Loperamide Hydrochloride Tablets USP 2mg Taj Pharma

1. Name of the medicinal product

Loperamide Hydrochloride Tablets USP 2mg Taj Pharma

2. Qualitative and quantitative composition

Loperamide Hydrochloride Tablets USP 2mg Taj Pharma
Each uncoated tablet contains:
Loperamide Hydrochloride USP 2mg
Excipients: Q.S.

Excipients with known effects:

Each tablet contains 100mg lactose monohydrate.

Each tablet contains 0.42mg sodium.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Capsule shaped uncoated Tablet (Caplets)

Light green coloured capsule-shaped, biconvex uncoated tablets

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical particulars

• Therapeutic indications

For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to 5 days in adults and children over 9 years. For the symptomatic treatment of chronic diarrhoea in adults.

• Posology and method of administration

Posology

Acute diarrhoea

Adults and children over 12 years

Two tablets (4mg) initially, followed by one tablet (2mg) after every loose stool. The usual dosage is 3-4 tablets (6mg-8mg) per day. The maximum daily dose should not exceed 8 tablets (16mg).

Children 9 to 12 years

One tablet (2mg) four times daily until diarrhoea is controlled (up to 5 days). This dose should not be exceeded.

Further investigation into the cause of the diarrhoea should be considered if there is no improvement within two days of starting treatment with Loperamide Taj Pharma.

Chronic diarrhoea

Adults

Patients may need widely differing amounts of Loperamide Taj Pharma. The starting dose should be between two and four tablets per day in divided doses, depending on severity. If required, this dose can be adjusted according to result up to a maximum of eight tablets daily.

Having established the patient’s daily maintenance dose, Loperamide Taj Pharma may be administered on a twice daily regimen. Tolerance has not been observed and therefore subsequent dosage adjustment should be unnecessary.

Elderly

No dose adjustment is required for the elderly.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Hepatic impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide Taj Pharma should be used with caution in such patients because of reduced first pass metabolism (see section 4.4).

Method of administration

Oral use. The tablets should be taken with liquid.

• Contraindications

Loperamide Taj Pharma is contraindicated in:

• patients with a known hypersensitivity to Loperamide Taj Pharma hydrochloride or to any of the excipients listed in section 6.1.
• children less than 9 years of age.
• Loperamide Taj Pharma should not be used as the primary therapy:
• patients with acute dysentery, which is characterised by blood in stools and high fever.
• patients with acute ulcerative colitis.
• patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter.
• patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

Loperamide Taj Pharma should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loperamide Taj Pharma must be discontinued promptly when constipation, abdominal distension or ileus develop.

• Special warnings and precautions for use

Treatment of diarrhoea with Loperamide Taj Pharma is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. The priority in acute diarrhoea is the prevention or reversal of fluid and electrolyte depletion. This is particularly important in young children and in frail and elderly patients with acute diarrhoea. Use of Loperamide Taj Pharma does not preclude the administration of appropriate fluid and electrolyte replacement therapy.

Since persistent diarrhoea can be an indicator of potentially more serious conditions, Loperamide Taj Pharma should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated.

In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of Loperamide Taj Pharma should be discontinued and patients should be advised to consult their doctor.

Patients with AIDS treated with Loperamide Taj Pharma for diarrhoea should have therapy stopped at the earliest signs of abdominal distension. There have been isolated reports of obstipation with an increased risk for toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with Loperamide Taj Pharma.

Although no pharmacokinetic data are available in patients with hepatic impairment, Loperamide Taj Pharma should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for sign of central nervous system (CNS) toxicity.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

To be used with caution in children or in patients with a low sodium diet.

Loperamide Taj Pharma must be discontinued promptly when constipation, abdominal distension or ileus develop.

Cardiac events including QT interval and QRS complex prolongation, torsades de pointes have been reported in association with overdose. Some cases had a fatal outcome (see section 4.9). Patients should not exceed the recommended dose and/or the recommended duration of treatment.

