STOPERAN 2 mg Lyophilisate

Contents of the leaflet

1. What is Stoperan Fast and what is it used for
2. When not to use this medicine or when to exercise special caution
   1. When not to use this medicine
   2. Warnings and precautions
   3. Children and adolescents
   4. Stoperan Fast and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
3. How to use Stoperan Fast
   1. Diarrhea may disappear after one dose. In this case, do not continue taking the medicine.
   2. Taking a higher dose of Stoperan Fast than recommended
   3. Procedure after overdose
   4. Missing a dose of Stoperan Fast
   5. Stopping Stoperan Fast
4. Possible side effects
   1. Like all medicines, this medicine can cause side effects, although not everybody gets them.
   2. Side effects of unknown frequency
   3. Reporting side effects
5. How to store Stoperan Fast
6. Contents of the packaging and other information
   1. What Stoperan Fast contains
   2. What Stoperan Fast looks like and what the packaging contains
   3. Packaging available:
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder:
   6. Manufacturer:

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

Stoperan Fast is an anti-diarrheal medicine, containing loperamide hydrochloride. It is a substance that reduces intestinal peristalsis and significantly prolongs the passage of food through the intestines, acting in this way against diarrhea. Stoperan Fast acts only where it is needed, i.e. in the intestines. It usually stops diarrhea within a few hours.
Stoperan Fast is a tablet with an oral lyophilisate, meaning it dissolves on the tongue within a few seconds. The tablet is then automatically swallowed with saliva. The tablet can also be taken without drinking.
Stoperan Fast is indicated for the symptomatic treatment of acute and chronic diarrhea in adults and children over 6 years old. Acutediarrhea starts suddenly and usually disappears within a week. Chronicdiarrhea persists for a long time. Stoperan Fast is used to stop diarrhea, but it does not treat its cause. If the cause of diarrhea is known, it should be treated.

2. When not to use this medicine or when to exercise special caution

When not to use this medicine

• If the patient is allergic to loperamideor any component of this medicine (listed in section 6 of this leaflet). Symptoms of an allergy are, for example, rash, itching, shortness of breath, and (or) swelling of the face. If such symptoms occur, stop taking Stoperan Fast and consult a doctor. In case of doubt, always consult a doctor or pharmacist.
• In children under 6 years of age. Tablets should not be used in children under 6 years of age (see "When to exercise special caution when using Stoperan Fast").
• If it is suspected that the cause of diarrhea may be poisoning, for example, with heavy metals (mercury, lead, or cadmium).
• If the patient has colonic dilation (megacolon). This is an abnormally enlarged large intestine, a very serious condition that can occur in patients with Hirschsprung's disease, Crohn's disease, or ulcerative colitis (colitis ulcerosa), whose symptoms are: painful abdominal distension, fever, and rapid heartbeat.

Disease or ulcerative colitis (colitis ulcerosa), whose symptoms are: painful abdominal distension, fever, and rapid heartbeat.

• If the patient has intestinal obstruction, which causes "leakage" of watery stools. This occurs in some intestinal disorders.
• 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.
• If the patient has bacterial colitisand/or enteritis caused by bacteria such as Salmonella, Shigella, and Campylobacter.
• If the patient has severe colitis(e.g., ulcerative colitis or pseudomembranous colitis caused by the use of certain antibiotics).
• In all cases where normal bowel movements should not be suppressed. Administration should be stopped immediately in case of constipation or abdominal distension.

