Loper

Package leaflet: Information for the patient

Loper, 2 mg, tablets
Loperamidi hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days, or if you feel worse, contact your doctor.

Table of contents

1. What Loper is and what it is 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 Loper is and what it is used for

The active substance in Loper is loperamide hydrochloride.
Loperamide hydrochloride is an oral antidiarrheal agent.
It reduces intestinal peristalsis and prolongs the transit time of intestinal contents. In addition,
it increases resting tone of the anal sphincter while simultaneously reducing the immediate urge to defecate.
Indications
Loper is indicated for symptomatic treatment of acute and chronic diarrhoea.
In patients with an ileostomy, Loper may be used to reduce the number and volume of stools and to increase their consistency.
Loper is intended for use only in adults and children above the age of 6 years.

2. Important information before using Loper medicine

When not to use Loper medicine

• 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 of age.
• As primary treatment: in patients with acute dysentery characterized by blood in stool and high fever; in patients with acute flare-up of ulcerative colitis; in patients with bacterial enterocolitis caused by pathogenic bacteria of the genus Salmonella, Shigella and Campylobacter; in patients

with antibiotic-associated pseudomembranous colitis caused by broad-spectrum
antibiotics.

• In cases where inhibition of intestinal peristalsis should be avoided due to the possible risk of severe complications, including intestinal obstruction, abdominal distension or toxic megacolon. Treatment with Loper medicine should be discontinued immediately if constipation, abdominal distension or intestinal obstruction occurs.

Treatment of diarrhoea with Loper medicine is purely symptomatic. In every case where the cause of diarrhoea can be identified, and when appropriate (or indicated), the physician will recommend suitable treatment.

Warnings and precautions

Before starting treatment with Loper medicine, discuss this with your doctor or pharmacist.

In patients with diarrhoea, particularly in children, dehydration and excessive loss of electrolytes may occur. Therefore, during diarrhoea, it is important to drink more fluids than usual to compensate for these losses.

If symptoms do not improve within 48 hours of starting treatment for acute diarrhoea, stop taking Loper medicine and consult your doctor.

Patients with AIDS who are taking this medicine for diarrhoea should immediately discontinue treatment and contact their doctor if the first signs of abdominal distension occur. Cases of toxic megacolon have been reported in patients with AIDS who also had infectious colitis caused by both viruses and bacteria and were treated with loperamide hydrochloride.

This product should not be used for purposes other than those indicated (see section 1) or in doses higher than recommended (see section 3). In patients taking excessive doses of loperamide (the active substance in Loper medicine), severe cardiac disorders (including rapid or irregular heartbeat) have been reported.

Loper and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, 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 (medicines used to treat fungal infections);
• gemfibrozil (a medicine used to reduce blood lipid levels).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The doctor should carefully weigh the expected benefits for the mother against the potential risks associated with using Loper medicine during pregnancy, especially during the first trimester.

Use of Loper medicine is not recommended during breastfeeding.

Driving and operating machinery

Fatigue, dizziness or drowsiness may occur during treatment of diarrhoea with loperamide. Therefore, caution should be exercised when driving or operating machinery.

Loper medicine contains lactose

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

3. How to use Loper

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If symptoms do not improve or worsen within 48 hours after taking Loper, or if new symptoms appear (e.g. fever), medical advice must be sought immediately.

Dosage
Adults and children over 6 years of age
Acute diarrhoea: initial dose – 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children, followed by 1 tablet (2 mg) after each subsequent loose bowel movement.
Chronic diarrhoea: initial dose – 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children; this initial dose should be adjusted until 1 to 2 normal bowel movements per day are achieved, usually maintained with a maintenance dose of 1 to 6 tablets (2 to 12 mg) per day.
Maximum dose in acute and chronic diarrhoea – 8 tablets (16 mg) per day for adults and children. In children, the dose should be adjusted according to body weight (3 tablets/20 kg body weight/day), but not exceeding 8 tablets (16 mg) per day.
Do not exceed the maximum recommended dose.

