Active ingredients: Zuclopentixolo (Zuclopentixolo dihydrochloride)
CLOPIXOL 10 mg film-coated tablets CLOPIXOL 25 mg film-coated tablets
Clopixol package inserts are available for pack sizes:- CLOPIXOL 10 mg film-coated tablets CLOPIXOL 25 mg film-coated tablets
- CLOPIXOL 20 mg / ml oral drops, solution
- CLOPIXOL 50 mg / ml solution for injection for intramuscular use suglopentixol acetate
Why is Clopixol used? What is it for?
Clopixol contains the active ingredient suglopentixol. Clopixol belongs to a group of medicines called antipsychotics (also called neuroleptics). These medicines work on the nerve centers in specific areas of the brain, helping to correct certain chemical imbalances in the brain that cause your symptoms to be unwell.
Clopixol is indicated for the treatment of acute and chronic schizophrenia and other dissociative syndromes characterized by symptoms such as hallucinations, agitation, psychomotor excitement, hostility, aggression and affective disorders.
Manic phase of manic-depressive psychosis.
In organic mental syndromes (mental retardation) accompanied by delirium, psychomotor hyperexcitability, agitation.
Contraindications When Clopixol should not be used
Do not take Clopixol
- if you are allergic (hypersensitive) to suglopentixol or any of the other ingredients of this medicine
- in case of acute intoxication with alcohol, barbiturates and opiates; comatose states.
In the absence of clinical data on safety and efficacy of Zuclopentixol in children, the product should not be used in pediatric age.
Precautions for use What you need to know before taking Clopixol
Talk to your doctor or pharmacist before taking Clopixol if:
- have liver problems
- suffer from convulsions or seizures
- if you are diabetic (the dose of your antidiabetic therapy may need to be adjusted)
- have organic brain syndrome (which may be the result of alcohol or organic solvent poisoning)
- have risk factors for stroke (such as smoking, hypertension)
- have hypokalaemia or hypomagnesaemia (low potassium or magnesium in the blood) or if you have a genetic predisposition for any of these conditions
- have cardiovascular disease or a family history of QT prolongation
- is on therapy with other neuroleptics
- You or someone in your family has a history of thrombotic events, as drugs such as these have been associated with thrombus formation
- If you have been told that you have a low white blood cell count (e.g. leukopenia, neutropenia or agranulocytosis).
Children and adolescents
The use of Clopixol in this patient group is not recommended
Interactions Which drugs or foods can modify the effect of Clopixol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Tricyclic antidepressants
- Guanethidine or other similar medicines (used to lower blood pressure)
- Barbiturates or similar medicines (which make you sleepy)
- Medicines used to treat epilepsy
- Levodopa and similar medicines (used to treat Parkinson's disease)
- Metoclopramide (used to treat some gastrointestinal disorders)
- Piperazine (used in the treatment of some gastrointestinal infestations)
- Medicines that alter the water-salt balance (which excessively deplete potassium or magnesium in the blood)
- Medicines known to increase the concentration of Clopixol in the blood.
The following medicines must not be taken together with Clopixol:
- Medicines that modify the heartbeat (such as quinidine, amiodarone, sotalol, erythromycin, terfenadine, astemizole, moxifloxacin, cisapride, lithium).
- Other antipsychotics (such as haloperidol, droperidol, pimozide).
Clopixol with food, drink and alcohol
Clopixol can be taken on a full or empty stomach.
Clopixol enhances the sedative effect of alcohol by increasing the sense of drowsiness.
It is recommended not to consume alcohol while taking Clopixol.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant or think you are pregnant.
Clopixol should not be used during pregnancy unless clearly necessary.
The general condition of the newborn may be affected by the use of this medicine.
The following symptoms have been observed in newborn babies of mothers who have taken conventional or atypical antipsychotics, including Clopixol, during the last trimester (last three months) of pregnancy: shaking, muscle stiffness and / or weakness, sleepiness, agitation, breathing problems and difficulty in food intake. If your baby shows any of these symptoms, please contact your doctor.
Feeding time
If you are breastfeeding, ask your doctor or pharmacist for advice before taking any medicine.
Clopixol should not be used during breastfeeding, as small amounts of this medicine can pass into breast milk.