Warnings and precautions

Stoperan Fast acts symptomatically, it does not treat the cause of diarrhea. When the cause becomes known, causal treatment should be initiated, if possible. In case of doubt, always consult a doctor.
In patients with diarrhea, especially in children and the elderly, dehydration and electrolyte deficiency may occur. Symptoms of dehydration may be: dryness in the mouth, dizziness, and (or) vomiting. Therefore, during diarrhea, first, water and mineral salt deficiencies should be supplemented, and proper hydration of the body should be ensured, which means drinking a lot and supplementing sugar and salt. In a pharmacy, you can buy a special mixture of salt and sugar (oral rehydration solution), which should be dissolved in water. Consult a doctor or pharmacist.
In patients with AIDS and being treated with Stoperan Fast for diarrhea, treatment should be stopped immediately in case of abdominal distension. In such a case, consult a doctor. In patients with AIDS and severe intestinal infection (infectious colitis) who take loperamide (a substance also found in Stoperan Fast), there have been cases of increased risk of toxic colonic dilation. This is a strong enlargement of the large intestine, whose symptoms include, among others, a very painfully distended abdomen, fever, and rapid heartbeat.
In case of liver failure, before taking Stoperan Fast, consult a doctor or pharmacist. It may be necessary to monitor the patient's health. Additionally, to avoid adverse reactions related to the nervous system, it may be necessary to adjust the dose of the medicine.
Stoperan Fast should not be used for other diseases than those for which it is indicated (see section 1), do not take a higher dose than recommended (see section 3). In patients who have taken too much loperamide, the active substance in Stoperan Fast, serious heart problems (symptoms of rapid or irregular heartbeat) have been reported.
Treatment with Stoperan Fast should be stopped in the following cases:

• If the stool becomes thicker or if there is no bowel movement for twelve hours.
• In acute diarrhea, if diarrhea does not decrease within 48 hours of taking Stoperan Fast, stop taking Stoperan Fast and consult a doctor.
• If constipation or abdominal distension occurs, stop taking Stoperan Fast immediately and consult a doctor.
• In cases of taking Stoperan Fast for chronic diarrhea, consult a doctor if it is possible to reduce the dose or stop treatment.
• Follow the recommended dosage. If a higher dose than recommended is taken, it may lead to intestinal blockage. Symptoms of this may be constipation, abdominal distension, and "leakage" of watery stools.

Children and adolescents

Stoperan Fast lyophilisate tablets are contraindicated in children under 6 years of age.

Stoperan Fast and other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as medicines you plan to take. Some medical products cannot be used at the same time, and sometimes concurrent use requires appropriate adjustment (e.g., dose).
In the case of using the following medicines, consult a doctor before using Stoperan Fast:

• medicinal products with similar pharmacological properties to loperamide, as they may enhance the effect of Stoperan Fast;
• medicinal products that accelerate the passage through the gastrointestinal tract, as they may weaken the effect of Stoperan Fast;
• ritonavir (a medicine used in 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).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult a doctor or pharmacist before using this medicine.
Pregnancy
Consult a doctor, as it is not recommended to take the medicine during the first trimester of pregnancy, and in the second and third trimesters, the medicine may be used only in cases where the expected benefit to the mother outweighs the potential risk to the mother and fetus.
Breastfeeding
The substance that causes the effect of Stoperan Fast passes into breast milk in very small amounts. Therefore, Stoperan Fast is not recommended if you are breastfeeding. If you decide to use it, you should stop breastfeeding. If necessary, consult a doctor.

Driving and using machines

During diarrhea treated with loperamide, the following may occur: fatigue, dizziness, or drowsiness.
Therefore, be careful when driving or operating machines.
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. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
The medicine contains glucose (a component of maltodextrin).
If you have previously been diagnosed with intolerance to some sugars, consult a doctor before taking the medicine.

3. How to use Stoperan Fast

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. When using Stoperan Fast on a doctor's prescription, follow their instructions. In case of doubt, consult a doctor or pharmacist.
Dosage:
Adults and children from 8 to 17 years old:
Acute diarrhea: initial dose 2 tablets (4 mg) for adults, or 1 tablet (2 mg) for children, and then 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 modified until 1 to 2 normal bowel movements per day are achieved, which is usually achieved by taking a maintenance dose of 1 to 6 tablets (2 mg to 12 mg) per day.
The maximum dose in acute and chronic diarrhea is 8 tablets (16 mg) per day for adults.
In children, the dose of the medicine should be adjusted according to body weight (3 tablets/20 kg body weight), while remembering that the total daily dose should not be higher than 8 tablets.
Children from 6 to 7 years old:
Acute diarrhea: 1 tablet (2 mg) after each loose bowel movement. Do not take a dose higher than 3 tablets (6 mg) per day.
Chronic diarrhea: 1 tablet (2 mg) after each loose bowel movement. Do not take a dose higher than 2 tablets (4 mg) per day.
Elderly:
No dose adjustment is necessary in the elderly.
Patients with renal impairment
No dose adjustment is necessary in patients with renal impairment.
Patients with hepatic impairment
Although there is a lack of data on the pharmacokinetics of Stoperan Fast in patients with hepatic impairment, in this group of patients, the medicine should be used with caution due to reduced metabolism associated with the first-pass effect through the liver (see section 2).
Place the Stoperan Fast tablet on the tongue, wait until it dissolves, and swallow it with saliva.
The minimum disintegration time of the tablet is a few seconds.
Tablets can be taken without drinking.