• Interaction with other medicinal products and other forms of interaction

Non-clinical data have shown that Loperamide Taj Pharma is a P-glycoprotein substrate. Concomitant administration of Loperamide Taj Pharma (16mg single dose) with quinidine, or ritonavir, which are both P-glycoprotein inhibitors, resulted in a 2 to 3-fold increase in Loperamide Taj Pharma plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when Loperamide Taj Pharma is given at recommended dosages, is unknown.

The concomitant administration of Loperamide Taj Pharma (4mg single dose) and itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4-fold increase in Loperamide Taj Pharma plasma concentrations. In the same study a CYP2C8 inhibitor, gemfibrozil, increased Loperamide Taj Pharma by approximately 2-fold. The combination of itraconazole and gemfibrozil resulted in a 4-fold increase in peak plasma levels of Loperamide Taj Pharma and a 13-fold increase in total plasma exposure. These increases were not associated with central nervous system (CNS) effects as measured by psychomotor tests (i.e., subjective drowsiness and the Digit Symbol Substitution Test).

The concomitant administration of Loperamide Taj Pharma (16mg single dose) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in Loperamide Taj Pharma plasma concentrations. This increase was not associated with increased pharmacodynamic effects as measured by pupillometry.

Concomitant treatment with oral desmopressin resulted in a 3‐fold increase of desmopressin plasma concentrations, presumably due to slower gastrointestinal motility.

It is expected that drugs with similar pharmacological properties may potentiate Loperamide Taj Pharma’s effect and that drugs that accelerate gastrointestinal transit may decrease its effect.

• Fertility, pregnancy and lactation

Pregnancy

Safety in human pregnancy has not been established although from animal studies there are no indications that Loperamide Taj Pharma possesses any teratogenic or embryotoxic properties. As with other drugs, it is not advisable to administer Loperamide Taj Pharma in pregnancy, especially during the first trimester.

Breast-feeding

Small amounts of Loperamide Taj Pharma may appear in human breast milk. Therefore, Loperamide Taj Pharma is not recommended during breast-feeding.

Women who are pregnant or breast-feeding infants should therefore be advised to consult their doctor for appropriate treatment.

Fertility

There is no relevant data to demonstrate the effect of Loperamide Taj Pharma on human fertility. Only high doses of Loperamide Taj Pharma hydrochloride affected female fertility in non-clinical studies (see section 5.3).

• Effects on ability to drive and use machines

Loss of consciousness, depressed level of consciousness, tiredness, dizziness, or drowsiness may occur when diarrhoea is treated with Loperamide Taj Pharma. Therefore, it is advisable to use caution when driving a car or operating machinery (see section 4.8).

• Undesirable effects

Adults and children aged ≥ 12 years

The safety of Loperamide Taj Pharma was evaluated in 3076 adults and children aged ≥ 12 years who participated in 31 controlled and uncontrolled clinical trials of Loperamide Taj Pharma used for the treatment of diarrhoea. Of these, 26 trials were in acute diarrhoea (N=2755) and 5 trials were in chronic diarrhoea (N=321).

The most commonly reported (i.e. ≥1% incidence) adverse reactions in clinical trials with Loperamide Taj Pharma hydrochloride in acute diarrhoea were: constipation (2.7%), flatulence (1.7%), headache (1.2%) and nausea (1.1%). In clinical trials in chronic diarrhoea, the most commonly reported (i.e. ≥1% incidence) adverse reactions were: flatulence (2.8%), constipation (2.2%), nausea (1.2%) and dizziness (1.2%).

Table 1 displays adverse reactions that have been reported with the use of Loperamide Taj Pharma from either clinical trials (in acute or chronic diarrhoea or both) or post-marketing experience.

The frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000).

Table 1: Adverse Drug Reactions

A number of the adverse reactions reported during the clinical investigations and post-marketing experience with Loperamide Taj Pharma hydrochloride are frequent symptoms of the underlying diarrhoeal syndrome (for example abdominal pain/discomfort, nausea, vomiting, dry mouth, tiredness, drowsiness, dizziness, constipation, and flatulence). These symptoms are often difficult to distinguish from undesirable drug effects.

Paediatric population

The safety of Loperamide Taj Pharma was evaluated in 607 patients aged 10 days to 13 years who participated in 13 controlled and uncontrolled clinical trials of Loperamide Taj Pharma used for the treatment of acute diarrhoea. In general, the adverse reaction profile (ADR) profile in this patient population was similar to that seen in clinical trials of Loperamide Taj Pharma in adults and children aged 12 years and over.

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

In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia and respiratory depression), constipation, urinary retention and ileus may occur. Children and patients with hepatic dysfunction may be more sensitive to CNS effects than adults.

In individuals who have ingested overdoses of Loperamide Taj Pharma, cardiac events such as QT interval and QRS complex prolongation, torsades de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been observed (see section 4.4). Fatal cases have also been reported.

Management

In cases of overdose, ECG monitoring for QT interval prolongation should be initiated.

If the patient develops respiratory depression, airway obstruction, vomiting with impaired consciousness or other CNS symptoms of overdose, naloxone can be given as an antidote. Since the duration of action of Loperamide Taj Pharma is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone might be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect any possible CNS depression. Other measures should be as indicated by the patient’s clinical condition.

5. Pharmacological properties

• Pharmacodynamic properties

Pharmacotherapeutic group: Antipropulsives

Mechanism of action

Loperamide Taj Pharma binds to the opiate receptor in the gut wall, reducing propulsive peristalsis, increasing intestinal transit time and enhancing resorption of water and electrolytes. Loperamide Taj Pharma increases the tone of the anal sphincter, which helps reduce faecal incontinence and urgency.

Clinical efficacy and safety

In a double blind randomised clinical trial in 56 patients with acute diarrhoea receiving Loperamide Taj Pharma, onset of anti-diarrhoeal action was observed within one hour following a single 4mg dose. Clinical comparisons with other antidiarrhoeal drugs confirmed this exceptionally rapid onset of action of Loperamide Taj Pharma.

• Pharmacokinetic properties

Absorption

Most ingested Loperamide Taj Pharma is absorbed from the gut, but as a results of significant first pass metabolism, systemic bioavailability is only approximately 0.3%.

Distribution

Studies on distribution in rats show high affinity for the gut wall with a preference for binding to the receptors in the longitudinal muscle layer. The plasma protein binding of Loperamide Taj Pharma is 95%, mainly to albumin. Non-clinical data have shown that Loperamide Taj Pharma is a P-glycoprotein substrate.

Biotransformation

Loperamide Taj Pharma is almost completely extracted by the liver, where it is predominantly metabolized, conjugated and excreted via the bile.

Oxidative N-demethylation is the main metabolic pathway for Loperamide Taj Pharma, and is mediated mainly through CYP3A4 and CYP2C8. Due to this very high first pass effects, plasma concentrations of unchanged drug remain extremely low.

Elimination

The half-life of Loperamide Taj Pharma in man is about 11 hours with a range of 9-14 hours. Excretion of the unchanged Loperamide Taj Pharma and the metabolites mainly occurs through the faeces.

Paediatric population:

No pharmacokinetic studies were performed in the paediatric population. It is expected that pharmacokinetic behaviour of Loperamide Taj Pharma and drug-drug interactions with Loperamide Taj Pharma will be similar to those in adults.

• Preclinical safety data

Acute and chronic studies on Loperamide Taj Pharma showed no specific toxicity. Results of in vivo and in vitro studies carried out indicated that Loperamide Taj Pharma is not genotoxic. In reproduction studies, very high doses (40mg/kg/day – 240 times the maximum human use level) Loperamide Taj Pharma impaired fertility and foetal survival in association with maternal toxicity in rats. Lower doses had no effects on maternal or foetal health and did not affect peri- and post-natal development.

Non-clinical in vitro and in vivo evaluation of Loperamide Taj Pharma indicates no significant cardiac electrophysiological effects within its therapeutically relevant concentration range and at significant multiples of this range (up to 47-fold). However, at extremely high concentrations associated with overdoses (see section 4.4), Loperamide Taj Pharma has cardiac electrophysiological actions consisting of inhibition of potassium (hERG) and sodium currents, and arrhythmias.

6. Pharmaceutical particulars

List of excipients

Maize starch,
Lactose monohydrate,
Povidone (K-30),
Brilliant Blue FCF,
Quinoline Yellow,
Magnesium stearate,
Talc,
Colloidal anhydrous silica,
Sodium starch glycolate (Type A),
Purified water.

