Loperamide Aurovitas

Leaflet accompanying the packaging: patient information

Loperamide Aurovitas, 2 mg, hard capsules

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 directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this 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 Loperamide Aurovitas and what is it used for
• 2. Important information before taking Loperamide Aurovitas
• 3. How to take Loperamide Aurovitas
• 4. Possible side effects
• 5. How to store Loperamide Aurovitas
• 6. Contents of the pack and other information

1. What is Loperamide Aurovitas and what is it used for

The medicine contains loperamide, which helps to stop diarrhea by making the stool more solid and reducing the frequency of bowel movements. This medicine is used to treat sudden, short-term (acute) attacks of diarrhea in adults and adolescents over 12 years of age. The medicine should not be taken for more than 2 days without consulting a doctor.
If after 2 days of taking the medicine the patient does not feel better or feels worse, they should consult a doctor.
If the symptoms persist for more than 2 days, the patient should stop taking the capsules and consult a doctor.

2. Important information before taking Loperamide Aurovitas

When not to take Loperamide Aurovitas

• If the patient is allergic to loperamide or any of the other ingredients of this medicine (listed in section 6). Allergy can be recognized, for example, by the occurrence of skin rash, itching, chest tightness, or swollen face. If such symptoms occur, the patient should stop taking Loperamide Aurovitas and consult a doctor.
• In children under 12 years of age.
• If the patient has colonic dilation (severely enlarged colon), acute colonic dilation (acute toxic colitis with colonic dilation), and intestinal obstruction, a serious condition that may occur in patients with Hirschsprung's disease, Crohn's disease, or ulcerative colitis, due to very 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.
• If the patient has persistent abdominal pain, high temperature, and/or stools containing mucus and/or blood. These symptoms may be caused by food poisoning or infection or

colitis.

• If the patient has bacterial colitis and/or small intestine infection caused by invasive organisms, including 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.

Warnings and precautions

Before taking Loperamide Aurovitas, the patient should discuss it with their doctor or pharmacist.

• Loperamide Aurovitas only stops diarrhea, but does not treat the cause of its occurrence. If possible, the cause of diarrhea should always be treated as well. In case of doubt, the patient should always consult a doctor.
• During diarrhea, the patient loses fluids (becomes dehydrated). Along with the fluid, other important substances are also lost. Symptoms of dehydration may include dry mouth, dizziness, and/or vomiting. The risk of dehydration is particularly high in small children and the elderly. Therefore, the patient should first take care to replenish and retain fluids in the body, which means drinking a lot and replenishing sugar and salt. In a pharmacy or drugstore, a special mixture of salt and sugar (oral rehydration solution) can be obtained, which should be dissolved in water. The patient should ask their doctor or pharmacist for advice.
• If diarrhea lasts longer than 48 hours, the patient should stop taking the capsules and consult a doctor.
• If the patient has liver disease. If there are liver function disorders or the disease persists, Loperamide Aurovitas should only be taken after consulting a doctor, as the breakdown of loperamide may be delayed, and the risk of side effects may be higher.
• If the patient has AIDS and is being treated for diarrhea with Loperamide Aurovitas. The patient should stop taking Loperamide Aurovitas as soon as stomach swelling occurs. In such a case, the patient should contact their doctor. In people with AIDS and severe intestinal infection (infectious colitis), who have taken loperamide (the substance used in Loperamide Aurovitas), a few cases of constipation with increased risk of toxic colitis have been reported. This is a highly enlarged colon, recognizable by very painful abdominal distension, fever, and rapid heartbeat.
• If the patient has liver function disorders. In such a case, the patient should contact their doctor before taking Loperamide Aurovitas. When taking Loperamide Aurovitas, it may be necessary to increase the patient's health monitoring. Additionally, to avoid side effects related to the nervous system, a different dose may be necessary.
• If intestinal obstruction occurs, the patient should stop taking the capsules and consult a doctor. The recommended dose should never be exceeded (see section 3). Serious heart problems (such as rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide.

Loperamide Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription, in particular:

• Ritonavir (used to treat HIV infection).
• Quinidine (used to treat heart rhythm disorders or malaria).
• Desmopressin taken orally (used to treat excessive urination).
• Itraconazole or ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to treat high blood lipid levels). Before taking Loperamide Aurovitas, the patient should consult their doctor if they are taking any of the above-mentioned medicines.

The patient should expect that medicines with a similar mechanism of action to Loperamide Aurovitas may enhance its effect, and medicines that accelerate gastrointestinal passage may weaken its effect,

Loperamide Aurovitas with food and drink

Loperamide Aurovitas can be taken with food and drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Loperamide should be avoided in the first trimester of pregnancy; however, it may be used in the second and third trimesters of pregnancy.

Breastfeeding

This medicine is not recommended if the patient is breastfeeding. Small amounts may pass into breast milk. The patient should consult their doctor about appropriate treatment.

Driving and using machines

This medicine may cause dizziness, fatigue, or drowsiness. The patient may also lose consciousness, feel weak, or be less alert. If such symptoms occur, the patient should not drive or operate machinery.

