Clopixol 2 mg/10 mg Tablets

What CLOPIXOL is: CLOPIXOL belongs to a group of medicines known as antipsychotics (also called neuroleptics). These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.

What CLOPIXOL is used for: Symptoms of restlessness, agitation, hostility, aggression, psychomotor excitement and other behavioural disturbances in acute and chronic schizophrenia, manic phase of bipolar affective disorder and mental retardation.

Do not take CLOPIXOL:

• If you are allergic (hypersensitive) to zuclopenthixol or any of the other ingredients of CLOPIXOL (listed in Section 6 What CLOPIXOL contains)
• If you are feeling less alert than usual, or are drowsy or sleepy

Warnings and precautions

Take special care with CLOPIXOL if you:

• have a liver problem
• have a history of convulsions or fits
• have diabetes (you may need an adjustment of your antidiabetic therapy)
• have an organic brain syndrome (which may be the result of poisoning with alcohol or organic solvents)
• have risk factors for stroke (e.g. smoking, hypertension)
• have too little potassium or magnesium in your blood, or a family history of these
• have a history of cardiovascular disorders
• use other antipsychotic medicine
• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

If you are pregnant or breast feeding your baby (see Pregnancy, breastfeeding and fertility).

Children and adolescents

CLOPIXOL is not recommended in this patient group.

Other medicines and CLOPIXOL

Always tell your health care provider if you are taking any other medicine. This includes complementary or traditional medicines. Tell your doctor or pharmacist if you are taking any of the following medicines:

• Tricyclic antidepressant medicines.
• Medicines used to lower the blood pressure.
• Barbiturates and similar medicines (make you feel drowsy).
• Medicines used to treat epilepsy.
• Levodopa and similar medicines (used to treat Parkinson’s disease).
• Metoclopramide (used in the treatment of gastro-intestinal disorders).
• Piperazine (used in the treatment of roundworm and threadworm infection).
• Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood).
• Medicines known to increase the concentration of CLOPIXOL in your blood.

The following medicines should not be taken at the same time as CLOPIXOL:

• Medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, dofetilide, erythromycin, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium).
• Other antipsychotic medicines (e.g. thioridazine).

CLOPIXOL with food and drink

CLOPIXOL can be taken with or without food. CLOPIXOL may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with CLOPIXOL.

Pregnancy, breastfeeding and fertility

Safe use of CLOPIXOL during pregnancy and breastfeeding has not been established.

Pregnancy: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking CLOPIXOL. The following symptoms may occur in new born babies, of mothers that have used CLOPIXOL in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Breastfeeding: If you are breastfeeding, ask your doctor for advice. You should not use CLOPIXOL when breastfeeding, as small amounts of the medicine can pass into the breast milk.

Fertility: Animal studies have shown that CLOPIXOL affects the fertility. Please ask your doctor for advice.

Driving and using machines

There is a risk of feeling drowsy and dizzy when using CLOPIXOL, especially in the beginning of the treatment. If this happens do not drive or use any tools or machines until these effects wear off.

CLOPIXOL tablets contain lactose and hydrogenated castor oil. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine. Patients with the rare hereditary conditions of lactose or galactose intolerance should not take CLOPIXOL. Hydrogenated castor oil may cause stomach upset and diarrhoea.

• Do not share medicines prescribed for you with any other person.

• Always take CLOPIXOL exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dose varies considerably and depends on the severity of the illness.

The recommended dose is:

Adults

Schizophrenia, mania, and other psychoses

The starting dose is usually between 10 mg and 50 mg per day. This dose may gradually be increased to 75 mg per day. The maintenance dose is usually 20 - 40 mg per day.

Agitation in mentally handicapped patients

The dose is usually between 6 mg and 20 mg per day. If necessary the dose may be increased to 25 - 40 mg per day.

Use in children

CLOPIXOL is not recommended for children.

If you have the impression that the effect of CLOPIXOL is too strong or too weak, talk to your doctor.

How and when to take CLOPIXOL

Swallow the tablets with a drink of water. Do not chew them. In the maintenance treatment CLOPIXOL can usually be taken as a single daily dose at bedtime.

Duration of treatment

It may take a couple of weeks before you start to feel better. Your doctor decides the duration of treatment. Continue to take the tablets for as long as your doctor recommends. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return. Never change the dose of the medicine without talking to your doctor first.

If you take more CLOPIXOL 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 immediately. Do this even if there are no signs of discomfort or poisoning. Take the CLOPIXOL container with you if you go to a doctor or hospital.

Symptoms of overdose may include:

• Drowsiness.
• Unconsciousness.
• Muscle movements or stiffness.
• Convulsions.
• Low blood pressure, weak pulse, fast heart rate, pallor, restlessness.
• High or low body temperature.
• Changes in the heartbeat including irregular heartbeat or slow heart rate has been seen when CLOPIXOL has been given in overdose together with medicines known to affect the heart.

If you forget to take CLOPIXOL

If you forget to take a dose, take the next dose 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 to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. difficulty in sleeping, muscle stiffness, feeling unwell).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

If you experience any of the following symptoms you should contact your doctor or go to the hospital straight away:

• Less frequent:
• Unusual movements of the mouth and tongue; this may be an early sign of a condition known as tardive dyskinesia.
• High fever, unusual stiffness of the muscles and disorder of your consciousness, especially if occurring with sweating and fast heart rate; these symptoms may be signs of a rare condition called neuroleptic malignant syndrome which has been reported with the use of different antipsychotics.
• Yellowing of the skin and the white in the eyes, this may mean that your liver is affected and a sign of a condition known as jaundice.

The following side effects are most pronounced in the beginning of the treatment and most of them usually wear off during continued treatment.

• Frequent:
• Sleepiness (somnolence), inability to sit still or remain motionless (akathisia), involuntary movements (hyperkinesia), slow or diminished movements (hypokinesia)
• Dry mouth
• Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations)
• Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle of contractions (dystonia), increased muscle stiffness (hypertonia), dizziness, headache, sensation tingling, pricking or numbness of the skin (paraesthesia), disturbance in attention, amnesia, gait abnormal
• Difficulties focusing on objects near to the eye (accommodation disorder), vision abnormalities
• Sensation of spinning or swaying while the body is stationary (vertigo)
• Blockage of the nasal passages (Nasal congestion), difficulty breathing or painful breathing (dyspnoea)
• Increased saliva secretion (salivary hypersecretion), constipation, vomiting, digestive problems or discomfort centered in the upper abdomen (dyspepsia), diarrhoea
• Urination disorder (micturition disorder), lack of ability to urinate (urinary retention), increased urination volume (polyuria)
• Increased sweating (hyperhidrosis), itching (pruritus)
• Muscle pain (myalgia)
• Increased appetite, increased weight
• Fatigue, weakness (asthenia), general feeling of discomfort or uneasiness (malaise), pain
• Sleeplessness (insomnia), depression, Anxiety, nervousness, abnormal dreams, agitation, decreased sexual drive (libido decreased)

• Less Frequent:
• Overactive or overresponsive reflexes (hyperreflexia), jerky movements (dyskinesia), parkinsonism, fainting (syncope), inability to coordinate muscle activity (ataxia), speech disorder, decreased muscle tone (hypotonia), convulsion, migraine
• Circular movement of the eye (oculogyration), dilated pupils (mydriasis)
• Oversensitivity to certain frequency ranges of sound or difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus)
• Abdominal pain, nausea, flatulence
• Rash, skin reaction due to sensitivity to light (photosensitivity reaction), pigmentation disorder, greasy, shiny and yellowish skin due to increased secretion of sebum (seborrhoea), eczema or inflammation of the skin (dermatitis), bleeding underneath the skin seen by red or purple discolorations on the skin (purpura)
• Muscle rigidity, inability to normally open the mouth (trismus), twisting of the neck and an unnatural position of the head (torticollis, wryneck, stiff neck)
• Decreased appetite, decreased weight
• Low blood pressure (hypotension), hot flush
• Thirst, abnormal low body temperature (hypothermia), fever (pyrexia)
• Abnormal liver function tests
• Sexual disturbance (delayed ejaculation, problems with erection, women may experience failure to achieve an orgasm, vaginal dryness (vulvovaginal dryness))
• Pronounced indifference to one’s surroundings (apathy), nightmare, increased sexual drive (libido increased), state of confusion
• Low blood platelet count (thrombocytopenia), low white blood platelet count (neutropenia), reduced white blood cell count (leukopenia), bone marrow poisoning (agranulocytosis)
• Increased level of prolactin in the blood (hyperprolactinaemia)
• High blood sugar (hyperglycaemia), impaired glucose tolerance, increased blood fat levels (hyperlipidaemia)
• Oversensitivity (hypersensitivity), acute systemic and severe allergic reaction (anaphylactic reaction)
• Development of breasts in men (gynaecomastia), excessive milk production (galactorrhoea), lack of menstrual periods (amenorrhoea), persistent, painful erection of the penis unaccompanied by sexual excitation or desire (priapism)

Cases of the following side effects have been reported for CLOPIXOL:

• QT prolongation (slow heart beat and change in the ECG)
• Irregular heart beat (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia)
• Torsades de Pointes (a special kind of irregular heartbeat)

Irregular heartbeats (arrhythmias) may have resulted in sudden death. 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. If you notice any of these symptoms seek medical advice immediately.

In elderly people with dementia, an increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

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, pharmacist or nurse. You can also report side effects to 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 CLOPIXOL.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from light. Do not use after the expiry date printed on the label or carton. Return all unused medicine to your pharmacist. Do not dispose unused medicine in drains and sewerage systems (e.g. toilets).