Zuclopenthixol decanoate Injection 200mg/ml Taj Pharma

Zuclopenthixol decanoate Injection 200mg/ml

1. Name of the medicinal product

Zuclopenthixol decanoate 200mg/ml solution for injection Taj Pharma.
Zuclopenthixol decanoate 500mg/ml solution for injection Taj Pharma.

2. Qualitative and quantitative composition

Zuclopenthixol decanoate Injection:
Zuclopenthixol decanoate 200mg/ml.

Zuclopenthixol decanoate Conc. Injection:
Zuclopenthixol decanoate 500mg/ml.

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Solution for injection.

4. Clinical particulars

4.1 Therapeutic indications

The maintenance treatment of schizophrenia and paranoid psychoses.

4.2 Posology and method of administration

Posology

Adults

Dosage and dosage interval should be adjusted according to the patient’s symptoms and response to treatment.

The usual dosage range of zuclopenthixol decanoate is 200 – 500mg every one to four weeks, depending on response, but some patients may require up to 600mg per week. The maximum single dose at any one time is 600mg. For example, 1200mg every 2 weeks should not be given. In patients who have not previously received depot antipsychotics, treatment is usually started with a small dose (e.g. 100mg) to assess tolerance. An interval, of at least one week should be allowed before the second injection is given at a dose consistent with the patient’s condition.

Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse.

Injection volumes of greater than 2 ml should be distributed between two injection sites.

Older patients

In accordance with standard medical practice initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older patients.

Paediatric population

Zuclopenthixol decanoate is not recommended for use in children due to lack of clinical experience.

Patients with renal impairment

Zuclopenthixol decanoate can be given in usual doses to patients with reduced renal function. Where there is renal failure dosage should be reduced to half the normal dosage.

Patients with hepatic impairment

Use with caution in patients with liver disease (see section 4.4). Patients with compromised hepatic function should receive half the recommended dosages. Serum-level monitoring is advised.

Method of administration

By deep intramuscular injection into the upper outer buttock or lateral thigh.

Note

As with all oil-based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

4.4 Special warnings and precautions for use

Caution should be exercised in patients having: liver disease; cardiac disease, or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy, e.g. alcohol withdrawal or brain damage); Parkinson’s disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; phaeochromocytoma and patients who have shown hypersensitivity to thioxanthenes or other antipsychotics.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. The plasma concentrations of zuclopenthixol decanoate gradually decrease over several weeks which make gradual dosage tapering unnecessary.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation and opiate and alcohol abuse are over-represented among fatal cases.

Treatment:

Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful. Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.

Like other neuroleptics, zuclopenthixol decanoate should be used with caution in patients with organic brain syndrome, convulsions or advanced hepatic disease.

Blood dyscrasias have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.

As with other drugs belonging to the therapeutic class of antipsychotics, zuclopenthixol decanoate may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, zuclopenthixol decanoate should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesaemia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

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 should be identified before and during treatment with zuclopenthixol decanoate and preventive measures undertaken.

Concomitant treatment with other antipsychotics should be avoided (see section 4.5).

As described for other psychotropics, zuclopenthixol decanoate may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including zuclopenthixol decanoate.

Long-acting depot antipsychotics should be used with caution in combination with other medicines known to have a myelosuppressive potential, as these cannot rapidly be removed from the body in conditions where this may be required.

Older people

Older people require close supervision because they are especially prone to experience such adverse effects as sedation, hypotension, confusion and temperature changes.

Cerebrovascular

An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Zuclopenthixol should be used with caution in patients with risk factors for stroke.

Increased Mortality in Older People with Dementia

Data from two large observational studies showed that older people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated.

There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Zuclopenthixol decanoate Conc. Injection and Zuclopenthixol decanoate Conc. Injection are not licensed for the treatment of dementia-related behavioural disturbances.

4.5 Interaction with other medicinal products and other forms of interaction

In common with other antipsychotics, zuclopenthixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants.

Zuclopenthixol may potentiate the effects of general anaesthetics and anticoagulants and prolong the action of neuromuscular blocking agents.

The anticholinergic effects of atropine or other drugs with anticholinergic properties may be increased.

