TRILAFON 8 mg Coated Tablets

Зміст інструкції

1. Trilafon 2 mg film-coated tablets, 4 mg film-coated tablets, 8 mg film-coated tablets
   1. What is Trilafon and what is it used for
   2. What you need to know before taking Trilafon
   3. How to take Trilafon
   4. Possible side effects
   5. How to store Trilafon
   6. Contents of the pack and other information

Trilafon 2 mg film-coated tablets, 4 mg film-coated tablets, 8 mg film-coated tablets

Perfenazine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Trilafon and what is it used for

Trilafon contains the active ingredient perphenazine.
Perphenazine belongs to a group of medicines called phenothiazines that act on the
central nervous system, reducing states of anxiety and distress (anxiolytic property), exerting therapeutic activity
against psychotic symptoms (delusions and hallucinations) and is also able to prevent
or eliminate vomiting and nausea (antiemetic property).
Trilafon is indicated for the treatment of the following disorders and diseases:

• schizophrenia, a mental disorder that manifests with various symptoms including hallucinations, delusions, a tendency to isolation, difficulty articulating thoughts;
• paranoid states, personality disorders characterized by a persistent tendency to interpret the behaviors of others with distrust and suspicion;
• psychological states that manifest with alterations of mood associated with euphoria and excitability and characterized by obsessive ideas and behaviors (manias);
• toxic psychoses, psychiatric disorders induced by the consumption of narcotic substances (amphetamines, LSD, cocaine, etc.);
• psychiatric disorders associated with organic causes and accompanied by delirium;
• severe anxiety disorders that do not show improvement with anxiolytic medicines;
• depression, if accompanied by agitation and delirium, in association with antidepressants;
• for the reduction of vomiting and persistent and continuous hiccups;
• in the treatment of severe pain, generally in association with analgesic (pain-relieving) medicines.

2. What you need to know before taking Trilafon

Do not take Trilafon if:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you are in a state of decreased consciousness (severe stupor) or in case of coma or severe depression;
• you are taking medicines that can slow down the normal activity of the brain (central nervous system depressants) such as alcohol, barbiturates, opioids, etc.; you are taking other medicines used to treat mental disorders (neuroleptics); in this case, inform your doctor;
• you have blood diseases (blood dyscrasias) or alterations in the functions of the bone marrow, which fails to produce a sufficient number of cells found in the blood (bone marrow depression);
• you have liver diseases;
• you have suffered brain damage (subcortical brain damage, with or without hypothalamic damage) presumed or confirmed;
• you are under 12 years of age (see section “Children and adolescents”);
• you are in the first trimester of pregnancy or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before taking Trilafon if:

• you are elderly;
• you suffer from cardiovascular diseases or have a family history of impaired cardiac function (QT prolongation);
• you have a tumor of the adrenal glands (pheochromocytoma) or valve abnormalities of the heart (mitral insufficiency). In this case, you will be subject to greater monitoring during the administration of perphenazine due to the risks associated with lowering blood pressure (hypotension);
• you have respiratory diseases caused by lung infections or chronic respiratory disorders such as severe asthma or emphysema;
• you have reduced kidney function;
• you suffer from a disease that causes increased pressure in the eye (glaucoma);
• you have diseases affecting the uro-genital system such as enlarged prostate (prostatic hypertrophy);
• you have narrowing of the gastrointestinal and urinary tract (stenotic diseases of the digestive and urinary tract);
• you suffer from psychiatric disorders, as Trilafon may worsen mood to the onset of depression;
• you have breast cancer. In this case, perphenazine will be administered with particular attention, as it induces an increase in the concentration of a hormone (prolactin) that can worsen your condition;
• you suffer from Parkinson's disease or Parkinson-like conditions, or other motor disorders, as perphenazine may increase muscle rigidity;
• you are withdrawing from alcohol;
• you suffer from seizures and are taking anticonvulsant medications (antiepileptics). In such cases, if your doctor deems it appropriate, it may be necessary to increase the dose of medications for the treatment of seizures;
• you are exposed to excessively high or low temperatures, as Trilafon may compromise the mechanisms of body temperature regulation;
• you are to undergo surgery and are taking high doses of this medicine. In this case, your doctor will keep you under close observation as there is a risk of low blood pressure (hypotension). Furthermore, it may be necessary to reduce the amount of anesthetics or sedatives you are taking;
• you are in the post-operative period, as aspiration of vomit has occurred in a limited number of patients treated with phenothiazines;
• you drink alcohol, as it may potentiate the effects of the medicine, lower blood pressure significantly (hypotension) and increase the risk of suicide;
• you suffer from dementia and are being treated with atypical antipsychotics, as an increased risk of cerebrovascular events (e.g., stroke, transient ischemic attack) has been observed in these cases;
• you have risk factors for stroke;
• you have had cardiovascular diseases associated with blood clot formation (venous thromboembolism) or have risk factors for these diseases.

