Stoperan

Package Leaflet: Information for the Patient

Stoperan

2 mg, Hard Capsules

Loperamide Hydrochloride

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

Take this medicine always exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in the package leaflet, tell your doctor or pharmacist. See section 4.
• If after 2 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Stoperan and what is it used for

Stoperan contains loperamide. It is an anti-diarrheal medicine. Stoperan slows down increased bowel movements and also increases water absorption. As a result, it slows down the passage of food through the intestines, reduces the frequency and number of bowel movements, and by reversing water absorption in the large intestine, changes the consistency of the stool. Stoperan is intended for use in adults and children over 6 years old.
Stoperan is indicated for the symptomatic treatment of acute and chronic diarrhea. If after 2 days there is no improvement or the patient feels worse, contact your doctor.

2. Important information before taking Stoperan

When not to take Stoperan:

• if you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6),
• in conditions where it is undesirable to slow down intestinal peristalsis due to the possible risk of severe complications, including intestinal obstruction, toxic megacolon, and the use of Stoperan should be discontinued immediately in case of constipation, abdominal distension, or intestinal obstruction,
• in intestinal obstruction, acute ulcerative colitis, acute bloody colitis, pseudomembranous colitis, especially associated with the use of broad-spectrum antibiotics,
• in bacterial enteritis and colitis caused by pathogenic bacteria of the genus Salmonella, Shigellaand Campylobacter,
• in acute bloody diarrhea with fever,
• in children under 6 years old.

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Warnings and precautions

Caution should be exercised when taking Stoperan in bacterial diarrhea.
In patients with liver function disorders, the medicine should be used with caution due to the possibility of toxic effects on the central nervous system.
In patients with diarrhea, especially in children, dehydration and electrolyte deficiency may occur.
Therefore, during diarrhea, water and mineral salts should be supplemented.
The administration of the medicine should be discontinued in case of constipation, bloating, or developing intestinal obstruction.
In patients with fever and blood in the stool, before starting loperamide, the cause of diarrhea should be determined.
In patients with AIDS, treated with Stoperan for diarrhea, the administration of the medicine should be discontinued in case of early symptoms of abdominal distension. In patients with AIDS and concurrent infectious colitis caused by both viruses and bacteria, single cases of toxic megacolon have been reported during the use of loperamide.
This product should not be taken for purposes 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 Stoperan), serious heart rhythm disorders (including accelerated or irregular heart rhythm) have been reported.

Children and adolescents

Stoperan is contraindicated in children under 6 years old.

Stoperan and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant administration of loperamide (16 mg in a single dose) with quinidine (a medicine used to treat heart rhythm disorders) or ritonavir (used to treat HIV infection), which are P-glycoprotein inhibitors, results in increased loperamide plasma concentrations. The clinical significance of these interactions is unknown.

Taking Stoperan with food and drink and alcohol

It is recommended to take Stoperan with water.
Stoperan can be taken on an empty stomach or after a meal.
Stoperan taken in doses used to treat diarrhea practically does not penetrate the central nervous system, so the risk of interaction with alcohol is minimal.

Pregnancy and breastfeeding

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.
Before taking the medicine, consult your doctor.

Driving and using machines

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

Stoperan contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
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3. How to take Stoperan

Take Stoperan exactly as directed in the package leaflet. If you are unsure, consult your doctor.
Take Stoperan orally.
Adults and children over 12 years old:
Acute diarrhea:
initial dose 2 capsules (4 mg), then 1 capsule (2 mg) after each loose bowel movement.
Do not take more than 8 capsules (16 mg) per day.
Chronic diarrhea:
initially 1 capsule (2 mg) twice a day, if necessary, the dose can be increased to 4-6 capsules (8-12 mg) per day.
Children from 9 to 12 years old:
Acute diarrhea:
1 capsule (2 mg) after each loose bowel movement. Do not take more than 3 capsules (6 mg) per day.
Chronic diarrhea:
1 capsule (2 mg) after each loose bowel movement. Do not take more than 3 capsules (6 mg) per day.
Children from 6 to 8 years old:
Acute diarrhea:
1 capsule (2 mg) after each loose bowel movement. Do not take more than 3 capsules (6 mg) per day.
Chronic diarrhea:
1 capsule (2 mg) after each loose bowel movement. Do not take more than 2 capsules (4 mg) per day.
No dose adjustment is necessary in patients with renal impairment or in elderly patients.

