Package leaflet: Information for the user

Stoperan Junior
0.2 mg/mL, oral solution
Loperamidi hydrochloridum
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 need advice or further information, please contact 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
1. What Stoperan Junior is and what it is used for
2. Important information before taking Stoperan Junior
3. How to take Stoperan Junior
4. Possible side effects
5. How to store Stoperan Junior
6. Contents of the pack and other information

1. What Stoperan Junior is and what it is used for
Stoperan Junior is an antidiarrhoeal medicine containing loperamide hydrochloride. This is a substance
which has a calming effect on increased intestinal peristalsis. Thus, the active ingredient in Stoperan
Junior counteracts diarrhoea. After taking Stoperan Junior, diarrhoea usually resolves within a few hours in most cases.
Stoperan Junior is used in the treatment of acute or chronic diarrhoea in adults and children aged 6 years and older.
Acute diarrhoea starts suddenly and usually resolves within a week. Chronic diarrhoea lasts longer.
Stoperan Junior is used for symptomatic treatment of diarrhoea. It does not treat the underlying cause of diarrhoea.
Once the cause of diarrhoea becomes known, the underlying condition should be treated appropriately.

2. Important information before taking Stoperan Junior

When not to take Stoperan Junior:

If you are allergic to loperamide or any of the other ingredients of this medicine (listed in section 6), symptoms of allergy may include rash, itching, shortness of breath or facial swelling. If these symptoms occur, stop taking Stoperan Junior and consult your doctor.
In children under 6 years of age.
If diarrhoea is suspected to be caused by poisoning, for example by heavy metals (mercury, lead or cadmium).
Do not take Stoperan Junior if acute colonic dilation is suspected. This is a severe swelling of the large intestine; a very serious condition that may occur in patients with Hirschsprung's disease, Crohn's disease or ulcerative

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colitis, which may present with: severe abdominal distension, fever and
rapid heartbeat.

If constipation is present, resulting in leakage of watery stools. This may occur in certain intestinal disorders.
Do not take Stoperan Junior if you have persistent cramping abdominal pain, nausea, vomiting, high fever, or blood or mucus in the stool. These symptoms may be associated with a condition called bacterial enterocolitis.
Do not take Stoperan Junior in bacterial infections of the large or small intestine caused by bacteria such as Salmonella, Shigella and Campylobacter.
Do not take Stoperan Junior in severe intestinal inflammation (e.g. in ulcerative colitis or pseudomembranous colitis resulting from taking certain antibiotics).
Do not take Stoperan Junior in any condition where normal intestinal motility should not be suppressed. Treatment must be stopped immediately if constipation or abdominal distension occurs.

Warnings and precautions
Stoperan Junior acts symptomatically and does not treat the underlying cause of diarrhoea. When the cause
becomes known, causal treatment should be initiated if possible. If in doubt, always consult your doctor.
In patients with diarrhoea, especially in children and elderly people, dehydration and electrolyte imbalance may occur.
Symptoms of dehydration may include: dryness of the mouth, dizziness and (or) vomiting. Therefore, during diarrhoea,
the first priority is to replenish fluid and mineral losses and ensure adequate hydration, which means drinking plenty
of fluids and replacing sugar and salt. In pharmacies, special salt and sugar mixtures (oral rehydration solutions)
are available, which should be dissolved in water. Please consult your doctor or pharmacist for advice.
In patients with AIDS being treated for diarrhoea with Stoperan Junior, treatment must be stopped immediately if
abdominal distension occurs. In such cases, contact your doctor. In patients with AIDS and severe intestinal infection
(infectious colitis) taking loperamide (the active substance also present in Stoperan Junior), there have been reports of
an increased risk of toxic megacolon. This is a severe dilation of the large intestine, presenting with symptoms such as
severe abdominal pain, fever and rapid heartbeat.
In patients with hepatic impairment, consult your doctor or pharmacist before taking Stoperan Junior.
Monitoring of the patient's condition may be necessary. Furthermore, to avoid nervous system-related adverse effects,
a dose adjustment may be required.
Do not use Stoperan Junior for conditions other than those for which it is indicated (see section 1), and do not take a higher dose than recommended (see section 3). In individuals who have taken an overdose of loperamide, the active ingredient in Stoperan Junior, serious heart problems (symptoms of rapid or irregular heartbeat) have been reported.
Treatment with Stoperan Junior should be discontinued in the following cases:

If stools become firmer or if no bowel movement occurs within twelve hours.
In acute diarrhoea, if diarrhoea does not improve within 48 hours of taking Stoperan Junior, discontinue use and consult your doctor.
If constipation or abdominal distension occurs, stop taking Stoperan Junior immediately and consult your doctor.
In cases where Stoperan Junior is taken for chronic diarrhoea, consult your doctor about the possibility of reducing the dose or discontinuing treatment.
Adhere strictly to the recommended dosage. Taking a higher dose than