The use for the treatment of vomiting and nausea in pregnancy should only occur in cases where alternative intervention is not possible and not in the frequent and common cases of pregnancy nausea and even less so to prevent it.

It is possible that during treatment with Trilafon you may experience:

• the appearance of inflammation of the mouth and upper airways. In this case, it is advisable to undergo blood tests;
• alteration of organ functions. The safe and effective use of Trilafon requires adequate control of the dose of medicine taken, and the performance of periodic checks to assess the values of blood cells, liver, kidney and heart function, especially if you are taking Trilafon at high doses or for prolonged periods of time. If abnormalities are found in the results, your doctor may decide to discontinue treatment;
• the appearance of involuntary movements of the muscles (tardive dyskinesia). Both the risk of developing dyskinesia and the possibility that it becomes irreversible increase with the duration of treatment and with the total dose of medicine taken. Discontinuation of treatment may induce resolution of these abnormalities. If you observe the onset of these symptoms, inform your doctor who will assess the possibility of adjusting the dose or stopping treatment;
• an increased risk of skin sensitivity to light (photosensitivity). For this reason, avoid excessive exposure to sunlight or use specific protective creams during treatment with Trilafon;
• an increased risk of having thoughts associated with suicide, if you suffer from depression. This condition persists during treatment with Trilafon and until significant improvement of symptoms. Therefore, you will be kept under close observation to prevent access to excessive amounts of Trilafon.

Stop taking Trilafon and inform your doctor if you experience:

• a complex of symptoms, potentially fatal, called neuroleptic malignant syndrome, whose symptoms are: increased body temperature, muscle rigidity, reduced movements (akinesia), vegetative disorders (irregularity of pulse and blood pressure, sweating, increased heart rate (tachycardia), alterations of heart rhythm (arrhythmias), alteration of consciousness that can progress to stupor and coma. The doctor will interrupt the therapy and provide treatment for these symptoms;
• a significant increase in body temperature not attributable to a specific cause. This increase in temperature may suggest a hypersensitivity to perphenazine and in this case your doctor will advise you to stop the therapy; abnormalities in liver or kidney function tests or blood dyscrasias, in which case your doctor will tell you to stop the therapy. Perphenazine reduces the sensation of nausea and vomiting and therefore may mask the signs of overdose of other medicines or make the diagnosis of diseases such as intestinal obstruction, Reye's syndrome and brain tumors more difficult.

Increased mortality in elderly patients with dementia
It has been observed that elderly patients with dementia treated with antipsychotics have a slight increase in the risk of death compared to untreated patients.
Trilafon is therefore not indicated for the treatment of behavioral disorders related to dementia.

Children and adolescents
The safety of use of Trilafon in children under 12 years of age has not been established, therefore its use in children is not recommended.

Other medicines and Trilafon
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Consult your doctor or pharmacist if you are taking:

• other antipsychotic medicines because concomitant therapy with Trilafon should be avoided;
• barbiturates, anxiolytics, anesthetics, antihistamines, meperidine and other opioid analgesics;
• medicines for the treatment of seizures, such as phenytoin, lithium, used for the treatment of some mood disorders;
• tricyclic antidepressants and selective serotonin re-uptake inhibitors (SSRIs);
• medicines for the treatment of high blood pressure, such as guanethidine, methyldopa and beta-blockers (e.g. propranolol);
• Quinidine, propafenone and flecainide (antiarrhythmics);
• Cimetidine (medicine used in the treatment of ulcers);
• medicines with anticholinergic action (inhibition of acetylcholine, a substance that acts at the level of the nervous system), such as atropine;
• phenylbutazone (used for inflammation and muscle trauma), medicines that suppress the production of thyroid hormones (thiouracils) and other medicines that suppress the bone marrow (myelotoxic);
• metrizamide, a compound used as a contrast agent in some examinations for the diagnosis of blood diseases. It is necessary to discontinue therapy with Trilafon at least 48 hours before performing the examination, due to the possibility of an increased risk of seizures. The administration of Trilafon should not be resumed before 24 hours after the examination;
• levodopa, a medicine used for the treatment of Parkinson's disease;
• medicines used to reduce stomach acid, such as aluminum salts, as concomitant use with Trilafon may reduce its absorption;
• medicines that prolong the QT interval, as in this case the risk of onset of heart rhythm disturbances (cardiac arrhythmias) increases;
• medicines that cause electrolyte alterations, such as medicines used for the treatment of high blood pressure (hypertension).

