Package leaflet: Information for the patient

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

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please 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, you should contact your doctor.

Contents of the leaflet

What Stoperan is and what it is used for
Important information before taking Stoperan
How to take Stoperan
Possible side effects
How to store Stoperan
Contents of the pack and other information

1. What Stoperan is and what it is used for

Stoperan contains loperamide. It is an antidiarrhoeal medicine. Stoperan reduces excessive intestinal motility and also increases water absorption. As a result, it slows the passage of intestinal contents through the gut, reduces the frequency and number of bowel movements, and by promoting reabsorption of water in the colon, improves stool consistency. Stoperan is intended for use in adults and children aged 6 years and older.
Stoperan is indicated for symptomatic treatment of acute and chronic diarrhoea. If there is no improvement after 2 days, or if you feel worse, you should contact your doctor.

2. Important information before using Stoperan

When not to use Stoperan:

if the patient is allergic to loperamide or any of the other ingredients of this medicine (listed in section 6),
in conditions where slowing of intestinal peristalsis is undesirable due to possible risk of severe complications, including intestinal obstruction, megacolon and toxic dilatation of the colon; treatment with Stoperan must be discontinued immediately if constipation, abdominal distension or intestinal obstruction occurs,
in intestinal obstruction, acute ulcerative colitis, acute attack of hemorrhagic colitis, pseudomembranous colitis, especially associated with administration of broad-spectrum antibiotics,
in bacterial infection of the small intestine and colon caused by pathogenic bacteria of the genera Salmonella, Shigella and Campylobacter,
in acute dysentery with blood in stool and accompanied by elevated body temperature,
in children under 6 years of age.

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Warnings and precautions
Caution should be exercised when using Stoperan in bacterial diarrhoea.
In patients with impaired liver function, the medicine should be used with caution due to the possible toxic effects of the drug on the central nervous system.
In patients with diarrhoea, especially in children, dehydration and electrolyte imbalance may occur.
Therefore, during diarrhoea, fluid and mineral salts should be replenished.
Treatment should be discontinued if constipation, bloating or developing intestinal obstruction occurs.
In patients presenting with fever and blood in stool, the cause of diarrhoea should be established before initiating loperamide therapy.
In patients with AIDS treated with Stoperan for diarrhoea, treatment should be discontinued at the first signs of abdominal distension. In patients with AIDS and concurrent infectious colitis caused by both viruses and bacteria, isolated cases of toxic dilatation of the colon have been reported during loperamide use.
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 Stoperan), severe cardiac disorders (including rapid or irregular heartbeat) have been reported.
Children and adolescents
Stoperan is contraindicated in children under 6 years of age.
Stoperan and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines you plan to use.
Concomitant administration of loperamide (16 mg as a single dose) with quinidine (a medicine used to treat heart rhythm disorders) or ritonavir (used in the treatment of HIV infection), both of which are P-glycoprotein inhibitors, increases plasma concentrations of loperamide. The clinical significance of these interactions is unknown.
Taking Stoperan with food, drink and alcohol
It is recommended to take Stoperan with water.
Stoperan may be taken on an empty stomach or after meals.
When used at doses recommended for the treatment of diarrhoea, Stoperan practically does not penetrate into the central nervous system; therefore, the risk of interaction with alcohol is minimal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Consult a doctor before using this medicine.
Driving and operating machinery
During treatment of diarrhoea with loperamide, fatigue, dizziness or drowsiness may occur.
Therefore, caution should be exercised when driving or operating machinery.
Stoperan contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
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3. How to use Stoperan

Stoperan should be used according to the recommendations provided in this leaflet. In case of doubt, consult your doctor.
Stoperan should be taken orally.

Adults and children over 12 years of age:
Acute diarrhoea:
Initial dose: 2 capsules (4 mg), followed by 1 capsule (2 mg) after each loose bowel movement.
Do not exceed a dose of 8 capsules (16 mg) per day.

Chronic diarrhoea:
Initially, 1 capsule (2 mg) twice daily. The dose may be increased if necessary to 4–6 capsules (8–12 mg) per day.

Children aged 9 to 12 years:
Acute diarrhoea:
1 capsule (2 mg) after each loose bowel movement. Do not exceed a dose of 3 capsules (6 mg) per day.

Chronic diarrhoea:
1 capsule (2 mg) after each loose bowel movement. Do not exceed a dose of 3 capsules (6 mg) per day.

Children aged 6 to 8 years:
Acute diarrhoea:
1 capsule (2 mg) after each loose bowel movement. Do not exceed a dose of 3 capsules (6 mg) per day.

Chronic diarrhoea:
1 capsule (2 mg) after each loose bowel movement. Do not exceed a dose of 2 capsules (4 mg) per day.

Dose adjustment is not necessary in patients with renal impairment or in elderly patients.

Diarrhoea may resolve after a single dose. In such case, further administration of the medicine should not be continued.

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

Taking more Stoperan than recommended
In case of overdose, constipation, intestinal obstruction, urinary retention, and symptoms of central nervous system depression may occur (increased muscle tone, stupor, confusion (disorientation), drowsiness, impaired neuromuscular coordination, pinpoint pupils, apnoea, respiratory depression). Children are more susceptible than adults to adverse effects of the drug on the central nervous system.

If a patient has taken too much Stoperan, seek immediate medical advice from a doctor or hospital. The following symptoms may occur: rapid heartbeat, irregular heart rhythm, changes in heart rhythm (these effects may be severe and life-threatening), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing.

Children may react more strongly to large doses of Stoperan than adults. If a child has taken too much Stoperan or develops any of the symptoms listed above, contact a doctor immediately.

Action to be taken in case of overdose
If you have taken more Stoperan than recommended, seek immediate advice from a doctor or pharmacist.

If symptoms of overdose occur, the doctor may recommend naloxone as an antidote. Because the duration of action of Stoperan is longer than that of naloxone (1 to 3 hours), repeated doses of naloxone may be necessary. Therefore, the patient should remain under strict medical supervision for at least 48 hours to monitor for possible central nervous system depression.

If you forget to take Stoperan
Do not take a double dose to make up for a missed dose.

Stopping Stoperan
Stoperan is taken on an as-needed basis; therefore, treatment may be discontinued once improvement is achieved.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everybody will experience them.
Contact a doctor immediately:
Rare (in less than 1 in 1,000 people)

allergic reactions, sometimes severe hypersensitivity reactions, including anaphylactic shock (a severe allergic reaction with sudden breathing difficulties, facial or throat swelling, severe dizziness) and anaphylactoid reactions;
rash, urticaria and itching, angioedema, bullous rash, including Stevens-Johnson syndrome (a skin disease characterized by epidermal detachment), erythema multiforme (a skin disorder presenting with erythematous lesions), and toxic epidermal necrolysis (Lyell's syndrome - a skin disease in which necrotic changes of the epidermis occur); Frequency unknown (cannot be estimated from available data)
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). If any of the above symptoms occur, discontinue use of the medicine and contact a doctor immediately.

Other adverse effects
Adverse effects occurring very rarely (in less than 1 in 10,000 people, including isolated cases):

headache and dizziness, fatigue, somnolence;
abdominal pain, constipation, nausea and vomiting, intestinal obstruction, colonic dilatation, including toxic colonic dilatation, flatulence with passage of wind and dyspepsia, dry mouth;
urinary retention.

Many adverse events associated with loperamide use are common symptoms of diarrhoeal syndromes (discomfort and abdominal pain, nausea, vomiting, dry mouth, fatigue, somnolence, dizziness, constipation, flatulence with passage of wind). Often these symptoms are difficult to distinguish from adverse effects of the medicine used.
In some individuals, other adverse effects may occur during treatment with Stoperan.
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If any other adverse effects not mentioned in this leaflet occur, they should be reported to a doctor.
Reporting of adverse effects
If any adverse effects occur, including all possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Stoperan

Keep this medicine below 25°C.
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the carton and on the immediate packaging (month/year).
The labelling used for the blister is: EXP – expiry date, Lot – batch number.

6. Contents of the packaging and other information

What Stoperan contains
The active substance is loperamide hydrochloride (Loperamidi hydrochloridum) 2 mg.
The excipients are: monohydrate lactose, corn starch, talc, magnesium stearate, composition
of the capsule shell: gelatin, erythrosine (E 127), patent blue (E 131), titanium dioxide (E 171), quinoline yellow (E 104).
What the medicine looks like and contents of the packaging
Hard capsule composed of blue and grey parts, containing white powder.
Available pack sizes:
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 authorisation holder and manufacturer:
US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50–507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, tel.: +48 (22) 543 60 00
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