Largactil 25 mg/100 mg Tablets

LARGACTIL contains the active ingredient chlorpromazine which belongs to a group of medicines known as phenothiazines, which act on the central nervous system of your body. LARGACTIL is used in the management of mental and emotional disorders. LARGACTIL is used in the management of psychotic conditions to manage excitement, agitation and other psychomotor disturbances (disturbances in movement due to conscious mental activity) in schizophrenic patients and in the treatment of the manic (excited) phase of bipolar depression. It is also given to control hyperkinetic states (excessive amount of uncontrolled muscular action) and aggression and sometimes to control anxiety and tension in psychiatric conditions. It may also be used for unstoppable hiccups.

Do not take LARGACTIL if:

• you are hypersensitive (allergic) to chlorpromazine hydrochloride or to any of the ingredients of LARGACTIL (listed in section 6).
• you or someone in your family has a history of circulatory problems or blood clots.
• you have a condition that causes depression of your central nervous system (decreased heart or breathing rate).
• you have a low number of blood cells (bone marrow suppression).
• you have kidney or liver disease.
• you have phaeochromocytoma (high blood pressure due to a tumour near the kidney).
• you have chronic respiratory disorders.
• you have glaucoma (increased pressure in the eye).
• you have a neurological disorder known as parkinsonism.
• you have diabetes mellitus.
• you have increased thyroid activity (hyperthyroidism).
• you have muscle weakness (myasthenia gravis).
• you have urine retention due to prostatic problems.
• you have epilepsy.
• you or your family have a heart condition known as QT-prolongation.

Warnings and precautions

Take special care with LARGACTIL:

• Before you take LARGACTIL, tell your doctor or health care professional if:
• you are taking medicine for epilepsy.
• you have heart problems or a family history of heart problems, especially if you or your family have a condition known as QT-prolongation, or if you are taking medicines which may affect the way your heart beats (medicines that can prolong the QT-interval). LARGACTIL should not be used if you have QT-prolongation (see Do not take LARGACTIL).
• you have any known risk factors or a family history of stroke.
• you are elderly (65 years of age or older) and if you suffer from dementia.
• you have diabetes since your doctor may want to monitor your blood sugar levels when you start to take LARGACTIL tablets.
• you are using a medicine which may suppress your central nervous system (causing drowsiness or sleepiness), e.g. opioid pain killers, sleeping tablets, sedatives or alcohol, or if you are going to have anaesthesia, since these effects may be enhanced when taken together with LARGACTIL.

You should avoid exposure to strong sunlight while taking LARGACTIL or wear suitable clothing if you cannot avoid sunlight. You should avoid very cold or very hot environments. LARGACTIL may make it difficult for your body to regulate its temperature. Before and during treatment your doctor may want to carry out some tests. These might include blood tests, an electrocardiogram (ECG) to check your heart is working properly and eye tests.

Do not share medicines prescribed for you with any other person. Always take LARGACTIL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long your treatment with LARGACTIL will last. Do not stop taking LARGACTIL early because you feel better or you have the impression that LARGACTIL is too strong or weak for you. Always swallow the tablets whole with a full glass of water. Do not chew the tablets.

The usual starting oral dose for adults is 25 to 50 mg three times daily. Daily doses of 75 mg may be given as a single dose at night. Lower doses may be sufficient in some cases. To treat intractable hiccups patients are given tablets orally: 25 to 50 mg three or four times a day for 2 to 3 days. For elderly and weak or infirm patients, the recommended LARGACTIL dose is one-third to one-half the normal adult dose. This formulation is not suitable for use in children.

If you have the impression that the effect of LARGACTIL is too strong or too weak, tell your doctor or pharmacist.

If you take more LARGACTIL than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forgot to take LARGACTIL

If you forgot to take a dose, simply continue to take LARGACTIL as prescribed by your doctor or pharmacist. Do not take a double dose to make up for forgotten individual doses.

If you stop taking LARGACTIL

Do not stop taking LARGACTIL without talking to your doctor or pharmacist, even if you feel better. Withdrawal symptoms can occur after you stop treatment abruptly, such as feeling sick, vomiting, diarrhoea, not being able to sleep, sweating, restlessness, anxiety and tremor (see section 4). Your doctor will advise you on how to gradually withdraw your treatment with LARGACTIL.

LARGACTIL can have side effects. Not all side effects reported for LARGACTIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LARGACTIL, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking LARGACTIL immediately and tell your doctor or pharmacist immediately or go to the nearest hospital:

• Less frequent:
• you have frequent infections such as fever, severe chills, sore throat or mouth ulcers (these could be signs of a blood problem called leucopenia or agranulocytosis).
• you bruise more easily than usual (this could be because of a blood disorder called thrombocytopenia).
• you feel tired and have a pale skin (this could be symptoms of anaemia (a deficiency of red cells in the blood)).

Frequency unknown:

• you have yellowing of the skin or eyes (jaundice) and your urine becomes darker in colour (these could be signs of liver damage which could be fatal if not treated).
• you have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swollen eyelids, lips, tongue or throat.
• you have joint aches and pains, swollen joints, feel tired or weak, with chest pain and shortness of breath. These could be signs of an illness called ‘systemic lupus erythematosus’ (SLE).
• you have a fit (seizure).
• you have blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
• you have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs (dystonia).
• you have trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless.
• you have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated (these could be signs of a serious but rare side effect called ‘neuroleptic malignant syndrome’).
• you have changes of the heart rhythm (called ‘prolongation of QT-interval’, seen on ECG, electrical activity of the heart).
• you have a very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain. These could be signs of very serious life-threatening heart problems which could lead to death if not treated.
• you are unable to move.
• you are breathing more slowly or less deeply than normal (CNS depression).
• you get a bloated feeling and cramping pain in the abdomen (stomach) be sick (vomit) have indigestion, heartburn, upset stomach, constipation and loss of appetite. This could be caused by an obstruction or blockage of the intestine.
• you have pain in your abdomen with vomiting or diarrhoea.
• you have a long lasting, painful erection of the penis.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LARGACTIL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent:
• feeling dizzy, light-headed or faint when you stand or sit up quickly (due to low blood pressure).

Less frequent:

• difficulty seeing at night or reduced eyesight.

Frequency unknown:

• passing large amounts of urine, excessive thirst and having a dry mouth or skin. You may be more likely to get infections, such as thrush. This could be due to too much sugar in your blood (hyperglycaemia).
• feeling tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood.
• confused thinking and reduced awareness of your environment (delirium).
• feeling restless and not being able to keep still (akathisia).
• problems with eyesight (blurred vision, constricted or dilated pupils, opacities or cloudy areas in the eye).
• pigment deposits in the eye or skin which may affect vision, after having LARGACTIL for a long time.
• you have difficulty in passing water (urine).
• you feel too hot or too cold.
• your jaw is tight and stiff.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• feeling drowsy or sleepy.

Less frequent:

• difficulty sleeping (insomnia).
• nightmares.
• feeling depressed (low mood).

Frequency unknown:

• abnormal production of breast milk in men and women.
• loss of menstrual periods.
• breast enlargement in men.
• elevated levels of a type of fat in your blood called triglycerides (hypertriglyceridaemia).
• putting on weight.
• feeling agitated.
• stuffy nose.
• dry mouth.
• constipation.
• being more sensitive to the sun than usual.
• difficulty in getting or keeping an erection (impotence).
• reduced sexual desire in women.
• skin rashes.
• withdrawal symptoms such as feeling sick, vomiting, diarrhoea, not being able to sleep, sweating, restlessness, anxiety and tremor may occur when LARGACTIL is stopped (see If you stop taking LARGACTIL).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to:

• The Pharmacovigilance Unit at Sanofi: [email protected] (email) or 011 256-3700 (tel), or
• SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of LARGACTIL.

Store at or below 25 °C, protected from light. Store all medicines out of reach of children. Do not take this medicine after the expiry date shown on the container. Keep in the outer container until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).