Stoperan S

Package Leaflet: Information for the Patient

Stoperan S

2 mg + 125 mg, tablets

Loperamide hydrochloride + Simethicone

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 for the patient or as advised by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those 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, you should contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Stoperan S and what is it used for

Stoperan S is indicated for the treatment of short-term diarrhea in adults and adolescents over 12 years of age, as well as for the symptomatic treatment of acute diarrhea associated with irritable bowel syndrome (IBS) in adults over 18 years of age, after initial diagnosis by a doctor, when acute diarrhea is accompanied by discomfort of the digestive tract, including bloating, cramps, or gas.

Stoperan S contains loperamide hydrochloride, which helps to alleviate diarrhea by slowing down the overactive bowel. It also helps the body absorb more water and electrolytes from the bowel.

Stoperan S also contains simethicone, which releases trapped gas in the bowel that causes cramps and bloating.

Depending on the indications, this medicine is intended for use in adults and adolescents over 12 years of age (short-term diarrhea) or only in adults over 18 years of age (acute diarrhea associated with IBS).

2. Important information before taking Stoperan S

When not to take Stoperan S

Salmonella, Shigella, and Campylobacter,
• in the case of short-term diarrhea, this medicine should not be used in children under 12 years of age,

Stoperan S should not be used in cases where it is necessary to avoid slowing down bowel peristalsis, due to the possible risk of serious complications, including bowel obstruction, colon enlargement, and toxic colon enlargement. The use of Stoperan S should be stopped immediately in case of constipation, bowel obstruction, or abdominal bloating.

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 S), serious heart rhythm disorders (including accelerated or irregular heart rhythm) have been reported.

Warnings and precautions

You should talk to your doctor or pharmacist before taking Stoperan S:

• Stoperan S only treats the symptoms of diarrhea. In some cases, it may be necessary to treat the cause of diarrhea. You should contact your doctor if symptoms persist or worsen.
• If you have severe diarrhea, as there may be a greater loss of water, sugars, and mineral salts than usual. You should drink more fluids than usual to replenish these deficiencies. You should ask your pharmacist about special powders that replenish sugar and mineral salt deficiencies.
• If you have AIDS and symptoms of abdominal bloating appear, you should stop taking the medicine immediately and contact your doctor.
• If you have liver disease. You should contact your doctor before taking the tablets. Some side effects may be more severe.

Stoperan S and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, as Stoperan S may interact with them.

• quinidine (a medicine used to treat heart rhythm disorders),
• itraconazole or ketoconazole (antifungal medicines),
• gemfibrozil (a medicine used to treat high cholesterol),
• ritonavir (a medicine used to treat HIV and AIDS infection),
• desmopressin (a medicine used to treat bedwetting and nocturnal enuresis). Interaction studies have been conducted only in adults.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
• Stoperan S may pass into breast milk in small amounts, so it should not be used during breastfeeding. You should ask your doctor about appropriate treatment.
• The effect on human fertility has not been evaluated.

Driving and using machines

Stoperan S may cause dizziness, fatigue, or drowsiness. You should not drive or operate machinery if you experience these symptoms.

Stoperan S contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Stoperan S

• This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
• Take orally.
• Swallow whole with a drink of water.
• The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Symptomatic treatment of acute diarrhea in adults and adolescents over 12 years of age, when acute diarrhea is accompanied by discomfort of the digestive tract, including bloating, cramps, or gas.

Use in adults over 18 years of age:

Take two tablets initially, and then one tablet after each loose stool (bowel movement). Do not take more than 4 tablets per day. If there is no improvement after 2 days, you should stop taking the medicine and contact your doctor.

Use in adolescents from 12 to 18 years of age:

Take one tablet initially, and then one tablet after each loose stool (bowel movement). Do not take more than 4 tablets per day. If there is no improvement after 2 days, you should stop taking the medicine and contact your doctor.

Use in children under 12 years of age:

This medicine should not be given to children under 12 years of age for short-term diarrhea.