Loperamide Aurovitas contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Loperamide Aurovitas

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults, elderly, and adolescents over 12 years of age

How to take:

The capsules should be swallowed whole with water.

Dosage and frequency of administration:

After the first loose stool (bowel movement), the patient should take 2 capsules and drink water. After each subsequent loose stool, the patient should take 1 capsule. Sachets containing powder for oral solution, which prevents dehydration of the body (electrolyte solution), are available as a separate product.

Do not give to children under 12 years of age.

• Do not take more than 6 capsules in 24 hours.
• If symptoms persist for more than 48 hours, the patient should stop taking the capsules and consult a doctor.

Lost fluids should be replenished by drinking more fluids than usual.

DO NOT EXCEED THE RECOMMENDED DOSE.

Using a higher dose of Loperamide Aurovitas than recommended

Overdose means that the patient or someone around them has taken more Loperamide Aurovitas than indicated in this leaflet (see the section "How to take Loperamide Aurovitas"). If the patient has taken too much Loperamide Aurovitas, they should immediately contact their doctor or hospital for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms may have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or shallow breathing, dry mouth, pupils may become smaller, abdominal pain, nausea, vomiting, or constipation. Children react more strongly to large amounts of Loperamide Aurovitas than adults. If a child has taken too much medicine or shows any of the above symptoms, the patient should immediately contact their doctor. Information for the doctor in case of overdose: Symptoms of loperamide hydrochloride overdose may also occur after relative overdose due to liver function disorders. Treatment depends on the symptoms of overdose and clinical diagnosis. During medical observation, EKG monitoring should be started to check for QT interval prolongation. If symptoms from the central nervous system occur after overdose, naloxone, an opioid receptor antagonist, can be administered as an antidote. Since loperamide has a longer duration of action than naloxone, it may be necessary to repeat the administration of naloxone. Therefore, the patient should be closely monitored for at least 48 hours to diagnose possible overdose symptoms.

If the patient forgets to take Loperamide Aurovitas

This medicine should only be taken as directed in the dosage instructions. If the patient forgets to take the medicine, they should take the dose after the next loose stool (bowel movement). The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects get serious or if the patient notices any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Serious side effects

In case of any of the following, the patient should stop taking the medicine and seek medical help immediately:

The patient should seek medical help immediately.

Rare: may affect up to 1 in 1,000 people

• Allergic reactions, including anaphylactic shock, unexplained wheezing, shortness of breath, swelling of the face and throat.
• Loss of consciousness or decreased level of consciousness (feeling weak or reduced alertness), increased muscle tone, abnormal coordination.
• Intestinal obstruction, colonic dilation, abdominal distension.
• Toxic allergic reaction of the skin and mucous membranes with redness, blistering, and peeling of the skin (bullous eruptions, including Stevens-Johnson syndrome, Lyell's syndrome, and erythema multiforme), facial swelling, urticaria, itching.
• Skin rash, which may be severe and include blistering and peeling of the skin.
• Colonic dilation (colonic dilation).
• Constipation (intestinal obstruction).

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

Abdominal pain radiating to the back, tender abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of pancreatitis (acute pancreatitis).

Other side effects

If any of the following occur, the patient should stop taking the medicine and consult their doctor:

Common: may affect up to 1 in 10 people

• Headache, dizziness
• Nausea (nausea), constipation, bloating (gas).

Uncommon: may affect up to 1 in 100 people

• Fatigue, drowsiness
• Abdominal pain, discomfort in the abdominal cavity, upper abdominal pain, vomiting, indigestion, and heartburn, dry mouth.

Rare: may affect up to 1 in 1,000 people

• Pupil constriction
• Difficulty urinating
• Fatigue.

Reporting suspected side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Loperamide Aurovitas

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Store in a temperature below 30°C. Store in the original package to protect from moisture. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Loperamide Aurovitas contains

• The active substance is loperamide hydrochloride. Each hard capsule contains 2 mg of loperamide hydrochloride.
• The other ingredients are: capsule contents:lactose monohydrate, corn starch, talc, magnesium stearate.

Capsule shell:titanium dioxide (E 171), gelatin. Ink:shellac, iron oxide black (E 172).

What Loperamide Aurovitas looks like and what the pack contains

Hard capsule. White, opaque cap/white opaque body, hard gelatin capsule size '4', with "2" printed on the cap and "L" printed on the body in black ink, filled with white or off-white powder. Loperamide Aurovitas hard capsules are available in PVC/Aluminum blisters and HDPE bottles, placed in a cardboard box.

Pack sizes:

Blister: 6, 10, 12, and 20 hard capsules. HDPE bottle: 30, 60, 200, 250, and 500 (packs of 250 and 500 are intended for hospital use or dose dispensing) hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd HF26 Hal Far Industrial Estate, Hal Far Birzebbugia BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus, n. 19, Venda Nova 2700-487 Amadora Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Loperamide AB 2 mg hard capsules Germany: Loperamid PUREN akut 2 mg Hartkapseln Netherlands: Loperamide HCL Sanias 2 mg, hard capsules Poland: Loperamide Aurovitas

Date of last revision of the leaflet:

01/2025