Package leaflet: Information for the patient

Stoperan FAST
2 mg, orodispersible tablet
Loperamidi hydrochloridum
Before using the medicine, read the entire leaflet carefully, as it contains important
information for the patient.
Stoperan Fast should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
If you experience any side effects listed in section 4 or not mentioned in this leaflet, contact your doctor or pharmacist.
If symptoms do not improve after 2 days, or if the patient feels worse, contact a doctor.

Table of contents

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

1. What Stoperan Fast is and what it is used for
Stoperan Fast is an antidiarrheal medicine containing loperamide hydrochloride. This active substance reduces intestinal peristalsis and significantly prolongs the transit time of intestinal contents, thereby exerting an antidiarrheal effect. Stoperan Fast acts only where needed, i.e. in the intestines. It stops diarrhea, often within a few hours.
Stoperan Fast is an orodispersible tablet, which dissolves on the tongue within a few seconds. The tablet is then automatically swallowed with saliva. The tablet may also be taken without water.
Stoperan Fast is indicated for symptomatic treatment of acute and chronic diarrhea in adults and children aged 6 years and older. Acute diarrhea starts suddenly and usually resolves within a week. Chronic diarrhea persists for a long time. Stoperan Fast helps control diarrhea but does not treat its underlying cause. If the cause of diarrhea is known, it should be treated specifically.

2. When not to use or when to exercise caution with Stoperan Fast
When not to use this medicine

If the patient is allergic to loperamide or any of the ingredients of this medicine (listed in section 6 of this leaflet). Symptoms of allergy may include, for example, rash, itching, shortness of breath, and/or facial swelling. If such symptoms occur, discontinue Stoperan Fast and consult a doctor. In case of doubt, always contact a doctor or pharmacist.
In children under 6 years of age. The tablets must not be used in children under 6 years of age (see "When to exercise caution with Stoperan Fast").
If diarrhea is suspected to be caused by poisoning, e.g. by heavy metals (mercury, lead, or cadmium).
If the patient has megacolon. This is an abnormally dilated colon, a serious condition that may occur in patients with Hirschsprung's disease, Crohn's disease, or ulcerative colitis (colitis ulcerosa), and is characterized by painful abdominal distension, fever, and rapid heartbeat.
If the patient has intestinal obstruction, which may lead to leakage of watery stools. This may occur in certain intestinal disorders.
In cases of persistent cramping abdominal pain, nausea, vomiting, high fever, or presence of mucus or blood in the stool. These symptoms may be associated with bacterial enterocolitis.
If the patient has bacterial infection of the large and/or small intestine caused by bacteria such as Salmonella, Shigella, or Campylobacter.
If the patient has severe intestinal inflammation (e.g. ulcerative colitis or pseudomembranous colitis caused by certain antibiotics).
In all cases where normal bowel movements should not be suppressed. Treatment must be stopped immediately if constipation or abdominal distension occurs.

Warnings and precautions
Stoperan Fast provides symptomatic relief and does not treat the cause of diarrhea. When the cause becomes known, specific treatment should be initiated if possible. In case of doubt, always consult a doctor.
In patients with diarrhea, especially in children and elderly individuals, dehydration and electrolyte imbalance may occur. Symptoms of dehydration may include dry mouth, dizziness, and/or vomiting. Therefore, during diarrhea, it is essential to replenish fluid and mineral losses and maintain adequate hydration by drinking plenty of fluids and replacing sugar and salt. In pharmacies, special mixtures of salt and sugar (oral rehydration solutions) are available, which should be dissolved in water. Consult your doctor or pharmacist for advice.
In patients with AIDS treated with Stoperan Fast for diarrhea, treatment must be stopped immediately if abdominal distension occurs. In such cases, contact a doctor. In patients with AIDS and severe intestinal infection (infectious colitis) taking loperamide (the active substance in Stoperan Fast), there have been cases of increased risk of toxic megacolon. This is a severe dilation of the colon, presenting with symptoms such as severe abdominal distension, fever, and increased heart rate.
In patients with hepatic impairment, consult a doctor or pharmacist before taking Stoperan Fast. Monitoring of the patient's condition may be necessary. Additionally, to avoid nervous system-related adverse effects, dose adjustment may be required.
Do not use Stoperan Fast for conditions other than those for which it is indicated (see section 1), and do not exceed the recommended dose (see section 3). Serious cardiac problems (such as rapid or irregular heartbeat) have been reported in individuals who took excessive doses of loperamide, the active substance in Stoperan Fast.
Treatment with Stoperan Fast must be discontinued in the following cases:

If stools become firmer or if no bowel movement occurs within twelve hours.
In acute diarrhea, if symptoms do not improve within 48 hours of taking Stoperan Fast, discontinue use and consult a doctor.
If constipation or abdominal distension occurs, stop taking Stoperan Fast immediately and consult a doctor.
In cases of chronic diarrhea, consult a doctor regarding the possibility of reducing or discontinuing treatment.
Follow the recommended dosing. Taking a higher than recommended dose may lead to intestinal obstruction. Symptoms may include constipation, abdominal distension, and leakage of watery stools.

Children and adolescents
Orodispersible tablets of Stoperan Fast are contraindicated in children under 6 years of age.
Stoperan Fast and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use. Some medicines should not be used together, and sometimes concomitant use requires dose adjustment. Before using Stoperan Fast, consult a doctor if taking any of the following medicines:

Medicinal products with pharmacological properties similar to loperamide, as they may enhance the effect of Stoperan Fast;
Medicinal products that accelerate gastrointestinal transit, as they may reduce the effect of Stoperan Fast;
Ritonavir (a medicine used in HIV infection);
Quinidine (a medicine used to treat cardiac arrhythmias);
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).

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, plans pregnancy, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Consult a doctor, as use of the medicine is not recommended during the first trimester of pregnancy. In the second and third trimesters, the medicine may be used only if, in the doctor's opinion, the expected benefit to the mother outweighs the potential risk to the mother and fetus.
Breastfeeding
The active substance in Stoperan Fast passes into breast milk in very small amounts. Therefore, Stoperan Fast is not recommended during breastfeeding. However, if the patient decides to use it, she should stop breastfeeding. Consult a doctor if necessary.
Driving and operating machinery
Fatigue, dizziness, or drowsiness may occur during diarrhea treatment with loperamide. Therefore, caution should be exercised when driving or operating machinery.
The medicine contains 1 mg of aspartame (E 951) per tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
The medicine contains glucose (component of maltodextrin).
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking the medicine.

3. How to take Stoperan Fast

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If prescribed by a doctor, follow the doctor's instructions. In case of doubt, contact a doctor or pharmacist.
Dosage:
Adults and children aged 8 to 17 years:
Acute diarrhea: initial dose of 2 tablets (4 mg) for adults or 1 tablet (2 mg) for children, followed by 1 tablet (2 mg) after each loose bowel movement.
Chronic diarrhea: initial dose is 2 tablets (4 mg) per day for adults and 1 tablet (2 mg) per day for children. The daily dose should be adjusted until 1 to 2 normal bowel movements per day are achieved, usually maintained with a dose of 1 to 6 tablets (2 to 12 mg) per day.
The maximum daily dose in acute and chronic diarrhea is 8 tablets (16 mg) for adults.
In children, the dose should be adjusted according to body weight (3 tablets/20 kg), while ensuring that the total daily dose does not exceed 8 tablets.
Children aged 6 to 7 years:
Acute diarrhea: 1 tablet (2 mg) after each loose bowel movement. Do not exceed 3 tablets (6 mg) per day.
Chronic diarrhea: 1 tablet (2 mg) after each loose bowel movement. Do not exceed 2 tablets (4 mg) per day.
Elderly patients:
No dose adjustment is necessary in elderly patients.
Patients with renal impairment
No dose adjustment is required in patients with renal impairment.
Patients with hepatic impairment
Although there are no pharmacokinetic data available for Stoperan Fast in patients with hepatic impairment, the medicine should be used with caution in this patient group due to reduced metabolism related to the first-pass effect in the liver (see section 2).
Place the Stoperan Fast tablet on the tongue, wait for it to dissolve, and swallow with saliva.
The tablet dissolves within a few seconds.
The tablets may be taken without water.
Diarrhea may resolve after a single dose. In such cases, do not continue treatment.
If the effect of Stoperan Fast seems too strong or too weak, consult a doctor.
Taking more than the recommended dose of Stoperan Fast
If a patient takes too high a dose of Stoperan Fast, seek immediate medical advice from a doctor or hospital. Possible symptoms include: rapid heartbeat, irregular heartbeat, changes in heart rhythm (which may have serious, life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, shallow breathing, dry mouth, pinpoint pupils, abdominal pain, nausea, vomiting, and constipation.
Children may react more strongly than adults to high doses of Stoperan Fast. If a child takes too high a dose or develops any of the above symptoms, contact a doctor immediately.
Management in case of overdose
If a higher than recommended dose is taken, seek immediate medical advice.
In case of overdose symptoms, a doctor may administer naloxone as an antidote. Since the duration of action of Stoperan Fast is longer than that of naloxone (1 to 3 hours), repeated administration 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.
Missed dose of Stoperan Fast
If a patient forgets to take a Stoperan Fast tablet, take the next dose as scheduled, provided a normal bowel movement has not occurred. Do not take a double dose to make up for the missed dose. Always ensure at least two hours between doses.
Stopping treatment with Stoperan Fast
Treatment with Stoperan Fast may be stopped at any time. However, if the medicine was prescribed by a doctor, do not discontinue treatment without consulting the doctor, and follow the doctor's instructions.
If you have further questions about the use of this medicine, contact your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will
experience them.
If any of the following symptoms occur, discontinue taking Stoperan FAST and
consult a doctor immediately.
Rare adverse reactions (may affect less 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 tone, 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:
Common adverse reactions (may affect less than 1 in 10 patients):

dizziness,
constipation, nausea, bloating.

Uncommon adverse reactions (may affect less than 1 in 100 patients):

drowsiness,
abdominal pain, discomfort in the abdominal cavity, dry mouth, epigastric pain, vomiting, dyspepsia,
rash.

Rare adverse reactions (may affect less than 1 in 1,000 patients):

miosis (pupil constriction),
urinary retention,
burning sensation of the tongue,
fatigue.

Adverse reactions with unknown frequency (cannot be estimated from available data):

epigastric 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).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of 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 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 FAST

No special storage temperature requirements. Store the medicine in its original packaging to protect from moisture.
Keep out of sight and reach of children.
Do not use after the expiry date stated on the carton and immediate packaging (month/year). The blister is labelled as follows: EXP – expiry date, Lot – batch number.

6. Contents of the packaging and other information

What Stoperan Fast contains
The active substance is loperamide hydrochloride (Loperamidi hydrochloridum) 2 mg.
Excipients: mannitol, pullulan, aspartame (E 951), mint flavour (containing: corn maltodextrin (contains glucose), flavouring substances, modified corn starch (E1450)), sodium hydrogen carbonate, polysorbate 80.

What Stoperan Fast looks like and contents of the pack
White or almost white, round, orally disintegrating lyophilisate with a "T" embossed on one side, approximately 10 mm in diameter.

Available pack sizes:
6 tablets in 1 blister, 10 tablets in 1 blister, 12 tablets (2 x 6) in 2 blisters.
Blister made of PVC/OPA/Aluminium/PVC with peelable lid made of paper/PET/Aluminium or PVC/OPA/Aluminium/OPA/PVC with peelable lid made of paper/PET/Aluminium, in a cardboard box.

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

Importer:
SANTA S.A
Str. Panselelor, no. 25, no. 27 and no. 29
Municipiul Braşov
500419 Judeţ Braşov
Romania

For more detailed information, please contact:
USP Zdrowie Sp. z o.o., Poleczki 35 Street, 02-822 Warsaw, Poland, tel.: +48 (22) 543 60 00