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recommended may lead to intestinal obstruction. Symptoms may include constipation, abdominal distension and leakage of watery stools.
Children and adolescents
Stoperan Junior is contraindicated in children under 6 years of age.
Stoperan Junior 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. Some medicinal products should not be used simultaneously, and sometimes concomitant use requires appropriate adjustment (e.g. dosage).
Before taking Stoperan Junior, consult your doctor if you are taking any of the following medicines:

Medicines with pharmacological properties similar to loperamide, as they may enhance the effect of Stoperan Junior;
Medicines that accelerate gastrointestinal transit, as they may reduce the effect of Stoperan Junior;
Ritonavir (a medicine used in HIV infection);
Quinidine (a medicine used to treat heart rhythm disorders);
Oral desmopressin (a medicine used to treat nocturnal enuresis);
Itraconazole or ketoconazole (medicines used to treat fungal infections);
Gemfibrozil (a medicine used to lower cholesterol levels).

Taking Stoperan Junior with food, drink and alcohol
It is recommended to take Stoperan Junior with water.
Pregnancy, breastfeeding and fertility
If you are pregnant or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Consult your doctor, as use of this medicine is not recommended during the first trimester of pregnancy, and in the second and third trimesters it should only be used if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the mother and foetus.
Breastfeeding
The active substance in Stoperan Junior passes into breast milk in small amounts. Therefore, taking Stoperan Junior during breastfeeding is not recommended. If Stoperan Junior is taken, breastfeeding should be discontinued and medical advice sought.
Driving and operating machinery
During loperamide-treated diarrhoea, fatigue, dizziness or drowsiness may occur. Therefore, caution should be exercised when driving or operating machinery.
Sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".
This medicine contains glycerol.
This medicine may cause headache, gastrointestinal disturbances and diarrhoea.
This medicine contains propylene glycol.
This medicine contains 5.8 mg of propylene glycol in each mL of solution.
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This medicine contains glucose (component of maltodextrin).
If you have been previously diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
This medicine contains sulphites - sulphur dioxide (E220).
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Stoperan Junior

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Stoperan Junior is for oral use.
Adults:
Acute diarrhoea
Treatment should begin with a dose of 20 mL (4 measuring spoons). Then take 10 mL (2 measuring spoons) after each loose bowel movement, for as long as diarrhoea persists. Never take more than 80 mL (16 measuring spoons) in one day.
Chronic diarrhoea
On the first day, take 20 mL (4 measuring spoons) per day. Then, depending on the severity of symptoms, the daily dose should be individually adjusted to achieve 1 to 2 formed bowel movements per day. Usually, this requires a daily dose ranging from 2 mg loperamide (10 mL solution = 2 measuring spoons) to 12 mg loperamide (60 mL solution = 12 measuring spoons). Never take more than 80 mL (16 measuring spoons) in one day.
Children aged 8 to 17 years:
Acute diarrhoea
Treatment should begin with a dose of 10 mL (2 measuring spoons). Then take 10 mL (2 measuring spoons) after each loose bowel movement, for as long as diarrhoea persists.
Chronic diarrhoea:
On the first day, take 2 mg loperamide (10 mL solution = 2 measuring spoons) per day.
Then, depending on the severity of symptoms, the daily dose should be individually adjusted to achieve 1 to 2 formed bowel movements per day. Usually, this requires a daily dose ranging from 2 mg loperamide (10 mL solution = 2 measuring spoons) to 12 mg loperamide (60 mL solution = 12 measuring spoons).
Children aged 6 to 8 years:
The dose to be administered depends on the child's body weight. The dose is 5 mL (1 measuring spoon) per 10 kg body weight. Several examples are shown in the table below.
Body weight 15 kg 20 kg 25 kg 30 kg
Single dose of Stoperan Junior 7½ mL 10 mL 12½ mL 15 mL
This dose should be administered to children 2 to 3 times daily.
The daily dose of Stoperan Junior that a child aged 6 to 17 years may take depends on body weight. For every 10 kg of body weight, the child must not take more than 15 mL (3 measuring spoons) per day. Take care never to exceed 80 mL (16 measuring spoons) per day. Several examples are shown in the table below.
Child's body weight 15 kg 20 kg 25 kg 30 kg 35 kg 40 kg 45 kg 50 kg above
53 kg
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Maximum daily amount of
22½ mL 30 mL 37½ mL 45 mL 52½ mL 60 mL 67½ mL 75 mL 80 mL
Stoperan Junior
Children under 6 years of age:
Stoperan Junior must not be used in children under 6 years of age.
Elderly patients
There is no need to adjust the dosage in elderly patients.
Renal impairment
There is no need to adjust the dosage in patients with renal impairment.
Hepatic impairment
Stoperan Junior should be used with caution in patients with hepatic impairment due to reduced metabolism related to the first-pass effect in the liver (see section 2 – "When must Stoperan Junior not be used?"). Extra caution is required.
Taking more than the recommended dose of Stoperan Junior
Overdose means that a higher dose of Stoperan Junior has been taken than recommended in this leaflet (see section "How to take Stoperan Junior?").
In case of overdose, consult a doctor immediately.
The following symptoms may occur: rapid heartbeat, heart rhythm disturbances, changes in heart rhythm (these symptoms may potentially be life-threatening), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, shallow breathing, dry mouth, pinpoint pupils, stomach pain, nausea, vomiting or constipation.
Children react more strongly than adults to high doses of Stoperan Junior. If a child has been given too much Stoperan Junior or develops any of the above symptoms, consult a doctor immediately.
Management in case of overdose
If a higher than recommended dose has been taken, seek medical advice immediately.
In case of symptoms of overdose, the doctor may administer naloxone as an antidote. Since the duration of action of Stoperan Junior is longer than that of naloxone (1 to 3 hours), repeated administration of naloxone may be necessary. Therefore, the patient should remain under close medical supervision for at least 48 hours to detect any possible central nervous system depression.
Missed dose of Stoperan Junior
If a dose of Stoperan Junior has been missed, take it as soon as possible, unless a normal bowel movement has occurred.
Never take a double dose to make up for a missed dose. At least a two-hour interval must separate consecutive doses.
Stopping treatment with Stoperan Junior
Stoperan Junior may be discontinued without concern. If Stoperan Junior has been taken on medical advice, follow your doctor's instructions regarding discontinuation of treatment.
If you have any questions about this medicinal product, contact your doctor or pharmacist.

