnancy tests.
LARGACTIL and alcohol
LARGACTIL may enhance the depressant effects of alcohol when taken together.
Avoid drinking alcoholic beverages during treatment with this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
The risk of harmful effects on the fetus following administration of chlorpromazine cannot be excluded.
Use this medicine only when strictly necessary and under direct medical supervision, as it may cause serious problems for your baby.
During pregnancy, this medicine is used to reduce vomiting (antiemetic) only when other medicines cannot be used.
Breastfeeding
Do not use this medicine if you are breastfeeding, as chlorpromazine hydrochloride passes into breast milk (See section “Do not use LARGACTIL”).
Driving and using machines
Avoid driving or operating machinery if you experience sedation or drowsiness.
LARGACTIL contains sodium, sodium sulfite, and potassium metabisulfite
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is practically “sodium-free”.
This medicine contains anhydrous sodium sulfite and potassium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use LARGACTIL

Use this medicine exactly as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Your doctor will determine the dose based on the patient's age, the type of illness being treated, and the response to the medicine.
At the beginning of treatment, your doctor should prescribe lower doses, which may then be gradually increased. The medicine should be administered every 6–8 hours, and the dose must not exceed 25 mg within the first 24 hours unless your doctor considers it strictly necessary.
For intramuscular administration, the contents of one vial should be diluted with sterile physiological saline solution to a volume of 5–6 ml.
For intravenous administration, the contents of one vial should be diluted with the fluid used for intravenous administration. In any case, transition to oral administration should occur as soon as possible.

Psychiatric disorders
At the beginning of treatment, the recommended dose is 25 mg per day, administered via intramuscular injection, which may be repeated if necessary.
Subsequently, for maintenance therapy, your doctor may decide to switch to oral administration. For hospitalized patients, the doctor may prescribe higher doses.
In hospitalized patients, significantly higher doses may be required, according to the specialist’s judgment.

Vomiting
The recommended dose is 25–50 mg per day, administered via intramuscular injection. If necessary, administration may be repeated 2–3 times daily. Subsequently, for maintenance therapy, your doctor may decide to switch to oral administration.

Intractable hiccough
The recommended dose is 25–50 mg, 2–3 times daily.

Preoperative treatment (pre-anesthetic medication)
The recommended dose is 12.5–25 mg, administered via intramuscular injection a few hours before surgery.

Use in the elderly
In elderly patients, dosage must be carefully determined by the doctor, who may consider reducing the doses indicated above.

Use in children
For the treatment of psychiatric disorders in children, the recommended dosage is 1 mg/kg/day, repeated if necessary 2–3 times daily.

If you use more LARGACTIL than you should
An overdose of this medicine may lead to an increase in adverse effects.
In case of accidental ingestion/overdose of LARGACTIL, contact your doctor immediately or go to the nearest hospital.

If you forget to use LARGACTIL
Do not take a double dose to make up for the missed dose.

If you stop using LARGACTIL
Do not stop using this medicine abruptly, as symptoms such as nausea, vomiting, dizziness, tremors, and difficulty remaining still (motor restlessness) may occur. Pay particular attention especially if you suffer from depression (psychic depression), as symptoms may worsen after discontinuation of LARGACTIL treatment.

If you have any doubts about how to use this medicine, contact your doctor, pharmacist, or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are listed below:
Common (may affect up to 1 in 10 people)

• Movement disorders, movement rigidity, tremors, slow movements or difficulty initiating movement (extrapyramidal symptoms). In particular, extrapyramidal reactions consist of: muscle dystonias characterized by contractions of neck and trunk muscles leading to torticollis and excessive body extension causing the body to arch (opisthotonos), upward deviation of the eyes (oculogyric crisis), difficulty opening the mouth (trismus), protrusion of the tongue, and contractions of hands and feet (carpo-pedal spasms). These symptoms are more frequent in children, appear very early and disappear if treatment is stopped; akathisia, frequent in children, characterized by motor restlessness and sometimes by inability to fall asleep (insomnia), more common during the first days of treatment. These symptoms may resolve spontaneously; otherwise, the doctor will monitor them by reducing the dose or with appropriate therapy; pseudo-parkinsonian syndromes, characterized by lack of movement (akinesia), rigidity, resting tremor, more frequent in elderly patients, especially those with brain damage. If necessary, the doctor may decide to reduce the dose or discontinue treatment; tardive dyskinesias characterized by rhythmic and uncontrollable movements, mainly affecting the tongue, lips and face, rarely hands and feet, especially in elderly patients or women and in patients taking the medicine for a long time and at high doses. In such cases, the doctor may decide to discontinue treatment;
• Low blood pressure (hypotension), especially in patients with adrenal gland tumour (pheochromocytoma) and heart problems (mitral insufficiency), increased heart rate (tachycardia), dizziness, temporary loss of consciousness due to low blood pressure (syncope). To avoid these effects, after injection the patient should remain lying down for 30–60 minutes.

