1. Name of the medicinal product

Loperamide Hydrochloride Capsules USP 2mg Taj Pharma
(Diarrhoea Relief Capsules)

  1. Qualitative and quantitative composition

Loperamide Hydrochloride Capsules USP 2mg Taj Pharma
Each hard gelatin capsule contains:
Loperamide Hydrochloride USP 2mg
Excipients: Q.S.

Excipient with known effect: lactose

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Capsules

Hard gelatin capsule,

  1. Clinical particulars

Therapeutic indications

For the symptomatic treatment of acute diarrhoea, in adults and children 12 years and over.

For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor.

Posology and method of administration

Posology:

Acute diarrhoea

Adults and children over 12:

2 capsules (4 mg) initially, followed by 1 capsule (2mg) after every loose stool. The usual dose is 3-4 capsules (6 mg – 8 mg) a day. The total daily dose should not exceed 6 capsules (12 mg).

Symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 and over

Two capsules (4 mg) to be taken initially, followed by 1 capsule (2mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 capsules (12mg).

Paediatric population

Loperamide Taj Pharma hydrochloride is contraindicated in children less than 12 years of age.

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 hydrochloride should be used with caution in such patients because of reduced first pass metabolism (see section 4.4 Special warnings and precautions for use).

Method of administration

Oral use. The capsules should be taken with liquid.

  • Contraindications

This medicine is contraindicated:

  • in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
  • in children less than 12 years of age.
  • in patients with acute dysentery, which is characterised by blood in stools and high fever.
  • in patients with acute ulcerative colitis.
  • in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter.
  • in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics.

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

  • Special warnings and precautions for use

Treatment of diarrhoea with Loperamide Taj Pharma hydrochloride 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 this medicine does not preclude the administration of appropriate fluid and electrolyte replacement therapy.

Since persistent diarrhoea can be an indicator of potentially more serious conditions, this medicine 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 hydrochloride should be discontinued and patients should be advised to consult their doctor.

Patients with AIDS treated with this medicine 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 hydrochloride.

Although no pharmacokinetic data are available in patients with hepatic impairment, this medicine should be used with caution in such patients because of reduced first pass metabolism, as it may result in a relative overdose leading to CNS toxicity.

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

If patients are taking this medicine to control episodes of diarrhoea associated with Irritable Bowel Syndrome previously diagnosed by their doctor, and clinical improvement is not observed within 48 hours, the administration of Loperamide Taj Pharma HCl should be discontinued and they should consult with their doctor. Patients should also return to their doctor if the pattern of their symptoms changes or if the repeated episodes of diarrhoea continue for more than two weeks.

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

Special Warnings to be included on the leaflet:

Only take this medicine to treat acute episodes of diarrhoea associated with Irritable Bowel Syndrome if your doctor has previously diagnosed IBS.

If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS:

  • If you are aged 40 or over and it is some time since your last IBS attack
  • If you are aged 40 or over and your IBS symptoms are different this time
  • If you have recently passed blood from the bowel
  • If you suffer from severe constipation
  • If you are feeling sick or vomiting
  • If you have lost your appetite or lost weight
  • If you have difficulty or pain passing urine
  • If you have a fever
  • If you have recently travelled abroad

Consult your doctor if you develop new symptoms, if your symptoms worsen, or if your symptoms have not improved over two weeks.

  • 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 (16 mg single dose) with quinidine or ritonavir, which are both P-glucoprotein 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 (4 mg 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 (16 mg 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 hydrochloride possesses any teratogenic or embryotoxic properties. As with other drugs, it is not advisable to administer this medicine in pregnancy, especially during the first trimester.

Breast-feeding

Small amounts of Loperamide Taj Pharma may appear in human breast milk. Therefore, this medicine 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.

  • 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 this medicine. Therefore, it is advisable to use caution when driving a car or operating machinery. See Section 4.8, Undesirable Effects.

  • Undesirable effects

Adults and children aged ≥12 years

The safety of Loperamide Taj Pharma hydrochloride was evaluated in 2755 adults and children aged ≥ 12 years who participated in 26 controlled and uncontrolled clinical trials of Loperamide Taj Pharma HCl used for the treatment of acute diarrhoea.

The most commonly reported (i.e., ≥1% incidence) adverse drug reactions (ADRs) 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%).

Table 1 displays ADRs that have been reported with the use of Loperamide Taj Pharma HCl from either clinical trial (acute diarrhoea) 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

System Organ ClassIndication
CommonUncommonRare
Immune System DisordersHypersensitivity reactiona

Anaphylactic reaction (including Anaphylactic shock)a

Anaphylactoid reactiona

Nervous System DisordersHeadacheDizziness

Somnolencea

Loss of consciousnessa

Stupora

Depressed level of consciousnessa

Hypertoniaa

Coordination abnormalitya

Eye DisordersMiosisa
Gastrointestinal DisordersConstipation

Nausea

Flatulence

Abdominal pain

Abdominal discomfort

Dry mouth

Abdominal pain upper

Vomiting

Dyspepsiaa

Ileusa (including paralytic ileus)

Megacolona (including toxic megacolonb)

Abdominal distension

Skin and Subcutaneous Tissue DisordersRashBullous eruptiona (including Stevens-Johnson syndrome, Toxic epidermal necrolysis and Erythema multiforme)

Angioedemaa

Urticariaa

Pruritusa

Renal and Urinary DisordersUrinary retentiona
General Disorders and Administration Site ConditionsFatiguea

a: Inclusion of this term is based on post-marketing reports for Loperamide Taj Pharma HCl. As the process for determining post marketing ADRs did not differentiate between chronic and acute indications or adults and children, the frequency is estimated from all clinical trials with Loperamide Taj Pharma HCl (acute and chronic), including trials in children ≤ 12 years (N=3683).

b: See section 4.4 Special Warnings and Special Precautions for use.

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.

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

Management:

If symptoms of overdose occur, 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 possible CNS depression.

  1. Pharmacological properties
  • Pharmacodynamic properties

Pharmacotherapeutic Group: Antipropulsives;

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.

In a double blind randomised clinical trial in 56 patients with acute diarrhoea receiving Loperamide Taj Pharma, onset of antidiarrhoeal action was observed within one hour following a single 4 mg 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 result of significant first pass metabolism, systemic bioavailability is only approximately 0.3%.

Distribution: Studies on distribution in rats show a high affinity for the gut wall with a preference for binding to receptors of 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.

Metabolism: 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 effect, 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.

  • 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 (40 mg/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.

  1. Pharmaceutical particulars

List of excipients

Maize Starch
Lactose
Povidone
Sodium Starch Glycollate
Magnesium Stearate

Gelatin Capsule Shell (Size 4):

Body

Titanium Dioxide
Black Iron Oxide
Gelatin

Cap

Patent Blue V
Titanium Dioxide
Yellow Iron Oxide
Gelatin

Printing ink

Shellac
Simeticone
Titanium dioxide
Propylene glycol

Incompatibilities

None known.

Shelf life

3 years from the date of manufacture.

Special precautions for storage

Store in the original container in order to protect from moisture.

Nature and contents of container

Packing type:

Tempered Aluminium and Blister pack

Pack Size:

Each pack contains 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50 and 60 capsules

Each box contains 30, 60, 90, 120, 240, 360 and 500 capsules

Not all pack size may be marketed.

Special precautions for disposal and other handling

No special requirements. 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

Loperamide Hydrochloride Capsules USP 2mg Taj Pharma
(Diarrhoea Relief Capsules)

Package leaflet: Information for the user

Loperamide Hydrochloride Capsules USP 2mg Taj Pharma

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

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

1. What Loperamide Taj Pharma 2mg Hard Capsules are and what they are used for

Loperamide Taj Pharma 2mg Hard Capsules are used to treat two types of diarrhoea.