Concomitant use of drugs such as metoclopramide, piperazine or antiparkinson drugs may increase the risk of extrapyramidal effects such as tardive dyskinesia.

Combined use of antipsychotics and lithium or sibutramine has been associated with an increased risk of neurotoxicity.

Antipsychotics may enhance the cardiac depressant effects of quinidine; the absorption of corticosteroids and digoxin.

The hypotensive effect of vasodilator antihypertensive agents such as hydralazine and α blockers (e.g. doxazosin), or methyl-dopa may be enhanced.

Concomitant use of zuclopenthixol and drugs known to cause QT prolongation or cardiac arrhythmias, such as tricyclic antidepressants or other antipsychotics should be avoided.

Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided.

Relevant classes include:

• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)
• some antipsychotics (e.g. thioridazine)
• some macrolides (e.g. erythromycin)
• some antihistamines
• some quinolone antibiotics (e.g. moxifloxacin)

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided. Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalemia) and drugs known to increase the plasma concentration of zuclopenthixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrhythmias (see section 4.4).

Antipsychotics may antagonise the effects of adrenaline and other sympathomimetic agents, and reverse the antihypertensive effects of guanethidine and similar adrenergic-blocking agents.

Antipsychotics may also impair the effect of levodopa, adrenergic drugs and anticonvulsants.

The metabolism of tricyclic antidepressants may be inhibited and the control of diabetes may be impaired.

Since zuclopenthixol is partly metabolised by CYP2D6 concomitant use of drugs known to inhibit this enzyme may lead to higher than expected plasma concentrations of zuclopenthixol, increasing the risk of adverse effects and cardiotoxicity.

4.6 Fertility, pregnancy and lactation

Pregnancy

Zuclopenthixol decanoate should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus.

Neonates exposed to antipsychotics (including zuclopenthixol decanoate) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

Animal studies have shown reproduction toxicity (see section 5.3).

Breast-feeding

As zuclopenthixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 1% of the weight related maternal dose (inmg/kg). Breast-feeding can be continued during zuclopenthixol decanoate therapy if considered of clinical importance, but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.

Fertility

In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, erectile dysfunction and ejaculation failure have been reported (see section 4.8). These events may have a negative impact on female and/or male sexual function and fertility.

If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation.

Administration of zuclopenthixol to male and female rats was associated with a slight delay in mating. In an experiment where zuclopenthixol was administered via the diet, impaired mating performance and reduced conception rate were noted.

4.7 Effects on ability to drive and use machines

Zuclopenthixol is a sedative drug.

Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their susceptibility is known.

Patients should not drive if they have blurred vision.

4.8 Undesirable effects

The majority of undesirable effects are dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended.

Antiparkinsonian drugs do not alleviate tardive dyskinsea and may aggravate them. Reduction in dosage or, if possible, discontinuation of zuclopenthixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias – ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for zuclopenthixol (see section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown.

Abrupt discontinuation of zuclopenthixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms: somnolence, coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.

Treatment: treatment is symptomatic and supportive. Measures aimed at supporting the respiratory and cardiovascular systems should be instituted.

Adrenaline (epinephrine) must not be used in these patients. There is no specific antidote.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Neuropleptics (antipsychotics),

Mechanism of action

The action of zuclopenthixol, as with other antipsychotics is mediated through dopamine receptor blockade. Zuclopenthixol has a high affinity for D₁ and D₂ receptors and activity has been demonstrated in standard animal models used to assess antipsychotic action. Serotonergic blocking properties, a high affinity for alpha-adrenoreceptors and slight antihistamine properties have been observed.

5.2 Pharmacokinetic properties

After deep intramuscular injection of Zuclopenthixol decanoate, serum levels of zuclopenthixol increase during the first week and decline slowly thereafter. A linear relationship has been observed between Zuclopenthixol decanoate dosage and serum level. Metabolism proceeds by sulphoxidation, dealkylation and glucuronic acid conjugation. Sulphoxide metabolites are mainly excreted in the urine while unchanged drug and the dealkylated form tend to be excreted in the faeces.

5.3 Preclinical safety data

Reproductive toxicity

Impaired mating performance and reduced conception rates were observed in rats treated with zuclopenthixol at doses equal to the maximum recommend human dose of 50mg on amg/m² basis.

There was no evidence of embryotoxicity or teratogenic effects in rats treated with zuclopenthixol, however adverse effects on pre-and postnatal development (i.e. increased stillbirths, reduced pup survival and delayed development of pups) was observed. The clinical significance of these findings is unclear and it is possible that the effect on pups was due to neglect from the dams that were exposed to doses of zuclopenthixol producing maternal toxicity.

6. Pharmaceutical particulars

6.1 List of excipients

Thin vegetable oil

6.2 Incompatibilities

This product may be mixed in the same syringe with other products in the Zuclopenthixol decanoate Injection range, including Zuclopenthixol decanoate-Acuphase Injection (zuclopenthixol acetate 50mg/ml).

It should not be mixed with any other injection fluids.

6.3 Shelf life

Zuclopenthixol decanoate Injection:

1 ml ampoules: 36 months.

10 ml vials: 36 months (unopened), shelf life after opening vials: 1 day

Zuclopenthixol decanoate Conc. Injection:

48 months.

6.4 Special precautions for storage

Keep the ampoules in the outer carton in order to protect from light.

6.5 Nature and contents of container

Zuclopenthixol decanoate Injection:

Ampoules containing 1 ml of 200mg/ml zuclopenthixol decanoate in thin vegetable oil. Pack size : 10 ampoules per box.

10 ml clear glass vials with a rubber stopper secured with an aluminium collar having a fliptop cap. Pack size: 1 vial per box.

Zuclopenthixol decanoate Conc. Injection:

Ampoules containing 1 ml of 500mg/ml zuclopenthixol decanoate in thin vegetable oil. Pack size : 5 ampoules per box.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Zuclopenthixol decanoate Injection 200mg/ml, 500mg/ml

Package leaflet: Information for the patient

Zuclopenthixol decanoate 200mg/ml, 500mg/ml solution for injection

zuclopenthixol decanoate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

The name of your medicine is Zuclopenthixol decanoate 200mg/ml solution for injection (called Zuclopenthixol decanoate Injection in this leaflet). Zuclopenthixol decanoate Injection contains the active substance zuclopenthixol. It 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.

Zuclopenthixol decanoate Injection is used for the treatment of schizophrenia and other psychoses.

Your doctor, however, may prescribe Zuclopenthixol decanoate Injection for another purpose. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What you need to know before Zuclopenthixol decanoate Injection is given

Zuclopenthixol decanoate Injection is not given

• If you are allergic (hypersensitive) to zuclopenthixol, other thioxanthene drugs or antipsychotic drugs or any of the other ingredients of this medicine (listed in section 6). Tell your doctor if you think you might be
• If you are feeling less alert than usual, or are drowsy or sleepy or have serious problems with your blood circulation

Warnings and precautions

Talk to your doctor, pharmacist or nurse before Zuclopenthixol decanoate Injection is given to you:

• If you have a heart condition, including an irregular heart beat (such as a slower heart beat); have had a recent heart attack or have problems that cause ankle swelling or shortness of breath
• If you have severe breathing problems (such as asthma or bronchitis)
• If you have liver, kidney or thyroid problems
• If you suffer from epilepsy, or have been told that you are at risk of having fits (for example because of a brain injury or because of alcohol withdrawal)
• If you suffer from Parkinson’s disease, or myasthenia gravis (a condition causing severe muscular weakness)
• If you have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney)
• If you suffer from glaucoma (raised pressure within the eye)
• If you have risk factors for stroke (e.g. smoking, hypertension)
• If you have too little potassium or magnesium in your blood or a family history of irregular heart beats
• If you use other antipsychotic medicines
• If you suffer from diabetes
• If you 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 being treated for cancer.

Children and adolescents

Zuclopenthixol decanoate Injection is not recommended in these patients.

Other medicines and Zuclopenthixol decanoate Injection

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 Zuclopenthixol decanoate Injection:

• Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)
• Other antipsychotic medicines

Tell your doctor or pharmacist if you are taking any of the following medicines:

• Tricyclic antidepressants
• Barbiturates or other medicines that make you feel drowsy
• Anticoagulant drugs used to prevent blood clots (e.g. warfarin)
• Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as well as other medicines)
• Metoclopramide (used to treat nausea and other stomach conditions)
• Piperazine (used to treat worm infections)
• Levodopa or other medicines used to treat Parkinson’s disease
• Sibutramine (used to reduce appetite)
• Digoxin (to control heart rhythm)
• Corticosteroids (e.g. prednisolone)
• Medicines used to lower the blood pressure such as hydralazine, alpha blockers (e.g. doxazosin) beta-blockers, methyldopa, clonidine or guanethidine
• Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood)
• Medicines known to increase the concentration of zuclopenthixol in your blood
• Medicines used to treat epilepsy.
• Medicines used to treat diabetes

Zuclopenthixol decanoate Injection can reduce the effect of adrenaline (epinephrine) and similar drugs.

Tell your doctor, dentist, surgeon or anaesthetist before any operation as Zuclopenthixol decanoate Injection can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.

Zuclopenthixol decanoate Injection with alcohol

Zuclopenthixol decanoate Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Zuclopenthixol decanoate Injection.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Your newborn baby might show side effects if this medicine is used during pregnancy.

The following symptoms may occur in newborn babies, of mothers that have used Zuclopenthixol decanoate Injection 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.

Breast-feeding

If you are breastfeeding, ask your doctor for advice. Zuclopenthixol decanoate Injection should not be used when breast-feeding, as small amounts of the medicine can pass into the breast milk.

Fertility

Zuclopenthixol may decrease your sexual activity and fertility. These are not lasting effects. Please talk to your doctor about any problems.

Driving and using machines

There is a risk of feeling drowsy and dizzy when being treated with Zuclopenthixol decanoate Injection, especially at the start of your treatment. If this happens do not drive or use any tools or machines until you know you are not affected in this way.

Do not drive if you have blurred vision.

3. How Zuclopenthixol decanoate Injection is given

A small amount of Zuclopenthixol decanoate Injection is drawn up into a syringe and then injected into muscle of your buttock or thigh.

Your doctor will decide on the correct amount of medicine to give, and how often to give it. The medicine is slowly released from the injection site so that a fairly constant amount of medicine gets into your blood during the period between each dose.

Adults

The usual dose lies between 200-500mg every 1 to 4 weeks but some patients require 600mg every week. The maximum single dose at any one time is 600mg. If you need more than 2 ml of medicine it will probably be divided between 2 injection sites.

If you haven’t received an injection like Zuclopenthixol decanoate Injection before, a small dose of 100mg is usually given one week before your normal dose to test how well you tolerate the medicine.

If you have been treated with Zuclopenthixol decanoate tablets and you are being transferred to Zuclopenthixol decanoate Injection you may be asked to continue taking the tablets for several days after the first injection.

Your doctor may decide to adjust the amount given, or the interval between injections, from time to time.

If you have liver problems, the level of zuclopenthixol in your blood may be checked.

Older patients (above 65 years of age)

Starting doses for older or frail patients are usually reduced to a quarter or a half of the dosage range.

Patients with special risks

If you have renal failure, your dosage should be reduced to half the usual dosage range. If you have liver problems, the level of zuclopenthixol in your blood may be checked. Patients with liver complaints normally receive doses at half the usual dosage range.

Use in children

Zuclopenthixol decanoate Injection is not recommended for children.

Duration of treatment

It may take between four and six months before you feel better.

Your doctor will decide the duration of treatment.

It is important that you continue to receive your medicine at regular intervals even if you are feeling completely well, because the underlying illness may persist for a long time. If you stop your treatment too soon your symptoms may return.

If you feel that the effect of Zuclopenthixol decanoate Injection is too strong or weak, talk to your doctor or pharmacist.

If you are given too much Zuclopenthixol decanoate Injection

Your medicine will be given by your doctor/nurse.

In the unlikely event that you receive too much Zuclopenthixol decanoate Injection you may experience some symptoms.