Rare (may affect up to 1 in 1,000 people)

• Heart rhythm disturbances (atrial arrhythmias, AV block, ventricular arrhythmias, torsade de pointes, ventricular tachycardia, ventricular fibrillation), QT interval prolongation, cardiac arrest;
• Severe blood disorders, such as reduced number of white blood cells (leucopenia, agranulocytosis), reduced number of platelets (thrombocytopenia), disease characterized by red skin spots and bleeding (purpura), reduced number of red blood cells (anaemia, haemolytic anaemia), and reduced bone marrow activity (aplastic anaemia).

Very rare (may affect up to 1 in 10,000 people)

• Sensation of suffocation (laryngospasm) associated with bluish skin discoloration (cyanosis) and suffocation (asphyxia);
• Prolonged involuntary muscle contractions leading to abnormal postures or movements, sometimes painful (tardive dystonia not associated with tardive dyskinesia), a condition that may become irreversible;
• Sudden death.

Not known (frequency cannot be estimated from the available data)

• Neonatal withdrawal syndrome that may occur in newborns of mothers who have taken this medicine during pregnancy;
• Sedation and drowsiness;
• Inability to sleep (insomnia), inability to stay still (restlessness), anxiety, euphoria, behavioural and motor agitation, depressed mood or worsening of mental disorders (psychotic symptoms);
• Dry mouth, pupil dilation (mydriasis), visual disturbances (visual disturbances), constipation (stipsis), intestinal obstruction caused by paralysis of the intestine (paralytic ileus), inability of the bladder to empty (urinary retention);
• Seizures;
• Changes in body temperature that may be due to an allergic reaction to the medicine; in this case, treatment must be discontinued;
• Diseases caused by accidental inhalation of liquids or ingested substances (affections ab ingestis);
• Electrocardiogram alterations;
• Allergic-type reactions (hypersensitivity reactions) that may affect the entire body (systemic) or the skin (contact) and skin sensitivity to light (photosensitivity). These reactions manifest as skin irritations and inflammation (erythema, urticaria, eczema), skin peeling (exfoliative dermatitis);
• Brownish skin discoloration, especially in sun-exposed areas and with prolonged treatment;
• Other allergic-type reactions (hypersensitivity reactions), such as swelling of the face, lips, mouth, tongue or throat that may cause difficulty in swallowing and breathing (laryngeal oedema or angioneurotic oedema), sensation of suffocation (laryngospasm), breathing difficulties (bronchospasm), allergic reactions even severe (anaphylactic), allergic reactions causing skin rashes, joint disorders and blood problems (syndromes resembling systemic lupus erythematosus);
• Increased levels of the hormone prolactin (hyperprolactinaemia), reduced levels of hormones regulating sexual functions (estrogens, progesterone and pituitary gonadotrophins);
• Breast enlargement, sudden milk production, absence of menstrual cycle (amenorrhoea) in women;
• Breast development (gynaecomastia), reduced testicle size, inability to achieve or maintain erection (impotence) in men;
• Weight gain, swelling due to fluid accumulation (peripheral oedema), increased blood sugar levels (hyperglycaemia) and presence of sugar in urine (glucosuria);
• Liver inflammation with yellowish discoloration of skin and eyes (cholestatic jaundice), liver problems and changes in certain blood test values (hyperbilirubinaemia, hypertransaminasaemia, increased alkaline phosphatase, eosinophilia). If liver function is impaired, the doctor will immediately discontinue treatment;
• Appearance of deposits in the eye that may cause vision problems, disease leading to reduced visual capacity (pigmentary retinopathy). These effects are dose- and duration-dependent, therefore the doctor will prescribe periodic check-ups;
• High body temperature (fever) associated with sweating, muscle rigidity, marked fatigue or fainting (Neuroleptic Malignant Syndrome) (See section 2 “Warnings and precautions”);
• Liver and kidney damage;
• Lung inflammation without evident clinical symptoms (silent pneumonia);
• Formation of blood clots in the veins (venous thromboembolism), including cases of pulmonary embolism and deep vein thrombosis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LARGACTIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine 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 LARGACTIL 50 mg/2 ml injectable solution contains

• The active substance is chlorpromazine. Each vial contains 55.71 mg of chlorpromazine hydrochloride, equivalent to 50 mg of chlorpromazine.
• The other components are: sodium chloride, anhydrous sodium sulfite, sodium citrate, potassium metabisulfite, water for injections.

Description of the appearance of LARGACTIL and package contents
Box containing 5 vials of 2 ml.
Marketing Authorization Holder
TEOFARMA S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. - Viale Certosa, 8/A - 27100 Pavia
Doppel Farmaceutici S.r.l.
Officina Quinto de Stampi
Rozzano (MI)