Stoperan Iunior

Leaflet attached to the packaging: patient information

Stoperan Junior

0.2 mg/mL, oral solution

Loperamide hydrochloride

Read the 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 patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 2 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

1. What is Stoperan Junior and what is it 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 packaging and other information

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

Stoperan Junior is an anti-diarrheal medicine that contains loperamide hydrochloride. It is a substance that has a soothing effect on increased intestinal peristalsis. In this way, the substance in Stoperan Junior counteracts diarrhea. After taking Stoperan Junior, diarrhea usually subsides within a few hours.

Stoperan Junior is used in cases of acute or chronic diarrhea in adults and children over 6 years old. Acute diarrhea occurs suddenly and usually lasts for a week. Chronic diarrhea lasts longer. Stoperan Junior is used to treat the symptoms of diarrhea. It does not cure the cause of diarrhea. When the cause of diarrhea becomes known, it should be treated.

2. Important information before taking Stoperan Junior

When not to take Stoperan Junior:

• If the patient is allergic to loperamide or any other ingredient of this medicine (listed in section 6), symptoms of allergy are, for example, rash, itching, shortness of breath or swelling of the face. If these symptoms occur, the use of Stoperan Junior should be stopped and medical advice should be sought.
• In children under 6 years old.
• If it is suspected that the cause of diarrhea is poisoning, for example, with heavy metals (mercury, lead, or cadmium).
• Stoperan Junior should not be taken in case of acute colonic dilation. This is a severe enlargement of the large intestine; a very serious situation that can occur in patients with Hirschsprung's disease, Crohn's disease, or ulcerative colitis, whose symptoms are: very painful abdominal distension, fever, and accelerated heart rate.

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The patient should consult a doctor if they have any questions about this medicine.

• If there is constipation, resulting in "leakage" of watery stool. This occurs in certain intestinal disorders.
• Stoperan Junior should not be taken in case of persistent, crampy abdominal pain, nausea, vomiting, high fever, and the presence of mucus or blood in the stool. These symptoms may be related to a disease called bacterial dysentery.
• Stoperan Junior should not be taken in case of colitis or enteritis of bacterial origin, caused by infection with bacteria such as Salmonella, Shigella, and Campylobacter.
• Stoperan Junior should not be taken in case of severe colitis (e.g., ulcerative colitis or pseudomembranous colitis caused by taking certain antibiotics).
• Stoperan Junior should not be taken in all cases where normal bowel movements should not be suppressed. Treatment should be stopped immediately if constipation or abdominal distension occurs.

Warnings and precautions

Stoperan Junior acts symptomatically, it does not cure the cause of diarrhea. When the cause becomes known, causal treatment should be initiated, if possible. In case of doubt, a doctor should always be consulted.

In patients with diarrhea, especially in children and the elderly, dehydration and electrolyte deficiency may occur. Symptoms of dehydration may include: dryness of the mouth, dizziness, and (or) vomiting. Therefore, during diarrhea, it is essential to replenish water and mineral salts and ensure proper hydration of the body, which means drinking plenty of water and replenishing sugar and salt. A special mixture of salt and sugar (oral rehydration solution) can be purchased at a pharmacy, which should be dissolved in water. A doctor or pharmacist should be consulted.

In patients with AIDS and being treated with Stoperan Junior for diarrhea, treatment should be stopped immediately if abdominal distension occurs. In such cases, a doctor should be consulted. In patients with AIDS and severe intestinal infection (infectious colitis), who are taking loperamide (the substance found in Stoperan Junior), there have been cases of increased risk of toxic colonic dilation. This is a severe enlargement of the large intestine, whose symptoms include, among others, very painful abdominal distension, fever, and accelerated heart rate.

In case of liver failure, before taking Stoperan Junior, a doctor or pharmacist should be consulted. It may be necessary to monitor the patient's condition. Additionally, to avoid adverse effects on the nervous system, it may be necessary to adjust the dose of the medicine.

Stoperan Junior should not be used for other diseases than those for which it is indicated (see section 1), and not more than the recommended dose should be taken (see section 3). In patients who have taken too much loperamide, the active substance in Stoperan Junior, serious heart problems (symptoms of rapid or irregular heart rhythm) have been reported.

Treatment with Stoperan Junior should be stopped in the following cases:

• If the stool becomes thicker or if there is no bowel movement for 12 hours.
• In acute diarrhea, if diarrhea does not decrease within 48 hours of taking Stoperan Junior, Stoperan Junior should be stopped and a doctor consulted.
• If constipation or abdominal distension occurs, Stoperan Junior should be stopped immediately and a doctor consulted.
• In cases of taking Stoperan Junior for chronic diarrhea, a doctor should be consulted to determine if it is possible to reduce the dose or stop treatment.
• The recommended dosage should be followed. If a higher dose than recommended is taken, it may lead to bowel obstruction. Symptoms of this may include constipation, abdominal distension, and "leakage" of watery stools.

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In case of any questions about this product, a doctor or pharmacist should be consulted.

Children and adolescents

Stoperan Junior is contraindicated in children under 6 years old.

Stoperan Junior and other medicines

A doctor should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take. Some medicinal products cannot be taken at the same time, and sometimes concurrent use requires appropriate adjustment (e.g., dose).

In case of taking the following medicines, a doctor should be consulted before taking Stoperan Junior:

• Medicines with similar pharmacological properties to loperamide, as they may enhance the effect of Stoperan Junior;
• Medicines that accelerate the passage through the digestive system, as they may weaken the effect of Stoperan Junior;
• Ritonavir (a medicine used to treat HIV infection);
• Quinidine (a medicine used to treat heart rhythm disorders);
• Desmopressin taken orally (a medicine used to treat bedwetting);
• Itraconazole or ketoconazole (medicines used to treat fungal infections);
• Gemfibrozil (a medicine used to lower cholesterol levels).

Using Stoperan Junior with food and drink and alcohol

It is recommended to take Stoperan Junior with water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or thinks she may be pregnant, she should consult a doctor or pharmacist before taking this medicine.

Pregnancy

A doctor should be consulted, as it is not recommended to take the medicine in the first trimester of pregnancy, and in the second and third trimesters, the medicine may only be used if, in the doctor's opinion, the expected benefit to the mother outweighs the potential risk to the mother and fetus.

Breastfeeding

The substance that causes the effect of 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 stopped and a doctor consulted.

Driving and using machines

During diarrhea treated with loperamide, fatigue, dizziness, or drowsiness may occur. Therefore, caution should be exercised when driving or operating machines.

Sodium:

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

The medicine contains glycerol.

The medicine may cause headache, gastrointestinal disorders, and diarrhea.

The medicine contains propylene glycol.

The medicine contains 5.8 mg of propylene glycol per mL of solution.

The medicine contains glucose (maltodextrin component).

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

The medicine contains sulfites - sulfur dioxide (E220).

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Stoperan Junior

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Stoperan Junior should be taken orally.

Adults:

Acute diarrhea

Treatment should be started with a dose of 20 mL (4 measures). Then, 10 mL (2 measures) should be taken after each loose bowel movement, as long as diarrhea persists. Never take more than 80 mL (16 measures) in one day.

Chronic diarrhea

On the first day, 20 mL (4 measures) should be taken per day. Then, depending on the severity of the symptoms, the daily dose should be individually adjusted to achieve 1 to 2 bowel movements with a solid consistency per day. Usually, it is sufficient to take 2 mg of loperamide (10 mL of solution = 2 measures) to 12 mg of loperamide (60 mL of solution = 12 measures) per day. Never take more than 80 mL (16 measures) in one day.

Children from 8 to 17 years old:

Acute diarrhea

Treatment should be started with a dose of 10 mL (2 measures). Then, 10 mL (2 measures) should be taken after each loose bowel movement, as long as diarrhea persists.

Chronic diarrhea:

On the first day, 2 mg of loperamide (10 mL of solution = 2 measures) should be taken per day.

Then, depending on the severity of the symptoms, the daily dose should be individually adjusted to achieve 1 to 2 bowel movements with a solid consistency per day. Usually, it is sufficient to take 2 mg of loperamide (10 mL of solution = 2 measures) to 12 mg of loperamide (60 mL of solution = 12 measures) per day.

Children from 6 to 8 years old:

The dose to be given to the child depends on their body weight. The dose is 5 mL (1 measure) per 10 kg of body weight. The following table shows a few examples.

Body weight

15 kg

20 kg

25 kg

30 kg

Single dose of Stoperan Junior

7.5 mL

10 mL

12.5 mL

15 mL

This dose should be taken 2 to 3 times a day.

The dose of Stoperan Junior that a child from 6 to 17 years old can take per daydepends on their body weight. Per 10 kg of body weight, the child should not take more than 15 mL (3 measures) per day. It should be ensured that never more than 80 mL (16 measures) is taken per day. The following table shows a few examples.