Symptomatic treatment of acute diarrhea associated with irritable bowel syndrome (IBS) in adults over 18 years of age, after initial diagnosis by a doctor, when acute diarrhea is accompanied by discomfort of the digestive tract, including bloating, cramps, or gas.

Use in adults over 18 years of age:

Take two tablets initially, and then one tablet after each loose stool (bowel movement). Do not take more than 4 tablets per day. If there is no improvement after 2 days, you should stop taking the medicine and contact your doctor.

Use in children and adolescents under 18 years of age:

This medicine should not be given to children and adolescents under 18 years of age for acute diarrhea associated with IBS.

Overdose of Stoperan S

If you have taken too many tablets of Stoperan S, you should immediately contact a doctor or hospital.

The following symptoms may occur: rapid heart rate, irregular heart rhythm, changes in heart rhythm (these symptoms can have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing, dry mouth, or constricted pupils, as well as abdominal pain, nausea, vomiting, or constipation.

In children, the reaction to taking large amounts of Stoperan S is stronger than in adults. If a child takes too much medicine or experiences any of the above symptoms, you should immediately contact a doctor.

Missed dose of Stoperan S

Take one tablet after the next loose stool (bowel movement). Do not take a double dose to make up for a missed dose.

If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, you should stop taking the medicine and seek medical help immediately:

• life-threatening anaphylactic shock (disorientation and fainting due to a sudden drop in blood pressure) (rare),
• allergic reactions or similar (rare), including swelling of the face, tongue, or throat, difficulty swallowing, wheezing, shortness of breath without a clear cause, which may be accompanied by a rash (not very common) or hives, itching (rare),
• skin rash, which can lead to blistering and peeling of the skin (rare),
• abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (frequency not known).

If you experience any of the following symptoms, you should stop taking the medicine and consult your doctor:

• difficulty urinating (rare),
• severe abdominal pain, abdominal bloating, abdominal swelling, or fever, which may be caused by bowel obstruction or colon enlargement (rare),
• severe constipation.

Other possible side effects may include:

Frequently reported side effects (may affect up to 1 in 10 people):

• headache,
• malaise,
• changes in taste perception.

Less frequently reported side effects (may affect up to 1 in 100 people):

• drowsiness,
• dizziness,
• weakness,
• constipation,
• abdominal pain, abdominal discomfort,
• abdominal swelling,
• vomiting,
• indigestion,
• passing gas,
• dry mouth.

Rarely reported side effects (may affect up to 1 in 1,000 people):

• loss of consciousness or decreased level of consciousness,
• lethargy and immobility (stupor),
• excessive muscle tension,
• impaired coordination,
• excessive pupil constriction.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, you should tell your doctor or pharmacist. Side effects can be reported 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, 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 S

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after 'Expiry date' or 'EXP'. The expiry date refers to the last day of the month stated.

There are no special precautions for storage of the medicinal product.

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 Stoperan S contains

The active substances are loperamide hydrochloride (2 mg in each tablet) and simethicone (in the form of 125 mg dimethicone in each tablet).

The other ingredients are microcrystalline cellulose (E460), sodium carboxymethylcellulose, hypromellose (E464), povidone (E1201), calcium phosphate (E341), mannitol (E421), and magnesium stearate (E572).

What Stoperan S looks like and contents of the pack

The tablets are white to almost white, with the inscription "LO-SI" on one side and "2" and "125" engraved on the other side on either side of the score line.

The pack contains 6, 8, 10, 12, 15, 16, 18, 20, 24, or 30 tablets in blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

Poland

Manufacturer/Importer

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

Poland

or

Manufacturer

Laboratorios Alcala Farma, S.L.

Avenida de Madrid 82

Alcalá de Henares

28802 Madrid

Spain

For more information, please contact:

USP Zdrowie Sp. z o.o.

ul. Poleczki 35

02-822 Warsaw

tel. +48 (22) 543 60 00

This medicinal product has been authorized in the EEA member states under the following names:

Poland: Stoperan S

Date of last revision of the package leaflet:September 2022