Loper

Package Leaflet: Information for the Patient

Loper, 2 mg, Tablets

Loperamide Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the package leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or further information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. See section 4.
• If after 2 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Loper and what is it used for

The active substance of Loper is loperamide hydrochloride.
Loperamide hydrochloride is an oral anti-diarrheal medicine.
It reduces intestinal peristalsis, prolongs the transit time of intestinal contents, and increases the resting tone of the anal sphincter, reducing the immediate need for bowel movements.

Indications

Loper is indicated for the symptomatic treatment of acute and chronic diarrhea.
In patients with an ileostomy, Loper may be used to reduce the number and volume of stools and increase their consistency.
Loper is intended for use in adults and children over 6 years of age.

2. Important information before taking Loper

When not to take Loper

• If you are allergic to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• In children under 6 years of age.
• As a primary 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 pseudo-membranous colitis associated with the use of broad-spectrum antibiotics.

• In cases where it is necessary to avoid slowing down intestinal peristalsis, due to the possible risk of developing severe complications, including intestinal obstruction, colonic dilatation, and toxic megacolon. The use of Loper should be stopped immediately if constipation, abdominal distension, or intestinal obstruction occurs.

Treatment of diarrhea with Loper 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

Before starting to take Loper, you should discuss it with your doctor or pharmacist.
In patients with diarrhea, especially in children, dehydration and excessive loss of electrolytes may occur. Therefore, during diarrhea, you should drink more fluids than usual to compensate for these deficiencies.
If, after taking the medicine in acute diarrhea, the symptoms do not disappear within 48 hours, you should stop taking Loper and consult your doctor.
Patients with AIDS taking the medicine for diarrhea should immediately stop taking it and consult their doctor if they experience early symptoms of abdominal distension.
Single cases of toxic megacolon have been reported in AIDS patients with infectious colitis treated with loperamide hydrochloride.
You should not take this product for a purpose other than its intended use (see section 1) or in doses higher than recommended (see section 3). In patients taking too high doses of loperamide (the active substance of Loper), severe heart rhythm disturbances (including accelerated or irregular heart rhythm) have been reported.

Loper and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
It is especially important to inform your doctor or pharmacist if you are taking:

• ritonavir (a medicine used to treat HIV infection);
• quinidine (a medicine used to treat certain heart conditions or malaria);
• oral desmopressin (a medicine used to treat frequent urination and nocturnal enuresis);
• itraconazole or ketoconazole (a medicine used to treat fungal infections);
• gemfibrozil (a medicine used to reduce blood fat levels).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
The doctor should carefully weigh the expected benefits for the mother against the potential risk associated with the use of Loper in pregnant women, especially during the first trimester.
Loper should not be used during breastfeeding.

Driving and using machines

During the treatment of diarrhea with loperamide, fatigue, dizziness, or drowsiness may occur.
Therefore, you should be cautious when driving or operating machinery.

Loper contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Loper

This medicine should always be taken exactly as described in the package leaflet or as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
If, within 48 hours of taking Loper, the symptoms do not disappear or worsen, and (or) other symptoms appear (e.g., fever), you should consult your doctor.

Dosage

Adults and children over 6 years of age
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 to 12 mg) per day.
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/day) - but not more than 8 tablets (16 mg) per day.
You should not take a higher dose than the maximum recommended dose.
Use of Loper in patients with liver and/or kidney impairment
In patients with liver impairment, the medicine should be used with caution and carefully monitored for signs of central nervous system toxicity (such as headache, dizziness, drowsiness, loss of consciousness, confusion, decreased level of consciousness, increased muscle tone, abnormal coordination).
In patients with kidney impairment, no dose adjustment is necessary.
Use of Loper in children
Loper should not be used in children under 6 years of age.
Use of the medicine in children over 6 years of age, see section 3.
Use of Loper in the elderly
In the elderly, no dose adjustment is necessary.

Overdose of Loper

If you have taken more than the recommended dose of Loper, you should immediately contact your doctor or pharmacist.
Symptoms
In case of overdose, the following symptoms may occur: stupor, coordination disorders, drowsiness, miosis, increased muscle tone, respiratory depression (i.e., shallow and slow breathing), urinary retention, and intestinal obstruction (manifested by abdominal pain, vomiting, bloating, and constipation). Children may be more sensitive than adults to the toxic effects of the medicine on the central nervous system.
If you have taken too much Loper, you should immediately consult your doctor or go to the hospital. The following symptoms may occur: rapid heartbeat, irregular heartbeat, changes in heart rhythm (these symptoms can have severe, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing.
In children, the reaction to taking large amounts of Loper is stronger than in adults. If a child has taken too much medicine or any of the above symptoms occur, you should immediately contact your doctor.
Loperamide is a type of opioid that acts directly on the intestines when taken as directed, but may cause other opioid effects when misused in large doses, in such situations, anxiety, insomnia, dilated pupils, and aggressive outbursts may occur. Such symptoms may also occur after the symptoms of overdose have resolved.
Treatment
In case of overdose symptoms, the doctor may administer naloxone as an antidote. 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 depression of the central nervous system.

4. Possible side effects

Like all medicines, Loper can cause side effects, although not everybody gets them.
Many side effects associated with loperamide are common symptoms of diarrhea (discomfort and abdominal pain, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, constipation, bloating, and gas). These symptoms are often difficult to distinguish from the side effects of the medicine.
The frequency of side effects is presented according to the following scheme:
Very common
occurring in 1 to 10 in 100 patients
Common
occurring in 1 to 10 in 1,000 patients
Uncommon
occurring in 1 to 10 in 10,000 patients
In clinical trials for the treatment of acute diarrhea
Very commonside effects reported were: headache, constipation, bloating, and nausea.
Commonside effects reported were: dizziness, dry mouth, abdominal pain and discomfort, vomiting, abdominal pain, and rash.
Uncommonside effects reported were: increased abdominal girth.
In clinical trials for the treatment of chronic diarrhea
Very commonside effects reported were: dizziness, bloating, constipation, and nausea.
Commonside effects reported were: headache, dry mouth, abdominal pain and discomfort, and indigestion.
After the marketing of loperamide
Very commonside effects reported were: headache, dizziness, constipation, nausea, and bloating.
Commonside effects reported were: insomnia, abdominal pain and discomfort, dry mouth, abdominal pain, vomiting, indigestion, and rash.
Uncommonside effects reported were: immune system disorders (hypersensitivity reaction, anaphylactic reaction, and anaphylactoid reaction), nervous system disorders (abnormal coordination, decreased level of consciousness, loss of consciousness, hypertonia - increased muscle tone, confusion), gastrointestinal disorders (intestinal obstruction, colonic dilatation, burning sensation in the tongue), increased abdominal girth, skin and subcutaneous tissue disorders (angioedema, blistering rash, itching, urticaria), and miosis, urinary retention, and fatigue.
You should immediately contact your doctor:
Frequency not known (cannot be estimated from the available data)
abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).
If you experience any of the above symptoms, you should stop taking the medicine and immediately contact your doctor.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Loper

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
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. You should 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 Loper contains

The active substance of Loper is loperamide hydrochloride.
One tablet contains 2 mg of loperamide hydrochloride.
The other ingredients of the medicine are:
cornstarch, lactose monohydrate, magnesium stearate

What Loper looks like and contents of the pack

Loper is a white, flat, round, beveled tablet with a score line on one side. The score line is not intended to break the tablet into two equal halves.
The pack contains 10 tablets in a PVC/PVDC/Aluminum blister pack in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69

Manufacturer/Importer

mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna, Germany

Date of last revision of the leaflet: