25 mg and 50 mg film-coated tablets
Klorprotixen
What Truxal is and what it is used for
Truxal contains the active substance chlorprothixene. Truxal is a neuroleptic . It affects the transmission of signals between different nerve cells in the brain and is thereby effective against anxiety, obsessions, worry, and tension.
Truxal is used to treat psychosis, schizophrenia, and paranoid conditions. Note that the doctor may have prescribed the medicine for a different area of use and/or a different dosage than stated in the package insert. Always follow the doctor’s prescription and the instructions on the medicine package.
What you need to know before you use Truxal
Do not use Truxal
- if you are allergic to chlorprothixene or any of the other ingredients of this medicine (listed in section 6)
- in case of reduced level of consciousness, e.g. in case of poisoning with alcohol, sleeping pills, or strong pain-relieving drugs (morphine or equivalent)
- in certain forms of blood disorders
- in pheochromocytoma (a rare benign tumor of the adrenal glands)
- in cases of morbid fatigue in the muscles ( myasthenia )
Warnings and precautions
Talk to your doctor or pharmacist before taking Truxal if you:
- have impaired liver function
- have impaired kidney function
- previously suffered from convulsions and seizures
- have an enlarged prostate
- has a brain injury caused by, for example, poisoning with alcohol or solvents
- have risk factors for stroke (e.g. smoking, high blood pressure )
- have previously suffered from cardiovascular disease or someone in your family has previously had prolongation of the QT interval (slow heart rhythm and ECG changes)
- using other antipsychotic drugs
- has a rare eye disease with a shallow anterior chamber and narrow chamber angle. Attacks of acute glaucoma may occur
- are older. Elderly patients are particularly susceptible to orthostatic hypotension (abnormally low blood pressure when standing up)
- or someone in your family has a history of blood clots, as medicines like these have been associated with blood clots
- have pheochromocytoma (a growth in the adrenal glands)
- have prolactin-dependent neoplasia (a prolactin-dependent tumor )
- have severe hypotension or orthostatic dysregulation (very low blood pressure or a significant drop in blood pressure when changing body position, e.g. from lying or sitting to standing position)
- have Parkinson’s disease
- have diseases affecting the hematopoietic system (diseases of organs involved in blood production, e.g. bone marrow, spleen, and lymph nodes )
- have hyperthyroidism (an overactive thyroid gland )
- have micturition disorders, urinary retention (difficulty and inability to urinate), pyloric stenosis (narrowing of the lower stomach mouth), ileus, bowel obstruction
With long-term treatment, dry mouth can cause damage to the teeth and oral mucosa. Clean your teeth thoroughly with fluoride toothpaste 2 times a day.
Children and young people
Truxal is not recommended for children and adolescents under 18 years of age due to a lack of data regarding safety and efficacy in this age group.
Other medicines and Truxal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines should not be taken at the same time as Truxal:
- Painkillers ( codeine ).
- Medicines are used to stop the formation of breast milk (bromocriptine, cabergoline).
Be especially careful with Truxal if you are also taking:
- Medicines that lower blood pressure, etc.
- Barbiturates and similar medicines (medicines that make you sleepy).
- Medicines for epilepsy.
- Levodopa and similar medicines (used in the treatment of Parkinson’s disease ).
- Metoclopramide (used in the treatment of gastrointestinal diseases).
- Piperazine (used for infections caused by roundworms and tapeworms).
- Disulfiram (used in the treatment of alcohol dependence).
- Medicines that are diuretics, eg thiazide diuretics (affect salt and fluid balance, which can cause too little potassium or magnesium in the blood).
- Medicines that affect the heart rhythm (such as other neuroleptics, tricyclic antidepressants, quinidine, cisapride, and lithium, certain antibiotics (moxifloxacin and erythromycin), antimalarials (mefloquine), and methadone.
- Medicines are known to increase the concentration of Truxal in the blood.
Antipsychotics such as Truxal are broken down in the liver. Medicines that inhibit this breakdown, eg paroxetine, fluoxetine, quinidine, duloxetine, sertraline, terbinafine, chloramphenicol, amiodarone, cimetidine, disulfiram, isoniazid, MAO inhibitors, oral contraceptives in tablet form, buspirone and citalopram can increase the concentration of Truxal in the blood.
Concomitant use of Truxal and drugs with known anticholinergic activity increases the anticholinergic effects.
Combination with any of these drugs, therefore, requires caution.
Truxal with food, drink, and alcohol
Truxal can be taken with or without food.
You should not drink alcohol while being treated with Truxal as this may have an increased sedative effect, making you sleepy.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
The following symptoms may occur in newborn babies of mothers who used Truxal during the last trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, restlessness, breathing problems, and difficulty eating. If your child shows any of these symptoms, you may need to see a doctor.
Truxal passes into breast milk but is unlikely to affect children who are breastfed. However, consult a doctor if more than occasional use of Truxal during breastfeeding.
Driving ability and use of machinery
In some people, Truxal can impair the ability to react, which should be taken into account at times when increased attention is required, for example when driving a car and working with precision.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Truxal contains lactose .
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Truxal
Always take Truxal as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
The usual dose for adults is 50-300 mg daily. For the elderly, treatment begins with a lower dose and a possible increase in dose should be done gradually and more slowly than is usual for adult patients. It is common for the daily dose to be divided into several dosing occasions. Since you can get tired from Truxal, most of it is best taken in the evening.
Elderly patients
For the elderly, treatment begins with a lower dose and a possible increase in dose should be done gradually and more slowly than is usual for adult patients.
Use for children and adolescents
Truxal is not recommended for children and adolescents under 18 years of age due to a lack of data regarding safety and efficacy in this age group.
Note that the effect against psychotic symptoms only comes after a few weeks of treatment. The length of treatment is determined in consultation with your doctor. Do not stop treatment without consulting your doctor.
If you have used too much Truxal
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Do this even if you/the child do not notice any symptoms.
In case of overdose, side effects become more pronounced. There may be impaired consciousness, breathing difficulties, convulsions, and heart attacks. Changes in heart rhythm including irregular or slower heart rhythm have been observed when overdoses of Truxal have been taken at the same time as medicines known to affect the heart.
Possible side effects
Like all medicines, Truxal can cause side effects, although not everybody gets them.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
Uncommon (more than 1 in 1,000 users but less than 1 in 100 users):
- Unusual movements of the mouth and tongue; may be an early sign of a condition known as tardive dyskinesia.
Very rare (less than 1 in 10,000 users):
- High fever, unusual muscle stiffness, and an effect on your level of consciousness, especially if accompanied by sweating and palpitations, these symptoms may be signs of a rare condition called neuroleptic malignant syndrome that has been reported with the use of various antipsychotics.
- Yellowing of the skin and whites of the eyes could mean that your liver is affected and be a sign of a condition called jaundice.
The following side effects are most characteristic at the beginning of treatment and most of them disappear during continued treatment:
Very common (more than 1 in 10 users):
- Sleepiness ( somnolence ), dizziness.
- Dry mouth, increased saliva secretion (salivary hypersecretion).
Common (more than 1 in 100 users but less than 1 in 10 users):
- Heart palpitations ( tachycardia ), the feeling of fast, forceful, or irregular heartbeats (palpitations)
- Twisting or repetitive movements or abnormal posture due to persistent muscle tension ( dystonia ), or headache.
- Difficulty focusing on objects near the eye (accommodation disorders), visual disturbances.
- Constipation, indigestion or discomfort centered in the upper part of the stomach ( dyspepsia ), nausea.
- Increased sweating ( hyperhidrosis ).
- Muscle pain ( myalgia ).
- Increased appetite, increased weight.
- Fatigue, weakness ( asthenia ).
- Insomnia, nervousness, agitation, reduced sex drive (reduced libido ).
Uncommon (more than 1 in 1,000 users but less than 1 in 100 users):
- Parkinsonism, convulsions, and inability to sit or stand still ( akathisia ).
- Circulating eye movements (oculogyration).
- Vomiting, diarrhea.
- Trouble urinating (micturition disorders) or inability to urinate ( urinary retention ).
- Rashes, itching ( pruritus ), skin reactions due to sensitivity to light (photosensitization), eczema, or inflammation of the skin ( dermatitis ).
- Muscle rigidity.
- Decreased appetite, decreased weight.
- Low blood pressure ( hypotension ), hot flashes.
- Abnormal liver function test.
- Sexual disorders (absence of ejaculation, erection problems).
Rare (more than 1 in 10,000 users but less than 1 in 1,000 users):
- The low number of blood platelets ( thrombocytopenia ), low number of white blood cells ( neutropenia ), reduced number of white blood cells ( leukopenia ), poisoning of the bone marrow ( agranulocytosis )
- Difficulty breathing or painful breathing ( dyspnea ).
- Increased prolactin levels in the blood ( hyperprolactinemia ).
- High blood sugar (hyperglycemia), and impaired glucose tolerance.
- Hypersensitivity (hypersensitivity), acute systemic, and severe allergic reaction ( anaphylactic reaction ).
- Development of breasts in men ( gynaecomastia ), excessive milk production ( galactorrhea ), and absence of menstruation ( amenorrhea ).
Very rare (less than 1 in 10,000 users):
- Blood clot (see information in the text below).
As with other drugs that work in a similar way to chlorprothixene (Truxal’s active ingredient), rare cases of the following side effects have been reported:
- QT prolongation (slow heart rate and ECG changes).
- Irregular heart rhythm (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia).
- Torsades de Pointes (a special kind of irregular heart rhythm).
- Cardiac arrest.
Persistent painful penile erection has been reported (occurring in an unknown number of users) for other drugs that work in a similar way to chlorprothixene (Truxal’s active ingredient). It is possible that Truxal also has this effect and if you experience this you should contact your doctor immediately.
In rare cases, irregular heart rhythms ( arrhythmias ) have resulted in sudden death.
Blood clots, especially in the legs (symptoms are swelling, pain, and redness of the legs), can be transported to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
In elderly people with dementia treated with antipsychotic drugs, a small increase in the number of deaths has been reported compared to those not receiving such treatment.
How to store Truxal
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is chlorprothixene hydrochloride 25 mg and 50 mg respectively.
- Other ingredients are corn starch, lactose monohydrate, copovidone, glycerol (85%), microcrystalline cellulose, croscarmellose sodium, talc, and magnesium stearate.
Colorants: iron oxide (E172), titanium dioxide (E171).
H. Lundbeck A/S
Ottiliavej 9
2500 Valby
Denmark
Agent:
H. Lundbeck AB
Hyllie Boulevard 34
215 32 Malmö
Phone: 040-699 82 00