Fertility
Animal studies have shown that Clopixol affects fertility. Ask your doctor for advice before taking this medicine.
Driving and using machines
You may feel sleepy or dizzy when taking Clopixol, particularly in the initial phase of treatment. In these cases, you should not drive, use tools or machines until these symptoms have disappeared.
Clopixol film-coated tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Clopixol film-coated tablets contain hydrogenated castor oil.
It can cause stomach upset and diarrhea.
Dose, Method and Time of Administration How to use Clopixol: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The dosage should be adjusted individually and according to the patient's condition. In general, therapy should be started with low doses to quickly reach the optimal dose according to the individual therapeutic response.
The recommended dose is:
Adults
Acute schizophrenia and other acute dissociative syndromes. Severe states of acute agitation.
Manic states
Oral treatment: generally 10-50 mg per day. In moderate or severe cases, start with 20 mg per day and increase by 10-20 mg every 2-3 days to 75 mg or more per day.
Chronic schizophrenia and other chronic dissociative syndromes
Oral treatment: the maintenance dose is generally 20-40 mg per day.
States of agitation in patients with mental retardation
Oral treatment: 6-20 mg per day. The dose can be increased to 25-40 mg per day as needed.
Use in children and adolescents
The use of Clopixol in children and adolescents is not recommended.
Overdose What to do if you have taken too much Clopixol
If you take more Clopixol than you should
In case of accidental ingestion / intake of an overdose of Clopixol, notify your doctor immediately or go to the nearest hospital. Do this even if you have no signs of being unwell or poisoning. Take the Clopixol pack with you if you go to a doctor or hospital.
Symptoms of overdose can include:
- drowsiness
- loss of consciousness
- muscle movements or stiffness
- convulsions
- low blood pressure, weak pulse, rapid heartbeat, paleness, agitation
- low or high body temperature.
When Clopixol was overdosed with other medicines known to affect heart activity, changes in the heart beat, including slowing or irregular heartbeat, were observed.
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
If you forget to take Clopixol
If you forget to take a Clopixol tablet, take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Clopixol
Your doctor will decide when and how you should stop taking Clopixol in order to avoid the appearance of unpleasant symptoms due to abrupt discontinuation of treatment (e.g. difficulty falling asleep, muscle stiffness, feeling unwell).
If you have any further questions on the use of Clopixol, ask your doctor or pharmacist.
Side Effects What are the side effects of Clopixol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, contact your doctor or go to a hospital straight away:
Uncommon (more than 1 in 1,000 patients and less than 1 in 100 patients):
- Tardive dyskinesia (disease characterized by early symptoms such as unusual movement of the mouth and tongue).
Very rare (in less than 1 out of 10,000 patients):
- Neuroleptic Malignant Syndrome (rare condition presenting with the following symptoms: high fever, unusual muscle stiffness, disturbed consciousness associated with sweating and rapid heartbeat);
- Jaundice (yellowing of the skin and whites of the eyes); cholestatic hepatitis.
The following side effects are most pronounced at the start of treatment and most of these tend to wear off during treatment:
Very common (in 1 or more in 10 patients):
- Drowsiness, akathisia (inability to sit still or stay still), hyperkinesia (involuntary movements), hypokinesia (slow or slowed movements);
- Dry mouth.
Common (in 1 or more in 100 patients and less than 1 in 10 patients):
- Tachycardia (rapid heartbeat), palpitations (feeling of having a rapid, firm, or irregular heartbeat);
- Tremor, dystonia (twisting or repetitive movements or abnormal posture caused by sustained muscle contractions), hypertonia (increased muscle stiffness), dizziness, headache, paraesthesia (sensation of tingling, tingling or numbness of the skin), disturbance in attention, amnesia , abnormal gait;
- Visual accommodation disturbance (difficulty focusing on an object near the eye), visual disturbances;
- Vertigo (sensation of spinning or rocking while the body is still);
- Nasal congestion (congestion of the nasal passages), wheezing (difficulty in breathing or pain in breathing);
- Salivary hypersecretion (increased salivary secretion), constipation, vomiting, dyspepsia (digestive problems or disorders localized in the upper abdomen), diarrhea;
- Disorders of urination (urinary disorders), urinary retention (inability to urinate) polyuria (increased volume of urine);
- Hyperhidrosis (increased sweating), itching;
- Myalgia (muscle aches);
- Increased appetite, body weight gain;
- Tiredness, asthenia (weakness), malaise (general feeling of discomfort or malaise), aches;
- Insomnia (difficulty sleeping), depression, anxiety, nervousness, intense dreams, agitation, decreased libido (decreased sexual desire).
