Metoclopramide Hydrochloride tablets USP 5mg Taj Pharma

1.NAME OF THE MEDICINAL PRODUCT
a) Metoclopramide Hydrochloride tablets USP 5mg Taj Pharma

b) Metoclopramide Hydrochloride tablets USP 10mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains:

Metoclopramide Hydrochloride USP
equivalent to 5mg anhydrous Metoclopramide.

b) Each tablet contains:
Metoclopramide Hydrochloride USP
equivalent to 10mg anhydrous Metoclopramide.
For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Tablet
White to off-white, round, biconvex tablets with a scoreline on the other side.
The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Adult population
Metoclopramide is indicated in adults for:

– Prevention of delayed chemotherapy induced nausea and vomiting (CINV)

– Prevention of radiotherapy induced nausea and vomiting (RINV).

– Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.

Paediatric population
Metoclopramide is indicated in children (aged 1-18 years) for:

– Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option

4.2  Posology and method of administration
Posology

Adult population

The recommended single dose is 10 mg, repeated up to three times daily.

The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.

The maximum recommended treatment duration is 5 days.

Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosing table

Age Body Weight Dose Frequency
1-3 years 10-14 kg 1 mg Up to 3 times daily
3-5 years 15-19 kg 2 mg Up to 3 times daily
5-9 years 20-29 kg 2.5 mg Up to 3 times daily
9-18 years 30-60 kg 5 mg Up to 3 times daily
15-18 years Over 60kg 10 mg Up to 3 times daily


The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Tablets are not suitable for use in children weighing less than 30 kg.

Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Method of administration:

A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).

Special population

Elderly

In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment:

In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).

Hepatic impairment:

In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).

Paediatric population

Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

4.3 Contraindications
• Hypersensitivity to the active substance or any of the excipients listed in 6.1.

  • Gastrointestinal haemorrhage, mechanical obstruction or gastrointestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk.
  • A history of neuroleptic or metoclopramide-induced tardive dyskinesia.
  • Epilepsy (increased crises frequency and intensity)
  • Parkinson’s disease
  • Confirmed or suspected phaeochromocytoma due to the risk of severe hypertension episode.
  • Combination with levodopa or dopaminergic agonists (see section 4.5).
  • Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.
  • Use in children less than 1 year of age due to an increased risk of extrapyramidal disorders (see section 4.4)

4.4 Special Warnings and precautions for use
Special warnings

Neurological Disorders

Extrapyramidal disorders may occur, particular in children and young adults, and/or when high doses are used.

These reactions occur usually at the beginning of the treatment and can occur after a single administration. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).

The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear.

Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs (see section 4.3)

Symptoms of Parkinson’s disease may also be exacerbated by metoclopramide.

Methaemoglobinemia

Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

Cardiac Disorders

There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following dministration of metoclopramide by injection, particularly via the intravenous route (see section 4.8).

Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).

Renal and Hepatic Impairment

In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended (see section 4.2).

Metoclopramide Hydrochloride tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicine.

4.5 Interaction with other medicinal products and other forms of interaction
Contraindicated combination

Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3).

Combination to be avoided

Alcohol potentiates the sedative effect of metoclopramide.

Combination to be taken into account

Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.

Anticholinergics and morphine derivatives

Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.

Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related)

Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.

Neuroleptics

Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.

Serotonergic drugs

The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.

Digoxin

Metoclopramide may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required.

Cyclosporine

Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%). Careful monitoring of cyclosporine plasma concentration is required. The clinical consequence is uncertain.

Mivacurium and suxamethonium

Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).

Strong CYP2D6 inhibitors

Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine. Although the clinical significance is uncertain, patients should be monitored for adverse reactions.

4.6 Fertility, Pregnancy and lactation
Pregnancy

A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded. Metoclopramide should be avoided at the end of pregnancy. If metoclopramide is used, neonatal monitoring should be undertaken.