Incompatibilities

Not applicable

Shelf life

3 years

Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

Nature and contents of container

Clear PVC/PVdC film/Aluminium blister strips. The blister strips are packed in cartons to contain 12 or 30 tablets.

Each box contains 10, 150, 20, 30, 40, 50, 60, 90, 120, 240, 360 and 500 tablets.

Not all pack sizes may be marketed.

• Special precautions for disposal and other handling

No special requirements for disposal

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

Loperamide Hydrochloride Tablets USP 2mg Taj Pharma

Package leaflet: Information for the user

Loperamide Taj Pharma

Loperamide Hydrochloride Tablets USP 2mg Taj Pharma

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Loperamide Taj Pharma Tablet is and What it is used for
2. What you need to know before you use Loperamide Taj Pharma Tablets
3. How to use Loperamide Taj Pharma Tablets
4. Possible side effects
5. How to store Loperamide Taj Pharma Tablets
6. Contents of the pack and other information

1. What Loperamide Taj Pharma Tablet is and What it is used for

Loperamide Taj Pharma hydrochloride is the active ingredient of Loperamide Taj Pharma Tablets. The tablets are available in one strength. Loperamide Taj Pharma is one of a group of medicines called “antidiarrhoeals” which are used to treat diarrhoea.

Loperamide Taj Pharma 2mg tablets are used to treat sudden short-lived (acute) attacks of diarrhoea in adults and children aged 9 years and over and long-lasting (chronic) diarrhoea in adults.

The tablets help reduce diarrhoea by slowing down an overactive bowel, which helps the body to absorb water and salts from this organ, making the stools more solid and less frequent.

2. What you need to know before you use Loperamide Taj Pharma Tablets

Do not use Loperamide Taj Pharma Tablets

• if you are allergic to Loperamide Taj Pharma hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have severe diarrhea after taking antibiotics
• if you are having a flare up of an inflammatory bowel condition like ulcerative colitis
• if you are constipated or your stomach appears swollen (particularly in children with severe dehydration)
• if you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature.

Do not give this medicine to a child under 9 years old.

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Loperamide Taj Pharma tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Loperamide Taj Pharma Tablets

• if you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor
• if you suffer from liver problems
• if you have severe diarrhoea as your body loses more fluid, sugars and salts than normal.
• if you have diarrhoea that lasts for more than 48 hours.

If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist.

Special warnings:

• Loperamide Taj Pharma only treats the symptoms of diarrhoea. When you have diarrhoea, your body can lose large amounts of fluids and salts. You will need to replace the fluid by drinking more liquid than usual. This is especially important for children. Ask your pharmacist about special powders (known as oral rehydration therapy) which replace fluids and salts lost during diarrhoea.

The prevention of fluid depletion (dehydration) is of particular importance in infants, children and frail and elderly people with acute diarrhoea.

Do not take this product for anything other than its intended use (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much

Loperamide Taj Pharma, the active ingredient in Loperamide Taj Pharma Tablet.

Other medicines and Loperamide Taj Pharma Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular, tell your doctor or pharmacist if you are taking any of the following:

• ritonavir (used to treat HIV)
• quinidine (used to treat abnormal heart rhythms or malaria)
• itraconazole, ketoconazole (used to treat fungal infections)
• gemfibrozil (used to reduce levels of cholesterol)
• oral desmopressin (used to treat excessive urination)
• other drugs that slow down or speed up movement in the gut

Pregnancy and breast-feeding

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.

Do not take this medicine if you are breast-feeding as small amounts may get into your milk.

Talk to your doctor about suitable treatment.

Driving and using machines

Do not drive if you feel dizzy, tired or sleepy after taking this medicine. You may also lose consciousness, feel faint or less alert. If affected do not drive or operate machinery.

Loperamide Taj Pharma Tablets contains 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 medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to use Loperamide Taj Pharma Tablets

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose of Loperamide Taj Pharma Tablets that you will need will depend on whether your diarrhoea is a sudden, short lived attack (acute) or a long-lasting condition (chronic).