4. Possible adverse effects

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Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following symptoms occur, stop taking Stoperan Junior and consult a doctor.
Adverse effects occurring rarely (may affect fewer than 1 in 1,000 people):

Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock) and anaphylactoid reaction (severe allergic reaction affecting the whole body);
Loss of consciousness, reduced level of consciousness, increased muscle tension, impaired coordination;
Intestinal obstruction, colon dilation, bloating;
Toxic allergic reaction of the skin and mucous membranes with redness, blister formation and skin peeling (bullous eruptions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), facial swelling, urticaria, itching.

Additionally, the following adverse effects may occur:
Adverse effects occurring frequently (may affect fewer than 1 in 10 people):

Headache, dizziness;
Constipation, nausea, bloating.

Adverse effects occurring not frequently (may affect fewer than 1 in 100 people):

Drowsiness;
Abdominal pain, discomfort in the abdominal cavity, dry mouth, epigastric pain, vomiting, dyspepsia;
Rash.

Adverse effects occurring rarely (may affect fewer than 1 in 1,000 people):

Miosis (pupil constriction);
Urinary retention;
Burning sensation of the tongue;
Fatigue.

Adverse effects of unknown frequency (cannot be estimated based on 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).

Reporting of adverse effects
If any adverse effects occur, including any 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 at 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 Junior

No special requirements for storage of the medicinal product.
Keep out of the sight and reach of children.
Do not use after the expiry date stated on the cardboard box and immediate packaging (month/year).
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6. Contents of the pack and other information

What Stoperan Junior contains
The active substance is loperamide hydrochloride (Loperamidi hydrochloridum) 0.2 mg/mL.
Excipients: glycerol; strawberry flavour (containing propylene glycol (E 1520), flavourings); raspberry flavour (containing corn maltodextrin, modified corn starch waxy, flavourings, flavour preparations (including trace amounts of sulphites (as sulphur dioxide (E 220)))); sodium saccharin (E 954); potassium sorbate (E 202); blackcurrant flavour (containing: propylene glycol (E 1520), flavourings, flavour preparations, natural flavourings); citric acid; purified water.

What the medicine looks like and contents of the pack
Clear yellowish solution with a characteristic berry odour.

Available pack sizes:
Orange glass bottle of Type III with a child-resistant HDPE screw cap, with a 5 mL measuring spoon made of PS graduated in 2.5 mL increments, packed in a cardboard box.
1 bottle contains 90 mL of oral solution.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40
50–507 Wrocław
Poland

Manufacturer:
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain

For further information about this medicinal product, please contact:
USP Zdrowie Sp. z o.o., Poleczki 35, 02-822 Warsaw, Poland, tel.: +48 (22) 543 60 00.
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