Brand name Largactil 5 mg/ml solution for injection

Form solution for injection

Active substance / Dosage

CHLORPROMAZINE HYDROCHLORide · 27,8 mg

Prescription type Prescription Only Medicine

ATC code

N05A N05AA N05AA01

Registration number 19622

Manufacturer Neuraxpharm Spain S.L.U.

Table of Contents

Package leaflet: Information for the user
Introduction
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 adverse effects
5. Storage of Largactil
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Largactil 5 mg/ml injection solution

Chlorpromazine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Largactil is and what it is used for
What you need to know before using Largactil
How to use Largactil
Possible side effects
How to store Largactil
Contents of the pack and other information

1. What Largactil is and what it is used for

It is an antipsychotic and neuroleptic drug belonging to the group of medicines known as phenothiazines. Its neuroleptic activity is manifested by its sedative effect, which is useful in states of agitation, aggressiveness, and mental distress in psychiatric patients. Chlorpromazine also has significant antiemetic activity (stops or prevents vomiting) and reduces anxiety.

Always under the prescription of your doctor, this medicine is indicated for the treatment of:

Psychomotor agitation states: acute psychoses, manic crises, delirious episodes, confusional syndromes, psychogeriatric conditions, etc.
- Psychotic disorders: schizophrenia, chronic delusional syndromes.
- Sleep cures.

2. What you need to know before using Largactil

Do not use Largactil

if you are allergic (hypersensitive) to chlorpromazine, other phenothiazines, or any of the other components of this medicine (listed in section 6).
if you are at risk of developing increased intraocular pressure (glaucoma).
if you are at risk of urinary retention due to urethral or prostate problems.
- in case of coma caused by alcohol or barbiturate intoxication.
- if you have previously suffered from a disease characterized by a decrease in the number of granulocytes in the blood (agranulocytosis).
- if you are allergic or intolerant to gluten.
- if you are breastfeeding.
- if you are a child under one year of age.
- if you are being treated with citalopram or escitalopram (see section “Use of Largactil with other medicines”).
- if you are being treated with dopaminergic medicines (see section “Use of Largactil with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Largactil:

If your body temperature increases inexplicably, consult your doctor immediately due to the risk of developing a condition called neuroleptic malignant syndrome, described during treatment with this type of medicine, which includes symptoms such as muscle rigidity, increased body temperature, and nervous system disturbances.
If you have risk factors for stroke.
If you have Parkinson’s disease.
If you have epilepsy. Treatment should be discontinued if seizures occur.
If you have serious heart and/or circulatory problems.
If you have liver or kidney disorders.
If you have a history of liver disease.
If you have intestinal obstruction (paralytic ileus).
Ensure the absence of certain factors that favor the occurrence of cardiac rhythm disturbances (ventricular arrhythmia): bradycardia < 55 beats per minute, low blood potassium levels, congenital QT interval prolongation, or if you are taking medicines that may cause the conditions described above.
If your treatment is prolonged, your doctor may recommend an eye examination and blood tests.
In case of fever, sore throat, infection, or mouth ulcers, your doctor will perform a blood test to rule out a possible decrease in a type of white blood cells, granulocytes, or an increase in the number of leukocytes.
If you suffer epileptic seizures. The risk of seizures may increase, so your doctor will monitor you closely and may perform an electroencephalogram.
This type of medicine may increase the risk of cardiac rhythm disturbances (prolongation of the QT interval), which can be severe (torsades de pointes) and potentially fatal. Therefore, your doctor will perform necessary checks to exclude possible risk factors before starting treatment and, if necessary, during treatment.
Elderly patients are more likely to experience sedation and low blood pressure (orthostatic hypotension). Due to the risk of hypotension, you should remain lying down (supine position) for at least half an hour after injection. Elderly patients with increased susceptibility to low blood pressure, sedation, extrapyramidal effects, chronic constipation, or prostate enlargement should be closely monitored.
When administered parenterally: your doctor must have all necessary equipment ready to rapidly initiate intravenous infusion to prevent possible hypovolemia and place you in a dorsal decubitus position if you experience orthostatic hypotension. Position changes should be made cautiously due to the risk of orthostatic hypotension.
In elderly patients with psychosis associated with dementia who are being treated with antipsychotics (possible increased risk of death).
If you have risk factors for thromboembolism (blood clot formation) (see section “4. Possible side effects”).
If you or your caregiver:
notice yellowing of the skin or eyes (jaundice) and urine becomes darker. These could be signs of liver damage.
suspect any allergic reaction while being treated with chlorpromazine.