The two types have different age limits.

Short-term diarrhoea

  • For adults and children aged 12 and over.
  • To treat attacks that last up to 48 hours.
  • If your attack lasts longer than 48 hours, talk to your doctor.

IBS diarrhoea

  • For adults and young people aged 18 and overwho have been diagnosed with IBS (Irritable Bowel Syndrome).
  • To treat attacks that last up to 48 hours.
  • You can use this medicine for up to 2 weeksfor repeated attacks, but if any one attack lasts continuously for longer than 48 hours, talk to your doctor.

The capsules contain Loperamide Taj Pharma hydrochloride, a substance that helps reduce diarrhoea by slowing down an overactive bowel.

This allows water and salts that are usually lost in diarrhoea to be absorbed by the body.

  1. What you need to know before you take Loperamide Taj Pharma 2mg Hard Capsules

This medicine is suitable for most people, but a few people should not use it:

Do not take Loperamide Taj Pharma 2mg Hard Capsules:

  • if you are allergic to Loperamide Taj Pharma or any of the other ingredients of this medicine (listed in section 6).
  • if it is for a child aged under 12(or under 18 for an IBS patient).
  • if you have severe diarrhoeaafter taking
  • if you are having a flare-up of an inflammatory bowel condition like ulcerative colitis.
  • if you are constipated, or your stomach appears swollen(especially in children with severe dehydration).
  • if you have acute dysentery,the symptoms of which may include blood in your stools and a high temperature.

If any of these applies to you, talk to your doctor or pharmacist and do not take Loperamide Taj Pharma 2mg Hard Capsules.

Warnings and Precautions

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 2mg Hard Capsules.

Talk to your doctor or pharmacist before taking Loperamide Taj Pharma 2mg Hard Capsules

  • If you have AIDSand your stomach becomes swollen, stop taking the capsules immediately and contact your doctor.
  • If you suffer from liver disease.
  • If you have diarrhoea that lasts for more than 48 hours.
  • If you have been told by your doctor that you have an intolerance to some sugars.
  • If you have severe diarrhoeaas your body loses more fluid, sugars and salts than normal.
  • If you are taking any other medicines,including:
  • ritonavir (used to treat HIV).
  • quinidine (used to treat abnormal heart rhythmsor malaria).
  • oral desmopressin (used to treat excessive urination).
  • itraconazole or ketoconazole (used to treat fungal infections).
  • gemfibrozil (used to treat high cholesterol).

If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these applies to you (now or in the past), talk to a doctor or pharmacist.

Special warnings about this medicine

Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about rehydration therapy to replace lost salts. This is especially important for children, and frail or older people.

Extra warnings for IBS patients

Use only if your doctor has previously diagnosed IBS.

Check the following:

Do not take this medicine:

  • If you are aged under 18.

Talk to your doctor first:

  • If you are aged 40 or overand it is some time since your last IBS attack.
  • If you are aged 40 or overand your IBS symptoms are different this time.
  • If you have recently passed blood from the bowel.
  • If you suffer from severe constipation.
  • If you are feeling sick or vomiting.
  • If you have lost your appetite or lost weight.
  • If you have difficulty or pain passing urine.
  • If you have a fever.
  • If you have recently travelled abroad.

If any of these applies to you, talk to your doctor before taking Loperamide Taj Pharma 2mg Hard Capsules.

Pregnancy and breast-feeding

  • If you are pregnant,think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • If you are breast-feedingdo not take this medicine. Small amounts may get into your milk. Talk to your doctor about a suitable treatment.

Driving and using machines

This medicine may make you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If you’re affected do not drive, cycle or use machines.

Loperamide Taj Pharma 2mg Hard Capsules contain lactose

This product 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.

  1. How to take Loperamide Taj Pharma 2mg Hard Capsules

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

Check the tables below to see how much medicine to take.

  • Swallow the correct number of capsules whole with a drink of water. For oral use only.
  • Do not use more than the dose shown in the tables
  • The capsules are not for long-term treatment.

