Imodium Instant

Leaflet attached to the packaging: patient information

Imodium Instant, 2 mg, orally disintegrating tablet

Loperamide hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 2 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Imodium Instant and what is it used for
• 2. Important information before taking Imodium Instant
• 3. How to take Imodium Instant
• 4. Possible side effects
• 5. How to store Imodium Instant
• 6. Contents of the pack and other information

1. What is Imodium Instant and what is it used for

Loperamide is an oral anti-diarrheal medicine.
It reduces intestinal peristalsis, prolongs the transit time of food through the intestines. Loperamide
increases the resting pressure of the anal sphincter, while reducing the immediate need for bowel movement.

Indications for use

Imodium Instant is indicated for the symptomatic treatment of acute and chronic diarrhea in adults and children over 6 years old.
In patients with an ileostomy, Imodium Instant may be used to reduce the number and volume of stools and increase their consistency.
The medicine can also be used for the symptomatic treatment of acute episodes of diarrhea associated with irritable bowel syndrome in adults (from 18 years old) after prior diagnosis of the disease by a doctor with the reservations mentioned in "Warnings and precautions" in section 2.

2. Important information before taking Imodium Instant

When not to take Imodium Instant:

• if the patient is allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• in children under 6 years old,
• as a basic treatment:
• in patients with acute dysentery, which is characterized by the presence of blood in the stool and high fever;
• in patients with an acute exacerbation of ulcerative colitis;
• in patients with bacterial enteritis and colitis caused by pathogenic bacteria of the genus Salmonella, Shigellaand Campylobacter;
• in patients with pseudomembranous colitis associated with the administration of broad-spectrum antibiotics,
• in cases where intestinal peristalsis should be avoided due to the possible risk of severe complications, including intestinal obstruction, colonic dilation, and toxic colonic dilation. The use of Imodium Instant should be stopped immediately in case of constipation, abdominal distension, or intestinal obstruction.

Treatment of diarrhea with Imodium Instant is only symptomatic. In any case where it is possible to determine the cause of diarrhea, when justified (or indicated), the doctor will recommend appropriate treatment.

Warnings and precautions

In patients with diarrhea, especially in children, dehydration and excessive loss of electrolytes may occur. Therefore, during diarrhea, it is necessary to take more fluids than usual to supplement these deficiencies.
If after administration of the medicine in acute diarrhea, the symptoms do not disappear within 48 hours, the administration of Imodium Instant should be stopped and a doctor consulted.
Patients with AIDS taking Imodium Instant for diarrhea should immediately stop taking the medicine and consult a doctor if they experience early symptoms of abdominal distension. There have been reports of individual cases of toxic colonic dilation in patients with AIDS and concomitant infectious colitis caused by both viruses and bacteria, treated with loperamide hydrochloride.
Patients diagnosed with irritable bowel syndrome by a doctor before taking the medicine should discuss treatment with their doctor or pharmacist, especially if:

• the patient is 40 years old or more and it has been some time since the last episode of irritable bowel syndrome symptoms, or if the symptoms are different from those that occurred previously,
• the patient has severe constipation,
• there has been a weight loss,
• the symptoms of irritable bowel syndrome have worsened,
• new symptoms have appeared,
• after administration of the medicine in acute diarrhea, the symptoms do not disappear within 48 hours,
• when recurrent episodes of diarrhea last longer than two weeks.

There have been reports of abuse and use of Imodium Instant not in accordance with its indications (see section 1) or in higher doses than recommended (see section 3). In patients taking too high doses of loperamide (the active substance of Imodium Instant), serious heart rhythm disturbances (including accelerated or irregular heart rhythm) have been noted.

Imodium Instant and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken and about medicines you plan to take.
It is especially important to inform your doctor or pharmacist about taking:

• ritonavir (a medicine used to treat HIV infection),
• quinidine (a medicine used to treat heart rhythm disorders),
• desmopressin administered orally (a medicine used to inhibit excessive urine production),
• itraconazole or ketoconazole (an antifungal medicine),
• gemfibrozil (a medicine that lowers lipid levels in the blood).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The doctor should carefully weigh the expected benefits to the mother's health against the potential risk associated with the use of Imodium Instant by pregnant women, especially in the first trimester.
It is not recommended to take Imodium Instant during pregnancy and breastfeeding. Pregnant or breastfeeding women should therefore consult a doctor to determine the appropriate treatment.

Driving and using machines

During the treatment of diarrhea with loperamide, fatigue, dizziness, or drowsiness may occur, so caution should be exercised when driving vehicles or operating machines.

Imodium Instant contains 0.75 mg of aspartame in each tablet

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Imodium Instant contains trace amounts of sulfites in the mint flavor composition

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Imodium Instant contains glucose as a component of maltodextrin in the mint flavor composition

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Imodium Instant contains 0.00066 mg of benzyl alcohol in each tablet

Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Imodium Instant

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Method of administration

Imodium Instant orally disintegrating tablet should be placed on the tongue, waited for it to dissolve, and swallowed with saliva. No liquid is needed to swallow.

Dosage

Symptomatic treatment of acute and chronic diarrhea

Adults and children over 6 years old
Acute diarrhea: initial dose - 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, and then 1 tablet (2 mg) after each subsequent loose stool.
Chronic diarrhea: initial dose - 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children; this initial dose should be modified until 1 to 2 normal stools per day are achieved, which is usually achieved by taking a maintenance dose of 1 to 6 tablets (2 mg to 12 mg) per day.
The maximum dose in acute and chronic diarrhea - 8 tablets (16 mg) per day for adults and children; in children, the dose of the medicine must be adjusted according to body weight (3 tablets/20 kg body weight).
Do not take a dose higher than the maximum recommended dose.

Symptomatic treatment of acute episodes of diarrhea associated with irritable bowel syndrome

Adults from 18 years old
Initial dose - 2 tablets (4 mg) per day, and then 1 tablet (2 mg) after each subsequent loose stool or as previously directed by a doctor. Imodium Instant can be taken for up to 2 weeks with recurrent episodes, but no longer than 48 hours with single episodes of diarrhea (see also "Warnings and precautions" in section 2).
The maximum dose in diarrhea associated with irritable bowel syndrome - 6 tablets (12 mg) per day.
Remember to supplement fluids and drink more water than usual during diarrhea.
Use of Imodium Instantin patients with liver and/or kidney function disorders
In patients with liver function disorders, Imodium Instant should be used with caution and closely monitored for signs of central nervous system toxicity.
In patients with kidney function disorders, no dose adjustment is necessary.
Use of Imodium Instantin children
Do not take Imodium Instant in children under 6 years old.
Use of the medicine in children over 6 years old, see section 3.
Use of Imodium Instantin the elderly
In the elderly, no dose adjustment is necessary.
If symptoms worsen or do not improve within 48 hours of taking Imodium Instant, consult a doctor.

Overdose of Imodium Instant

Symptoms
In case of overdose, the following symptoms may occur: accelerated heart rate, irregular heart rhythm, changes in heart rhythm (these symptoms may have severe, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, shallow breathing, slow breathing, stupor, and intestinal obstruction (manifested by abdominal pain, vomiting, bloating, and constipation). In children, the reaction to taking large amounts of Imodium Instant is stronger than in adults.
Treatment
If a patient has taken too much Imodium Instant, they should immediately consult a doctor or go to the hospital.
If a child has taken too much medicine or any of the above symptoms occur, they should immediately consult a doctor.
The doctor will take appropriate actions, such as performing a control ECG and administering naloxone if necessary. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), it may be necessary to repeat the administration of naloxone. Therefore, the patient should remain under close supervision for at least 48 hours to detect any possible central nervous system depression.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many adverse events associated with the use of loperamide are common symptoms of diarrhea (discomfort and abdominal pain, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, constipation, bloating). Often these symptoms are difficult to distinguish from the side effects of the medicine taken.
The frequency of adverse events is presented according to the following scheme:
Common
occurs in 1 to 10 out of 100 patients
Uncommon
occurs in 1 to 10 out of 1,000 patients
Rare
occurs in 1 to 10 out of 10,000 patients
Frequency not known cannot be determined based on available data
In clinical trials of acute diarrhea treatment, the most commonly reported adverse events were headache, constipation, bloating, and nausea.
Uncommonly reported were dizziness, dry mouth, abdominal pain and discomfort, vomiting, abdominal pain, and rash.
Rarely reported was abdominal distension.
In clinical trials of chronic diarrhea treatment, the most commonly reported adverse events were dizziness, bloating, constipation, and nausea, and uncommonly reported were headache, dry mouth, abdominal pain and discomfort, and indigestion.
After the introduction of Imodium Instant to the market, the most commonly reported adverse events were headache, dizziness, constipation, nausea, and bloating.
Uncommonly reported were insomnia, abdominal pain and discomfort, dry mouth, abdominal pain, vomiting, indigestion, and rash.
Rarely reported were immune system disorders (hypersensitivity reaction, anaphylactic reaction, and anaphylactoid reaction), nervous system disorders (impaired coordination, decreased level of consciousness, loss of consciousness, increased muscle tone, drowsiness, stupor), gastrointestinal disorders (intestinal obstruction, colonic dilation, tongue burning, abdominal distension), skin and subcutaneous tissue disorders (angioedema, blistering rash, itching, urticaria), and miosis, urinary retention, and fatigue.
After the introduction of Imodium Instant to the market, the following have also been reported (frequency not known - cannot be determined based on available data): abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, accelerated heart rate, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).
If any of the above symptoms occur, the use of the medicine should be stopped and a doctor consulted immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Imodium Instant

Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Imodium Instant contains

The active substance of the medicine is loperamide hydrochloride. Each orally disintegrating tablet contains 2 mg of loperamide hydrochloride.
The other ingredients are: gelatin, mannitol, aspartame, mint flavor composition 051296 TP0551 MINT (contains sulfites, glucose, benzyl alcohol, and propylene glycol (E1520), benzyl salicylate), sodium bicarbonate.

What Imodium Instant looks like and contents of the pack

PVC/OPA/Al/OPA/PVC blisters in a cardboard box.
The pack contains 6 or 12 orally disintegrating tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:McNeil Healthcare (Ireland) Limited, Office 5, 6 & 7, Block 5, High Street,
Tallaght, Dublin 24, D24 YK8N, Ireland.
Manufacturer:Janssen-Cilag S.p.A, Via C. Janssen, Borgo S. Michele, 04010 Latina, Italy.
JNTL Consumer Health (France) SAS, Domaine de Maigremont, 27100 Val de Reuil,
France.
To obtain more detailed information, please contact:
email: [email protected]
Date of last revision of the leaflet:April 2024