You must immediately inform a doctor if you experience symptoms such as fatigue (asthenia), loss of appetite, nausea, vomiting, abdominal pain, due to the severe liver toxicity of this medicine, which can sometimes be fatal. Your doctor should immediately initiate investigations including clinical examination and biological assessment of your liver function (see section “4. Possible side effects”).

If you have diabetes mellitus or risk factors for it, since if you use Largactil, you must adequately control your blood glucose (blood sugar levels).
If you are being treated with lithium, other medicines that may prolong the QT interval, or dopaminergic anti-Parkinson medicines (see section “Use of Largactil with other medicines”).
Alcohol consumption or medicines containing alcohol should be avoided (see sections “Use of Largactil with food, drinks, and alcohol” and “Use of Largactil with other medicines”).
Use in children (see section “3. How to use Largactil”).
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Largactil.
DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash accompanied by elevated body temperature, increased liver enzyme levels in blood tests, increased white blood cells (eosinophilia), and enlarged lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking chlorpromazine and contact your doctor or seek immediate medical attention.

Use of Largactil with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Contraindicated combinations

Quinagolide, cabergoline (medicines to treat elevated prolactin hormone levels).
Citalopram and escitalopram (medicines to treat depression).

Not recommended combinations

Medicines to treat Parkinson’s disease such as amantadine, bromocriptine, cabergoline, levodopa, lisuride, pergolide, piribedil, ropinirole.
Levodopa (medicine to treat Parkinson’s disease): if movement disorders occur, your doctor will not prescribe or will replace levodopa with another medicine.
Medicines that may prolong the QT interval (heart disorder): the risk of arrhythmias increases when chlorpromazine is used simultaneously with medicines that prolong the QT interval (including some antiarrhythmics and other antipsychotics such as sultopride) and medicines that may cause electrolyte imbalance.
Alcohol: alcohol intake enhances the sedative effect of Largactil.
Guanethidine (medicine to treat hypertension): concomitant administration with guanethidine reduces its antihypertensive effect.
Sultopride (medicine to treat psychosis): administering Largactil together with sultopride may cause cardiac rhythm disturbances that can be severe (torsades de pointes).
Lithium (medicine to treat bipolar disorder): concomitant administration of lithium and chlorpromazine may cause confusion, increased muscle tone, and increased reflexes.

Combinations requiring caution

Medicines for diabetes treatment: administration of high doses of chlorpromazine (100 mg/day) together with antidiabetic medicines may increase blood glucose levels. Dose adjustment of the antidiabetic medicine may be necessary.
Concomitant administration with antacids (aluminum, magnesium, and calcium salts, oxides, and hydroxides) reduces the absorption of Largactil. Therefore, it is recommended to take them at least two hours apart.
Concomitant administration with CYP1A2 inhibitors leads to increased chlorpromazine concentrations.
A possible interaction exists between CYP2D6 inhibitors, such as phenothiazines (including chlorpromazine), and CYP2D6 substrates. Administration of Largactil with amitriptyline / amitriptyline N-oxide may lead to increased plasma levels of amitriptyline / amitriptyline N-oxide. Possible adverse reactions associated with amitriptyline / amitriptyline N-oxide treatment should be monitored.

Combinations to be aware of

Administration of Largactil with medicines used to lower blood pressure (antihypertensives) increases their effect and the risk of low blood pressure upon standing, possibly causing dizziness.
Medicines acting on the brain, such as: tranquilizers, morphine derivatives, barbiturates, antiallergic medicines, sleep-inducing medicines, medicines for anxiety treatment, benzodiazepines, other non-benzodiazepine anxiolytics, sedative antidepressants, centrally acting antihypertensives, clonidine and related substances, and methadone, enhance the effect of Largactil. They may also cause changes in alertness that make driving or operating machinery dangerous.
Medicines for depression (such as imipramine), antiallergic medicines acting on the brain, tranquilizers, medicines for Parkinson’s disease, medicines for spasms, and disopyramide, when administered together with Largactil, increase the occurrence of the following adverse reactions: urinary retention, constipation, and dry mouth.

Use of Largactil with food, drinks, and alcohol

During treatment, avoid alcoholic beverages. Alcohol enhances sedation.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Pregnancy:

Largactil is not recommended during pregnancy.

Consult your doctor before using this medicine:

if you are a woman of childbearing age and not using effective contraceptive methods, or
if you are pregnant, think you might be pregnant, or plan to become pregnant.

If your doctor considers treatment with Largactil necessary to maintain the mother’s psychological stability, treatment should be initiated and maintained at the effective dose throughout pregnancy.

The following symptoms have been reported in newborns of mothers treated with Largactil during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, feeding problems, slow or fast heart rate, abdominal distension, meconium ileus (an obstruction of the small intestine by meconium), delayed meconium excretion. If your baby develops any of these symptoms, contact your doctor immediately.

Breastfeeding:

If you are breastfeeding, you should not use Largactil, as chlorpromazine passes into breast milk. Your doctor should consider replacing breastfeeding with artificial feeding or discontinuing treatment with Largactil.

Fertility:

Largactil may cause increased secretion of the hormone prolactin (hyperprolactinemia), which may be associated with fertility problems in women.

Driving and using machines

Largactil may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the underlying illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor evaluates your response to this medicine.

Important information about some of the components of Largactil

This medicine may cause serious allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite and anhydrous sodium sulfite.

This medicine contains less than 23 mg of sodium (1 mmol) per 5 ml vial; hence, it is essentially “sodium-free”.

3. How to use Largactil

Follow exactly the instructions given by your doctor for the administration of this medicine.

If in doubt, consult your doctor again if you are unsure about the dose to be used.

Remember to take your medicine.

The usual dose is:

In adults, administered by parenteral route: intramuscular or intravenous infusion, 25 to 50 mg of chlorpromazine (1–2 vials of 5 ml) several times a day, not exceeding, except in particular cases and always at the physician's discretion, 150 mg per day.

Elderly patients ≥ 65 years of age

If you experience any adverse effects, consult your doctor, as your doctor will periodically review the dose.

Use in children

Chlorpromazine must not be administered to children under 1 year of age.
In children aged 1 to 5 years, the recommended dose is 1 mg of chlorpromazine per kg of body weight per day.
From this age onwards, the recommended dose is 1/3 or 1/2 of the adult dose, depending on body weight.

Never change the dose prescribed by your doctor. If you feel that the effect of Largactil is too strong or too weak, inform your doctor or pharmacist.

Your doctor will determine the duration of your treatment with Largactil. Do not stop treatment prematurely.

Method of administration

When Largactil is administered intramuscularly (IM), it must be injected deeply into the muscle. Since the solution is irritating, superficial intramuscular administration should be avoided in order to minimize local reactions.

When Largactil is administered intravenously (IV), it must be given by infusion to minimize local reactions.

If you use more Largactil than you should

Contact your doctor immediately or go to the nearest hospital.

Symptoms of Largactil poisoning may include: seizures, severe parkinsonism, and even coma.

Although there is no specific antidote, in case of accidental poisoning, specialized treatment should be carried out in a hospital setting (gastric lavage and administration of antiparkinsonian drugs and cardiac stimulants intravenously), and respiratory and cardiac monitoring should be performed.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount administered or ingested.

If you forget to use Largactil

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, Largactil may produce adverse effects, although not everyone experiences them.

The classification of possible adverse effects is based on the following frequency data:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data

These may include:

Blood and lymphatic system disorders

Frequency not known: decrease in the overall number of white blood cells (leucopenia), decrease in a type of white blood cells, granulocytes (agranulocytosis), eosinophilia, which is an increase in the number of eosinophils (a type of white blood cells) found in a blood test, thrombocytopenia, which is a decrease in the number of platelets (blood cells that help with clotting) found in a blood test, which may lead to bleeding and bruising (thrombocytopenic purpura).