Use of Loper in patients with impaired liver and/or kidney function
Loper should be used with caution in patients with impaired liver function, and careful observation for signs of toxic effects on the central nervous system is required (such as headache, dizziness, drowsiness, loss of consciousness, confusion, reduced level of consciousness, increased muscle tone, lack of coordination).
Dosage adjustment is not necessary in patients with impaired kidney function.

Use of Loper in children
Loper must not be used in children under 6 years of age.
For use in children over 6 years of age, see section 3 above.

Use of Loper in elderly patients
Dosage adjustment is not necessary in elderly patients.

Overdose of Loper
If more than the recommended dose has been taken, seek immediate advice from a doctor or pharmacist.

Symptoms
In case of overdose, the following symptoms may occur: lethargy, coordination disorders, drowsiness, pinpoint pupils, increased muscle tone, respiratory depression (i.e. shallow and slowed breathing), urinary retention, and intestinal obstruction (manifesting as 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 a patient has taken an excessive dose of Loper, immediate medical advice should be sought. The following symptoms may occur: rapid heartbeat, irregular heartbeat, changes in heart rhythm (which may have serious, life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing.
Children may react more severely than adults to an overdose of Loper. If a child has taken too much Loper or develops any of the symptoms listed above, contact a doctor immediately.

Loperamide is an opioid-type medicine that acts directly on the intestines when used as directed, but may produce other opioid effects when misused in large doses. In such cases, symptoms such as restlessness, insomnia, dilated pupils, and aggressive outbursts may occur. These symptoms may also appear after the initial overdose symptoms have subsided.

Treatment
In the event 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), repeated administration of naloxone may be required. Therefore, the patient should remain under close medical supervision for at least 48 hours to detect any possible recurrence of central nervous system depression.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Many of the adverse reactions associated with the use of loperamide are common symptoms of diarrhoeal syndromes (abdominal discomfort and pain, nausea, vomiting, dry mouth, fatigue, drowsiness, dizziness, constipation, bloating with flatulence). Often, these symptoms are difficult to distinguish from adverse reactions of the medicine being used.

The frequency of adverse reactions is presented according to the following classification:
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients

In clinical trials for the treatment of acute diarrhoea:
Common: headache, constipation, bloating and nausea.
Uncommon: dizziness, dry mouth, abdominal pain and discomfort, vomiting, epigastric pain and rash.
Rare: increased abdominal girth.

In clinical trials for the treatment of chronic diarrhoea:
Common: dizziness, bloating, constipation and nausea.
Uncommon: headache, dry mouth, abdominal pain and discomfort, and dyspepsia.

After loperamide was placed on the market:
Common: headache, dizziness and constipation, nausea and bloating.
Uncommon: insomnia, abdominal pain and discomfort, dry mouth, epigastric pain, vomiting and dyspepsia, and rash.
Rare: 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 tension, stupor), gastrointestinal disorders (intestinal obstruction, colonic dilatation, burning sensation of the tongue), increased abdominal girth, skin and subcutaneous tissue disorders (angioedema, bullous rash, pruritus, urticaria), as well as miosis (pupil constriction), urinary retention and fatigue.

Contact a doctor immediately:
Frequency not known (cannot be estimated from the available data)
epigastric pain, abdominal pain radiating to the back, abdominal tenderness on pressure, fever, rapid heartbeat, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If any of the above symptoms occur, treatment with this medicine should be discontinued and medical advice should be sought immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Loper

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

6. Contents of the packaging and other information

What Loper contains
The active substance is loperamide hydrochloride.
Each tablet contains 2 mg of loperamide hydrochloride.
Other components of the medicine are:
corn starch, monohydrate lactose, magnesium stearate.

What Loper looks like and contents of the pack
Loper is a white, round, biconvex tablet with a bevel and a division line on one side.
The division line is not intended for dividing the tablet into two equal parts.
Loper is available in PVC/PVDC/Aluminum blisters, in cardboard boxes containing 10 or 20 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer/Importer
mibe GmbH Arzneimittel
Münchener Strasse 15
06796 Brehna, Germany