Diarrhea may disappear after one dose. In this case, do not continue taking the medicine.

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

Taking a higher dose of Stoperan Fast than recommended

If you have taken too much Stoperan Fast, immediately consult a doctor or hospital. The following symptoms may occur: rapid heartbeat, irregular heartbeat, changes in heartbeat (these symptoms can have serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, and shallow breathing, dryness in the mouth, narrowing of the pupils, abdominal pain, nausea, vomiting, and constipation.
In children, the reaction to taking large amounts of Stoperan Fast is stronger than in adults. If a child takes too much Stoperan Fast or experiences any of the above symptoms, immediately consult a doctor.

Procedure after overdose

In case of taking a higher dose of the medicine than recommended, immediately consult a doctor.
In case of overdose symptoms, as an antidote, the doctor may recommend the administration of naloxone. Since the duration of action of Stoperan Fast is longer than that of naloxone (1 to 3 hours), it may be necessary to repeat the administration of naloxone. Therefore, the patient should remain under close medical supervision for at least 48 hours to detect any possible inhibition of the central nervous system.

Missing a dose of Stoperan Fast

If you forget to take Stoperan Fast, take the next dose, provided that there has been no normal bowel movement. Do not take a double dose to make up for the missed dose. Remember to leave at least two hours between taking individual doses.

Stopping Stoperan Fast

Taking Stoperan Fast can be stopped at any time. If you are taking Stoperan Fast on a doctor's prescription, do not stop treatment on your own without consulting a doctor, but follow their instructions.
If you have any further questions about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

In case of the following symptoms, stop taking Stoperan Fast and consult a doctor.
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, impaired 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 complaints may also occur:
Common side effects(may affect less than 1 in 10 patients):

• dizziness,
• constipation, nausea, bloating.

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

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

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

• pupil constriction,
• urinary retention,
• tongue burning sensation,
• fatigue.

Side effects of unknown frequency

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, consult a doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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, you can help provide more information on the safety of this medicine.

5. How to store Stoperan Fast

There are no special recommendations for storage temperature. Store the medicine in its original packaging to protect it from moisture.
Store in a place out of sight and reach of children.
Do not use after the expiry date stated on the carton and blister packaging (month/year). The applied labeling for the blister is: EXP - expiry date, Lot - batch number.

6. Contents of the packaging and other information

What Stoperan Fast contains

The active substance of the medicine is loperamide hydrochloride (Loperamidi hydrochloridum) 2 mg.
The excipients are: mannitol, pullulan, aspartame (E 951), peppermint flavor (containing: corn maltodextrin (contains glucose), flavoring substances, modified corn starch (E1450)), sodium bicarbonate, polysorbate 80.

What Stoperan Fast looks like and what the packaging contains

White or almost white, round, oral lyophilisate with "T" embossed on one side, approximately 10 mm in diameter.

Packaging available:

6 tablets in 1 blister pack, 10 tablets in 1 blister pack, 12 tablets (2 x 6) in 2 blister packs.
Blister pack made of PVC/OPA/Aluminum/PVC film with a tear-off lid made of paper/PET/Aluminum or PVC/OPA/Aluminum/OPA/PVC film with a tear-off lid made of paper/PET/Aluminum, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o.,
ul. Ziębicka 40,
50-507 Wrocław

Manufacturer:

SANTA S.A
Str. Panselelor, nr. 25, nr. 27 și nr. 29
Municipiul Braşov
500419 Judeţ Braşov
Romania
To obtain more detailed information, contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, tel.: +48 (22) 543 60 00
Date of last update of the leaflet: