Largactil 40 mg/ml oral solution drops: detailed information

Brand name Largactil 40 mg/ml oral solution drops

Form solution, oral

Active substance / Dosage

CHLORPROMAZINE HYDROCHLORide · 44,58 mg

Prescription type Prescription Only Medicine

ATC code

N05A N05AA N05AA01

Registration number 23661

Manufacturer Neuraxpharm Spain S.L.U.

Largactil 40 mg/ml oral solution drops solution, oral

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 taking Largactil
3. How to take 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 40 mg/ml oral drops solution

Chlorpromazine

Read this entire leaflet carefully before you start taking 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet:

What Largactil is and what it is used for
What you need to know before taking Largactil
How to take Largactil
Possible adverse 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. Chlorpromazine also has marked 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 taking Largactil

Do not take 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 reduced number of granulocytes in the blood (agranulocytosis).
- if you are allergic or intolerant to gluten, do not take Largactil tablets.
- if you are breastfeeding.
- if the patient is under one year of age.
- if you are being treated with citalopram or escitalopram (see section “Taking Largactil with other medicines”).
- if you are being treated with dopaminergic medicines (see section “Taking Largactil with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Largactil:

If your body temperature rises inexplicably, consult your doctor immediately due to the risk of developing a condition known as neuroleptic malignant syndrome, which has been reported during treatment with this type of medicine. Symptoms include muscle rigidity, increased body temperature, and disturbances of the nervous system.
If you have risk factors for stroke.
If you suffer from 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 any 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 may favor the occurrence of cardiac rhythm disturbances (ventricular arrhythmia): bradycardia < 55 beats per minute, low blood potassium levels, congenital QT interval prolongation, or concomitant use of 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 development of mouth ulcers, your doctor will perform a blood test to rule out a possible decrease in a type of white blood cells called granulocytes, or an increase in leukocyte count.
If you suffer from 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 carry out necessary checks to exclude possible risk factors before starting treatment and, if needed, during treatment.
Elderly patients are more likely to experience sedation and low blood pressure (orthostatic hypotension). Elderly patients who are particularly susceptible to low blood pressure, sedation, extrapyramidal effects, chronic constipation, or prostate hypertrophy should be closely monitored.
In elderly patients with dementia-related psychosis 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 darkening of the urine. These may be signs of liver damage.
suspect any allergic reaction while taking 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 potential for severe liver toxicity of this medicine, which may occasionally be fatal. Your doctor should immediately initiate investigations including clinical examination and biological assessment of liver function (see section “4. Possible side effects”).

If you have diabetes mellitus or risk factors for it, since glucose levels (blood sugar) should be carefully monitored while taking Largactil.
If you are being treated with lithium, other medicines that may prolong the QT interval, or dopaminergic anti-Parkinson medicines (see section “Taking Largactil with other medicines”).
Alcohol consumption or medicines containing alcohol should be avoided (see sections “Taking Largactil with food, drinks and alcohol” and “Taking Largactil with other medicines”).
Use in children (see section “3. How to take 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, elevated body temperature, increased liver enzyme levels in blood tests, increased levels of a type of white blood cell (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.

Taking Largactil with other medicines

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

Contraindicated combinations

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

Combinations not recommended

Medicines used to treat Parkinson's disease such as amantadine, bromocriptine, cabergoline, levodopa, lisuride, pergolide, piribedil, ropinirole.
Levodopa (medicine for Parkinson's disease): if movement disorders occur, your doctor will either 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 for treating hypertension): concomitant administration with guanethidine reduces its antihypertensive effect.
Sultopride (medicine for treating psychosis): administering Largactil together with sultopride may cause cardiac rhythm disturbances that can be severe (torsades de pointes).
Lithium (medicine for treating 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. A dose adjustment of the antidiabetic medicine may be necessary.
Concomitant administration with antacids (salts, oxides, and hydroxides of aluminium, magnesium, and calcium) reduces the absorption of Largactil. Therefore, it is recommended to take them at least two hours apart.
Concomitant administration of Largactil with CYP1A2 inhibitors increases 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 increase 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

Concomitant administration of Largactil with medicines used to lower blood pressure (antihypertensives) enhances their effect and increases the risk of low blood pressure upon standing, which may cause dizziness.
Medicines acting on the brain, such as: tranquilizers, morphine derivatives, barbiturates, antihistamines, hypnotics, medicines for anxiety, benzodiazepines, non-benzodiazepine anxiolytics, sedative antidepressants, centrally acting antihypertensives, clonidine and related substances, and methadone, enhance the effect of Largactil and may cause changes in alertness, making driving or operating machinery dangerous.
Medicines for depression (such as imipramine), antihistamines acting on the brain, tranquilizers, medicines for Parkinson's disease, medicines for spasms, and disopyramide, when taken together with Largactil, increase the risk of adverse effects such as urinary retention, constipation, and dry mouth.

Taking 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 that treatment with Largactil is 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 whose mothers received 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 rapid heartbeat, abdominal distension, meconium ileus (an obstruction of the small intestine by meconium), and delayed meconium excretion. If your baby develops any of these symptoms, contact your doctor immediately.

Breastfeeding:

You should not take Largactil if you are breastfeeding, as chlorpromazine passes into breast milk.

Your doctor should consider replacing breastfeeding with artificial feeding or discontinuing treatment with Largactil.

Fertility:

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

Driving and use of machines

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

Largactil 40 mg/ml oral drops in solution contains alcohol

This medicine contains 91.4 mg of alcohol (ethanol) per ml of oral solution, equivalent to 9.14% (w/v). The amount in 1 ml of this oral solution is equivalent to less than 2.3 ml of beer or 0.9 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

Largactil 40 mg/ml oral drops in solution contains sucrose

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

May cause dental caries.

3. How to take Largactil

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

If in doubt, consult your doctor again if you are unsure about the dose you should take.

To facilitate and ensure accurate dosing, the bottle includes a dropper.

Invert the bottle to obtain the prescribed dose.

Remember to take your medicine.

The usual dose is:

In adults, 75 to 150 mg of chlorpromazine divided into 3 doses every 24 hours, starting with low daily doses (25–50 mg) and gradually increasing until the effective dosage is reached. The daily dose of chlorpromazine should not exceed 300 mg, except in special cases and always at the discretion of your doctor.

Elderly patients ≥ 65 years of age

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

Use in children

Chlorpromazine must not be given to children under 1 year of age.
The administration of chlorpromazine oral solution in children under 6 years of age is reserved for exceptional circumstances in a specialized unit.
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 how long your treatment with Largactil should last. Do not stop treatment prematurely.

If you take 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 administered in a hospital setting (gastric lavage and intravenous administration of antiparkinsonian drugs and agents to restore cardiac activity), along with respiratory and cardiac monitoring.

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

If you forget to take Largactil

Do not take a double dose to make up for forgotten 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, the 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 development 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 (hyperglycaemia), high triglyceride levels (hypertriglyceridaemia), low sodium concentration in the blood (hyponatraemia), 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 stay 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), syndrome characterized by hyperactivity, 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 disturbances in heart rhythm (ventricular arrhythmia).

Frequency not known: disturbances in cardiac rhythm 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, ischaemic 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 result in death.

Skin and subcutaneous tissue disorders

Frequency not known: allergic dermatitis, increased skin sensitivity 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: disturbance in temperature regulation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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.

Do not store above 25°C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Largactil 40 mg/ml oral drops solution

The active substance is chlorpromazine. Each ml of solution contains 40 mg of chlorpromazine (as hydrochloride), considering that 1 drop of Largactil drops corresponds to 1 mg of chlorpromazine.
The other components are: 96% ethyl alcohol (ethanol), sucrose, monohydrate citric acid, glycerol, peppermint flavor, ammonium glycyrrhizinate, caramel colorant (E-150), and purified water.

Appearance of the product and contents of the pack

Largactil 40 mg/ml oral drops solution is a brown-colored oral solution.

It is presented in 30 ml glass bottles.