Child's body weight

15 kg

20 kg

25 kg

30 kg

35 kg

40 kg

45 kg

50 kg and above

53 kg

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Maximum daily amount of Stoperan Junior

22.5 mL

30 mL

37.5 mL

45 mL

52.5 mL

60 mL

67.5 mL

75 mL

80 mL

Children under 6 years old:

Stoperan Junior should not be used in children under 6 years old.

Elderly patients

There is no need to change the dosage in elderly patients.

Renal impairment

There is no need to change the dosage in patients with renal impairment.

Hepatic impairment

In patients with hepatic impairment, Stoperan Junior should be taken with caution due to reduced metabolism associated with the first-pass effect (see section 2 - "When not to take Stoperan Junior"), and additional caution should be exercised.

Taking a higher dose of Stoperan Junior than recommended

Overdose means taking a higher dose of Stoperan Junior than recommended in this leaflet (see "How to take Stoperan Junior").

In case of overdose, a doctor should be consulted immediately.

The following symptoms may occur: accelerated heart rate, arrhythmia, changes in heart rhythm (these symptoms may be potentially life-threatening), muscle stiffness, uncoordinated movements, drowsiness, urinary retention, shallow breathing, dry mouth, pupil constriction, abdominal pain, nausea, vomiting, or constipation.

Children are more sensitive to high doses of Stoperan Junior than adults. If a child is given too much Stoperan Junior or experiences any of the above symptoms, a doctor should be consulted immediately.

Procedure after overdose

In case of taking a higher dose of the medicine than recommended, a doctor should be consulted immediately.

In case of overdose symptoms, a doctor may recommend the administration of 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 potential central nervous system depression.

Missing a dose of Stoperan Junior

If a dose of Stoperan Junior is missed, it should be taken unless a normal bowel movement has occurred.

A double dose should never be taken to make up for a missed dose. Subsequent doses should be taken at 2-hour intervals.

Stopping Stoperan Junior

Stoperan Junior can be stopped without any concerns.

If Stoperan Junior was taken on a doctor's advice, their recommendations regarding stopping treatment should be followed.

In case of questions about this medicinal product, a doctor or pharmacist should be consulted.

4. Possible side effects

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

If the following symptoms occur, Stoperan Junior should be stopped and a doctor consulted.

Uncommon side effects (may affect less than 1 in 100 people):

• -hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock) and anaphylactoid reaction (severe allergic reaction throughout the body);
• -loss of consciousness, decreased level of consciousness, increased muscle tone, abnormal coordination;
• -intestinal obstruction, colonic dilation, bloating;
• -toxic allergic skin and mucous membrane reaction with redness, blistering, and peeling of the skin (bullous eruptions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme), facial swelling, urticaria, itching.

The following additional symptoms may occur:

Common side effects (may affect less than 1 in 10 people):

• headache, dizziness;
• constipation, nausea, bloating.

Uncommon side effects (may affect less than 1 in 100 people):

• drowsiness;
• abdominal pain, discomfort in the abdominal cavity, dry mouth, epigastric pain, vomiting, indigestion;
• rash.

Rare side effects (may affect less than 1 in 1,000 people):

• -pupil constriction;
• -urinary retention;
• tongue burning sensation;
• -fatigue.

Frequency not known (cannot be estimated from the available data):

• epigastric pain, abdominal pain radiating to the back, abdominal tenderness, fever, accelerated heart rate, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, a doctor or pharmacist should be consulted.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be gathered on the safety of the medicine.

5. How to store Stoperan Junior

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

Store in a place out of sight and reach of children.

Do not use after the expiry date stated on the carton and blister pack (month/year).

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6. Contents of the packaging and other information

What Stoperan Junior contains

The active substance of the medicine is loperamide hydrochloride (Loperamidi hydrochloridum) 0.2 mg/mL.

The excipients are: glycerol; strawberry flavor (contains propylene glycol (E 1520), flavoring substances); raspberry flavor (contains corn maltodextrin, modified cornstarch, flavoring substances, flavor preparations (including trace amounts of sulfites (as sulfur dioxide (E 220)))); sodium saccharin (E 954); potassium sorbate (E 202); blackcurrant flavor (contains: propylene glycol (E 1520), flavoring substances, flavor preparations, natural flavoring substances); citric acid; purified water.

What Stoperan Junior looks like and contents of the pack

A clear yellowish solution with a characteristic odor of berries.

Available packs:

An orange type III glass bottle with an HDPE cap with a child-resistant closure, together with a 5 mL measuring spoon made of PS with a scale every 2.5 mL, in a cardboard box.

1 bottle contains 90 mL of oral solution.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

US Pharmacia Sp. z o.o.

ul. Ziębicka 40

50-507 Wrocław

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain