1. Name of the medicinal product

Metoclopramide Tablets USP 5mg Taj Pharma
Metoclopramide Tablets USP 10mg Taj Pharma

  1. Qualitative and quantitative composition

a) Metoclopramide Tablets USP 5mg Taj Pharma
Each uncoated tablet contains:
Metoclopramide Hydrochloride USP
Equivalent to Metoclopramide (anhydrous) 5mg
Excipients: Q.S.

b) Metoclopramide Tablets USP 10mg Taj Pharma
Each uncoated tablet contains:
Metoclopramide Hydrochloride USP
Equivalent to Metoclopramide (anhydrous) 10mg
Excipients: Q.S.

Excipients with known effect:

Lactose: contains 125.00 mg of lactose per tablet

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

White to ivory-white circular double convex tablet with a single break bar on one side.

  1. Clinical particulars
  • Therapeutic indications

Adult population

Metoclopramide Taj Pharma 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 Taj Pharma can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.

Diagnostic procedures:

Radiology,

Duodenal intubation

‘Metoclopramide Taj Pharma’ speeds up the passage of a barium meal by increasing the rate of gastric emptying, co-ordinating peristalsis and dilating the duodenal bulb.

‘Metoclopramide Taj Pharma’ also facilitates duodenal intubation procedures.

Paediatric population

Metoclopramide Taj Pharma is indicated in children (aged 1-18 years) for:

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

Posology and method of administration

Posology:

Adult patients

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.

Paediatric population:

The safety and efficacy of Metoclopramide Taj Pharma in children below 1 year has not yet been established (see section 4.3).

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 0.5mg/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 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

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.

Patients with 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).

Patients with Hepatic impairment:

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

Other pharmaceutical forms/strengths may be more appropriate for administration to these populations.

Diagnostic indications:

A single dose of ‘Metoclopramide Taj Pharma’ may be given 5-10 minutes before the examination, subject to body weight consideration, (see above).

Method of administration:

For oral use only.

  • Contraindications
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk
  • Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes
  • History of neuroleptic or Metoclopramide Taj Pharma-induced tardive dyskinesia
  • Epilepsy (increased crises frequency and intensity)
  • Parkinson’s disease
  • Combination with levodopa or dopaminergic agonists (see section 4.5)
  • Known history of methaemoglobinaemia with Metoclopramide Taj Pharma 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)

‘Metoclopramide Taj Pharma’ should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.

  • Special warnings and precautions for use

Precautions:

If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation.

Neurological Disorders

Extrapyramidal disorders may occur, particularly 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 Taj Pharma 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 Taj Pharma administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Prolonged treatment with Metoclopramide Taj Pharma 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 Taj Pharma in combination with neuroleptics as well as with Metoclopramide Taj Pharma monotherapy (see section 4.8). Metoclopramide Taj Pharma 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 Taj Pharma.

Methaemoglobinemia

Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, Metoclopramide Taj Pharma 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 administration of Metoclopramide Taj Pharma by injection, particularly via the intravenous route (see section 4.8).

Special care should be taken when administering Metoclopramide Taj Pharma, 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 Taj Pharma may cause elevation of serum prolactin levels.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency of glucose-galactose malabsorption should not take this medicine.

Care should be exercised when using Metoclopramide Taj Pharma in patients with a history of atopy (including asthma) or porphyria.

Metoclopramide Taj Pharma should not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastrointestinal contractions may adversely affect healing.

Special care should be taken when administering Metoclopramide Taj Pharma intravenously to patients with “sick sinus syndrome” or other cardiac conduction disturbances.

There have been very rare reports of abnormalities of cardiac conduction with intravenous Metoclopramide Taj Pharma. Metoclopramide Taj Pharma should be used with care with other drugs affecting cardiac conduction.

  • Interaction with other medicinal products and other forms of interaction

Contraindicated combination

Levodopa or dopaminergic agonists and Metoclopramide Taj Pharma have a mutual antagonism (see section 4.3).

Combination to be avoided

Alcohol potentiates the sedative effect of Metoclopramide Taj Pharma.

Combination to be taken into account

Due to the prokinetic effect of Metoclopramide Taj Pharma, the absorption of certain drugs may be modified.

Anticholinergics and morphine derivatives

Anticholinergics and morphine derivatives may have both a mutual antagonism with Metoclopramide Taj Pharma 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 Taj Pharma are potentiated.

Neuroleptics

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

Serotonergic drugs

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

Digoxin

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

Cyclosporine

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

Strong CYP2D6 inhibitors

Metoclopramide Taj Pharma 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.

‘Metoclopramide Taj Pharma’ may reduce plasma concentrations of atovaquone.

  • 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 Taj Pharma can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of Metoclopramide Taj Pharma administration at the end of pregnancy, extrapyramidal syndrome in new born cannot be excluded.

Metoclopramide Taj Pharma should be avoided at the end of pregnancy. If Metoclopramide Taj Pharma is used, neonatal monitoring should be undertaken.

Breast-feeding

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

  • Effects on ability to drive and use machines

Metoclopramide Taj Pharma has moderate influence on the ability to drive and use machines. Metoclopramide Taj Pharma may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

  • Undesirable effects

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

System 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
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 including oculogyric crisis, 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 and 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.

  • 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.

  1. Pharmacological properties
  • Pharmacodynamic properties

(Drugs for Functional Gastrointestinal Disorders- Propulsives)

Mechanism of action

The action of Metoclopramide Taj Pharma is closely associated with parasympathetic nervous control of the upper gastro-intestinal tract where it has the effect of encouraging normal peristaltic action. This provides for a fundamental approach to the control of those conditions where disturbed gastrointestinal motility is a common underlying factor.

  • Pharmacokinetic properties

Metoclopramide Taj Pharma is metabolised in the liver and the predominant route of elimination of Metoclopramide Taj Pharma and its metabolites is via the kidney.

Renal impairment

The clearance of Metoclopramide Taj Pharma 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 Taj Pharma has been observed, associated with a 50% reduction in plasma clearance.

  • Preclinical safety data

No additional data available.

  1. Pharmaceutical particulars
  • List of excipients

Maize starch (dried)

Colloidal silicon dioxide

Magnesium stearate

Pregelatinised maize starch

Lactose.

  • Incompatibilities

Not applicable.

  • Shelf life

Sixty months.

  • Special precautions for storage

Do not store above 30°C

  • Nature and contents of container

Each tablets contains active substance Metoclopramide Hydrochloride Taj Pharma 5mg and 10mg uncoated tablets.

Standard aluminium containers of 3, 6, 9, 12, 100 or 500 tablets.

Plastic reclosable containers packed into carton of 42, 84, 100 or 500 tablets.

Amber glass bottles of 100 or 500 tablets.

PVC blister (300 microns) of 20, 21, 42 or 84 tablets backed with aluminium foil (20 microns). The underside of the foils is coated with vinyl based laquer.

PVC (200 microns) / PVDC (60gsm) blister of 20, 21, 42 or 84 tablets.

Not all pack sizes may be marketed.

  • Special precautions for disposal and other handling

No special requirements for disposal.

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

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 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, 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 of the side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet (See section 4).

The name of your medicine is Metoclopramide Taj Pharma 10mg Tablets but will be referred to as ‘Metoclopramide Taj Pharma Tablets’ throughout this leaflet.

What is in this leaflet

  1. What Metoclopramide Taj Pharma Tablets are and what they are used for
  2. What you need to know before you take Metoclopramide Taj Pharma Tablets
  3. How to take Metoclopramide Taj Pharma Tablets
  4. Possible side effects
  5. How to store Metoclopramide Taj Pharma Tablets
  6. Contents of pack and other information

1. WHAT Metoclopramide Taj Pharma TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Metoclopramide Taj Pharma 10mg Tablets.

Metoclopramide Taj Pharma Tablets contain the active ingredient

Metoclopramide Taj Pharma Hydrochloride BP 10 mg which belongs to a group of medicines called antiemetics. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).

Adult population

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

Paediatric population

Metoclopramide Taj Pharma Tablets are 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.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Metoclopramide Taj Pharma TABLETS

Do not take Metoclopramide Taj Pharma Tablets if:

  • you are allergic to Metoclopramide Taj Pharma or any of the other ingredients of this medicine (listed in section 6)
  • you have bleeding, obstruction or a tear in your stomach or gut
  • you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma)
  • you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine
  • you have epilepsy
  • you have Parkinson’s disease
  • you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see below “Other medicines and Metoclopramide Taj Pharma Tablets”)
  • you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency.

Do not give Metoclopramide Taj Pharma 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 Taj Pharma 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 Taj Pharma dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.

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 Taj Pharma Tablets if”).

Other medicines and Metoclopramide Taj Pharma Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Metoclopramide Taj Pharma Tablets work or

Metoclopramide Taj Pharma 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 Taj Pharma 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 Taj Pharma Tablets with food, drink and alcohol

Alcohol should not be consumed during treatment with Metoclopramide Taj Pharma because it increases the sedative effect of Metoclopramide Taj Pharma Tablets.

Pregnancy, breast-feeding and fertility

Pregnancy:

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

If necessary, Metoclopramide Taj Pharma Tablets may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Breast-feeding:

Metoclopramide Taj Pharma Tablets are not recommended if you are breast-feeding because Metoclopramide Taj Pharma 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 Taj Pharma Tablets. This may affect your vision and also interfere with your ability to drive and use machines.

Metoclopramide Taj Pharma Tablets contain Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This is because Metoclopramide Taj Pharma

Tablets contains Lactose, a type of sugar.

  1. How to take Metoclopramide Taj Pharma 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.

Use in children and adolescents

Metoclopramide Taj Pharma must not be used in children aged less than 1 year (see section 2).

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 (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 10-14Kg 1mg Up to 3 times daily
3-5 years 15-19Kg 2mg Up to 3 times daily
5-9 years 20-29Kg 2.5mg Up to 3 times daily
1-3 years 30-60Kg 5mg Up to 3 times daily
1-3 years >60Kg 10mg Up to 3 times daily

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

Metoclopramide Taj Pharma Tablets are not suitable for use in children weighing less than 61 kg.

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

Method of administration

For oral use, to be swallowed with some water.

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

Elderly:

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

Hepatic impairment:

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

If you take more Metoclopramide Taj Pharma 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. Your doctor may prescribe you a treatment for these signs if necessary.

If you forget to take Metoclopramide Taj Pharma 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.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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) such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity). 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
  • signs of severe allergic reaction (particularly with intravenous route)
  • convulsions (fits).

The other side effects are very common (may affect more than 1 in 10 people)

  • feeling drowsy.

Common (may affect up to 1 in 10 people)

  • depression
  • 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
  • involuntary upward deviation of eye ball
  • hallucination
  • decreased level of consciousness
  • slow heartbeat (particularly with intravenous route).

Rare (may affect up to 1 in 1,000 people)

  • confusional state.
  • 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
  • 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)
  • sudden increase in blood pressure in patients with tumour of the adrenal gland (pheochromocytoma)
  • 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 safety of this medicine.

  1. HOW TO STORE Metoclopramide Taj Pharma TABLETS

Keep this medicine out of the sight and reach of children.

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

Do not store above 30°C.

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 pack and other information

What Metoclopramide Taj Pharma Tablets contains

Metoclopramide Taj Pharma Tablets contains 5mg and 10mg of the active ingredient Metoclopramide Taj Pharma hydrochloride USP.

Other inactive ingredients are: maize starch (dried), colloidal silicon dioxide, magnesium stearate, pregelatinised maize starch and lactose.

What Metoclopramide Taj Pharma Tablets looks like and content of the pack

White to ivory-white circular double convex uncoated tablet.

Pack Size:

Metoclopramide Taj Pharma Tablets are available in aluminium canisters of 3, 6, 9, 12, 100 or 500 tablets; plastic recloseable

containers packed into a carton of 42,84,100 or 500 tablets; amber glass bottles of 100 or 500 tablets; blister packs of 20,21,42 or 84 tablets.

Not all pack size 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