• Take this medicine by mouth.
• Swallow the correct number of tablets whole with a drink of water.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

Short-lived (acute) diarrhoea

Adults and children over 12 years:

• Take two tablets to begin with and then one tablet after each episode of diarrhoea for up to 5 days.
• Never take more than 8 tablets in any 24 hour period.

Children aged 9-12 years:

• Take one tablet 4 times daily until diarrhoea is controlled or for up to 5 days.
• Never take more than this dose.

Children aged under 9 years old:

This medicine should not be given to children under 9 years old. Other pharmaceutical forms/strengths (e.g. syrup) are available for children aged 4 years and over.

If your symptoms are not getting better within 2 days of taking your first dose of this medicine, you should see your doctor again, who may want to examine you to further check on the cause of the diarrhoea.

Long-lasting (chronic) diarrhea

Adults only:

• Your doctor will tell you how much Loperamide Taj Pharma tablets to take.
• The initial dose will probably be between two and four tablets per day taken in divided doses, but will depend on each individual’s needs. When your doctor is satisfied that you are receiving the daily dose that best suits you, he or she will then probably suggest that you take your tablets twice a day.
• Never take more than 8 tablets in any 24 hour period.

If you take more Loperamide Taj Pharma Tablets than you should

If you have taken too many Loperamide Taj Pharma tablets, immediately contact a doctor or hospital for advice.

Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing, reduction in size of the pupils in the eye (miosis), constipation and a condition where the bowel does not work properly (ileus). Children react more strongly to large amounts of Loperamide Taj Pharma than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

If you forget to take Loperamide Taj Pharma Tablets

• You should only take this medicine as required following the dosage instructions above carefully.
• If you forget to take a dose, take a dose after the next loose stool (bowel movement).
• 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Loperamide Taj Pharma tablets and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.

• Sudden swelling of the face lips, or throat. Hives (also known as nettle rash or urticaria). Severe irritation, reddening or blistering of your skin.

These may be signs of a severe allergic reaction

• Blistering of your skin, mouth, eyes or genitals
• Stomach pain or severe swollen stomach
• Severe constipation
• Loss of consciousness or reduced level of consciousness (feeling faint)

Tell your doctor if you notice any of the following side effects while using Loperamide Taj Pharma

Tablets:

Common side effects (may affect up to 1 in 10 people)

• Headache
• Feeling sick (nausea)
• Constipation
• Wind

Uncommon side effects (may affect up to 1 in 100 people)

• Feeling sleepy or drowsy
• Dry mouth
• Being sick (vomiting), indigestion (dyspepsia)
• Rash
• Abdominal pain or discomfort
• Feeling dizzy

Rare side effects (affects fewer than 1 in 1000 patients)

• Tiny pupils
• Itchy skin
• Difficulty passing water
• Feeling tired
• Problems with co-ordination
• Unusually stiff muscles causing poor control of movement
• Burning, tingling mouth (glossodynia)

Some of the listed side effects may be due to the diarrhoea, such as discomfort around the middle, feeling sick or being sick, dry mouth, feeling tired, drowsy or dizzy and wind.

Reporting of side effects

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

5. How to store Loperamide 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 label or carton after ‘EXP’.

The expiry date refers to the last day of that month.

Store in the original package.

If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

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.

6. Contents of the pack and other information

What Loperamide Taj Pharma Tablets contains

• The active substance is Loperamide Taj Pharma hydrochloride. Each tablet contains 2mg Loperamide Taj Pharma hydrochloride.
• The other ingredients are maize starch, lactose monohydrate, povidone (K-30), Brilliant Blue FCF, quinoline yellow, magnesium stearate, talc, colloidal anhydrous silica and sodium starch glycolate and purified water.

What Loperamide Taj Pharma Tablets looks like and contents of the pack

Loperamide Taj Pharma Tablets are light green coloured capsule shaped, biconvex uncoated tablets.

Pack Size:

Clear PVC/PVdC film/Aluminium blister strips. The blister strips are packed in cartons to contain 12 or 30 tablets.

Each box contains 10, 150, 20, 30, 40, 50, 60, 90, 120, 240, 360 and 500 tablets.

Not all pack sizes may be marketed.

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