Uncommon (in more than 1 in 1,000 patients and less than 1 in 100 patients):
- Hyperreflexia (hyperactive or hyper reactive reflexes), dyskinesia (jerky movements), parkinsonism, syncope (fainting), ataxia (inability to coordinate muscle activity), speech disorders, hypotonia (decreased muscle tone), convulsions, migraine;
- Oculogyric crisis (circular movement of the eye), mydriasis (dilated pupils);
- Hyperacusis (hypersensitivity to certain noises or difficulty tolerating habitual noises), tinnitus (noises in the ears);
- Abdominal pain, nausea, flatulence;
- Rash, photosensitivity reaction (skin reaction due to sensitivity to light), pigmentation disorders, seborrhea (skin that is chapped, shiny and yellow due to increased sebum secretion), dermatitis (eczema or inflammation of the skin), purpura (bleeding of the skin recognizable by red or dark red spots);
- Muscle stiffness, trismus (inability to open the mouth easily), stiff neck (twisting of the neck and unnatural position of the head, stiffness or immobility of the neck);
- Decreased appetite, loss of body weight;
- Hypotension (low blood pressure), hot flashes;
- Thirst, hypothermia (unusually low body temperature), pyrexia (fever);
- Liver function tests abnormal
- Sexual disorders (delayed ejaculation, erection problems, women may have difficulty reaching orgasm), vulvovaginal dryness (vaginal dryness);
- Apathy (marked indifference to what is happening), nightmares, increased libido (increased sexual desire), confusion.
Rare (in more than 1 out of 10,000 patients and less than 1 out of 1,000 patients):
- Thrombocytopenia (low blood platelet count), neutropenia (low white blood cell count), leukopenia (decreased white blood cell count), agranulocytosis (spinal cord toxicity);
- Hyperprolactinemia (increase in the level of prolactin in the blood);
- Hyperglycemia (increased blood glucose), decreased glucose tolerance, hyperlipidemia (increased blood fat levels);
- Hypersensitivity (marked sensitivity), anaphylactic reactions (acute and severe systemic allergic reactions);
- Gynecomastia (development of breasts in a man), galactorrhea (excessive milk production), amenorrhea (lack of menstruation), priapism (painful and continuous erection of the penis without arousal or sexual desire).
Rare cases of QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest have been observed with Clopixol and other drugs of the same therapeutic class as antipsychotics. Very rare cases of sudden death.
Venous thrombi, especially in the legs (symptoms include swelling, pain and redness in the leg), which can travel up through blood vessels to the lungs, causing chest pain and difficulty in breathing. If you notice any of these symptoms, consult your doctor immediately.
In older people with dementia, a small increase in the number of deaths has been reported among patients taking antipsychotics compared with those not taking them.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
The expiry date refers to the last day of that month
Store at a temperature below 25 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Clopixol contains
The active ingredient is suglopentixol (as dihydrochloride)
Each film-coated tablet of Clopixol contains 10 or 25 mg of suglopentixol
The other components are: potato starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerin 85%, talc, hydrogenated castor oil and magnesium stearate.
Coating: hypromellose 5 and macrogol 6000.
Dyes: titanium dioxide (E 171) and red iron oxide (E 172).
Description of what Clopixol looks like and contents of the packs
Clopixol comes as 10 mg or 25 mg film-coated tablets.
The 10 mg film-coated tablets are pale red-brown, round, biconvex.
The 25 mg film-coated tablets are red-brown, round, biconvex.
Clopixol film-coated tablets are available in the following pack sizes: 10 mg:
30 tablets in blister packs.
25 mg: 20 tablets in blister packs
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CLOPIXOL 10 - 25 MG TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clopixol 10 mg film-coated tablets
Each tablet contains:
10 mg of Zuclopentixol (equal to 11.82 mg of Zuclopentixol dihydrochloride).
Clopixol 25 mg film-coated tablets
Each tablet contains:
25 mg of Zuclopentixol (equal to 29.55 mg of Zuclopentixol dihydrochloride).
Excipients with known effects:
Lactose monohydrate, hydrogenated castor oil.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Film-coated tablets (tablets).
10 mg: pale red-brown, round, biconvex film-coated tablet.
25 mg: red-brown, round, biconvex film-coated tablet.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Acute and chronic schizophrenia and other dissociative syndromes characterized by symptoms such as hallucinations, agitation, psychomotor excitement, hostility, aggression and affective disorders.
Manic phase of manic-depressive psychosis.
In organic mental syndromes (mental retardation) accompanied by delirium, psychomotor hyperexcitability, agitation.
04.2 Posology and method of administration
Dosage
Adults
The dosage should be adjusted individually and according to the patient's condition. In general, therapy should be started with low doses to rapidly reach the optimal dose according to the individual therapeutic response.
Acute schizophrenia and other acute dissociative syndromes. Severe states of acute agitation. Manic states
Oral treatment: generally 10-50 mg per day. In moderate or severe cases, start with 20 mg per day and increase by 10-20 mg every 2-3 days to 75 mg or more per day.
Chronic schizophrenia and other chronic dissociative syndromes
Oral treatment: the maintenance dose is generally 20-40 mg per day.
States of agitation in patients with mental retardation
Oral treatment: 6-20 mg per day. The dose can be increased to 25-40 mg per day as needed.
Children
The use of Clopixol in children is not recommended.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Acute intoxication with alcohol, barbiturates and opiates. Comatose states. In the absence of clinical data on safety and efficacy of Zuclopentixol in children, the product should not be used in pediatric age.
04.4 Special warnings and appropriate precautions for use
The intake of any neuroleptic involves the possibility of developing a neuroleptic malignant syndrome (hyperthermia, muscle stiffness, fluctuating state of consciousness, autonomic nervous system instability). The risk may be greater with more potent drugs. Cases with a fatal outcome. they are most often associated with patients with pre-existing organic brain syndrome, mental retardation, and opioid and alcohol abuse.
Treatment: discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine can help.
Symptoms may persist for more than a week after discontinuation of oral neuroleptics and for a longer period of time when combined with drugs with "depot" formulations.
Like other neuroleptics, Zuclopentixol should be administered with caution in patients with organic brain syndrome, seizures and severe liver disease.
As described for other psychotropic drugs, suglopentixol may alter the response to insulin and glucose, making it necessary to adjust antidiabetic therapy in diabetic patients.
Patients on therapy for a long time, particularly those treated at high doses, should be carefully monitored and periodically it is necessary to evaluate the possible reduction of the maintenance dose.
As with other drugs belonging to the therapeutic class of antipsychotics, Zuclopentixol can cause QT interval prolongation. Persistent QT prolongation can increase the risk of malignant arrhythmia.
For this reason, Zuclopentixol should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesaemia or genetic predisposition) and in patients with previous cardiovascular disorders, such as QT interval prolongation, significant bradycardia (beats per minute), a recent acute myocardial infarction , heart failure or cardiac arrhythmia, or with a family history of QT interval prolongation.
Avoid concomitant therapy with other neuroleptics (see section 4.5).
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE must be identified before and during treatment with Zuclopentixol and preventive measures taken.
Cases of leukopenia, neutropenia and agranulocytosis have been reported following administration of antipsychotic drugs, including suglopentixol.
Senior citizens
Cerebrovascular events
An approximately three-fold increase in the risk of cerebrovascular events was observed in randomized placebo-controlled clinical trials in a population of patients with dementia treated with some atypical antipsychotics. The mechanism of this increased risk is unknown.An increased risk for other antipsychotics or other patient populations cannot be excluded. Zuclopentixol should be used with caution in patients with stroke risk factors.
Increased mortality in elderly patients with dementia
Data from two large-scale observational studies have shown that elderly people with dementia treated with antipsychotics have a slightly increased risk of death compared to those who have not been treated. There are insufficient data to provide an accurate estimate of the exact magnitude of the risk and the cause of the increased risk is unknown.
Zuclopentixol is not indicated for the treatment of dementia-related behavioral disorders.
Important information about some of the ingredients
Clopixol film-coated tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Clopixol film-coated tablets contain hydrogenated castor oil, can cause stomach upset and diarrhea.
04.5 Interactions with other medicinal products and other forms of interaction
Associations requiring precautions for use
Zuclopentixol may potentiate the sedative effect of alcohol, barbiturates and other central nervous system depressants.
Neuroleptics may increase or decrease the effect of antihypertensive drugs; the antihypertensive effect of guanethidine and similarly acting molecules is reduced.
Concomitant use of neuroleptics and lithium increases the risk of neurotoxicity.
Tricyclic antidepressants and neuroleptics mutually inhibit their metabolism.
Zuclopentixol can reduce the effect of levodopa and adrenergic drugs.
Concomitant use of metoclopramide and piperazine increases the risk of developing extrapyramidal symptoms.
Since Zuclopentixol is partially metabolised by CYP2D6, concomitant use of drugs known as inhibitors of this enzyme may cause a reduction in the clearance of Zuclopentixol.
When neuroleptics are administered concomitantly with drugs that prolong the QT interval, the risk of developing cardiac arrhythmias is increased. It is therefore recommended to avoid concomitant administration of these drugs.
Relevant drug classes include:
• class IA and III antiarrhythmics (such as quinidine, amiodarone, sotalol)
• some antipsychotics (such as haloperidol, droperidol, pimozide)
• some macrolides (such as erythromycin)
• some antihistamines (such as terfenadine, astemizole)
• some quinolone antibiotics (such as moxifloxacin).
The above list is not exhaustive therefore concomitant use of any other molecule known to significantly prolong the QT interval (such as cisapride, lithium) should be avoided.
Do not administer concomitantly with drugs that cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) and use caution with drugs known to increase the plasma concentration of suglopentixol as they may increase the risk of prolongation of the QT interval and the risk of developing arrhythmias. malignant (see section 4.4).
04.6 Pregnancy and lactation
Pregnancy
Zuclopentixol should not be used during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the fetus.
Infants born to mothers treated with neuroleptics during late pregnancy, or during labor, may show signs of intoxication such as lethargy, tremor and hyperexcitability and a low apgar score.
Infants exposed to conventional or atypical antipsychotics, including suglopentixol, during the third trimester of pregnancy are at risk for side effects including extrapyramidal or withdrawal symptoms which may vary in severity and duration after birth. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, food intake disturbances. Infants should therefore be closely monitored.
Animal studies with Zuclopentixol have shown reproductive toxicity (see section 5.3 - reproductive toxicity).
Feeding time
Since Zuclopentixol is present in low concentrations in breast milk, it is unlikely to affect the neonate at therapeutic doses. The dose ingested by the neonate is less than 1% of the maternal weight-related dose (in mg / kg). Breastfeeding may be continued during treatment with Zuclopentixol if considered to be of clinical importance, however it is recommended that the neonate be observed. , especially in the first 4 weeks after birth.
Fertility
In humans, undesirable effects such as hyperprolactinaemia, galactorrhoea, amenorrhea, erectile dysfunction and ejaculation disturbances have been reported (see section 4.8). These side effects can have a negative impact on female and / or male sexual function and fertility.
If clinically significant hyperprolactinaemia, galactorrhoea, amenorrhea or sexual dysfunction occur, dose reduction (if possible) or discontinuation should be considered. The effects are reversible upon discontinuation of treatment.
Administration of suglopentixol in male and female rats was associated with a slight delay in mating. In an experiment where suglopentixol was administered with the diet, a reduction in mating performance and a reduction in the rate of conception were noted. .
04.7 Effects on ability to drive and use machines
Zuclopentixol is a sedative medicine. Patients being treated with psychotropic medicinal products may have impaired general attention and concentration therefore they should be warned about the ability to drive and use machines.
04.8 Undesirable effects
The undesirable effects are largely dose dependent. The frequency and severity are more pronounced in the first phase of treatment and improve with continued treatment.
Extrapyramidal reactions may arise, especially during the first phase of treatment. In most cases, these side effects can be successfully controlled by reducing the dose and / or using antiparkinsonian drugs. A habitual preventive use of antiparkison drugs is not recommended. Antiparkison drugs do not relieve tardive dyskinesia and can make it worse. Dosage reduction or, if possible, discontinuation of suglopentixol therapy is recommended. In persistent akathisia, a benzodiazepine or propranolol may help.
The frequencies reported are those of literature and spontaneous reports.
The frequency is defined as: very common (≥1 / 10), common (≥1 / 100 to
Rare cases of QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest have been observed with Zuclopentixol and other drugs of the same therapeutic class as antipsychotics. Very rare cases of sudden death (see section 4.4). .
Abrupt discontinuation of Zuclopentixol may lead to withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhea, runny nose, sweating, myalgia, paraesthesia, insomnia, restlessness, anxiety and agitation. Patients may also experience dizziness, alternating heat and cold, and tremor. Symptoms generally begin within the first 4 days of stopping treatment and resolve within 7-14 days.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
04.9 Overdose
Symptoms
Somnolence, coma, movement disorders, convulsions, shock, hyperthermia / hypothermia.
ECG changes, QT interval prolongation, torsades de pointes, cardiac arrest and ventricular arrhythmias have been reported when taken in overdose and concomitantly with other drugs known to affect cardiac activity.
The highest dose of orally administered suglopentixol in clinical trials was 450 mg per day.
Treatment
Treatment is symptomatic and supportive. It is necessary to institute measures to support the respiratory and cardiovascular systems. Adrenaline should not be administered as it could cause a further lowering of blood pressure. Convulsions can be treated with diazepam, movement disorders with biperidene.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antipsychotics, thioxanthene derivatives.
ATC code: N05AF05.
Clopixol is a powerful sedative neuroleptic belonging to the group of thioxanthenes.
The antipsychotic activity of neuroleptics is generally related to their ability to block dopaminergic receptors; thioxanthenes, including suglopentixol, have a "high affinity for both D-1 and D-2 receptors and their antistereotypic effect it is not significantly affected by concomitant treatment with anticholinergics. Thanks to the high affinity for D-1 receptors, thioxanthenes induce less supersensitivity than other neuroleptics, and consequently less chance of onset of dyskinesia.
In addition to the antipsychotic action, Clopixol has an immediate sedative action; the prolonged non-specific sedative effect is established after a few weeks of treatment.
The specific sedative effect makes Clopixol particularly indicated in the treatment of psychotic patients with manifestations of agitation, aggression and hostility.
05.2 "Pharmacokinetic properties
Clopixol is rapidly absorbed after oral administration; blood levels are well correlated with the administered dose. The metabolites do not possess pharmacological activity.
05.3 Preclinical safety data
Reproductive toxicity
In a three-generation study of rats, a delay in mating was observed. Once mated there was no effect on fertility. In an experiment in which suglopentixol was administered with the diet, a reduction in mating performance and a reduction in the conception rate was noted.
Animal reproduction studies did not show embryotoxic or teratogenic effects.
In a peri / postnatal study in rats, doses of 5 and 15 mg / kg / day resulted in increased stillbirths, reduced survival and developmental delay of the young.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Core of the tablets:
Potato starch
Lactose monohydrate
Microcrystalline cellulose
Copovidone
Glycerin 85%
Talc
Hydrogenated castor oil
Magnesium stearate.
Coating of tablets:
Hypromellose 5,
Macrogol 6000.
Dyes:
Titanium dioxide (E 171)
Red iron oxide (E 172).
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Store below 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Clopixol 10 mg: 30 tablets in white PVC blister with aluminum foil, placed in a cardboard box.
Clopixol 25 mg: 20 tablets in white PVC blister with aluminum foil, placed in a cardboard box.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Lundbeck Italia S.p.A., Via della Moscova n. 3, 20121 Milan
08.0 MARKETING AUTHORIZATION NUMBER
"10 mg film-coated tablets" - 30 tablets - A.I.C. n. 026890107
"25 mg film-coated tablets" - 20 tablets - A.I.C. n. 026890119
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Clopixol 10 mg and 25 mg film-coated tablets
Date of first authorization: December 1991
Date of last renewal: May 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 29 October 2013
