Categories: , , , , ,
Date:

Prochlorperazine mesilate Injection 12.5mg/ml Taj Pharma

 

  1. Name of the medicinal product

Prochlorperazine mesilate 12.5mg/ml Injection

  1. Qualitative and quantitative composition

Each 1 ml contains
Prochlorperazine mesylate       12.5mg
Excipients                                 q.s

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Colourless sterile solution.

  1. Clinical particulars

4.1 Therapeutic indications

Prochlorperazine mesilate is a potent phenothiazine neuroleptic.

Uses: The treatment of nausea and vomiting and in schizophrenia (particularly the chronic stage) and acute mania.

4.2 Posology and method of administration

Posology

Adults

Indication Dosage
Treatment of nausea and vomiting 12.5mg by deep i.m. injection followed by oral medication 6 hours later if necessary.
Schizophrenia and other psychotic disorders 12.5 – 25mg b.i.d. or t.d.s. by deep i.m. injection until oral treatment becomes possible.

Paediatric population

Intramuscular Prochlorperazine mesilate should not be given to children.

Elderly

A lower dose is recommended (see section 4.4).

Method of administration

For deep intramuscular injection.

4.3 Contraindications

  • Known hypersensitivity to prochlorperazine or to any of the other ingredients listed in section 6.1.
  • The use of Prochlorperazine mesilate injection is contraindicated in children as it has been associated with dystonic reactions after the cumulative dose of 0.5mg/kg.

4.4 Special warnings and precautions for use

Prochlorperazine mesilate should be avoided in patients with liver or renal dysfunction, Parkinson’s disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided in patients known to be hypersensitive to phenothiazines or with a history of narrow angle glaucoma or agranulocytosis.

Close monitoring is required in patients with epilepsy or a history of seizures, as phenothiazines may lower the seizure threshold.

As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8), and requires immediate haematological investigation.

Neuroleptic malignant syndrome

It is imperative that treatment be discontinued in the event of unexplained fever, as this may be a sign of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity). Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs. Although neuroleptic malignant syndrome may be idiosyncratic in origin, dehydration and organic brain disease are predisposing factors.

Withdrawal

Acute withdrawal symptoms, including nausea, vomiting and insomnia, have very rarely been reported following the abrupt cessation of high doses of neuroleptics. Relapse may also occur, and the emergence of extrapyramidal reactions has been reported. Therefore, gradual withdrawal is advisable.

In schizophrenia, the response to neuroleptic treatment may be delayed. If treatment is withdrawn, the recurrence of symptoms may not become apparent for some time.

QT prolongation

Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and congenital or acquired (i.e. drug induced) QT prolongation. The risk-benefit should be fully assessed before Prochlorperazine mesilate treatment is commenced. If the clinical situation permits, medical and laboratory evaluations (e.g. biochemical status and ECG) should be performed to rule out possible risk factors (e.g. cardiac disease; family history of QT prolongation; metabolic abnormalities such as hypokalaemia, hypocalcaemia or hypomagnesaemia; starvation; alcohol abuse; concomitant therapy with other drugs known to prolong the QT interval) before initiating treatment with Prochlorperazine mesilate and during the initial phase of treatment, or as deemed necessary during the treatment (see sections 4.5 and 4.8).

Avoid concomitant treatment with other neuroleptics (see section 4.5).

Stroke

In randomised clinical trials versus placebo performed in a population with elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Prochlorperazine mesilate should be used with caution with stroke risk factors.

Depression

As with all antipsychotic drugs, Prochlorperazine mesilate should not be used alone where depression is predominant. However, it may be combined with antidepressant therapy to treat those conditions in which depression and psychosis coexist.

Photosensitivity

Because of the risk of photosensitisation, patients should be advised to avoid exposure to direct sunlight.

Skin reactions

To prevent skin sensitisation in those frequently handling preparations of phenothiazines, the greatest care must be taken to avoid contact of the drug with the skin (see section 4.8).

Postural hypotension with tachycardia as well as local pain or nodule formation may occur after i.m. administration.

Elderly

It should be used with caution in the elderly, particularly during very hot or very cold weather (risk of hyper-, hypothermia).

The elderly are particularly susceptible to postural hypotension.

Prochlorperazine mesilate should be used cautiously in the elderly owing to their susceptibility to drugs acting on the central nervous system and a lower initial dosage is recommended. There is an increased risk of drug-induced Parkinsonism in the elderly particularly after prolonged use. Care should also be taken not to confuse the adverse effects of Prochlorperazine mesilate, e.g. orthostatic hypotension, with the effects due to the underlying disorder.

Increased mortality in elderly people with dementia

Data from two large observational studies showed that elderly 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.

Prochlorperazine mesilate is not licensed for the treatment of dementia-related behavioural disturbances.

Venous thromboembolism

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 Prochlorperazine mesilate and preventative measures undertaken.

Hyperglycaemia

Hyperglycaemia or intolerance to glucose had been reported in patients treated with antipsychotic phenothiazines. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes, who are started on Prochlorperazine mesilate, should get appropriate glycaemic monitoring during treatment (see section 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

Adrenaline must not be used in patients overdosed with Prochlorperazine mesilate (see section 4.9).

The CNS depressant actions of neuroleptic agents may be intensified (additively) by alcohol, barbiturates and other sedatives. Respiratory depression may occur.

Anticholinergic agents may reduce the antipsychotic effect of neuroleptics and the mild anticholinergic effect of neuroleptics may be enhanced by other anticholinergic drugs, possibly leading to constipation, heat stroke, etc.

Some drugs interfere with absorption of neuroleptic agents: antacids, anti-Parkinson drugs and lithium.

Where treatment for neuroleptic-induced extrapyramidal symptoms is required, anticholinergic antiparkinsonian agents should be used in preference to levodopa, since neuroleptics antagonise the antiparkinsonian action of dopaminergics.

High doses of neuroleptics reduce the response to hypoglycaemic agents, the dosage of which might have to be raised.

The hypotensive effect of most antihypertensive drugs especially alpha adrenoceptor blocking agents may be exaggerated by neuroleptics.

The action of some drugs may be opposed by phenothiazine neuroleptics; these include amfetamine, levodopa, clonidine, guanethidine, adrenaline.

Increases or decreases in the plasma concentrations of a number of drugs, e.g. propranolol, phenobarbital have been observed but were not of clinical significance.

Simultaneous administration of desferrioxamine and prochlorperazine has been observed to induce transient metabolic encephalopathy characterised by loss of consciousness for 48 – 72 hours.

There is an increased risk of arrhythmias when antipsychotics are used with concomitant QT prolonging drugs (including certain antiarrhythmics, antidepressants and other antipsychotics) and drugs causing electrolyte imbalance.

There is an increased risk of agranulocytosis when neuroleptics are used concurrently with drugs with myelosuppressive potential, such as carbamazepine or certain antibiotics and cytotoxics.

In patients treated concurrently with neuroleptics and lithium, there have been rare reports of neurotoxicity.

Some phenothiazines are potent inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co-administration of phenothiazines with amitriptyline/amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with amitriptyline/amitriptylinoxide.

4.6 Fertility, pregnancy and lactation

Pregnancy

Animal studies are insufficient with respect to reproductive toxicity. However, potential harmful effect in animals cannot be ruled out. There is inadequate evidence of safety in pregnancy. Data from epidemiological studies do not suggest a risk of congenital malformations in children exposed in utero to Prochlorperazine mesilate.

As a precautionary measure, Prochlorperazine mesilate should be avoided during pregnancy unless the potential benefits outweigh the potential risks.

Neuroleptics may occasionally prolong labour and at such time should be withheld until the cervix is dilated 3 – 4 cm. Possible adverse effects on the neonate include lethargy or paradoxical hyperexcitability, tremor and low apgar score.

Neonates exposed to antipsychotics (including Prochlorperazine mesilate) 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.

Breast-feeding

Phenothiazines may be excreted in milk, therefore breast feeding should be suspended during treatment.

4.7 Effects on ability to drive and use machines

Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.

4.8 Undesirable effects

Generally, adverse reactions occur at a low frequency; the most common reported adverse reactions are nervous system disorders.

Immune system disorders:

  • Type I hypersensitivity reactions such as angioedema and urticaria.

Blood and lymphatic system disorders:

  • A mild leukopenia occurs in up to 30% of patients on prolonged high dosage.
  • Agranulocytosis may occur rarely: it is not dose related (see section 4.4).

Endocrine disorders:

  • Hyperprolactinaemia which may result in galactorrhoea, gynaecomastia, amenorrhoea and impotence.

Nervous system disorders:

  • Acute dystonia or dyskinesias, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.
  • Akathisia characteristically occurs after large initial doses.
  • Parkinsonism is more common in adults and the elderly. It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism. Commonly just tremor.
  • Tardive dyskinesia: If this occurs it is usually, but not necessarily, after prolonged or high dosage. It can even occur after treatment has been stopped. Dosage should therefore be kept low whenever possible.
  • Insomnia and agitation may occur.
  • Convulsions.