Inform your doctor if you are exposed to organophosphorus insecticides.

Trilafon and laboratory tests
Taking Trilafon may turn urine dark and cause alterations in the results of some laboratory tests:

• false-positive values in the following tests: urobilinogen, amylase, uroporphyrins, porphobilinogens and 5-hydroxy-indoleacetic acid;
• alterations in the results of hypothalamus-pituitary function tests, as the medicine may cause a decrease in some hormones;
• false-positive and false-negative in pregnancy tests performed on urine.
• alterations in the electrocardiogram and specifically of the QT interval.

Trilafon with food, drinks and alcohol
Do not take Trilafon at the same time as alcohol due to the possible increase in the effects of the medicine, including a decrease in blood pressure (hypotension). Furthermore, this association may increase the risk of suicide and the danger of overdose.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Trilafon should not be used in the first trimester of pregnancy. In the following months, your doctor will assess whether or not to take Trilafon.
Perphenazine is rapidly excreted into breast milk, therefore your doctor will decide whether to stop breastfeeding or therapy with Trilafon, considering the importance of therapy for you.

Driving and operating machinery
Trilafon may cause sedation and drowsiness. Keep this in mind when driving vehicles and operating machinery.

Trilafon contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this medicine.

3. How to take Trilafon

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The optimal dose of Trilafon must be established by the doctor, based on the severity of the illness and your response to therapy.
It is always preferable to use the minimum effective dose, considering that the frequency and severity of undesirable effects is proportional to the increase in the dose.
The need to continue treatment must be evaluated periodically by the doctor.
The recommended dose for the treatment of outpatients is 4 - 8 mg of Trilafon three times a day or 8 - 16 mg twice a day.
In hospitalised patients the recommended dose is 8-16 mg two/four times a day, or 8 - 32 mg twice a day. In any case, you should not exceed 64 mg of perphenazine taken orally per day.
The use of Trilafon for the reduction of vomiting requires dosages of 8 - 12 mg divided during the day.

Use in children and adolescents
Trilafon should not be used in children and adolescents under 12 years of age (see paragraph “Children and adolescents”).
For adolescents over 12 years of age, the same treatment scheme indicated for adults applies (see previous paragraph).

Use in the elderly
The dose and frequency of administration of Trilafon in elderly patients must be carefully established by the doctor, who will assess a possible reduction of the above dose based on individual needs.

If you take more Trilafon than you should
In case of ingestion/taking an excessive dose of Trilafon, contact your doctor immediately or go to the nearest hospital.
The symptoms of taking an excessive dose of perphenazine manifest with abnormalities of the motor system (extrapyramidal symptoms). A progressive slowing of mental functions may occur (depression of the central nervous system), from drowsiness to temporary detachment from external reality (stupor) or coma with loss of reflexes. Children may experience convulsions. Patients with moderate or early-stage intoxication may experience restlessness, confusion and excitement. Other symptoms of overdose include: lowering of blood pressure (hypotension), increased heart rate (tachycardia), reduced body temperature (hypothermia), reduced pupil size (miosis), tremors, muscle contractions, involuntary contractions (spasms), rigidity or decreased muscle tone (hypotonia), convulsions, difficulty swallowing and breathing, bluish discoloration of the skin and mucous membranes (cyanosis), respiratory and/or vasomotor collapse, sometimes with sudden apnea.

Treatment methods in case of taking an excessive dose of Trilafon
There is no specific substance capable of counteracting the effect of an overdose of Trilafon. In hospital, you will immediately undergo appropriate emergency treatments (e.g. induction of vomiting or gastric lavage) and will be kept under strict medical control monitoring your condition.