Diarrhea may resolve after a single dose. In this case, do not continue taking the medicine.

If you feel that the effect of Stoperan is too strong or too weak, consult your doctor.

Taking too much Stoperan

In case of overdose, constipation, intestinal obstruction, urinary retention, and symptoms of central nervous system depression (increased muscle tone, stupor, confusion, drowsiness, coordination disorders, miosis, apnea, respiratory depression) may occur. Children are more sensitive than adults to the occurrence of adverse effects of the medicine on the central nervous system.
If you have taken too much Stoperan, seek medical advice immediately. The following symptoms may occur: accelerated heart rate, irregular heart rhythm, 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 Stoperan is stronger than in adults. If a child has taken too much Stoperan or any of the above symptoms occur, seek medical advice immediately.

Procedure after overdose

In case of taking a higher dose of the medicine than recommended, seek medical advice immediately.
In case of overdose symptoms, the doctor may recommend the administration of naloxone. Since the duration of action of Stoperan is longer than that of naloxone (1 to 3 hours), repeated administration of naloxone may be necessary. Therefore, the patient should be under close medical supervision for at least 48 hours to detect any possible depression of the central nervous system.

Missing a dose of Stoperan

Do not take a double dose to make up for a missed dose.

Stopping Stoperan

Stoperan is taken as needed, so after improvement, its use can be stopped.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Stoperan can cause side effects, although not everybody gets them.
Contact your doctor immediately:
Rare (less than 1 in 1,000 people)

• -allergic reactions, sometimes severe hypersensitivity reactions, including anaphylactic shock (severe allergic reaction with sudden difficulty breathing, swelling of the face or throat, severe dizziness) and reactions similar to anaphylaxis;
• -rash, urticaria, and itching, angioedema, blistering rash, including Stevens-Johnson syndrome (a skin disease characterized by peeling of the skin), erythema multiforme (a skin disease that occurs with the formation of rash-like changes) and toxic epidermal necrolysis (Lyell's syndrome - a skin disease in which there are necrotic changes in the skin); Frequency not known (cannot be estimated from the available data)
• abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, accelerated pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis). If any of the above symptoms occur, discontinue the medicine and contact your doctor immediately.

Other side effects
Side effects that occur very rarely (less than 1 in 10,000 people, including single cases):

• -headache and dizziness, fatigue, drowsiness;
• -abdominal pain, constipation, nausea, and vomiting, intestinal obstruction, megacolon, including toxic megacolon, bloating with gas, and indigestion, dry mouth;
• -urinary retention.

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 with gas). Often these symptoms are difficult to distinguish from the adverse effects of the medicine taken.
In some people, during the use of Stoperan, other side effects may occur.
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If you experience any other side effects not mentioned in this package leaflet, inform your doctor.

Reporting side effects

If you experience any side effects, including any not listed in the package leaflet, contact your doctor or pharmacist.
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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stoperan

Store the medicine at a temperature below 25°C.
Keep out of sight and reach of children.
Do not use after the expiry date stated on the carton and blister pack (month/year). The applied marking for the blister is: EXP - expiry date, Lot - batch number.

6. Contents of the package and other information

What Stoperan contains

The active substance of Stoperan is loperamide hydrochloride (Loperamidi hydrochloridum) 2 mg.
The excipients are: lactose monohydrate, maize starch, talc, magnesium stearate, capsule shell: gelatin, erythrosine (E 127), patent blue (E 131), titanium dioxide (E 171), quinoline yellow (E 104).

What Stoperan looks like and contents of the pack

A hard capsule consisting of a blue and gray part, containing a white powder.

Available packs:

2 hard capsules in 1 blister, 4 hard capsules in 1 blister, 8 hard capsules in 1 blister, 18 hard capsules in 1 blister.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław
For more detailed information, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw, tel.: +48 (22) 543 60 00
Date of last revision of the package leaflet: May 2022
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