Breastfeeding

Metoclopramide is excreted in breast milk at low level. Adverse reactions in the breast-fed baby cannot be excluded. Therefore metoclopramide is not recommended during breastfeeding. Discontinuation of metoclopramide in breastfeeding women should be considered.

 4.7 Effects on ability to drive and use machines
Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

4.8 Undesirable Effects
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

Systeme Organ Class Frequency Adverse reactions
Blood and lymphatic system disorders
Not known Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates (see section 4.4)

Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicinal products

Cardiac disorders
Uncommon Bradycardia, particularly with intravenous Formulation
Not known Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4);

Atrioventricular block, Sinus arrest particularly with intravenous formulation;

Electrocardiogram QT prolonged; Torsade de Pointes;

Endocrine disorders*
Uncommon Amenorrhoea, Hyperprolactinaemia,
Rare Galactorrhoea
Not known Gynaecomastia
Gastrointestinal disorders
Common Diarrhoea
General disorders and administration site conditions
Common Asthenia
Immune system disorders
Uncommon Hypersensitivity
Not known Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation
Nervous system disorders Nervous system disorders

Very Common

Somnolence
Common Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4), Parkinsonism, Akathisia
Uncommon Dystonia, Dyskinesia, Depressed level of Consciousness
Rare Convulsion especially in epileptic patients
Not known Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Psychiatric disorders
Common Depression
Uncommon Hallucination
Rare Confusional state
Vascular disorder
Common Hypotension, particularly with intravenous Formulation
Not known Shock, syncope after injectable use Acute hypertension in patients with phaeochromocytoma (see section 4.3), Transient increase in blood pressure

* Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).

The following reactions, sometimes associated, occur more frequently when high doses are used:

– Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).

– Drowsiness, decreased level of consciousness, confusion, hallucination.

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

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).

A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Metoclopramide is a substituted benzamide. It is used among other things because of its anti-emetic properties. The anti-emetic effect is the result of two mechanisms of action involving the central nervous system:

  • antagonism of the dopaminergic D2 receptors in the chemoreceptor trigger zone and in the vomiting centre of the medulla which is affected in apomorphine-induced vomiting;
  • antagonism of the serotoninergic 5HT3 receptors and agonist effect on the 5HT4 receptors which are affected in chemotherapy-induced vomiting.

In addition to the central action, metoclopramide has a stimulant effect on gastrointestinal motility via a peripheral mechanism of action. There is an antidopaminergic effect and potentiation of the effect of acetylcholine. This causes accelerated emptying of the stomach and there is an increase in the pressure exerted by the lower oesophageal sphincter. Metoclopramide has no effect on gastric secretions.

5.2 Pharmacokinetic properties
Following oral administration the relative bioavailability compared with intravenous administration is 60 to 100%. Peak plasma concentrations are reached within 0.5 to 2 hours.

The distribution volume is 2-3 l/kg; 13-22% is bound to plasma proteins. Metoclopramide is excreted primarily in the urine, both in unchanged form and in sulfate or glucuronide conjugate form. The principal metabolite is an N-4 sulphur conjugate.

The plasma elimination half-life is 5 to 6 hours, irrespective of the route of administration.

Special patient populations

Renal impairment

The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).

Hepatic impairment

In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.

5.3 Preclinical safety data
No abnormalities have been found in animal studies to indicate a safety risk in humans. This is based on data from pharmacological studies relating to safety, and data on toxicity following repeated administration, genotoxicity, carcinogenicity and reproductive toxicity.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
The tablet contains the following excipients:
Lactose monohydrate.
Pre-gelatinised starch.
Maize starch.
Anhydrous colloidal silica.
Magnesium stearate.

6.2 Incompatibilities
No particulars.

6.3  Shelf life
The shelf life is 2 years in PVC/PVdC/aluminium blister strips.

6.4 Special precautions for storage
Store below 30 °C.

6.5 Nature and contents of container
Metoclopramide Hydrochloride Tablets are packaged in PVC/PVdC/aluminium blister strips. The carton contains 20, 24, 28, 30, 40, 50, 60, 84, 100, 500 tablets.

6.6 Special precautions for disposal and other handling
No special 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

Metoclopramide Hydrochloride tablets USP 5mg Taj Pharma

Package leaflet: Information for the patient

a) Metoclopramide Hydrochloride tablets USP 5mg Taj Pharma
b) Metoclopramide Hydrochloride tablets USP 10mg Taj Pharma

Read all of this leaflet carefully before you start taking 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 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Metoclopramide Hydrochloride tablets is and what it is used for
2. Before you are given Metoclopramide Hydrochloride tablets
3. How you will be given  Metoclopramide Hydrochloride tablets
4. Possible side effects
5. How Metoclopramide Hydrochloride tablets is stored
6. Further Information

1. What Metoclopramide Hydrochloride tablets is and what it is used for
Metoclopramide Hydrochlride is an antiemetic. It contains a medicine called “metoclopramide”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).
Adult population:
Metoclopramide Hydrochloride is used in adults:
· to prevent delayed nausea and vomiting that may occur after chemotherapy
· to prevent nausea and vomiting caused by radiotherapy
· to treat nausea and vomiting including nausea and vomiting which may occur with a migraine.

Metoclopramide can be taken with oral painkillers in case of migraine to help painkillers work more effectively.

Paediatric population
Metoclopramide Hydrochloride is indicated in children (aged 1-18 years) if other treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy

2. Before you are given Metoclopramide Hydrochloride tablets
Do not take Metoclopramide Hydrochloride tablets:
· if you are allergic (hypersensitive) to metoclopramide or any of the other ingredients of this medicine (listed in section 6)
· if you have bleeding, obstruction or a tear in your stomach or gut.
· if you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma).
· if you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine.
· if you have  epilepsy
·  if you have Parkinson’s disease
·  if you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic
· agonists (see below “Other medicines and Metoclopramide Hydrochloride tablets”)
· if you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency

Do not give Metoclopramide Hydrochloride tablets to a child less than 1 year of age (see below “Children and adolescents”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Metoclopramide Hydrochloride tablets if:
· you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems
· you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
· you are using other medicines known to affect the way your heart beats
· you have any neurological (brain) problems
· you have liver or kidney problems. The dose may be reduced (see section 3).

Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped.

You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Children and adolescents
Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above “Do not take Metoclopramide Hydrochloride tablets if”).

Other medicines and Metoclopramide Hydrochloride tablets
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Metoclopramide Hydrochloride tablets works or Metoclopramide Hydrochloride tablets can affect how other medicines work. These medicines include the following:
– levodopa or other medicines used to treat Parkinson’s disease (see above “Do not take Metoclopramide Hydrochloride tablets if”)
– anticholinergics (medicines used to relieve stomach cramps or spasms)
– morphine derivatives (medicines used to treat severe pain)
– sedative medicines
– any medicines used to treat mental health problems
– digoxin (medicine used to treat heart failure)
– cyclosporine (medicine used to treat certain problems with the immune system)
– mivacurium and suxamethonium (medicines used to relax muscles)
– fluoxetine and paroxetine (medicine used to treat depression)

Metoclopramide Hydrochloride tablets with alcohol Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Metoclopramide Hydrochloride tablets.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine. If necessary, Metoclopramide Hydrochloride tablets may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Trade Metoclopramide Hydrochloride tablets name is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines
You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking Metoclopramide Hydrochloride tablets. This may affect your vision and also interfere with your ability to drive and use machines.

Metoclopramide Hydrochloride tablets contains Lactose
This drug contains lactose monohydrate. Patients with rare hereditary abnormalities of galactose tolerance, those with Lapp lactase deficiency or glucose-galactose malabsorption should not use this medication. Tell your doctor if you know you have a sugar intolerance.

3. How you will be given Metoclopramide Hydrochloride tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adult population:
The recommended single dose is 10 mg, repeated up to three times daily.

The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight.
The maximum recommended treatment duration is 5 days.
To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 1-18 years)
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by Mouth.
The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosing table

Age Body Weight Dose Frequency
1-3 years 10-14 kg 1 mg Up to 3 times daily
3-5 years 15-19 kg 2 mg Up to 3 times daily
5-9 years 20-29 kg 2.5 mg Up to 3 times daily
9-18 years 30-60 kg 5 mg Up to 3 times daily
15-18 years Over 60kg 10 mg Up to 3 times daily

Device / instruction for use
You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.

Metoclopramide Hydrochloride tablets is not suitable for use in children weighing less than 30 kg.
Other pharmaceutical forms/strengths may be more appropriate for administration

Method of administration
Swallow the tablet with glass of water.
You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Older people
The dose may need to be reduced depending on kidney problems, liver problems and overall health.

Adults with kidney problems
Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems.

Adults with liver problems
Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.

Children and adolescents
Metoclopramide must not be used in children aged less than 1 year (see section 2).

If you take more Metoclopramide Hydrochloride tablets than you should
Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucination and heart problems. You doctor may prescribe you a treatment for these signs if necessary.

If you forget to take Metoclopramide Hydrochloride tablets
Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible Side Effects
Like all medicines, Metoclopramide Hydrochloride tablets can cause side effects, although not everybody gets them.

Stop the treatment and talk straight away to your doctor, pharmacist or nurse if you experience one of the following signs while having this medicine:
– uncontrollable movements (often involving head or neck). These may occur in children or young adults and particularly when high doses are used. These signs usually occur at the beginning of treatment and may even occur after one single administration. These movements will stop when treated appropriately.
– high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome.
– Itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing. These may be signs of an allergic reaction, which may be severe.

Very common (may affect more than 1 in 10 people)
• feeling drowsy.

Common (may affect up to 1 in 10 people)
• depression
• uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)
• symptoms similar to Parkinson disease (rigidity, tremor)
• feel restless
• blood pressure decrease (particularly with intravenous route)
• diarrhoea
• feeling weak.

Uncommon (may affect up to 1 in 100 people)
• raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding
• irregular periods
• hallucination
• decreased level of consciousness
• slow heartbeat (particularly with intravenous route)
• allergy

Rare (may affect up to 1 in 1,000 people)
• confusional state
• convulsion (especially in patients with epilepsy).

Not known (frequency cannot be estimated from the available data)
• abnormal blood pigment levels: which may change the colour of your skin
• abnormal development of breasts (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome
• changes in heart beat, which may be shown on an ECG test
• cardiac arrest (particularly with injection route)
• shock (severe decrease of heart pressure) (particularly with injection route)
• fainting (particularly with intravenous route)
• allergic reaction which may be severe (particularly with intravenous route)
• very high blood pressure.

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

5. How Metoclopramide Hydrochloride tablets is stored
Keep this medicine out of the sight and reach of children.
· Store below 30° C.
· Do not use this medicine after the expiry date which is stated on the strips and carton after ‘EXP’. The expiry date refers to the last day of that month.
· Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.

6. Further information

What Metoclopramide Hydrochloride tablets contains
The name of your medicine is Metoclopramide Hydrochloride tablets, and the active substance is metoclopramide hydrochloride.

a) Each tablet contains:
Metoclopramide Hydrochloride USP
equivalent to 5mg anhydrous Metoclopramide.
Excipients          q.s.

b) Each tablet contains:
Metoclopramide Hydrochloride USP
equivalent to 10mg anhydrous Metoclopramide
Excipients            q.s.

The tablets contain the following non-active ingredients: Lactose monohydrate, pre-gelatinised starch, maize starch, anhydrous colloidal silica, magnesium stearate.

What Metoclopramide Hydrochloride tablets looks like and contents of the pack
White to off-white, round, biconvex tablets. The tablet can be divided into equal halves. The tablets are packaged in PVC/PVdC/aluminium blister strips. The carton contains 20, 24, 28, 30, 40, 50, 60, 84, 100, 500 tablets.

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