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

If you stop taking Trilafon
Do not stop taking Trilafon before consulting your doctor.
Generally, phenothiazines do not cause dependence. However, if you suddenly stop therapy, you may experience effects such as: gastritis, nausea, vomiting, dizziness, tremors and hyperactivity.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trilafon can cause side effects, although not everyone gets them.
Stop treatment with Trilafon and contact your doctor immediately if you experience:

• Neuroleptic Malignant Syndrome (NMS) which is characterized by the manifestation of symptoms such as increased body temperature, muscle rigidity, reduced movements (akinesia), vegetative disorders (irregular pulse and blood pressure, sweating, increased heart rate (tachycardia), heart rhythm disturbances (arrhythmias)), altered state of consciousness that can progress to stupor and coma;
• persistent abnormalities in muscle and movement contraction, such as abnormal, involuntary movements of the tongue, jaw, trunk, or limbs (tardive persistent dyskinesia);
• skin rash, similar to hives, accompanied by swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema);
• increased body temperature (hyperpyrexia);
• excessive accumulation of fluid in the brain (cerebral edema), circulatory collapse and death due to hypersensitivity to phenothiazines (extremely rare side effects);
• swelling, pain and redness in the legs possibly accompanied by chest pain and difficulty breathing. These symptoms are due to the formation of blood clots in the veins, especially in the legs, which can migrate through the blood vessels to the lungs (the frequency of this side effect cannot be defined based on available data).

The most commonly reported symptoms during treatment with perphenazine, as with all
medicines belonging to the same pharmacological class as perphenazine, are alterations and
abnormalities of the motor system (extrapyramidal reactions), such as:

• abnormal posture characterized by excessive extension of the neck, rigidity and severe arching of the back (opisthotonus), abnormal contraction of the jaw muscles with difficulty opening the mouth (trismus), limited mobility or locking of the neck accompanied by cervical pain and contraction of the lateral neck muscles (torticollis), torticollis associated with a deviated head posture in which sudden muscle spasms can occur, causing abrupt head rotations (torticollis in a “spastic” form), pain and tingling in the limbs, a state of agitation with excessive motor activity (motor restlessness), alteration and deviation of the eyes in one direction (oculogyric crisis), hyper-reactivity of reflexes characterized by abnormal muscle contractions (hyper-reflexia), movement disorder characterized by

involuntary muscle contractions (dystonia) including deformation of the spine
(protrusion), alteration affecting the tongue (color, pain and involuntary movements),
sudden and involuntary contractions of the chewing muscles, a feeling of constriction in the throat,
difficulty pronouncing words and swallowing (dysphagia), inability to sit,
abnormalities in muscle movements and contraction (dyskinesia), muscle rigidity and
slowing of movement speed (parkinsonism) and loss of
muscle coordination (ataxia).
It is also possible to experience:

• abnormalities in the composition of the proteins in the fluid found in the central nervous system (cerebrospinal fluid), convulsions, headache, drowsiness;
• worsening of psychotic symptoms such as thought disorders, delusions and hallucinations, motor, emotional and behavioral abnormalities (catatonic-like states), thought forms that deviate from reality (paranoid reactions), a state of deep sleep (lethargy), worsening of the symptoms being treated (paradoxical excitement) restlessness and hyperactivity, nocturnal confusional states with bizarre dreams, sleep disorders (insomnia);
• abnormal secretion of milk (galactorrhea), enlargement of the breasts in women and men (gynecomastia), menstrual cycle disorders, prolonged absence of menstruation (amenorrhea), alterations in sexual desire, inhibition of ejaculation, increase and decrease in blood sugar concentration (hyperglycemia and hypoglycemia), presence of sugar in the urine (glycosuria), excessive release of an antidiuretic hormone that can cause headache, nausea and malaise (syndrome of inappropriate antidiuretic hormone secretion, SIADH);
• false positive pregnancy tests;
• lowering of blood pressure when getting up from a sitting or lying position (postural hypotension), increased and decreased heart rate (tachycardia and bradycardia), cardiac arrest, temporary loss of consciousness and dizziness, non-specific changes in the electrocardiogram, abnormalities in heart rhythm conduction (prolongation of the QT interval, rarely observed), ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest;
• decrease in white blood cells (agranulocytosis, leukopenia), increase in a particular type of white blood cells (eosinophilia), decrease in the number of red blood cells (hemolytic anemia), abnormal destruction of platelets (thrombocytopenic purpura), reduction in the number of all blood cells (pancytopenia);
• inflammation and obstruction of particular ducts that transport bile (biliary stasis), yellowing of the skin and the white of the eyes (jaundice).