Immune system disorders

Frequency not known: a chronic, autoimmune, systemic disease that can affect almost any part of the human body (systemic lupus erythematosus), positive antinuclear antibodies (may be observed without evidence of clinical disease).

Endocrine disorders

Common: increased levels of the hormone prolactin in the blood, absence of menstrual periods (amenorrhea).
Frequency not known: abnormal milk secretion (galactorrhea), excessive breast enlargement in men (gynecomastia), impotence, sexual arousal disorders in women.

Metabolism and nutrition disorders

Very common: weight gain.
Common: glucose intolerance.
Frequency not known: high blood glucose levels (hyperglycemia), high triglyceride levels (hypertriglyceridemia), low sodium concentration in blood (hyponatremia), inappropriate secretion of antidiuretic hormone.

Psychiatric disorders

Common: anxiety.
Frequency not known: drowsy state (lethargy), changes in mood.

Nervous system disorders

Very common: sedation and drowsiness (particularly at the start of treatment), disturbances in voluntary movements (dyskinesia, tardive dyskinesia), movement disorder characterized by inability to remain still (akathisia), extrapyramidal syndrome.
Common: increased muscle tone (hypertonia), seizure.
Frequency not known: movement disturbances such as acute dyskinesias (incoordination or difficulty in movement, characterized by contraction of neck, eye, or mouth muscles), reduction or absence of voluntary movement (akinesia), hyperactivity and lack of attention (hyperkinesia), neuroleptic malignant syndrome characterized by muscle rigidity, elevated body temperature, and nervous system disturbances.

Eye disorders

Frequency not known: ocular accommodation disorder, pigment deposits in the anterior segment of the eye.

Cardiac disorders

Common: prolonged QT interval on electrocardiogram, which may trigger heart rhythm disturbances (ventricular arrhythmia).
Frequency not known: heart rhythm disturbances such as ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia, torsade de pointes (a type of arrhythmia), cardiac arrest. Cases of sudden death associated with cardiac disturbances or without apparent explanation have been reported in patients receiving this type of medication.

Vascular disorders

Very common: drop in blood pressure upon standing (orthostatic hypotension).
Frequency not known: blood clot formation (venous thromboembolism) which may affect the lungs (pulmonary embolism), sometimes fatal, and deep vein thrombosis.

Gastrointestinal disorders

Very common: dry mouth, constipation.
Frequency not known: intestinal obstruction and other gastrointestinal disorders such as paralytic ileus, ischemic colitis, gastrointestinal necrosis (sometimes fatal), necrotizing colitis (sometimes fatal), intestinal perforation (sometimes fatal).

Hepatobiliary disorders

Frequency not known: liver damage and cholestatic jaundice. Yellowing of the skin or eyes (jaundice) and darkening of the urine. These could be signs of liver damage.

Cases of hepatocellular, cholestatic, and mixed-type liver injury have been reported, which in some cases may be fatal.

Skin and subcutaneous tissue disorders

Frequency not known: allergic dermatitis, increased sensitivity of the skin to sunlight (erythema, pigmentation), swelling (angioedema), skin rash (urticaria).

Renal and urinary disorders

Frequency not known: urinary retention.

Pregnancy, puerperium, and perinatal conditions

Frequency not known: withdrawal syndrome in newborns.

Reproductive system and breast disorders

Frequency not known: erection in the absence of sexual desire (priapism).

General disorders and administration site conditions

Frequency not known: temperature regulation disorder.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Largactil

Keep out of the sight and reach of children.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Largactil 5 mg/ml injectable solution

The active substance is chlorpromazine. Each 5 ml ampoule contains 25 mg of chlorpromazine (as hydrochloride).
The other components are: ascorbic acid, sodium citrate, sodium chloride, sodium metabisulfite, anhydrous sodium sulfite, and water for injections.

Appearance of the product and contents of the pack

Each pack contains 5 ampoules.

Each ampoule contains 5 ml.