Stoperan s

Package leaflet: Information for the user

Stoperan S
2 mg + 125 mg, tablets
Loperamide hydrochloride + Simethicone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed
by your doctor or pharmacist.

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

Contents of the leaflet

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

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

Stoperan S contains loperamide hydrochloride, which helps relieve diarrhoea by slowing down the overactive intestine. It also helps the body absorb more water and electrolytes from the intestine.

Stoperan S also contains simethicone, which helps release trapped intestinal gases causing cramps and bloating.

Depending on the indication, this medicine is intended for use in adults and adolescents over 12 years of age (for short-term diarrhoea) or only in adults aged 18 years and older (for acute diarrhoea associated with irritable bowel syndrome).

2. Important information before taking Stoperan S

Do not take Stoperan S:

• if you are allergic (hypersensitive) to loperamide hydrochloride, simethicone, or any of the other ingredients of this medicine (see section 6),
• if you have a high fever (above 38°C) or blood in your stool,
• if you have an acute flare-up of inflammatory bowel disease such as ulcerative colitis,
• if you have severe diarrhoea following antibiotic use,
• if you have constipation or abdominal distension,
• if you have bacterial enteritis caused by pathogenic bacteria of the genera Salmonella, Shigella, or Campylobacter,
• for short-term diarrhoea, do not use this medicine in children under 12 years of age,
• for acute diarrhoea associated with irritable bowel syndrome, do not use this medicine in children or adolescents under 18 years of age.

Stoperan S must not be used in situations where inhibition of intestinal peristalsis should be avoided, due to the possible risk of serious complications, including intestinal obstruction, colonic dilatation, or toxic megacolon. Treatment with Stoperan S must be discontinued immediately if constipation, intestinal obstruction, or abdominal distension occurs.

Do not take this product for an unapproved use (see section 1) or in doses higher than recommended (see section 3). In patients taking excessive doses of loperamide (the active substance in Stoperan S), severe cardiac disorders (including rapid or irregular heartbeat) have been reported.

Warnings and precautions

Talk to your doctor or pharmacist before taking Stoperan S:

• Stoperan S treats only the symptoms of diarrhoea. In some cases, treatment of the underlying cause of diarrhoea may be necessary. Contact your doctor if symptoms persist or worsen.
• If you have severe diarrhoea, you may lose more fluid, sugar, and minerals than normal. You should drink more fluids than usual to replace these losses. Ask your pharmacist about special powders that replenish sugar and mineral deficiencies.
• If you have AIDS and develop symptoms of abdominal distension, stop taking the medicine immediately and contact your doctor.
• If you have liver disease. Consult your doctor before taking these tablets. Some side effects may be more pronounced.

Stoperan S and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Stoperan S may interact with them.

In particular, inform your doctor or pharmacist if you are taking, have recently taken, or may take any of the following medicines:

• quinidine (a medicine used to treat heart rhythm disorders),
• itraconazole or ketoconazole (antifungal medicines),
• gemfibrozil (a medicine used to treat high cholesterol levels),
• ritonavir (a medicine used to treat HIV infection and AIDS),
• desmopressin (a medicine used to treat diabetes insipidus 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 are planning to have a baby, consult your doctor or pharmacist before using this medicine.
• Stoperan S may pass into breast milk in small amounts; therefore, it should not be used during breastfeeding. Ask your doctor for appropriate treatment.
• The effect on fertility in humans has not been evaluated.

Driving and operating machinery

Stoperan S may cause dizziness, fatigue, or drowsiness. Do not drive or operate machinery if these symptoms occur.

Stoperan S contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Stoperan S

• 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.
• Take orally.
• Swallow whole with liquid.
• The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.

Symptomatic treatment of acute diarrhoea in adults and adolescents over 12 years of age, when acute diarrhoea is accompanied by gastrointestinal discomfort including bloating, cramps, or gas.
Use in adults aged 18 years and above:
Take two tablets initially, followed by one tablet after each loose stool (bowel movement). Do not take more than 4 tablets per day. If there is no improvement after two days, discontinue use and consult your doctor.
Use in adolescents aged 12 to 18 years:
Take one tablet initially, followed by one tablet after each loose stool (bowel movement). Do not take more than 4 tablets per day. If there is no improvement after two days, discontinue use and consult your doctor.
Use in children under 12 years of age:
Do not give this medicine to children under 12 years of age in cases of short-term diarrhoea.

Symptomatic treatment of acute diarrhoea associated with irritable bowel syndrome (IBS) in adults aged 18 years and above, after initial diagnosis by a doctor, when acute diarrhoea is accompanied by gastrointestinal discomfort including bloating, cramps, or gas.
Use in adults aged 18 years and above:
Take two tablets initially, followed by one tablet after each loose stool (bowel movement). Do not take more than 4 tablets per day. If there is no improvement after two days, discontinue use and consult your doctor.
Use in children and adolescents under 18 years of age:
Do not give this medicine to children and adolescents under 18 years of age for acute diarrhoea associated with irritable bowel syndrome (IBS).

Taking more Stoperan S than recommended
If you take too many Stoperan S tablets, seek immediate medical advice from your doctor or go to hospital.
The following symptoms may occur: increased heart rate, irregular heartbeat, changes in heart rhythm (these may have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, shallow breathing, dry mouth, or constricted pupils, as well as abdominal pain, nausea, vomiting, or constipation.
Children are more sensitive to large doses of Stoperan S than adults. If a child takes an excessive dose or develops any of the symptoms listed above, contact a doctor immediately.

If you forget to take 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following symptoms occur, stop taking the medicine immediately
and seek medical help without delay:

• life-threatening anaphylactic shock (disorientation and fainting due to a sudden drop in blood pressure) (rare),
• allergic or allergy-like reactions (rare), including swelling of the face, tongue or throat, difficulty swallowing, wheezing without an apparent cause, shortness of breath, which may be accompanied by a rash (not very common) or hives, itching (rare),
• skin rash, which may lead to blistering and peeling of the skin (rare),
• upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid heartbeat, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis) (frequency unknown (cannot be determined from available data)).

If any of the following symptoms occur, stop taking the medicine and consult
your doctor:

• difficulty passing urine (rare),
• severe abdominal pain, abdominal bloating, abdominal swelling or fever, which may be caused by intestinal obstruction or intestinal distension (rare),
• severe constipation.

Other possible adverse reactions may include:
Commonly reported adverse reactions (may affect less than 1 in 10 people):

• headache,
• malaise,
• changes in the perception of certain tastes.

Not very commonly reported adverse reactions (may affect less than 1 in 100 people):

• drowsiness,
• dizziness,
• weakness,
• constipation,
• abdominal pain, abdominal discomfort,
• increased abdominal circumference,
• vomiting,
• dyspepsia,
• flatulence,
• dry mouth.

Rarely reported adverse reactions (may affect less than 1 in 1,000 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Stoperan S
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after “Expiry date” or “EXP”. The expiry date refers to the last day of the stated month.
No special precautions for storage are required.
Medicines must 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 Stoperan S contains
The active substances are: loperamide hydrochloride (2 mg per tablet) and simethicone
(in the form of 125 mg dimethicone per tablet).
Other ingredients: microcrystalline cellulose (E460), sodium carboxymethyl starch, hypromellose
(E464), povidone (E2101), 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 "LO-SI" embossed on one side and "2" and "125"
embossed on either side of the break line on the other side.
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.
Ziębicka Street 40
50-507 Wrocław
Poland
Manufacturer/Importer
US Pharmacia Sp. z o.o.
Ziębicka Street 40
50-507 Wrocław
Poland
or
Manufacturer
Laboratorios Alcala Farma, S.L.
Avenida de Madrid 82
Alcalá de Henares
28802 Madrid
Spain
For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw
Tel. +48 (22) 543 60 00
This medicinal product has been authorised in EEA Member States under the following
names:
Poland: Stoperan S