Less frequent side effects:

• sedation, blood diseases (hematologic dyscrasia), loss of consciousness associated with involuntary muscle contractions (convulsions) and effects on the autonomic nervous system. Occasionally, it may occur:
• dry mouth and hypersalivation, feeling unwell (nausea), vomiting and diarrhea, gastric retention, anorexia, constipation, stubborn constipation and formation of a hard mass of dehydrated feces (fecaloma), difficulty emptying the bladder (urinary retention), frequent need to urinate and involuntary loss of urine (incontinence), loss of bladder function (bladder paralysis), increased urine output (polyuria);
• nasal congestion;
• pallor, increase (mydriasis) and reduction (miosis) in pupil size, blurred vision, eye disease that causes increased pressure inside the eye (glaucoma), excessive sweating, increased blood pressure (hypertension), decreased blood pressure (hypotension), altered pulse rate, alterations and blockage of the intestinal muscles (intestinal ileus) which in severe cases can cause complications and death;
• allergic skin reactions (urticaria), irritation and appearance of red spots on the skin (erythema), inflammatory skin reactions that cause itching (eczema), inflammation of the

skin with the formation of lesions and loss of the superficial layer (exfoliative dermatitis), itching,
skin sensitivity to light (photosensitivity), asthma, fever, allergic reactions
(anaphylactoid), accumulation of fluid in the upper airways (laryngeal edema), contact dermatitis.
Side effects related to long-term therapy:

• appearance of spots on the skin (skin pigmentation), alterations in vision that, in the most severe cases, lead to opacity of the lens in a star shape, inflammation of the cornea (epithelial keratitis), retinal alterations, destruction of the retina up to loss of vision (pigmentary retinopathy).

Other side effects:

• accumulation of fluid in the lower limbs (peripheral edema), state of sedation (reverse epinephrine effect), alteration in the amount of proteins that bind iodine (increased PBI not attributable to increased thyroxine), swelling of the salivary glands (parotid swelling), syndrome similar to systemic lupus erythematosus (an inflammatory disease of the immune system that affects various organs and tissues of the body), increased appetite and weight, abnormal increase in food consumption (polyphagia), excessive sensitivity to light (photophobia), muscle weakness.

Sudden death has been occasionally reported in patients undergoing treatment with phenothiazines.
In some patients, it has not been possible to determine the cause of death or to establish whether death was attributable to the phenothiazine.

Side effects in children
Newborns whose mothers have taken antipsychotics, including Trilafon, during the last three months of
pregnancy are at risk of alterations and abnormalities of the motor system (extrapyramidal symptoms) and
neonatal withdrawal syndrome. Agitation, muscle rigidity and/or weakness, tremor, drowsiness, breathing problems, difficulty feeding and hyperactive reflexes have also been reported.
If your child should show any of these symptoms, contact your doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through
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 Trilafon

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 packaging after “Scad”.
The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Trilafon contains
The active ingredient is perphenazine.
Each tablet of Trilafon 2 mg coated tabletscontains 2 mg of perphenazine.
Each tablet of Trilafon 4 mg coated tabletscontains 4 mg of perphenazine.
Each tablet of Trilafon 8 mg coated tabletscontains 8 mg of perphenazine.
The other ingredients are

Trilafon 2 mg coated tablets: corn starch, lactose, magnesium stearate, pregelatinized starch,
hypromellose, macrogol, white opaspray, paraffin.

Trilafon 4 mg coated tabletsand Trilafon 8 mg coated tablets: corn starch, lactose,
magnesium stearate, pregelatinized starch, Opadry white (hypromellose, macrogol, titanium dioxide,
hydroxypropylcellulose).

Description of Trilafon and contents of the pack
Trilafon is presented in the form of coated tablets contained in blisters. Each pack contains 20
tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Neopharmed Gentili S.r.l.
Via San Giuseppe Cottolengo, 15
20143 Milan

Manufacturer
VAMFARMA S.r.l.
Via Kennedy, 5
26833 Comazzo (CO).