Short-term diarrhoea

Age Dose

Adults and children aged 12 and over Take two capsules to start treatment.

Take one capsule after each loose bowel movement.

  • Do not take for attacks lasting longer than 48 hours.
  • Do not take more than six capsulesin a 24-hour period.
  • Replace lost fluid by drinking more liquid than usual.
  • Not for children aged under 12.

How long to take Loperamide Taj Pharma 2mg Hard Capsules for short-term diarrhoea

You can use this medicine for up to 48 hours. If your attack lasts longer than 48 hours, stop taking Loperamide Taj Pharma 2mg Hard Capsules and talk to your doctor.

IBS diarrhoea

Age Dose

Adults aged 18 and over Take two capsules to start treatment.

Take one capsule after each loose bowel movement (or as advised by your doctor).

  • You can use this medicine for up to 2 weeksfor repeated attacks, but do not take for any one attack lasting longer than 48 hours
  • Do not take more than six capsulesin a 24-hour period.
  • Replace lost fluid by drinking more liquid than usual.
  • Not for children and young people aged under 18.

Talk to your doctor and stop taking this medicine:

  • If you have been using this medicine continuously for 48 hours
  • If you develop new IBS symptoms
  • If your IBS symptoms get worse
  • If your IBS symptoms have not improved after 2 weeks.

How long to take Loperamide Taj Pharma 2mg Hard Capsules for IBS diarrhoea

You can use this medicine for up to 2 weeks for repeated attacks of IBS diarrhoea. But if any one attack lasts for longer than 48 hours, stop taking Loperamide Taj Pharma 2mg Hard Capsules and talk to your doctor.

If you take more Loperamide Taj Pharma 2mg Hard Capsules than you should

If you have taken too many Loperamide Taj Pharma 2mg Hard Capsules, 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.

Children react more strongly to large amounts of Loperamide Taj Pharma 2mg Hard Capsules 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 2mg Hard Capsules

You should only take this medicine as you need it, 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.

  1. Possible side effects

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

Most are usually mild.

Get medical help at once

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

  • Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat.
  • Skin rashes, which may be severe and include blistering or peeling skin.
  • Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), uncoordinated movements.

If you get any of these, stop using the medicine and get medical help at once.

Talk to a doctor as soon as possible

Uncommon: (may affect up to 1 in 100 people)

  • Itchiness or hives.
  • Stomach pain or swollen stomach.

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

  • Difficulties passing water.
  • Severe constipation.
  • Miosis (narrowing of the pupils of the eye).

If you notice any of the above, stop using the medicine and talk to a doctor.

Other effects that may occur

Common: (may affect up to 1 in 10 people)

  • Feeling sick, constipation or wind.

Uncommon: (may affect up to 1 in 100 people)

  • Dizziness or drowsiness.
  • Vomiting, indigestion.
  • Dry mouth.

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

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.

  1. How to store Loperamide Taj Pharma 2mg Hard Capsules

Keep out of the sight and reach of children.

Store in the original container in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the outside packaging {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 you no longer use.

These measures will help protect the environment.

  1. Contents of the pack and other information

What Loperamide Taj Pharma 2mg Hard Capsules contain

The active substance is Loperamide Taj Pharma hydrochloride. Each hard gelatin capsule contains 2mg Loperamide Taj Pharma hydrochloride.

The other ingredients are Maize Starch, Lactose, Povidone, Sodium Starch Glycollate And Magnesium Stearate. The Capsule Shell Contains Gelatin, Titanium Dioxide, Iron Oxides and Patent Blue V. The Printing Ink Contains Shellac, Simeticone, Titanium Dioxide and Propylene Glycol (see section 2).

What Loperamide Taj Pharma 2mg Hard Capsules look like and contents of the pack

Packing type:

Tempered Aluminium and Blister pack

Pack Size:

Each pack contains 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50 and 60 capsules
Each box contains 30, 60, 90, 120, 240, 360 and 500 capsules

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