Symptoms of overdose may include:

• Drowsiness
• Unconsciousness
• Muscle movements or stiffness
• Fits
• Low blood pressure, weak pulse, fast heart rate, pale skin, restlessness
• High or low body temperature
• Changes in the heartbeat including irregular heartbeat or slow heart rate

You will receive treatment for any of these symptoms from your doctor or nurse.

4. Possible side effects

Like all medicines, Zuclopenthixol decanoate Injection can cause side effects, although not everybody gets them. Older people tend to be more likely to suffer from some of these effects than younger people and this may mean your treatment is supervised more closely.

Serious side effects

Stop using Zuclopenthixol decanoate and seek medical advice immediately if you have any of the following allergic reactions:

• Difficulty in breathing
• Swelling of face, lips, tongue or throat which causes difficulty in swallowing or breathing
• Severe itching of the skin (with raised lumps)

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.

If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped:

• High fever, unusual stiffness of the muscles and changes in consciousness, especially if occurring with sweating and fast heart rate. These symptoms may be signs of a rare but serious condition called neuroleptic malignant syndrome that has been reported with the use of Zuclopenthixol decanoate and similar medicines
• Unusual movements of the mouth and tongue as these may be early signs of a condition known as tardive dyskinesia
• Unusual muscle movements (such as circular movements of the eyes), stiffness, tremor and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called “extra-pyramidal” reaction
• Any yellowing of the skin and the white of the eyes (jaundice); your liver may be affected

Other side effects

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

• Throbbing or fast heartbeats
• Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes.
• Drowsiness
• Loss of co-ordination or altered muscle movements (including unusual movements of the mouth, tongue and eyeballs)
• Tremor
• Stiff or floppy muscles (including stiff jaw and neck muscles)
• Dizziness or vertigo
• Headache or migraine
• Numbness or tingling in the arms and legs
• Poor concentration, loss of memory or confusion
• A changed walking pattern
• Abnormal reflexes
• Rigidity of the whole body
• Fainting
• Speech problems
• Fits
• Enlarged pupils or blurred, abnormal vision
• Sensitive hearing or ringing in the ears (tinnitus)
• Stuffy nose
• Shortness of breath
• Dry mouth or increase in saliva
• Feeling sick or vomiting
• Indigestion or stomach pain
• Flatulence (wind), constipation or diarrhoea
• Abnormal urination (increases or decreases in the frequency or amount)
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to sunlight)
• Skin reactions at injection site
• Changes in skin colour
• Bruising under the skin
• Muscle pain
• Raised blood levels of glucose, lipids or the hormone prolactin
• Loss of control of blood sugar levels
• Changes in appetite or weight
• Low blood pressure
• Hot flushes
• General weakness or pain, tiredness or feeling unwell
• Increased thirst
• Reduced or increased body temperature (including fever)
• Abnormal liver function tests
• Liver enlargement
• Unexpected excretion of breast milk
• Insomnia, abnormal dreams or nightmares
• Depression or anxiety
• Nervousness or agitation
• Lack of emotion or indifference to your surroundings (apathy)
• Changes to your sex drive
• Men may experience breast enlargement or problems with ejaculation or erections (including prolonged erections)
• Women may experience an absence of menstrual periods, vaginal dryness or problems with orgasms

As with other medicines that work in a way similar to zuclopenthixol (the active ingredient of Zuclopenthixol decanoate), rare cases of the following side effects have been reported:

• Slow heartbeat and abnormal ECG heart tracing
• Life threatening irregular heart beats

In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Zuclopenthixol decanoate Injection

Usually your doctor or nurse will store the medicine for you. If you keep it at home:

• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date that is printed on the label and carton after EXP. The expiry date refers to the last day of that month
• Keep the ampoules in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Zuclopenthixol decanoate Injection contains

The active substance is zuclopenthixol decanoate.

Each millilitre (ml) of Zuclopenthixol decanoate Injection contains 200mg zuclopenthixol decanoate.

The other ingredient is thin vegetable oil.

What Zuclopenthixol decanoate Injection looks like and contents of the pack

Zuclopenthixol decanoate Injection is an oily liquid.

Zuclopenthixol decanoate Injection is available in glass ampoules containing 1 ml (200mg) in cartons of 10 ampoules and single-packed vials of 10 ml.

Not all pack sizes may be marketed.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com