Eye disorders:

Ocular changes and the development of metallic greyish-mauve coloration of exposed skin have been noted in some individuals mainly females, who have received chlorpromazine continuously for long periods (four to eight years). This could possibly happen with Prochlorperazine mesilate.

Cardiac disorders:

  • ECG changes include QT prolongation (as with other neuroleptics), ST depression, U-Wave and T-Wave changes.
  • Cardiac arrhythmias, including ventricular arrhythmias and atrial arrhythmias, A-V block, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy, possibly related to dosage. Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.
  • There have been isolated reports of sudden death, with possible causes of cardiac origin (see section 4.4), as well as cases of unexplained sudden death, in patients receiving neuroleptic phenothiazines.

Vascular disorders:

  • Hypotension, usually postural, commonly occurs. Elderly or volume depleted subjects are particularly susceptible; it is more likely to occur after intramuscular injection.
  • Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown.

Gastrointestinal disorders:

Dry mouth may occur.

Metabolism and nutrition disorders:

  • Hyponatraemia
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Respiratory, thoracic and mediastinal disorders:

  • Respiratory depression is possible in susceptible patients.
  • Nasal stuffiness may occur.

Hepatobiliary disorders:

Jaundice, usually transient, occurs in a very small percentage of patients taking neuroleptics. A premonitory sign may be sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Neuroleptic jaundice has the biochemical and other characteristics of obstructive jaundice and is associated with obstruction of the canaliculi by bile thrombi; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon. Treatment should be withheld on the development of jaundice (see section 4.4).

Skin and subcutaneous tissue disorders:

  • Contact skin sensitisation may occur rarely in those frequently handling preparations of certain phenothiazines (see section 4.4).
  • Skin rashes of various kinds may also be seen in patients treated with the drug.
  • Patients on high dosage should be warned that they may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight.

General disorders and administration site conditions:

  • Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness) may occur with any neuroleptic (see section 4.4).
  • Intolerance to glucose, hyperglycaemia (see section 4.4).

Pregnancy, puerperium and perinatal conditions:

Drug withdrawal syndrome neonatal (see section 4.6) – Frequency not known.

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 of phenothiazine overdose include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur.

If the patient is seen sufficiently soon (up to 6 hours) after ingestion of a toxic dose, gastric lavage may be attempted. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment is supportive.

Generalised vasodilatation may result in circulatory collapse; raising the patient’s legs may suffice. In severe cases, volume expansion by intravenous fluids may be needed; infusion fluids should be warmed before administration in order not to aggravate hypothermia.

Positive inotropic agents such as dopamine may be tried if fluid replacement is insufficient to correct the circulatory collapse. Peripheral vasoconstrictor agents are not generally recommended. Avoid the use of adrenaline.

Ventricular or supraventricular tachy-arrhythmias usually respond to restoration of normal body temperature and correction of circulatory or metabolic disturbances. If persistent or life threatening, appropriate anti-arrhythmic therapy may be considered. Avoid lidocaine and, as far as possible, long acting anti-arrhythmic drugs.

Pronounced central nervous system depression requires airway maintenance or, in extreme circumstances, assisted respiration. Severe dystonic reactions usually respond to procyclidine (5 – 10mg) or orphenadrine (20 – 40mg) administered intramuscularly or intravenously. Convulsions should be treated with intravenous diazepam.

Neuroleptic malignant syndrome should be treated with cooling. Dantrolene sodium may be tried.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics; Phenothiazines with piperazine structure.

Prochlorperazine mesilate is a potent phenothiazine neuroleptic.

5.2 Pharmacokinetic properties

There is little information about blood levels, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

  1. Pharmaceutical particulars

6.1 List of excipients

Sodium sulphite anhydrous, Sodium metabisulphite powder

Sodium chloride, Ethanolamine

Water for injections (non-sterilised)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Keep ampoules in the outer carton, in order to protect from light. Discoloured solutions should not be used.

6.5 Nature and contents of container

Prochlorperazine mesilate injection is supplied in colourless glass ampoules in packs of 10 x 1 ml and 10 x 2 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements

 

  1. 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

 

Prochlorperazine mesilate Injection 12.5mg/ml Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Prochlorperazine mesilate 12.5 mg/ml Injection

prochlorperazine mesilate

Read all of this leaflet carefully before you start having 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, nurse or pharmacist.
  • 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Prochlorperazine mesilate Injection contains a medicine called prochlorperazine mesilate. This belongs to a group of medicines called ‘phenothiazine antipsychotics’. It works by blocking the effects of a chemical in the brain.

Prochlorperazine mesilate Injection can be used to:

  • Stop you feeling sick (nausea) or being sick (vomiting).
  • Treat schizophrenia.
  • Treat overactive behaviour or thoughts (mania).
  1. What you need to know before you have Prochlorperazine mesilate Injection

Do not have Prochlorperazine mesilate Injection if:

  • You are allergic (hypersensitive) to prochlorperazine mesilate or any of the other ingredients of Prochlorperazine mesilate Injection (listed in section 6).
    Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
  • The person is a child. This is because children may develop unusual face and body movements (dystonic reactions).

Warnings and precautions

Talk to your doctor, nurse or pharmacist before having Prochlorperazine mesilate Injection if:

  • You are allergic to phenothiazine medicines such as chlorpromazine.
  • You have heart problems or a family history of heart problems.
  • You have ever had a stroke.
  • You have liver or kidney problems.
  • You have thyroid problems.
  • You have an enlarged prostate gland. This means you may have problems when passing water (urine).
  • You have Parkinson’s disease.
  • You have dementia.
  • You have epilepsy or have ever had fits (seizures).
  • You have depression.
  • You have a tumour on your adrenal gland called ‘phaeochromocytoma’.
  • You have a type of muscle weakness called ‘myasthenia gravis’.
  • You have or have ever had glaucoma (signs include painful eyes with blurred vision).
  • You have or have ever had a low number of white blood cells (agranulocytosis). This would lead you to get infections more easily than usual.
  • 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.
  • You have low blood levels of potassium, calcium and magnesium. Your doctor may perform blood tests to check on these.
  • You are not eating properly or are very underweight.
  • You have a history of alcohol problems.
  • You are elderly (65 years of age or older).
  • You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your doctor may want to monitor you more closely.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Prochlorperazine mesilate Injection.

Other medicines and Prochlorperazine mesilate Injection

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Prochlorperazine mesilate Injection can affect the way some other medicines work. Also some medicines can affect the way Prochlorperazine mesilate Injection works.

In particular, tell your doctor if you are taking any of the following:

  • Medicines to help you sleep (sedatives, barbiturates).
  • Other medicines used to calm emotional and mental conditions.
  • Medicines used for depression, including amitriptyline.
  • Medicines used for Parkinson’s disease such as levodopa.
  • Medicines for fits (epilepsy) such as carbamazepine.
  • Medicines used to control your heartbeat such as amiodarone, disopyramide, propanolol or quinidine.
  • Medicines for high blood pressure such as doxazosin, terazosin, guanethidine or clonidine.
  • Medicines used for diabetes.
  • Medicines used for cancer (cytotoxics).
  • Medicines used for infections (antibiotics).
  • Anticholinergic medicines – includes some medicines used for irritable bowel syndrome, asthma or incontinence.
  • Amphetamines – used for Attention Deficit Hyperactivity Disorder (ADHD).
  • Adrenaline – used for life threatening allergic reactions.
  • Desferrioxamine – used when you have too much iron in your blood.
  • Lithium – used for some types of mental illness.

Prochlorperazine mesilate Injection with alcohol

Do not drink alcohol while you are having Prochlorperazine mesilate Injection. This is because alcohol can add to the effects of Prochlorperazine mesilate Injection and can cause serious breathing difficulties.

Pregnancy and breast-feeding

Do not have Prochlorperazine mesilate Injection if:

  • You are pregnant, think you may be pregnant or are planning to have a baby.
  • You are breast-feeding or planning to breast-feed.

The following symptoms may occur in newborn babies, of mothers that have used Prochlorperazine mesilate 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.

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

Driving and using machines

You may feel sleepy after having this medicine. If this happens, do not drive or use any tools or machines.

Prochlorperazine mesilate Injection contains

  • Sodium: This medicine contains 2.91mg of sodium per injection. This should be taken into consideration by people on a controlled sodium diet.
  • Sulphites: This medicine contains small amounts of sulphites. These may cause severe allergic (hypersensitivity) reactions and difficulty in breathing (bronchospasm). This is more likely to happen if you have a history of asthma or allergies. The chances of this happening are rare. Stop having the medicine if you get a rash, swallowing or breathing problems or swelling of your lips, face, throat or tongue.
  1. How Prochlorperazine mesilate Injection is given

Prochlorperazine mesilate Injection is normally given by a doctor or nurse. This is because it needs to be given as a deep injection into a muscle.

How much Prochlorperazine mesilate Injection is given

If you are not sure why you are being given Prochlorperazine mesilate Injection or have any questions about how much Prochlorperazine mesilate Injection is being given to you, speak to your doctor or nurse. The usual doses are:

Schizophrenia and overactive behaviour or thoughts (mania):

Adults: 12.5 – 25 mg two or three times a day. You will be given injections until you are able to take Prochlorperazine mesilate Tablets or syrup.

Stopping you feeling sick or being sick:

Adults: To begin with 12.5 mg by injection. This may be followed by oral medication 6 hours later if necessary.

Elderly: Your doctor may prescribe a lower dose. You should be careful during very hot or very cold weather to make sure that you do not get too hot or too cold.

Children and adolescents

Prochlorperazine mesilate Injection is not given to children.

If you have more Prochlorperazine mesilate Injection than you should

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Always ask if you are not sure why you are getting a dose of medicine.

Having too much Prochlorperazine mesilate may make you feel sleepy or dizzy, increased or rapid heartbeat, feeling very cold and confused, writhing movements, feeling restless, stiffness or shaking. You may lose consciousness.

If you miss a dose of Prochlorperazine mesilate Injection

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you do think you have missed a dose, tell your doctor or nurse.

If you stop having Prochlorperazine mesilate Injection

Keep having Prochlorperazine mesilate Injection until your doctor tells you to stop. If you stop having Prochlorperazine mesilate Injection, your illness may come back and you may have other effects such as feeling or being sick or difficulty sleeping. Your doctor will gradually stop your medicine to prevent these effects happening.

Exposure to sunlight

Prochlorperazine mesilate Injection can cause your skin to be more sensitive to sunlight. You should avoid exposure to direct sunlight while having this medicine.

Tests

Your doctor may do regular tests while you are having this medicine. These might include blood tests and an ECG to check your heart is working properly.

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

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell a doctor or nurse straight away if:

  • You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
  • You have an unusually pale complexion, sweating, high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’.
  • You have frequent infections such as fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia.
  • You may get infections more easily than usual. This could be because of a blood disorder (agranulocytosis).
  • You have yellowing of your skin or eyes (jaundice). These could be signs of liver problems.
  • You have very fast, uneven or forceful heartbeats (palpitations) and experience breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain.
  • 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. If you notice any of these symptoms seek medical advice immediately.
  • You have rigid or stiff muscles, trembling or shaking, unusual eye movements (including rolling of the eyes), difficulty moving, or loss of muscle power.

Tell your doctor or nurse as soon as possible if you have any of the following side effects:

  • Breathing problems.
  • Changes in your skin or eye colour after having Prochlorperazine mesilate Injection for a long period of time.
  • Problems with your eyesight after having Prochlorperazine mesilate Injection for a long period of time.
  • Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure).
  • You have fits (convulsions).
  • 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 (hyponatraemia).
  • Feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be something called a syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
  • 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).

Tell your doctor, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days:

  • Abnormal production of breast milk in men and women
  • Breast enlargement in men
  • Loss of menstrual periods
  • Difficulty in getting or maintaining an erection (impotence)
  • Difficulty sleeping (insomnia)
  • Feeling restless or agitated
  • Dry mouth
  • Your skin being more sensitive to the sun than usual
  • Stuffy nose
  • Skin rashes
  • Skin redness, swelling and itching from touching the medicine

As with other phenothiazine medicines, there have been very rare reports of sudden death with Prochlorperazine mesilate Injection. These are possibly caused by heart problems.

In elderly 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Prochlorperazine mesilate Injection

This medicine will be kept by your doctor or nurse out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Keep the ampoules in the original 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 protect the environment.

  1. Contents of the pack and other information

What Prochlorperazine mesilate Injection contains

  • Each 1 ml of Prochlorperazine mesilate Injection contains 12.5 mg of the active substance, prochlorperazine mesilate.
  • The other ingredients are sodium sulphite anhydrous, sodium metabisulphite powder, sodium chloride, ethanolamine and water for injection.

What Prochlorperazine mesilate Injection looks like and contents of the pack

Prochlorperazine mesilate Injection is a colourless sterile solution.

Prochlorperazine mesilate Injection is available in packs containing 10 x 1 ml ampoules or 10 x 2 ml ampoules.

Not all pack sizes may be marketed

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